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  • Systematic Review
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Identifying outcomes and outcome measures in neonatal family-centered care trials: a systematic review

Pediatric Research volume 97, pages 56–66 (2025)Cite this article

Abstract

Background

A wide range of outcomes for infants and parents has been reported in clinical trials testing FCC interventions. This systematic review aimed to identify outcomes, outcome measures, and time-points reported in experimental studies testing FCC interventions in neonatal care units.

Methods

This review included experimental studies investigating FCC interventions in neonatal settings. Database searches were conducted in MEDLINE, EMBASE, CINAHL, Cochrane, PsycINFO, Scopus, JBI, Lilacs, and SciELO, completed in December 2022 and updated in November 2023. Critical appraisal was performed using the JBI checklist for randomized controlled trials, and a narrative synthesis process was used. Outcomes were categorized into the Comet Taxonomy core areas.

Results

The search identified 8787 papers; 42 studies were included in the analysis. Totally, 60 outcomes were identified: 42 infant and 18 parents’ outcomes. Outcomes were clustered into 12 domains for infants and five domains for parents and measured by 97 outcome measures. The included studies reported 25 and 27 different time-points for infants and parents, respectively.

Conclusion

This review of studies testing FCC interventions identified heterogeneity and inconsistency of outcomes, outcome measures, and time-points measuring the outcomes. Developing a core outcome set for FCC studies is warranted to benchmark the evidence and identify best-practices.

Impact

  • This systematic review identified inconsistency of outcomes, outcome measures, and time-points reported in quantitative studies testing family-centered care interventions in neonatal care settings.

  • The lack of standardized outcomes and outcome measures reported in clinical trials makes it difficult to synthesize data to provide conclusive recommendations.

  • This systematic review will contribute to the development of a core outcome set for research testing family-centered care interventions in neonatal care settings.

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Fig. 1: Flow diagram of study selection in December 2022 and updated in November 2023.

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Data availability

The dataset generated during and /or analyzed during the current study are available from the corresponding author on reasonable request.

References

  1. World Health Organization (WHO). Preterm Birth. https://www.who.int/news-room/fact-sheets/detail/preterm-birth (2021).

  2. Mactier, H. et al. Perinatal management of extreme preterm birth before 27 weeks of gestation: a framework for practice. Arch. Dis. Child Fetal Neonatal Ed. 105, 232–239 (2020).

    Article  PubMed  Google Scholar 

  3. van den Hoogen, A. et al. Parents’experience of VOICE: Anovel support programme in the NICU. Nurs. Crit. Care 26, 201–208 (2021).

    Article  PubMed  Google Scholar 

  4. Ding, X. et al. Effects of family-centred care interventions on preterm infants and parents in neonatal intensive care units: a systematic review and meta-analysis of randomised controlled trials. Aust. Crit. Care 32, 63–75 (2019).

    Article  PubMed  Google Scholar 

  5. Mendelson, T. et al. A mindfulness intervention to reduce maternal distress in neonatal intensive care: a mixed methods pilot study. Arch. Women’s Ment. Health 21, 791–799 (2018).

    Article  Google Scholar 

  6. European Standards of Care Newborn Health. Infant & family-centered developmental care. https://newborn-health-standards.org/standards/standards-english/infant-family-centred-developmental-care/ (2019).

  7. Mikkelsen, G. & Frederiksen, K. Family-centred care of children in hospital - a concept analysis. J. Adv. Nurs. 67, 1152–1162 (2011).

    Article  PubMed  Google Scholar 

  8. Oude Maatman, S. M. et al. Factors influencing implementation of family-centered care in a neonatal intensive care unit. Front. Pediatr. 8, 222 (2020).

  9. Abukari, A. S. & Schmollgruber, S. Concepts of family-centered care at the neonatal and paediatric intensive care unit: a scoping review. J. Pediatr. Nurs. 71, e1–e10 (2023).

    Article  PubMed  Google Scholar 

  10. Banerjee, J., Aloysius, A., Platonos, K. & Deierl, A. Family centred care and family delivered care—what are we talking about? J. Neonatal Nurs. 24, 8–12 (2018).

    Article  Google Scholar 

  11. Institute for Patient and Family Centred Care. What is PFCC? https://www.ipfcc.org/about/pfcc.html (2021).

  12. Segers, E., Ockhuijsen, H., Baarendse, P., van Eerden, I. & van den Hoogen, A. The impact of family centred care interventions in a neonatal or paediatric intensive care unit on parents’ satisfaction and length of stay: a systematic review. Intensive Crit. Care Nurs. 50, 63–70 (2019).

    Article  PubMed  Google Scholar 

  13. Yu, X. & Zhang, J. Family‐centred care for hospitalized preterm infants: a systematic review and meta‐analysis. Int. J. Nurs. Pract. 25, e12705 (2019).

    Article  PubMed  Google Scholar 

  14. Williamson, P. R. et al. The Comet Handbook: Version 1.0. Trials 18, 1–50 (2017).

  15. Webbe, J. W. H. et al. Core outcomes in neonatology: development of a core outcome set for neonatal research. Arch. Dis. Child. Fetal Neonatal Ed. 105, 425–431 (2020).

    Article  PubMed  Google Scholar 

  16. Page, M. J. et al. The PRISMA 2020 statement: an updated guideline for reporting systematic reviews. Syst. Rev. 10, 89 (2021).

    Article  PubMed  PubMed Central  Google Scholar 

  17. Latour, J., van den Hoogen, A., Axelin, A., Kostenzer, J. Evaluating family-centered care interventions and outcomes in neonatal care. PROSPERO. https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42022297580 (2022).

  18. Westrup, B. Newborn individualized developmental care and assessment program (Nidcap)—family-centered developmentally supportive care. Early Hum. Dev. 83, 443–449 (2007).

    Article  PubMed  Google Scholar 

  19. Tufanaru, C., Munn, Z., Aromataris, E., Campbell, J., Hopp, L. Systematic reviews of effectiveness. In: Aromataris E, Munn Z, editors, JBI Manual for Evidence Synthesis. https://synthesismanual.jbi.global (2020).

  20. Dodd, S. et al. A taxonomy has been developed for outcomes in medical research to help improve knowledge discovery. J. Clin. Epidemiol. 96, 84–92 (2018).

    Article  PubMed  PubMed Central  Google Scholar 

  21. Abdeyazdan, Z., Shahkolahi, Z., Mehrabi, T. & Hajiheidari, M. A family support intervention to reduce stress among parents of preterm infants in neonatal intensive care unit. Iran. J. Nurs. Midwifery Res. 19, 349–353 (2014).

    PubMed  PubMed Central  Google Scholar 

  22. Ahlqvist‐Björkroth, S. et al. Fewer maternal depression symptoms after the close collaboration with parents intervention: two‐year follow‐up. Acta Paediatr. 111, 1160–1166 (2022).

    Article  PubMed  PubMed Central  Google Scholar 

  23. Ansari, N. S., Franck, L. S., Tomlinson, C., Colucci, A. & O’Brien, K. A pilot study of family-integrated care (FICare) in critically Ill preterm and term infants in the Nicu: FICare Plus. Children 10, 1337 (2023).

    Article  PubMed  PubMed Central  Google Scholar 

  24. Bastani, F., Abadi, T. A. & Haghani, H. Effect of family-centered care on improving parental satisfaction and reducing readmission among premature infants: a randomized controlled trial. J. Clin. Diagn. Res. 9, SC04–SC08 (2015).

    PubMed  PubMed Central  Google Scholar 

  25. Borimnejad, L., Mehrnoosh, N., Fatemi, N. S. & Haghani, H. Impacts of creating opportunities for parent empowerment on maternal stress: a quasi-experimental study. Iran. J. Nurs. Midwifery Res. 18, 218–221 (2013).

    PubMed  PubMed Central  Google Scholar 

  26. Bostanabad, M., NamdarArshatnab, H., Balila, M., Asghari Jafarabadi, M. & Ravanbakhsh, K. Effect of family-centered intervention in neonatal intensive care unit on anxiety of parents. Int. J. Pediatr. 5, 5101–5111 (2017).

    Google Scholar 

  27. Chen, H. & Dong, L. The effect of family integrated care on the prognosis of premature infants. BMC Pediatr. 22, 1–7 (2022).

    Article  Google Scholar 

  28. Dai, K. et al. Application of family-centered empowerment model in primary caregivers of premature infants: a quasi-experimental study. Front. Pediatr. 11, 1137188 (2023).

    Article  PubMed  PubMed Central  Google Scholar 

  29. De Bernardo, G., Svelto, M., Giordano, M., Sordino, D. & Riccitelli, M. Application of family-centered empowerment model in primary caregivers of premature infants: a quasi-experimental study. Italian Journal of Pediatrics 43, 1–11 (2017).

  30. Franck, L. S. et al. Neonatal outcomes from a quasi-experimental clinical trial of family integrated care versus family-centered care for preterm infants in U.S. Nicus. BMC Pediatr. 22, 1–14 (2022).

    Article  Google Scholar 

  31. Franck, L. S. et al. Maternal mental health after infant discharge: a quasi-experimental clinical trial of family integrated care versus family-centered care for preterm infants in U.S. Nicus. BMC Pediatrics 23, 396 (2023).

  32. Glazebrook, C. et al. Randomised Trial of a Parenting Intervention During Neonatal Intensive Care. Arch. Dis. Child. - Fetal Neonatal Ed. 92, F438–F443 (2007).

    Article  PubMed  PubMed Central  Google Scholar 

  33. He, F. B. et al. Effectiveness of the close collaboration with parents intervention on parent-infant closeness in Nicu. BMC Pediatr. 21, 1–8 (2021).

  34. He, S.-W. et al. Impact of Family Integrated Care on Infants’ Clinical Outcomes in Two Children’s Hospitals in China: A Pre-Post Intervention Study. Ital. J. Pediatr. 44, 1–7 (2018).

  35. Hei, M. et al. Family integrated care for preterm infants in china: a cluster randomized controlled trial. J. Pediatr. 228, 36–43 e32 (2021).

    Article  PubMed  Google Scholar 

  36. Heo, Y. J. & Oh, W. O. The effectiveness of a parent participation improvement program for parents on partnership, attachment infant growth in a neonatal intensive care unit: a randomized controlled trial. Int J. Nurs. Stud. 95, 19–27 (2019).

    Article  PubMed  Google Scholar 

  37. Horner, S., Benbrook, K., Hoffman, M. & Libutti, L. Implementing Guidelines for Nicu Parent Presence: Effects on Parent and Infant Stress. J. Perinat. Neonatal. Nurs. (2023).

  38. Ingram, J. C. et al. Does family-centred neonatal discharge planning reduce healthcare usage? A before and after study in South West England. BMJ Open 6, e010752 (2016).

    Article  PubMed  PubMed Central  Google Scholar 

  39. Khanjari, S. et al. The effect of family-centered education on the quality of life of the parents of premature infants. J. Neonatal Nurs. 28, 407–412 (2022).

    Article  Google Scholar 

  40. Lehtonen, L. et al. Parent–infant closeness after preterm birth and depressive symptoms: a longitudinal study. Front. Psychol. 13, 906531 (2022).

  41. Liang, X., Miao, A., Zhang, W., Li, M. & Xing, Y. Effect of family integrated care on physical growth and language development of premature infants: a retrospective study. Transl. Pediatr. 11, 965–977 (2022).

    Article  PubMed  PubMed Central  Google Scholar 

  42. Liu, M., Xu, Y. & Li, Y. Effects of family participatory nursing on clinical outcomes of premature infants in Nicu and families’ psychological status. Contrast Media Mol. Imaging 2022, 1–8 (2022).

    CAS  Google Scholar 

  43. Lv, B. et al. Family-centered care improves clinical outcomes of very-low-birth-weight infants: a quasi-experimental study. Front. Pediatr. 7, 138 (2019).

  44. Månsson, C., Sivberg, B., Selander, B. & Lundqvist, P. The impact of an individualised neonatal parent support programme on parental stress: a quasi‐experimental study. Scand. J. Caring Sci. 33, 677–687 (2019).

    Article  PubMed  Google Scholar 

  45. McLean, M. A. et al. Lower maternal chronic physiological stress and better child behavior at 18 months: follow-up of a cluster randomized trial of neonatal intensive care unit family integrated care. J. Pediatr. 243, 107–115.e104 (2022).

    Article  PubMed  Google Scholar 

  46. Melnyk, B. M. et al. Improving cognitive development of low‐birth‐weight premature infants with the cope program: a pilot study of the benefit of early Nicu intervention with mothers. Res. Nurs. Health 24, 373–389 (2001).

    Article  CAS  PubMed  Google Scholar 

  47. Melnyk, B. M. et al. Reducing premature infants’ length of stay and improving parents’ mental health outcomes with the Creating Opportunities for Parent Empowerment (COPE) neonatal intensive care unit program: a randomized, controlled trial. Pediatrics 118, e1414–e1427 (2006).

    Article  PubMed  Google Scholar 

  48. Mianaei, S. J., Karahroudy, F. A., Rassouli, M. & Tafreshi, M. Z. The effect of creating opportunities for parent empowerment program on maternal stress, anxiety, and participation in Nicu Wards in Iran. Iran. J. Nurs. Midwifery Res. 19, 94–100 (2014).

    PubMed  PubMed Central  Google Scholar 

  49. Nieves, H., Clements-Hickman, A. & Davies, C. C. Effect of a parent empowerment program on parental stress, satisfaction, and length of stay in the neonatal intensive care unit. J. Perinat. Neonatal Nurs. 35, 92–99 (2021).

    Article  PubMed  Google Scholar 

  50. O’Brien, K. et al. Effectiveness of family integrated care in neonatal intensive care units on infant and parent outcomes: a multicentre, multinational, cluster-randomised controlled trial. Lancet Child Adolesc. Health 2, 245–254 (2018).

    Article  PubMed  Google Scholar 

  51. Ou, J., Zhong, X. & Zhang, X. Effects of family integrated care on weight gain in extremely preterm infants. Minerva Pediatr. 75, 253–259 (2023).

    Article  Google Scholar 

  52. Penticuff, J. H. & Arheart, K. L. Effectiveness of an intervention to improve parent-professional collaboration in neonatal intensive care. J. Perinat. Neonatal Nurs. 19, 187–202 (2005).

  53. Rajabzadeh, Z., Moudi, Z., Abbasi, A. & Miri-Aliabad, G. The effect of family-centered educational supportive intervention on parental stress of premature infants hospitalized in the Nicu. Med. Surg. Nurs. J. 9, e111847 (2021).

  54. Sajadi, H., Akhoundzadeh, G. & Hojjati, H. The effect of empowerment program on participation of mothers with premature infants hospitalized in neonatal intensive care unit of Sayyed Shirazi Hospital in Gorgan, in 2018. Indian J. Forensic Med. Toxicol. 14, 1269–1276 (2020).

    Google Scholar 

  55. Samsudin, S. et al. The impact of structured kangaroo care education on premature infants’ weight gain, breastfeeding and length of hospitalization in Malaysia. J. Multidiscip. Healthc. 16, 1023–1035 (2023).

    Article  PubMed  PubMed Central  Google Scholar 

  56. Van Veenendaal, N. R. et al. Association of a family integrated care model with paternal mental health outcomes during neonatal hospitalization. JAMA Netw. Open 5, e2144720 (2022).

    Article  PubMed  PubMed Central  Google Scholar 

  57. Verma, A. et al. Family-centered care to complement care of sick newborns: a randomized controlled trial. Indian Pediatr. 54, 455–459 (2017).

    Article  PubMed  Google Scholar 

  58. Weis, J., Zoffmann, V., Greisen, G. & Egerod, I. The effect of person-centred communication on parental stress in a Nicu: a randomized clinical trial. Acta Paediatr. 102, 1130–1136 (2013).

    Article  CAS  PubMed  Google Scholar 

  59. Yu, Y.-T. et al. Family-centered care improved neonatal medical and neurobehavioral outcomes in preterm infants: randomized controlled trial. Phys. Ther. 97, 1158–1168 (2017).

    Article  PubMed  Google Scholar 

  60. Yu, Y.-T. et al. Family-centered care enhanced neonatal neurophysiological function in preterm infants: randomized controlled trial. Phys. Ther. 99, 1690–1702 (2019).

    Article  PubMed  Google Scholar 

  61. Zhang, R. et al. Involvement of parents in the care of preterm infants: a pilot study evaluating a family-centered care intervention in a chinese neonatal ICU. Pediatr. Crit. Care Med. 19, 741–747 (2018).

    Article  PubMed  Google Scholar 

  62. Zhang, Y. et al. Effect of family integrated care on maternal stress in preterm infants in the neonatal intensive care unit: a bi‐center experience. Asia-Pac. Psychiatry 15, e12521 (2023).

  63. Beaton, D., Maxwell, L., Grosskleg, S., Shea, B. and Tugwell, P. The OMERACT Handbook Version 2.1. https://omeract.org/wp-content/uploads/2021/12/ (2021)

  64. Williamson, P. R. et al. Developing core outcome sets for clinical trials: issues to consider. Trials 13, 132 (2012).

    Article  PubMed  PubMed Central  Google Scholar 

  65. Bialy, L., Vandermeer, B., Lacaze‐Masmonteil, T., Dryden, D. M. & Hartling, L. A meta‐epidemiological study to examine the association between bias and treatment effects in neonatal trials. Evid. Based Child Health 9, 1052–1059 (2014).

    Article  PubMed  Google Scholar 

  66. Page, M. J. et al. Epidemiology and reporting characteristics of systematic reviews of biomedical research: a cross-sectional study. PLoS Med. 13, e1002028 (2016).

    Article  PubMed  PubMed Central  Google Scholar 

  67. Moher, D., Tetzlaff, J., Tricco, A. C., Sampson, M. & Altman, D. G. Epidemiology and reporting characteristics of systematic reviews. PLoS Med. 4, e78 (2007).

    Article  PubMed  PubMed Central  Google Scholar 

  68. Franck, L. S. et al. Improving family-centered care for infants in neonatal intensive care units: recommendations from frontline healthcare professionals. Adv. Neonatal Care 22, 79–86 (2022).

    Article  PubMed  Google Scholar 

  69. Raiskila, S. et al. Parents’ presence and parent–infant closeness in 11 neonatal intensive care units in six European countries vary between and within the countries. Acta Paediatr. 106, 878–888 (2017).

    Article  PubMed  PubMed Central  Google Scholar 

  70. Alsadaan, N. et al. Impacts of integrating family-centered care and developmental care principles on neonatal neurodevelopmental outcomes among high-risk neonates. Children 10, 1751 (2023).

    Article  PubMed  PubMed Central  Google Scholar 

  71. North, K. et al. Family Involvement in the Routine Care of Hospitalized Preterm or Low Birth Weight Infants: A Systematic Review and Meta-Analysis. Pediatrics 150, e2022057092O (2022).

  72. Vetcho, S., Cooke, M. & Ullman, A. J. Family-centred care in dedicated neonatal units: an integrative review of international perspectives. J. Neonatal Nurs. 26, 73–92 (2020).

    Article  Google Scholar 

  73. Tugwell, P. et al. Omeract: an international initiative to improve outcome measurement in rheumatology. Trials 8, 38 (2007).

    Article  PubMed  PubMed Central  Google Scholar 

  74. Fink, E. L. et al. A core outcome set for pediatric critical care. Crit. Care Med. 48, 1819–1828 (2020).

    Article  PubMed  PubMed Central  Google Scholar 

  75. Henry, C. J. et al. Neonatal sepsis: a systematic review of core outcomes from randomised clinical trials. Pediatr. Res. 91, 735–742 (2022).

    Article  PubMed  PubMed Central  Google Scholar 

  76. Gallagher, K., Chant, K., Mancini, A., Bluebond-Langner, M. & Marlow, N. The neopace study: study protocol for the development of a core outcome set for neonatal palliative care. BMC Palliat. Care 22, 203 (2023).

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Funding

This work was partially funded by the Republic of Turkey Ministry of National Education. The first author, Cansel Kocakabak, received a PhD studentship of the Republic of Turkey Ministry of National Education.

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Authors and Affiliations

  1. School of Nursing and Midwifery, Faculty of Health, University of Plymouth, Plymouth, UK

    Cansel Kocakabak, Patricia Schofield & Jos M. Latour

  2. Department Women and Baby, Neonatology, Wilhelmina Children’s Hospital, University Medical Centre Utrecht, The Netherlands, Utrecht University, Utrecht, The Netherlands

    Agnes van den Hoogen

  3. Dalhousie Libraries, Dalhousie University, Halifax, NS, Canada

    Melissa Rothfus

  4. School of Nursing, Faculty of Health, Dalhousie University, Halifax, NS, Canada

    Marsha Campbell-Yeo

  5. European Foundation for the Care of Newborn Infants, Munich, Germany

    Johanna Kostenzer

  6. Department of Nursing Science, University of Turku, Turku, Finland

    Anna Axelin

  7. Department of Nursing, Zhongshan Hospital, Fudan University, Shanghai, China

    Jos M. Latour

  8. Curtin School of Nursing, Curtin University, Perth, WA, Australia

    Jos M. Latour

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  1. Cansel Kocakabak
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  2. Agnes van den Hoogen
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  4. Marsha Campbell-Yeo
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Contributions

A.v.d.H. and J.M.L. designed the review protocol. M.R. devised the search strategies for each database and ran the searches. C.K., M.S., A.v.d.H., J.M.L., M.C.Y., and J.K. screened articles to be included in the review. C.K., A.v.d.H., and J.M.L. performed the data synthesis. A.A., J.K., M.C.Y., M.S., and P.S. checked and confirmed the data synthesis. C.K., A.v.d.H., J.M.L., and P.S. drafted the first manuscript. A.A., J.K., M.C.Y., M.S. contributed to revised manuscript versions. All authors agreed on the final manuscript version and agreed to be accountable for the work reported in the manuscript.

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Correspondence to Cansel Kocakabak.

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Kocakabak, C., van den Hoogen, A., Rothfus, M. et al. Identifying outcomes and outcome measures in neonatal family-centered care trials: a systematic review. Pediatr Res 97, 56–66 (2025). https://doi.org/10.1038/s41390-024-03293-2

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