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Cited by 121Infant Development and Preterm CareFamily and Patient Care in Intensive Care UnitsMaternal and Neonatal Healthcare

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Evaluation of the Family Integrated Care model of neonatal intensive care: a cluster randomized controlled trial in Canada and Australia

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O’Brien, Karel, Bracht, Marianne, Robson, Kate, Ye, Xiang Y., Mirea, Lucia, Cruz, Melinda, Ng, Eugene, Monterrosa, Luis, Soraisham, Amuchou, Alvaro, Ruben, Narvey, Michael, Da Silva, Orlando, Lui, Kei, Tarnow-Mordi, William, Lee, Shoo K.·2015·BMC Pediatrics
DOI 10.1186/s12887-015-0527-0PMC PMC4681024
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Abstract

BACKGROUND: Admission to the neonatal intensive care unit (NICU) may disrupt parent-infant interaction with adverse consequences for infants and their families. Several family-centered care programs promote parent-infant interaction in the NICU; however, all of these retain the premise that health-care professionals should provide most of the infant's care. Parents play a mainly supportive role in the NICU and continue to feel anxious and unprepared to care for their infant after discharge. In the Family Integrated Care (FICare) model, parents provide all except the most advanced medical care for their infants with support from the medical team. Our hypothesis is that infants whose families complete the FICare program will have greater weight gain and better clinical and parental outcomes compared with infants provided with standard NICU care. METHODS/DESIGN: FICare is being evaluated in a cluster randomized controlled trial among infants born at ≤ 33 weeks' gestation admitted to 19 Canadian, 6 Australian, and 1 New Zealand tertiary-level NICU. Trial enrollment began in April, 2013, with a target sample size of 675 infants in each arm, to be completed by August, 2015. Participating sites were stratified by country, and by NICU size within Canada, for randomization to either the FICare intervention or control arm. In intervention sites, parents are taught how to provide most of their infant's care and supported by nursing staff, veteran parents, a program coordinator, and education sessions. In control sites standard NICU care is provided. The primary outcome is infants' weight gain at 21 days after enrollment, which will be compared between the FICare and control groups using Student's t-test adjusted for site-level clustering, and multi-level hierarchical models accounting for both clustering and potential confounders. Similar analyses will examine secondary outcomes including breastfeeding, clinical outcomes, safety, parental stress and anxiety, and resource use. The trial was designed, is being conducted, and will be reported according to the CONSORT 2010 guidelines for cluster randomized controlled trials. DISCUSSION: By evaluating the impact of integrating parents into the care of their infant in the NICU, this trial may transform the delivery of neonatal care. TRIAL REGISTRATION: NCT01852695 , registered December 19, 2012.

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  • The FICare program involves parents as primary caregivers and fosters active interactions and shared decision-making with the NICU team rather than limiting them to observational roles.

    “The FICare program addresses this by involving parents as primary caregivers and fostering active interactions and shared decision‐making with the NICU team rather than limiting them to observational roles (O'Brien et al. 2015).”

    From Experiences and Perceptions of Hospital to Home Transitional Care for Parents of Premature Infants in Neonatal Intensive Care Unit: A Qualitative Meta‐Synthesis (2025) · cites this paper as O'Brien et al. 2015

    The Background and rationale describes FICare as integrating parents into the NICU care team and empowering them to provide as much infant care as they can, in contrast to a merely supportive or observational role. The Methods/Design (Intervention) describes parents attending medical rounds and communicating with the team, but does not establish that they share in clinical decision-making. (LLM, conf=0.84)

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  1. Gooding JS, Cooper LG, Blaine AI, Franck LS, Howse JL, Berns SD. Family support and family-centered care in the neonatal intensive care unit: origins, advances, impact. Semin Perinatol. 2011;35(1):20–8. · DOI
  2. Bhutta ZA, Khan I, Salat S, Raza F, Ara H. Reducing length of stay in hospital for very low birthweight infants by involving mothers in a stepdown unit: an experience from Karachi (Pakistan). BMJ. 2004;329(7475):1151–5. · DOI
  3. Ramanathan K, Paul VK, Deorari AK, Taneja U, George G. Kangaroo mother care in very low birth weight infants. Indian J Pediatr. 2001;68(11):1019–23. · DOI
  4. Cleveland LM. Parenting in the neonatal intensive care unit. J Obstet Gynecol Neonatal Nurs. 2008;37(6):666–91. · DOI
  5. Flacking R, Lehtonen L, Thomson G, Axelin A, Ahlqvist S, Moran VH, et al. Closeness and separation in neonatal intensive care. Acta Paediatr. 2012;101(10):1032–7. · DOI
  6. Gottfried AW. Environment of newborn infants in special care units. In: Gottfried AW, Gaiter JL, editors. Infant stress under intensive care: environmental neonatology. Baltimore: University Park Press; 1985. p. 23–54.
  7. Fenwick J, Barclay L, Schmied V. Struggling to mother: a consequence of inhibitive nursing interactions in the neonatal nursery. J Perinat Neonatal Nurs. 2001;15(2):49–64. · DOI
  8. Harrison L, Klaus MH. Commentary: a lesson from Eastern Europe. Birth. 1994;21(1):45–6. · DOI
  9. Levin A. The Mother-Infant unit at Tallinn Children’s Hospital, Estonia: a truly baby-friendly unit. Birth. 1994;21(1):39–44. · DOI
  10. Ebrahim GJ. The Baby Friendly Hospital Initiative. J Trop Pediatr. 1993;39(1):2–3. · DOI
  11. Kyenkya-Isabirye M. UNICEF launches the Baby-Friendly Hospital Initiative. MCN Am J Matern Child Nurs. 1992;17(4):177–9. · DOI
  12. Bowlby J. Maternal care and mental health. Bull World Health Organ. 1951;3(3):355–533.
  13. Filippa M, Devouche E, Arioni C, Imberty M, Gratier M. Live maternal speech and singing have beneficial effects on hospitalized preterm infants. Acta Paediatr. 2013;102(10):1017–20. · DOI
  14. Picciolini O, Porro M, Meazza A, Gianni ML, Rivoli C, Lucco G, et al. Early exposure to maternal voice: effects on preterm infants development. Early Hum Dev. 2014;90(6):287–92. · DOI
  15. Chorna OD, Slaughter JC, Wang L, Stark AR, Maitre NL. A pacifier-activated music player with mother’s voice improves oral feeding in preterm infants. Pediatrics. 2014;133(3):462–8. · DOI
  16. Krueger C, Parker L, Chiu SH, Theriaque D. Maternal voice and short-term outcomes in preterm infants. Dev Psychobiol. 2010;52(2):205–12. · DOI
  17. Yildiz A, Arikan D, Gozum S, Tastekin A, Budancamanak I. The effect of the odor of breast milk on the time needed for transition from gavage to total oral feeding in preterm infants. J Nurs Scholarsh. 2011;43(3):265–73.
  18. Raimbault C, Saliba E, Porter RH. The effect of the odour of mother’s milk on breastfeeding behaviour of premature neonates. Acta Paediatr. 2007;96(3):368–71. · DOI
  19. Doheny L, Hurwitz S, Insoft R, Ringer S, Lahav A. Exposure to biological maternal sounds improves cardiorespiratory regulation in extremely preterm infants. J Matern Fetal Neonatal Med. 2012;25(9):1591–4. · DOI
  20. Forcada-Guex M, Pierrehumbert B, Borghini A, Moessinger A, Muller-Nix C. Early dyadic patterns of mother-infant interactions and outcomes of prematurity at 18 months. Pediatrics. 2006;118(1):e107–14. · DOI · Paper page
  21. Jean AD, Stack DM. Full-term and very-low-birth-weight preterm infants’ self-regulating behaviors during a Still-Face interaction: influences of maternal touch. Infant Behav Dev. 2012;35(4):779–91. · DOI
  22. Moore GA, Hill-Soderlund AL, Propper CB, Calkins SD, Mills-Koonce WR, Cox MJ. Mother-infant vagal regulation in the face-to-face still-face paradigm is moderated by maternal sensitivity. Child Dev. 2009;80(1):209–23. · DOI · Paper page
  23. Delobel-Ayoub M, Arnaud C, White-Koning M, Casper C, Pierrat V, Garel M, et al. Behavioral problems and cognitive performance at 5 years of age after very preterm birth: the EPIPAGE Study. Pediatrics. 2009;123(6):1485–92. · DOI
  24. Singer LT, Fulton S, Davillier M, Koshy D, Salvator A, Baley JE. Effects of infant risk status and maternal psychological distress on maternal-infant interactions during the first year of life. J Dev Behav Pediatr. 2003;24(4):233–41. · DOI
  25. Treyvaud K, Anderson VA, Howard K, Bear M, Hunt RW, Doyle LW, et al. Parenting behavior is associated with the early neurobehavioral development of very preterm children. Pediatrics. 2009;123(2):555–61. · DOI
  26. Treyvaud K, Anderson VA, Lee KJ, Woodward LJ, Newnham C, Inder TE, et al. Parental mental health and early social-emotional development of children born very preterm. J Pediatr Psychol. 2010;35(7):768–77. · DOI
  27. Jiang S, Warre R, Qiu X, O’Brien K, Lee SK. Parents as practitioners in preterm care. Early Hum Dev. 2014;90(11):781–5. · DOI
  28. Lee SK, O’Brien K. Parents as primary caregivers in the neonatal intensive care unit. CMAJ. 2014;186(11):845–7. · DOI
  29. Bracht M, O’Leary L, Lee SK, O’Brien K. Implementing Family-Integrated Care in the NICU: a parent education and support program. Adv Neonatal Care. 2013;13(2):115–26. · DOI
  30. Galarza-Winton ME, Dicky T, O’Leary L, Lee SK, O’Brien K. Implementing family-integrated care in the NICU: educating nurses. Adv Neonatal Care. 2013;13(5):335–40. · DOI
  31. MacDonell K, Christie K, Robson K, Pytlik K, Lee SK, O’Brien K. Implementing family-integrated care in the NICU: engaging veteran parents in program design and delivery. Adv Neonatal Care. 2013;13(4):262–9. quiz. · DOI
  32. O’Brien K, Bracht M, MacDonell K, McBride T, Robson K, O’Leary L, et al. A pilot cohort analytic study of Family Integrated Care in a Canadian neonatal intensive care unit. BMC Pregnancy Childbirth. 2013;13 Suppl 1:S12. · DOI
  33. Preyde M, Ardal F. Effectiveness of a parent “buddy” program for mothers of very preterm infants in a neonatal intensive care unit. CMAJ. 2003;168(8):969–73.
  34. Lee SK, McMillan DD, Ohlsson A, Pendray M, Synnes A, Whyte R, et al. Variations in practice and outcomes in the Canadian NICU network: 1996–1997. Pediatrics. 2000;106(5):1070–9. · DOI
  35. Fenton TR, Sauve RS. Using the LMS method to calculate z-scores for the Fenton preterm infant growth chart. Eur J Clin Nutr. 2007;61(12):1380–5. · DOI
  36. Lee SK, Anderson L. Report on tertiary neonatal costs in BC. Centre for healthcare innovation and improvement. 2004.
  37. Bell MJ, Ternberg JL, Feigin RD, Keating JP, Marshall R, Barton L, et al. Neonatal necrotizing enterocolitis. Therapeutic decisions based upon clinical staging. Ann Surg. 1978;187(1):1–7. · DOI
  38. Jobe AH, Bancalari E. Bronchopulmonary dysplasia. Am J Respir Crit Care Med. 2001;163(7):1723–9. · DOI
  39. Garner JS, Jarvis WR, Emori TG, Horan TC, Hughes JM. CDC definitions for nosocomial infections, 1988. Am J Infect Control. 1988;16(3):128–40. · DOI
  40. International Committee for the Classification of Retinopathy of Prematurity. The International Classification of Retinopathy of Prematurity revisited. Arch Ophthalmol. 2005;123(7):991–9. · DOI
  41. Papile LA, Burstein J, Burstein R, Koffler H. Incidence and evolution of subependymal and intraventricular hemorrhage: a study of infants with birth weights less than 1,500 gm. J Pediatr. 1978;92(4):529–34. · DOI
  42. Guittet L, Ravaud P, Giraudeau B. Planning a cluster randomized trial with unequal cluster sizes: practical issues involving continuous outcomes. BMC Med Res Methodol. 2006;6:17. · DOI
  43. Kerry SM, Bland JM. Unequal cluster sizes for trials in English and Welsh general practice: implications for sample size calculations. Stat Med. 2001;20(3):377–90. · DOI
  44. Adams G, Gulliford MC, Ukoumunne OC, Eldridge S, Chinn S, Campbell MJ. Patterns of intra-cluster correlation from primary care research to inform study design and analysis. J Clin Epidemiol. 2004;57(8):785–94. · DOI · Paper page
  45. Lee SK, Aziz K, Singhal N, Cronin CM, James A, Lee DS, et al. Improving the quality of care for infants: a cluster randomized controlled trial. CMAJ. 2009;181(8):469–76. · DOI
  46. Donner A, Klar N. Design and analysis of cluster randomization trials in health research. John Wiley & Sons, Ltd: Chichester, UK; 2000.
  47. Reed III JF. Adjusted chi-square statistics: application to clustered binary data in primary care. Ann Fam Med. 2004;2(3):201–3. · DOI
  48. Rothman KJ, Greenland S. Modern epidemiology. 2nd ed. Philadelphia: Lippincott Raven; 1998.
  49. Puffer S, Torgerson D, Watson J. Evidence for risk of bias in cluster randomised trials: review of recent trials published in three general medical journals. BMJ. 2003;327(7418):785–9. · DOI · Paper page
  50. Ma J, Akhtar-Danesh N, Dolovich L, Thabane L. Imputation strategies for missing binary outcomes in cluster randomized trials. BMC Med Res Methodol. 2011;11:18. · DOI
  51. Taljaard M, Donner A, Klar N. Imputation strategies for missing continuous outcomes in cluster randomized trials. Biom J. 2008;50(3):329–45. · DOI

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Metadata

Authors
O’Brien, K., Bracht, M., Robson, K., Ye, X. Y., Mirea, L., Cruz, M., Ng, E., Monterrosa, L., Soraisham, A., Alvaro, R., Narvey, M., Da Silva, O., Lui, K., Tarnow-Mordi, W., & Lee, S. K.
Affiliations
  • Mount Sinai Hospital (CA)
  • Sunnybrook Health Science Centre (CA)
  • Dalhousie University (CA)
  • University of Calgary (CA)
  • University of Manitoba (CA)
  • Western University (CA)
  • Royal Hospital for Women (AU)
Corresponding author
O’Brien, Karel
ORCID
Venue
BMC Pediatrics
Publisher
Springer Science and Business Media LLC
Published
2015-12
Volume
15
Issue
1
Pages
210-210
ISSN
1471-2431 (ISSN-L)
DOI
10.1186/s12887-015-0527-0
PMC
PMC4681024
OpenAlex
W2213958229
Cited by
121
References
4
Citations by year
2026: 12 · 2025: 10 · 2024: 9 · 2023: 14 · 2022: 10 · 2021: 15 · 2020: 13 · 2019: 8 · 2018: 15 · 2017: 11 · 2016: 2
FWCI
8.46
Type
journal article
Language
en
Open access
Licence
Locations
  • BMC Pediatrics (publishedVersion, cc-by)
  • Europe PMC (PubMed Central) (publishedVersion, cc-by)
  • PubMed Central (publishedVersion, cc-by)
  • PubMed (publishedVersion)
  • TSpace (University of Toronto) (submittedVersion)
  • Scholarship@Western (Western University) (submittedVersion)
Funders
  • Ontario Ministry of Health and Long-Term Care
  • Canadian Institutes of Health Research (CTP 87 518)
Topics
  • Health Sciences › Medicine › Pediatrics, Perinatology and Child Health › Infant Development and Preterm Care
  • Health Sciences › Medicine › Critical Care and Intensive Care Medicine › Family and Patient Care in Intensive Care Units
  • Health Sciences › Medicine › Pediatrics, Perinatology and Child Health › Maternal and Neonatal Healthcare
Keywords
family integrated care, neonatal intensive care, parent-infant interaction, family-centered care, parental involvement in infant care, preterm infants, infant weight gain, breastfeeding, parental stress and anxiety, resource utilization (health care)
MeSH terms
Anxiety, Australia, Breast Feeding, Canada, Humans, Infant, Newborn, Infant, Premature, Parents, Patient Education as Topic, Pilot Projects, Social Support, Stress, Psychological, Weight Gain, Intensive Care, Neonatal, Cost Savings, Hospital Costs, Family Nursing

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