Effectiveness of Family Integrated Care in neonatal intensive care units on infant and parent outcomes: a multicentre, multinational, cluster-randomised controlled trial

FICare Study Group and FICare Parent Advisory Board

doi:10.1016/S2352-4642(18)30039-7

Effectiveness of Family Integrated Care in neonatal intensive care units on infant and parent outcomes: a multicentre, multinational, cluster-randomised controlled trial

FICare Study Group and FICare Parent Advisory Board

Nursing

Research output: Contribution to journal › Article › peer-review

359 Citations (Scopus)

Abstract

Background: Despite evidence suggesting that parent involvement was beneficial for infant and parent outcomes, the Family Integrated Care (FICare) programme was one of the first pragmatic approaches to enable parents to become primary caregivers in the neonatal intensive care unit (NICU). We aimed to analyse the effect of FICare on infant and parent outcomes, safety, and resource use. Methods: In this multicentre, cluster-randomised controlled trial, we stratified 26 tertiary NICUs from Canada, Australia, and New Zealand by country and size, and assigned them, using a computer-generated random allocation sequence, to provide FICare or standard NICU care. Eligible infants were born at 33 weeks' gestation or earlier, and had no or low-level respiratory support; parents gave written informed consent for enrolment. To be eligible, parents in the FICare group had to commit to be present for at least 6 h a day, attend educational sessions, and actively care for their infant. The primary outcome, analysed at the individual level, was infant weight gain at day 21 after enrolment. Secondary outcomes were weight gain velocity, high frequency breastfeeding (≥6 times a day) at hospital discharge, parental stress and anxiety at enrolment and day 21, NICU mortality and major neonatal morbidities, safety, and resource use (including duration of oxygen therapy and hospital stay). This trial is registered with ClinicalTrials.gov, number NCT01852695. Findings: From Oct 1, 2012, 26 sites were randomly assigned to provide FICare (n=14) or standard care (n=12). One site assigned to FICare discontinued because of poor site enrolment. Parents and infants were enrolled between April 1, 2013, and Aug 31, 2015, with 895 infants being eligible in the FICare group and 891 in the standard care group. At day 21, weight gain was greater in the FICare group than in the standard care group (mean change in Z scores 1·58 [SD 0·51] vs 1·45 [0·49]; p<0·0001). Average daily weight gain was significantly higher in infants receiving FICare than those receiving standard care (mean daily weight gain 26·7 g [SD 9·4] vs 24·8 g [9·5]; p<0·0001). The high-frequency exclusive breastmilk feeding rate at discharge was higher for infants in the FICare group (279 [70%] of 396) than those in the standard care group (394 [63%] of 624; p=0·016). At day 21, parents in the FICare group had lower mean stress scores than did parents in the standard care group (2·3 [SD 0·8] vs 2·5 [0·8]; p<0·00043), and lower mean anxiety scores (70·8 [20·1] vs 74·2 [19·9]; p=0·0045). There were no significant differences between groups in the rates of the secondary outcomes of mortality, major morbidity, duration of oxygen therapy, and duration of hospital stay. Although the safety assessment was not completed, there were no adverse events. Interpretation: FICare improved infant weight gain, decreased parent stress and anxiety, and increased high-frequency exclusive breastmilk feeding at discharge, which together suggest that FICare is an important advancement in neonatal care. Further research is required to examine if these results translate into better long-term outcomes for families. Funding: Canadian Institutes of Health Research Partnerships for Health System Improvement, and Ontario Ministry of Health and Long-Term Care.

Original language	English
Pages (from-to)	245-254
Number of pages	10
Journal	The Lancet Child and Adolescent Health
Volume	2
Issue number	4
DOIs	https://doi.org/10.1016/S2352-4642(18)30039-7
Publication status	Published - Apr 2018

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10.1016/S2352-4642(18)30039-7

Cite this

@article{2ae0557aba9b4438ae0eef52487ff2d7,

title = "Effectiveness of Family Integrated Care in neonatal intensive care units on infant and parent outcomes: a multicentre, multinational, cluster-randomised controlled trial",

abstract = "Background: Despite evidence suggesting that parent involvement was beneficial for infant and parent outcomes, the Family Integrated Care (FICare) programme was one of the first pragmatic approaches to enable parents to become primary caregivers in the neonatal intensive care unit (NICU). We aimed to analyse the effect of FICare on infant and parent outcomes, safety, and resource use. Methods: In this multicentre, cluster-randomised controlled trial, we stratified 26 tertiary NICUs from Canada, Australia, and New Zealand by country and size, and assigned them, using a computer-generated random allocation sequence, to provide FICare or standard NICU care. Eligible infants were born at 33 weeks' gestation or earlier, and had no or low-level respiratory support; parents gave written informed consent for enrolment. To be eligible, parents in the FICare group had to commit to be present for at least 6 h a day, attend educational sessions, and actively care for their infant. The primary outcome, analysed at the individual level, was infant weight gain at day 21 after enrolment. Secondary outcomes were weight gain velocity, high frequency breastfeeding (≥6 times a day) at hospital discharge, parental stress and anxiety at enrolment and day 21, NICU mortality and major neonatal morbidities, safety, and resource use (including duration of oxygen therapy and hospital stay). This trial is registered with ClinicalTrials.gov, number NCT01852695. Findings: From Oct 1, 2012, 26 sites were randomly assigned to provide FICare (n=14) or standard care (n=12). One site assigned to FICare discontinued because of poor site enrolment. Parents and infants were enrolled between April 1, 2013, and Aug 31, 2015, with 895 infants being eligible in the FICare group and 891 in the standard care group. At day 21, weight gain was greater in the FICare group than in the standard care group (mean change in Z scores 1·58 [SD 0·51] vs 1·45 [0·49]; p<0·0001). Average daily weight gain was significantly higher in infants receiving FICare than those receiving standard care (mean daily weight gain 26·7 g [SD 9·4] vs 24·8 g [9·5]; p<0·0001). The high-frequency exclusive breastmilk feeding rate at discharge was higher for infants in the FICare group (279 [70%] of 396) than those in the standard care group (394 [63%] of 624; p=0·016). At day 21, parents in the FICare group had lower mean stress scores than did parents in the standard care group (2·3 [SD 0·8] vs 2·5 [0·8]; p<0·00043), and lower mean anxiety scores (70·8 [20·1] vs 74·2 [19·9]; p=0·0045). There were no significant differences between groups in the rates of the secondary outcomes of mortality, major morbidity, duration of oxygen therapy, and duration of hospital stay. Although the safety assessment was not completed, there were no adverse events. Interpretation: FICare improved infant weight gain, decreased parent stress and anxiety, and increased high-frequency exclusive breastmilk feeding at discharge, which together suggest that FICare is an important advancement in neonatal care. Further research is required to examine if these results translate into better long-term outcomes for families. Funding: Canadian Institutes of Health Research Partnerships for Health System Improvement, and Ontario Ministry of Health and Long-Term Care.",

author = "{FICare Study Group and FICare Parent Advisory Board} and Karel O'Brien and Kate Robson and Marianne Bracht and Melinda Cruz and Kei Lui and Ruben Alvaro and {da Silva}, Orlando and Luis Monterrosa and Michael Narvey and Eugene Ng and Amuchou Soraisham and Ye, {Xiang Y.} and Lucia Mirea and William Tarnow-Mordi and Lee, {Shoo K.} and Karel O'Brien and Shoo Lee and Marianne Bracht and Georges Caouette and Eugene Ng and Douglas McMillan and Linh Ly and Kimberly Dow and Richard Taylor and Luis Monterrosa and Roderick Canning and Koravangattu Sankaran and William Bingham and Amuchou Soraisham and {el Helos}, Salhab and Ruben Alvaro and Michael Narvey and {da Silva}, Orlando and Horacio Osiovich and Julie Emberley and Celine Catelin and {St. Aubin}, Lucia and Tammy Warkentin and Zarin Kalapesi and Jaya Bodani and Kei Lui and Guan Kho and Zsuzsoka Kecskes and Jacqueline Stack and Peter Schmidt and Mary Paradisis and Roland Broadbent and Clare Raiman and Charlene Wong and Michele Cabot and Maryse L'Herault and Gignac, {Marie Andree} and Marquis, {Marie Helene} and Mylene Leblanc and Cathy Travell and Marlene Furlong and {Van Bergen}, Annette and Maryanne Ottenhof and Heather Keron and Clare Bowley and Shannon Cross and Gillian Kozinka and Valerie Cobham-Richards and Kelly Northrup and Cindy Gilbert-Rogers and Pat Pidgeon and Kim McDuff and Norma Leger and Cindy Thiel and Shannon Willard and Evelyn Ma and Linda Kostecky and David Pogorzelski and Sherin Jacob and Kim Kwiatkowski and Valerie Cook and Naomi Granke and Nicola Geoghegan-Morphet and Hannah Bowell and Jennifer Claydon and Nicole Tucker and Thomas Lemaitre and Myriam Doyon and Candace Ryan and Joanne Sheils and Elizabeth Sibbons and Feary, {Anne Marie} and Ian Callander and Robyn Richard and Jennifer Orbeso and Margaret Broom and Alexis Fox and Jan Seuseu and Jack Hourigan and Cynthia Schaeffer and Ginette Mantha and Melanie Lataigne and Kate Robson and Leah Whitehead and Natasha Skinner and Rita Visconti and Deedee Crosland and Kate Griffin and Brandon Griffin and Lisa Collins and Kirsten Meyer and Ian Silver and Britt Burnham and Rachel Freeman and Kristi Muralt and Cara Ramsay and Pawulina McGrath and Michelle Munroe and Denise Hales",

note = "Funding Information: In this study, FICare resulted in improved weight gain among infants in the NICU and improved mental wellbeing among parents. Given that growth is an important independent determinant of neurodevelopmental outcomes in preterm infants, the increased weight gain and enhanced high-frequency breastmilk feeding in the FICare group are important improvements in preterm care that might have long-term benefits for infant health. 26,27 Furthermore, the improved psychological wellbeing of parents in the FICare group could translate into better long-term mental health for the infant's parents, improved parent–infant bonding, and enhanced outcomes for the infant. 28,29 Family-centred care is a philosophy that uses principles to guide the provision of care, ultimately focusing on building partnerships between patients, their families, and health-care providers to facilitate shared decision making. FICare draws on all elements of family-centred care, but advances it further by enabling parents to become their infant's primary caregiver and to actively participate in their care. 8,13,14 Parent involvement in infant care creates a more consistent care environment for the infant, which could help protect the infant from trauma associated with the NICU, such as isolation, stress, and lack of support during painful procedures, while also providing a mechanism for parents to build the confidence and skills required to better support their infant after discharge. Unlike other family-centred interventions, FICare combines a care-by-parent model with specific interventions to educate, support, and engage parents at their infants' bedside. 13 Furthermore, FICare aims to facilitate parent involvement by engaging staff and providing both education and support for the nurses and health-care team, which enables the staff to better educate and include parents as partners in their infants' care. The observed outcomes of this study cannot be attributed to one or the other of these FICare components, but rather to the programme as a whole. Other studies have reported that individual elements of FICare might have specific benefits for infants and their families, but they do not assess all of the elements together. 7,10 Our work with families during the development of FICare suggested that the care-by-parent model needed to be multidimensional, with interdependent components that ensure its success. For example, providing a parent education programme without facilitating parent engagement in infant care would lessen the influence of the education programme. Similarly, encouraging parents to care for their infants without providing nurses with the knowledge and skillset to support parents as partners could create conflict at the bedside. By implementing and supporting a culture change within the entire NICU, FICare can help maximise the effect of family-integrated care on the health of the whole family and on staff, who might experience less conflict with parents and greater job satisfaction as a result. Findings from our study indicate that FICare significantly improves two outcomes important for minimising morbidity in preterm infants: infant weight gain and parental stress and anxiety. Both outcomes are important variables associated with positive neurodevelopmental outcomes. First, infants whose families participated in FICare had a small, but significant, improvement in Z score and weight gain. Although the absolute difference in weight gain was small, it compares favourably with the reported effects of specific feeding interventions 30 and also indicates that FICare has the potential to positively affect the physical development of preterm infants. FICare did not aim to change the feeding patterns of infants, but rather to engage parents as caregivers, enabling them to provide more skin-to-skin and developmentally responsive care, as well as empowering them to be active participants in decisions about feeding. Second, parents' responsiveness to their infant is an important determinant of positive neurodevelopmental outcomes; therefore, the reduction of parent stress and anxiety in the FICare group is important for improving both parents' connection with their infant, long-term health outcomes for the entire family, and developmental outcomes of the infants. 10,29 The significant difference in the PSS:NICU scores between the FICare and standard care groups after the intervention is similar in magnitude to that reported by Melnyk and colleagues. 10 Finally, previous reports 27,30 indicated that breastmilk feeding improves neurodevelopmental outcomes, underscoring the importance of the results in our study that suggest that the rate of high-frequency breastmilk feeding at discharge home is increased in the infants receiving FICare. Being able to provide at least six feeds per day of breastmilk is a good indicator of maternal breastmilk supply and is therefore an indicator of long-term breastfeeding success. To date, most care-by-parent programmes have been studied in lower acuity hospitals. 4 FICare was designed specifically to support parents as primary caregivers for their infant in tertiary care NICUs, and our findings suggest that FICare can be implemented in such units. Ongoing pre-implementation and post-implementation studies of how FICare might be applied in lower acuity units will provide the much needed evidence to establish the feasibility of FICare in these contexts. The intervention requires that staff communicate effectively with parents, despite language differences, and that education is provided to diverse populations, which are all parts of best neonatal care practices. Our study might be generalisable to units in high-income countries with similar organisation of perinatal health services, but further study is required to assess the practicality of implementing FICare in low-income and middle-income countries. Expansion of the FICare programme will require input from both parents and staff, particularly nurses. In our pilot study, we investigated the attitudes of nurses and parents towards FICare as well as their acceptance of the FICare model, and received mostly positive feedback, although there were also suggestions for improvement. 8 The attitudes of staff and parents will need to be assessed on a larger scale to determine how to effectively promote the expansion of FICare to other types of units. FICare challenges the current philosophy of neonatal intensive care with three fundamental aims—parent engagement, parent empowerment, and shifting the focus of care to the family. Traditionally, medical professionals have provided care for preterm infants, but actively including parents as integral members in the care team might be a preferable strategy for future neonatal care. 13 Our findings suggest that how care is provided to the family, not just the infant, has a positive effect on the wellbeing of both infant and family. Cluster-randomised controlled trials are more prone to bias than are individual patient randomised controlled trials because of variations in practice, unbalanced patient populations, and staff cultures that are not captured or measured during the study. For example, our study had a random imbalance in infants younger than 29 weeks' gestation (there were more in the FICare group) and singletons (more in standard care group). To address possible confounding factors in neonatal practice, we stratified sites by country and size before they were randomly assigned. We were unable to control for nutritional policies or resource use. Specific to this study, FICare parents were asked to make a very different commitment than were standard care parents, resulting in the possibility that more committed parents enrolled in FICare; the proportion of families who participated at FICare sites (30%) was different than at the standard care sites (44%). However, our sensitivity analysis, which included family demographic data as well as the infant data, showed that the intervention effects remained significant, regardless of the family demographics. One last potential source of bias from the study design is that over the duration of the study, some standard care sites could have adopted local family-oriented practices that were not recorded and might have biased the results towards a less detectable difference. Our study had other limitations that were independent of the study design. First, we have less information about the status of infants in the FICare group on discharge home than about infants in the standard care group. The increased rate of transfer of infants from FICare sites to level 2 NICUs before discharge home was not something that we anticipated when assigning sites. These missing data might have resulted in a type I error, which limits our conclusions about the success of breastfeeding in this population. Furthermore, we did not report the difference in weight gain at 36 weeks and at discharge home between infants in both groups because many of the data were missing. Second, some secondary outcomes (eg, intraventricular haemorrhage, nosocomial infection, or bronchopulmonary dysplasia) either occur before trial enrolment or are predetermined at the time at enrolment. We decided to include these secondary outcomes in our study despite the ir early occurrence because they are neonatal outcomes that are important indicators of the infant's health. Finally, many infants included in the intention-to-treat analysis were transferred before receiving 3 weeks of the FICare intervention, thus resulting in fewer measurements at later timepoints. In conclusion, both infants and parents enrolled in FICare showed improved outcomes. Further research on the barriers to implementing and sustaining this model of care in NICUs and other hospital settings, and the effect of FICare on long-term neurodevelopment, is warranted. Contributors KO'B did the literature review. SKL, KO'B, KR, MB, KL, RA, OdS, LMo, MN, EN, AS, XYY, LMi, and WT-M were involved in the design of the study. SKL, KO'B, MC, KL, RA, OdS, LMo, MN, EN, AS, and WT-M were involved in acquisition of data. SKL, KO'B, KR, MB, MC, KL, RA, OdS, LMo, MN, EN, AS, LMi, and WT-M were involved in interpretation of the analysis. KO'B drafted the paper. XYY did the statistical analyses and prepared the figures. SKL, KO'B, KR, MB, MC, KL, RA, OdS, LMo, MN, EN, AS, XYY, LMi, and WT-M approved the paper. Declaration of interests KO'B and SKL report grants from the Canadian Insitute of Health Research and Ontario Ministry of Health and Long-Term Care during the study. All other authors declare no competing interests. Acknowledgments This trial was funded by grants from the Canadian Institutes of Health Research Partnerships for Health System Improvement (CIHR-PHSI; #PHE122173) and CIHR Team (#CTP87518), and additional partner funding from the Ontario Ministry of Health and Long-Term Care (grant #06465). We would like to thank the Mount Sinai FICare Steering Committee for their tireless efforts in developing and implementing the pilot FICare programme, as well as the site investigators, neonatal intensive care unit (NICU) educators, NICU staff, veteran parents, and study coordinators across Canada, Australia, and New Zealand for their dedication to this trial. We would also like to thank the current and former members of the Maternal-Infant Care Research Centre (MiCare)—Sarah Hutchinson, Natasha Musrap, Charlene Wong, and Sonny Yeh—for editorial assistance, organisational support, coordination, and data management. MiCare is supported by a team grant from the CIHR (FRN87518) and in-kind support from Mount Sinai Hospital. Publisher Copyright: {\textcopyright} 2018 Elsevier Ltd",

year = "2018",

month = apr,

doi = "10.1016/S2352-4642(18)30039-7",

language = "English",

volume = "2",

pages = "245--254",

journal = "The Lancet Child and Adolescent Health",

issn = "2352-4642",

publisher = "Elsevier",

number = "4",

}

Effectiveness of Family Integrated Care in neonatal intensive care units on infant and parent outcomes: a multicentre, multinational, cluster-randomised controlled trial. / FICare Study Group and FICare Parent Advisory Board.
In: The Lancet Child and Adolescent Health, Vol. 2, No. 4, 04.2018, p. 245-254.

Research output: Contribution to journal › Article › peer-review

TY - JOUR

T1 - Effectiveness of Family Integrated Care in neonatal intensive care units on infant and parent outcomes

T2 - a multicentre, multinational, cluster-randomised controlled trial

AU - FICare Study Group and FICare Parent Advisory Board

AU - O'Brien, Karel

AU - Robson, Kate

AU - Bracht, Marianne

AU - Cruz, Melinda

AU - Lui, Kei

AU - Alvaro, Ruben

AU - da Silva, Orlando

AU - Monterrosa, Luis

AU - Narvey, Michael

AU - Ng, Eugene

AU - Soraisham, Amuchou

AU - Ye, Xiang Y.

AU - Mirea, Lucia

AU - Tarnow-Mordi, William

AU - Lee, Shoo K.

AU - O'Brien, Karel

AU - Lee, Shoo

AU - Bracht, Marianne

AU - Caouette, Georges

AU - Ng, Eugene

AU - McMillan, Douglas

AU - Ly, Linh

AU - Dow, Kimberly

AU - Taylor, Richard

AU - Monterrosa, Luis

AU - Canning, Roderick

AU - Sankaran, Koravangattu

AU - Bingham, William

AU - Soraisham, Amuchou

AU - el Helos, Salhab

AU - Alvaro, Ruben

AU - Narvey, Michael

AU - da Silva, Orlando

AU - Osiovich, Horacio

AU - Emberley, Julie

AU - Catelin, Celine

AU - St. Aubin, Lucia

AU - Warkentin, Tammy

AU - Kalapesi, Zarin

AU - Bodani, Jaya

AU - Lui, Kei

AU - Kho, Guan

AU - Kecskes, Zsuzsoka

AU - Stack, Jacqueline

AU - Schmidt, Peter

AU - Paradisis, Mary

AU - Broadbent, Roland

AU - Raiman, Clare

AU - Wong, Charlene

AU - Cabot, Michele

AU - L'Herault, Maryse

AU - Gignac, Marie Andree

AU - Marquis, Marie Helene

AU - Leblanc, Mylene

AU - Travell, Cathy

AU - Furlong, Marlene

AU - Van Bergen, Annette

AU - Ottenhof, Maryanne

AU - Keron, Heather

AU - Bowley, Clare

AU - Cross, Shannon

AU - Kozinka, Gillian

AU - Cobham-Richards, Valerie

AU - Northrup, Kelly

AU - Gilbert-Rogers, Cindy

AU - Pidgeon, Pat

AU - McDuff, Kim

AU - Leger, Norma

AU - Thiel, Cindy

AU - Willard, Shannon

AU - Ma, Evelyn

AU - Kostecky, Linda

AU - Pogorzelski, David

AU - Jacob, Sherin

AU - Kwiatkowski, Kim

AU - Cook, Valerie

AU - Granke, Naomi

AU - Geoghegan-Morphet, Nicola

AU - Bowell, Hannah

AU - Claydon, Jennifer

AU - Tucker, Nicole

AU - Lemaitre, Thomas

AU - Doyon, Myriam

AU - Ryan, Candace

AU - Sheils, Joanne

AU - Sibbons, Elizabeth

AU - Feary, Anne Marie

AU - Callander, Ian

AU - Richard, Robyn

AU - Orbeso, Jennifer

AU - Broom, Margaret

AU - Fox, Alexis

AU - Seuseu, Jan

AU - Hourigan, Jack

AU - Schaeffer, Cynthia

AU - Mantha, Ginette

AU - Lataigne, Melanie

AU - Robson, Kate

AU - Whitehead, Leah

AU - Skinner, Natasha

AU - Visconti, Rita

AU - Crosland, Deedee

AU - Griffin, Kate

AU - Griffin, Brandon

AU - Collins, Lisa

AU - Meyer, Kirsten

AU - Silver, Ian

AU - Burnham, Britt

AU - Freeman, Rachel

AU - Muralt, Kristi

AU - Ramsay, Cara

AU - McGrath, Pawulina

AU - Munroe, Michelle

AU - Hales, Denise

N1 - Funding Information: In this study, FICare resulted in improved weight gain among infants in the NICU and improved mental wellbeing among parents. Given that growth is an important independent determinant of neurodevelopmental outcomes in preterm infants, the increased weight gain and enhanced high-frequency breastmilk feeding in the FICare group are important improvements in preterm care that might have long-term benefits for infant health. 26,27 Furthermore, the improved psychological wellbeing of parents in the FICare group could translate into better long-term mental health for the infant's parents, improved parent–infant bonding, and enhanced outcomes for the infant. 28,29 Family-centred care is a philosophy that uses principles to guide the provision of care, ultimately focusing on building partnerships between patients, their families, and health-care providers to facilitate shared decision making. FICare draws on all elements of family-centred care, but advances it further by enabling parents to become their infant's primary caregiver and to actively participate in their care. 8,13,14 Parent involvement in infant care creates a more consistent care environment for the infant, which could help protect the infant from trauma associated with the NICU, such as isolation, stress, and lack of support during painful procedures, while also providing a mechanism for parents to build the confidence and skills required to better support their infant after discharge. Unlike other family-centred interventions, FICare combines a care-by-parent model with specific interventions to educate, support, and engage parents at their infants' bedside. 13 Furthermore, FICare aims to facilitate parent involvement by engaging staff and providing both education and support for the nurses and health-care team, which enables the staff to better educate and include parents as partners in their infants' care. The observed outcomes of this study cannot be attributed to one or the other of these FICare components, but rather to the programme as a whole. Other studies have reported that individual elements of FICare might have specific benefits for infants and their families, but they do not assess all of the elements together. 7,10 Our work with families during the development of FICare suggested that the care-by-parent model needed to be multidimensional, with interdependent components that ensure its success. For example, providing a parent education programme without facilitating parent engagement in infant care would lessen the influence of the education programme. Similarly, encouraging parents to care for their infants without providing nurses with the knowledge and skillset to support parents as partners could create conflict at the bedside. By implementing and supporting a culture change within the entire NICU, FICare can help maximise the effect of family-integrated care on the health of the whole family and on staff, who might experience less conflict with parents and greater job satisfaction as a result. Findings from our study indicate that FICare significantly improves two outcomes important for minimising morbidity in preterm infants: infant weight gain and parental stress and anxiety. Both outcomes are important variables associated with positive neurodevelopmental outcomes. First, infants whose families participated in FICare had a small, but significant, improvement in Z score and weight gain. Although the absolute difference in weight gain was small, it compares favourably with the reported effects of specific feeding interventions 30 and also indicates that FICare has the potential to positively affect the physical development of preterm infants. FICare did not aim to change the feeding patterns of infants, but rather to engage parents as caregivers, enabling them to provide more skin-to-skin and developmentally responsive care, as well as empowering them to be active participants in decisions about feeding. Second, parents' responsiveness to their infant is an important determinant of positive neurodevelopmental outcomes; therefore, the reduction of parent stress and anxiety in the FICare group is important for improving both parents' connection with their infant, long-term health outcomes for the entire family, and developmental outcomes of the infants. 10,29 The significant difference in the PSS:NICU scores between the FICare and standard care groups after the intervention is similar in magnitude to that reported by Melnyk and colleagues. 10 Finally, previous reports 27,30 indicated that breastmilk feeding improves neurodevelopmental outcomes, underscoring the importance of the results in our study that suggest that the rate of high-frequency breastmilk feeding at discharge home is increased in the infants receiving FICare. Being able to provide at least six feeds per day of breastmilk is a good indicator of maternal breastmilk supply and is therefore an indicator of long-term breastfeeding success. To date, most care-by-parent programmes have been studied in lower acuity hospitals. 4 FICare was designed specifically to support parents as primary caregivers for their infant in tertiary care NICUs, and our findings suggest that FICare can be implemented in such units. Ongoing pre-implementation and post-implementation studies of how FICare might be applied in lower acuity units will provide the much needed evidence to establish the feasibility of FICare in these contexts. The intervention requires that staff communicate effectively with parents, despite language differences, and that education is provided to diverse populations, which are all parts of best neonatal care practices. Our study might be generalisable to units in high-income countries with similar organisation of perinatal health services, but further study is required to assess the practicality of implementing FICare in low-income and middle-income countries. Expansion of the FICare programme will require input from both parents and staff, particularly nurses. In our pilot study, we investigated the attitudes of nurses and parents towards FICare as well as their acceptance of the FICare model, and received mostly positive feedback, although there were also suggestions for improvement. 8 The attitudes of staff and parents will need to be assessed on a larger scale to determine how to effectively promote the expansion of FICare to other types of units. FICare challenges the current philosophy of neonatal intensive care with three fundamental aims—parent engagement, parent empowerment, and shifting the focus of care to the family. Traditionally, medical professionals have provided care for preterm infants, but actively including parents as integral members in the care team might be a preferable strategy for future neonatal care. 13 Our findings suggest that how care is provided to the family, not just the infant, has a positive effect on the wellbeing of both infant and family. Cluster-randomised controlled trials are more prone to bias than are individual patient randomised controlled trials because of variations in practice, unbalanced patient populations, and staff cultures that are not captured or measured during the study. For example, our study had a random imbalance in infants younger than 29 weeks' gestation (there were more in the FICare group) and singletons (more in standard care group). To address possible confounding factors in neonatal practice, we stratified sites by country and size before they were randomly assigned. We were unable to control for nutritional policies or resource use. Specific to this study, FICare parents were asked to make a very different commitment than were standard care parents, resulting in the possibility that more committed parents enrolled in FICare; the proportion of families who participated at FICare sites (30%) was different than at the standard care sites (44%). However, our sensitivity analysis, which included family demographic data as well as the infant data, showed that the intervention effects remained significant, regardless of the family demographics. One last potential source of bias from the study design is that over the duration of the study, some standard care sites could have adopted local family-oriented practices that were not recorded and might have biased the results towards a less detectable difference. Our study had other limitations that were independent of the study design. First, we have less information about the status of infants in the FICare group on discharge home than about infants in the standard care group. The increased rate of transfer of infants from FICare sites to level 2 NICUs before discharge home was not something that we anticipated when assigning sites. These missing data might have resulted in a type I error, which limits our conclusions about the success of breastfeeding in this population. Furthermore, we did not report the difference in weight gain at 36 weeks and at discharge home between infants in both groups because many of the data were missing. Second, some secondary outcomes (eg, intraventricular haemorrhage, nosocomial infection, or bronchopulmonary dysplasia) either occur before trial enrolment or are predetermined at the time at enrolment. We decided to include these secondary outcomes in our study despite the ir early occurrence because they are neonatal outcomes that are important indicators of the infant's health. Finally, many infants included in the intention-to-treat analysis were transferred before receiving 3 weeks of the FICare intervention, thus resulting in fewer measurements at later timepoints. In conclusion, both infants and parents enrolled in FICare showed improved outcomes. Further research on the barriers to implementing and sustaining this model of care in NICUs and other hospital settings, and the effect of FICare on long-term neurodevelopment, is warranted. Contributors KO'B did the literature review. SKL, KO'B, KR, MB, KL, RA, OdS, LMo, MN, EN, AS, XYY, LMi, and WT-M were involved in the design of the study. SKL, KO'B, MC, KL, RA, OdS, LMo, MN, EN, AS, and WT-M were involved in acquisition of data. SKL, KO'B, KR, MB, MC, KL, RA, OdS, LMo, MN, EN, AS, LMi, and WT-M were involved in interpretation of the analysis. KO'B drafted the paper. XYY did the statistical analyses and prepared the figures. SKL, KO'B, KR, MB, MC, KL, RA, OdS, LMo, MN, EN, AS, XYY, LMi, and WT-M approved the paper. Declaration of interests KO'B and SKL report grants from the Canadian Insitute of Health Research and Ontario Ministry of Health and Long-Term Care during the study. All other authors declare no competing interests. Acknowledgments This trial was funded by grants from the Canadian Institutes of Health Research Partnerships for Health System Improvement (CIHR-PHSI; #PHE122173) and CIHR Team (#CTP87518), and additional partner funding from the Ontario Ministry of Health and Long-Term Care (grant #06465). We would like to thank the Mount Sinai FICare Steering Committee for their tireless efforts in developing and implementing the pilot FICare programme, as well as the site investigators, neonatal intensive care unit (NICU) educators, NICU staff, veteran parents, and study coordinators across Canada, Australia, and New Zealand for their dedication to this trial. We would also like to thank the current and former members of the Maternal-Infant Care Research Centre (MiCare)—Sarah Hutchinson, Natasha Musrap, Charlene Wong, and Sonny Yeh—for editorial assistance, organisational support, coordination, and data management. MiCare is supported by a team grant from the CIHR (FRN87518) and in-kind support from Mount Sinai Hospital. Publisher Copyright: © 2018 Elsevier Ltd

PY - 2018/4

Y1 - 2018/4

N2 - Background: Despite evidence suggesting that parent involvement was beneficial for infant and parent outcomes, the Family Integrated Care (FICare) programme was one of the first pragmatic approaches to enable parents to become primary caregivers in the neonatal intensive care unit (NICU). We aimed to analyse the effect of FICare on infant and parent outcomes, safety, and resource use. Methods: In this multicentre, cluster-randomised controlled trial, we stratified 26 tertiary NICUs from Canada, Australia, and New Zealand by country and size, and assigned them, using a computer-generated random allocation sequence, to provide FICare or standard NICU care. Eligible infants were born at 33 weeks' gestation or earlier, and had no or low-level respiratory support; parents gave written informed consent for enrolment. To be eligible, parents in the FICare group had to commit to be present for at least 6 h a day, attend educational sessions, and actively care for their infant. The primary outcome, analysed at the individual level, was infant weight gain at day 21 after enrolment. Secondary outcomes were weight gain velocity, high frequency breastfeeding (≥6 times a day) at hospital discharge, parental stress and anxiety at enrolment and day 21, NICU mortality and major neonatal morbidities, safety, and resource use (including duration of oxygen therapy and hospital stay). This trial is registered with ClinicalTrials.gov, number NCT01852695. Findings: From Oct 1, 2012, 26 sites were randomly assigned to provide FICare (n=14) or standard care (n=12). One site assigned to FICare discontinued because of poor site enrolment. Parents and infants were enrolled between April 1, 2013, and Aug 31, 2015, with 895 infants being eligible in the FICare group and 891 in the standard care group. At day 21, weight gain was greater in the FICare group than in the standard care group (mean change in Z scores 1·58 [SD 0·51] vs 1·45 [0·49]; p<0·0001). Average daily weight gain was significantly higher in infants receiving FICare than those receiving standard care (mean daily weight gain 26·7 g [SD 9·4] vs 24·8 g [9·5]; p<0·0001). The high-frequency exclusive breastmilk feeding rate at discharge was higher for infants in the FICare group (279 [70%] of 396) than those in the standard care group (394 [63%] of 624; p=0·016). At day 21, parents in the FICare group had lower mean stress scores than did parents in the standard care group (2·3 [SD 0·8] vs 2·5 [0·8]; p<0·00043), and lower mean anxiety scores (70·8 [20·1] vs 74·2 [19·9]; p=0·0045). There were no significant differences between groups in the rates of the secondary outcomes of mortality, major morbidity, duration of oxygen therapy, and duration of hospital stay. Although the safety assessment was not completed, there were no adverse events. Interpretation: FICare improved infant weight gain, decreased parent stress and anxiety, and increased high-frequency exclusive breastmilk feeding at discharge, which together suggest that FICare is an important advancement in neonatal care. Further research is required to examine if these results translate into better long-term outcomes for families. Funding: Canadian Institutes of Health Research Partnerships for Health System Improvement, and Ontario Ministry of Health and Long-Term Care.

AB - Background: Despite evidence suggesting that parent involvement was beneficial for infant and parent outcomes, the Family Integrated Care (FICare) programme was one of the first pragmatic approaches to enable parents to become primary caregivers in the neonatal intensive care unit (NICU). We aimed to analyse the effect of FICare on infant and parent outcomes, safety, and resource use. Methods: In this multicentre, cluster-randomised controlled trial, we stratified 26 tertiary NICUs from Canada, Australia, and New Zealand by country and size, and assigned them, using a computer-generated random allocation sequence, to provide FICare or standard NICU care. Eligible infants were born at 33 weeks' gestation or earlier, and had no or low-level respiratory support; parents gave written informed consent for enrolment. To be eligible, parents in the FICare group had to commit to be present for at least 6 h a day, attend educational sessions, and actively care for their infant. The primary outcome, analysed at the individual level, was infant weight gain at day 21 after enrolment. Secondary outcomes were weight gain velocity, high frequency breastfeeding (≥6 times a day) at hospital discharge, parental stress and anxiety at enrolment and day 21, NICU mortality and major neonatal morbidities, safety, and resource use (including duration of oxygen therapy and hospital stay). This trial is registered with ClinicalTrials.gov, number NCT01852695. Findings: From Oct 1, 2012, 26 sites were randomly assigned to provide FICare (n=14) or standard care (n=12). One site assigned to FICare discontinued because of poor site enrolment. Parents and infants were enrolled between April 1, 2013, and Aug 31, 2015, with 895 infants being eligible in the FICare group and 891 in the standard care group. At day 21, weight gain was greater in the FICare group than in the standard care group (mean change in Z scores 1·58 [SD 0·51] vs 1·45 [0·49]; p<0·0001). Average daily weight gain was significantly higher in infants receiving FICare than those receiving standard care (mean daily weight gain 26·7 g [SD 9·4] vs 24·8 g [9·5]; p<0·0001). The high-frequency exclusive breastmilk feeding rate at discharge was higher for infants in the FICare group (279 [70%] of 396) than those in the standard care group (394 [63%] of 624; p=0·016). At day 21, parents in the FICare group had lower mean stress scores than did parents in the standard care group (2·3 [SD 0·8] vs 2·5 [0·8]; p<0·00043), and lower mean anxiety scores (70·8 [20·1] vs 74·2 [19·9]; p=0·0045). There were no significant differences between groups in the rates of the secondary outcomes of mortality, major morbidity, duration of oxygen therapy, and duration of hospital stay. Although the safety assessment was not completed, there were no adverse events. Interpretation: FICare improved infant weight gain, decreased parent stress and anxiety, and increased high-frequency exclusive breastmilk feeding at discharge, which together suggest that FICare is an important advancement in neonatal care. Further research is required to examine if these results translate into better long-term outcomes for families. Funding: Canadian Institutes of Health Research Partnerships for Health System Improvement, and Ontario Ministry of Health and Long-Term Care.

UR - http://www.scopus.com/inward/record.url?scp=85043582228&partnerID=8YFLogxK

U2 - 10.1016/S2352-4642(18)30039-7

DO - 10.1016/S2352-4642(18)30039-7

M3 - Article

C2 - 30169298

AN - SCOPUS:85043582228

SN - 2352-4642

VL - 2

SP - 245

EP - 254

JO - The Lancet Child and Adolescent Health

JF - The Lancet Child and Adolescent Health

IS - 4

ER -

Effectiveness of Family Integrated Care in neonatal intensive care units on infant and parent outcomes: a multicentre, multinational, cluster-randomised controlled trial

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