Objective To examine whether the family integrated care (FICare) programme, a multifaceted approach which enables parents to be engaged as primary caregivers in the neonatal intensive care unit, impacts infant neurodevelopment and growth at 18 months’ corrected age.
Design/Methods Prospective cohort study of infants born <29 weeks’ gestational age (GA) who participated in the FICare cluster randomised control trial (cRCT) and were assessed in the Canadian Neonatal Follow-Up Network (CNFUN). The primary outcome measure, Cognitive or Language composite score <85 on the Bayley-III, was compared between FICare exposed and routine care children using logistic regression, adjusted for potential confounders and employing generalised estimation equations to account for clustering of infants within sites.
Results Of 756 infants <29 weeks’ GA in the FICare cRCT, 505 were enrolled in CNFUN and 455 were assessed (238 FICare, 217 control). Compared with controls, FICare infants had significantly higher incidence of intraventricular haemorrhage (IVH) (19.5% vs 11.7%, p=0.024) and higher proportion of employed mothers (76.6% vs 73.6%, p=0.043). There was no significant difference in the odds of the primary outcome (adjusted OR: 0.92 (0.59 to 1.42) FiCare vs Control) on multivariable analyses adjusted for GA, IVH and maternal employment. However, Bayley-III Motor scores (adjusted difference in mean (95% CI) 3.87 (1.22 to 6.53) and body mass index 0.67 (0.36 to 0.99) were higher in the FICare group.
Conclusions Very preterm infants exposed to FICare had no significant difference in incidence of cognitive or language delay but had better motor development.
Trial registration number Participants in this cohort study were previously enrolled in a registered trial: NCT01852695
- health services research
Data availability statement
No data are available according to network data sharing agreements.
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Collaborators Canadian Neonatal Network Investigators who participated in this study: Jaideep Kanungo, MD, Victoria General Hospital, Victoria, British Columbia; Joseph Ting, MD, British Columbia Women’s Hospital, Vancouver; British Columbia; Ayman Abou Mehrem, MD, Foothills Medical Centre, Calgary, Alberta; Ruben Alvaro, MD, St. Boniface General Hospital, Winnipeg, Manitoba; Mohammad Adie, MD, Windsor Regional Hospital, Windsor, Ontario; Orlando Da Silva, MD, MSc, London Health Sciences Centre, London, Ontario; Prakesh S Shah, MD, MSc (Director, Canadian Neonatal Network), Mount Sinai Hospital, Toronto, Ontario; Eugene Ng, MD, Sunnybrook Health Sciences Centre, Toronto, Ontario; Christine Drolet, MD, and Bruno Piedboeuf, MD, Centre Hospitalier Universitaire de Québec, Sainte Foy, Québec; Jehier Afifi, MB BCh, MSc, IWK Health Centre, Halifax, Nova Scotia; Canadian Neonatal Follow-Up Network Investigators who participated in this study: Thevanisha Pillay, MD, Victoria General Hospital, Victoria, British Columbia; Anne Synnes, MDCM, MHSC (director), Ruth Grunau PhD (steering committee) British Columbia Women’s Hospital, Vancouver, British Columbia; Jill Zwicker PhD (steering committee) Leonora Hendson MB.BCH, MSc, Alberta’s Children’s Hospital, Foothills Medical Centre, Calgary, Alberta; Diane Moddemann, MD (steering committee), Cecilia de Cabo MD, Winnipeg Health Sciences Centre, St. Boniface General Hospital, Winnipeg, Manitoba; Chukwuma Nwaesei, MD, Windsor Regional Hospital, Windsor, Ontario; Kevin Coughlin, MD (steering committee), Lynn Whitty RN (steering committee), Children’s Hospital London Health Sciences Centre, London, Ontario; Edmond Kelly, MD, Mount Sinai Hospital, Toronto, Ontario; Paige Church, MD, Rudaina Banihani MD (steering committee) Sunnybrook Health Sciences Centre, Toronto, Ontario Thuy Mai Luu MD, MSc (Co-director), Centre Hospitalier Universitaire Sainte-Justine, Montréal, Québec; Sylvie Bélanger, MD, Centre Hospitalier Universitaire de Québec, Québec City, Québec; Jehier Afifi, MB BCh, MSc, (steering committee) IWK Health Centre, Halifax, Nova Scotia.
Contributors ARS is the director of the CNFUN, conceptualised the study, contributed to data collection and wrote the manuscript. She is the author responsible for all correspondence and page proofs. JP-T, PC, EK and DM conceptualised the study, contributed to data collection and critically reviewed and approved the manuscript. REG conceptualised the study and critically reviewed and approved the manuscript. XY did the statistical analyses and critically reviewed and approved the manuscript. KO’B and SKL conceptualised the original FICare cluster RCT, obtained funding, conceptualised this study and critically reviewed and approved the manuscript. The Canadian Neonatal Follow-Up Network and Canadian Neonatal Network collected and analysed the outcome data.
Funding This work was supported by the Canadian Institutes of Health Research through grants to the CIHR Team in Maternal-Infant Care (CTP 87518 and 142488). The study coordinating centre, the Maternal-Infant Care Research Centre, is supported by program funding from the Ontario Ministry of Health and Long-Term Care. In addition, participating sites contributed additional funding for patient outcome assessments. Participants in this cohort study were previously enrolled in a registered trial: ClinicalTrials.gov identifier: NCT01852695.
Disclaimer The funding agencies had no role in the design and conduct of the study; collection, management, analysis and interpretation of the data; preparation, review or approval of the manuscript and decision to submit the manuscript for publication.
Competing interests None declared.
Provenance and peer review Not commissioned; externally peer reviewed.