Research

The FICare model was originally developed by a team of doctors, nurses, parents and other health professionals at Mount Sinai Hospital in Toronto.

Our group has conducted and published the results of a pilot study investigating the impact of FICare on infants and parents. The study is summarized below. We have also completed a cluster randomised controlled trial investigating outcomes observed under the FICare model in 19 Canadian, 6 Australian and 1 New Zealand NICUs (13 intervention sites, 13 control sites) also summarized below.

Pilot Study Details *

Pilot start date: March, 2011
Length of study: 12 months
Number of patients enrolled: 40 patients
Location: 4 bed spaces reserved in Level II FICare area
Time Commitment for Parents: Minimum 8 hours each day – during day

Inclusion Criteria:

< 35 weeks gestation, on low level respiratory support, a primary caregiver parent, willing and able to commit to spending 8 hours per day with their baby between the hours of 0700 and 2000, parental consent.

Exclusion criteria:

Palliative care, severe congenital anomaly, critical illness (unlikely to survive), parental request for early transfer, parental inability to participate.

Subjects:

The pilot study enrolled 42 mothers (4 sets of twins), 17 (40%) of whom had other children at home. The majority (22, 55%) were Canadian born; 11 lived in Canada >10 years. All subjects had at least grade 10 high school education; and 27 (71%) were employed outside the home. The subjects varied in age from 23-45 years (mean 33 years).

Key Outcomes of the Pilot Study:

Improved weight gain, fewer nosocomial infections, increased breastfeeding rates, less ROP, and fewer incident reports were filed. Parents also reported decreased parental stress.

* A pilot cohort analytic study of Family Integrated Care in a Canadian neonatal intensive care unit. BMC Pregnancy Childbirth, Volume 13 Suppl 1:S12, 2013

Randomized Control Trial

Number of centers enrolled: 19 Canadian, 6 Australian, and 1 New Zealand NICUs randomized to FICare or current standard-of-care (13 intervention sites/13 control sites). Teams from the intervention sites received a 2-day workshop on how FICare was to be implemented at their sites.

Intervention sites:

  • All intervention sites were expected to: train nursing staff to support FICare, provide an ongoing parent education program, develop and provide opportunities for veteran parent/peer-to-peer support, and develop environmental and policy supports for FICare
  • Each site had a visit by research staff to support and assess the implementation of the model

Inclusion Criteria:

Infants born < 33 weeks gestation, on low level respiratory support, a primary caregiver parent, willing and able to commit to spending 6 hours per day with their baby between the hours of 0700 and 2000, parental consent.

Exclusion Criteria:

Palliative care, severe congenital anomaly, critical illness (unlikely to survive), on high level of respiratory support, parental request for early transfer, parental inability to participate.

Outcomes Being Measured:

The primary outcome is weight gain. Secondary outcomes include breastfeeding rates, clinical outcomes, safety, parental stress and anxiety, and resource use.

Key outcomes of the cRCT:

Improved weight gain, decreased parent stress and anxiety, improved breast feeding

Research paper:

Evaluation of the Family Integrated Care model of neonatal intensive care: a cluster randomized controlled trial in Canada and Australia.
O’Brien K, Bracht M, Robson K, Ye XY, Mirea L, Cruz M, Ng E, Monterrosa L, Soraisham A, Alvaro R, Narvey M, Da Silva O, Lui K, Tarnow-Mordi W, Lee SK.

            BMC Pediatr 2015 Dec 15;15:210.  doi: 10.1186/s12887-015-0527-0.

Research papers

2013:

Implementing family-integrated care in the NICU: a parent education and support program.
Bracht M, OʼLeary L, Lee SK, OʼBrien K.Adv Neonatal Care. 2013 Apr;13(2):115-26. doi: 10.1097/ANC.0b013e318285fb5b.PMID: 23532031

Implementing family-integrated care in the NICU: educating nurses.

Galarza-Winton ME, Dicky T, OʼLeary L, Lee SK, OʼBrien K.Adv Neonatal Care. 2013 Oct;13(5):335-40. doi: 10.1097/ANC.0b013e3182a14cde.PMID: 24042139

Implementing family-integrated care in the NICU: engaging veteran parents in program design and delivery.

Macdonell K, Christie K, Robson K, Pytlik K, Lee SK, OʼBrien K.Adv Neonatal Care. 2013 Aug;13(4):262-9, quiz 270-1. doi: 10.1097/ANC.0b013e31829d8319.PMID: 23912018 

A pilot cohort analytic study of Family Integrated Care in a Canadian neonatal intensive care unit.

O’Brien K, Bracht M, Macdonell K, McBride T, Robson K, O’Leary L, Christie K, Galarza M, Dicky T, Levin A, Lee SK.BMC Pregnancy Childbirth. 2013;13 Suppl 1(Suppl 1):S12. doi: 10.1186/1471-2393-13-S1-S12. Epub 2013 Jan 31.PMID: 23445639 Free PMC article.

 

2014:

Parents as practitioners in preterm care.

Jiang S, Warre R, Qiu X, O’Brien K, Lee SK.Early Hum Dev. 2014 Nov;90(11):781-5. doi: 10.1016/j.earlhumdev.2014.08.019. Epub 2014 Sep 20.PMID: 25246323 Review.

Parents as primary caregivers in the neonatal intensive care unit.

Lee SK, O’Brien K.CMAJ. 2014 Aug 5;186(11):845-7. doi: 10.1503/cmaj.130818. Epub 2014 Apr 7.PMID: 24710910 Free PMC article. 

 

2015:

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

O’Brien K, Bracht M, Robson K, Ye XY, Mirea L, Cruz M, Ng E, Monterrosa L, Soraisham A, Alvaro R, Narvey M, Da Silva O, Lui K, Tarnow-Mordi W, Lee SK.

            BMC Pediatr 2015 Dec 15;15:210.  doi: 10.1186/s12887-015-0527-0.

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

O’Brien K, Bracht M, Robson K, Ye XY, Mirea L, Cruz M, Ng E, Monterrosa L, Soraisham A, Alvaro R, Narvey M, Da Silva O, Lui K, Tarnow-Mordi W, Lee SK.BMC Pediatr. 2015 Dec 15;15:210. doi: 10.1186/s12887-015-0527-0.PMID: 26671340 Free PMC article. Clinical Trial.

 

2017:

Family Integrated Care (FICare) in Level II Neonatal Intensive Care Units: study protocol for a cluster randomized controlled trial.

Benzies KM, Shah V, Aziz K, Isaranuwatchai W, Palacio-Derflingher L, Scotland J, Larocque J, Mrklas K, Suter E, Naugler C, Stelfox HT, Chari R, Lodha A; Alberta FICare Level II NICU Study Team.Trials. 2017 Oct 10;18(1):467. doi: 10.1186/s13063-017-2181-3.PMID: 29017578 Free PMC article. Clinical Trial.

 

2018:

Family Integrated Care for very preterm infants: evidence for a practice that seems self-evident?

Gale C.Lancet Child Adolesc Health. 2018 Apr;2(4):230-231. doi: 10.1016/S2352-4642(18)30038-5. Epub 2018 Feb 8.PMID: 30169291 Free article. 

Impact of family integrated care on infants’ clinical outcomes in two children’s hospitals in China: a pre-post intervention study.

He SW, Xiong YE, Zhu LH, Lv B, Gao XR, Xiong H, Wang H, Shi HR, Latour JM.Ital J Pediatr. 2018 Jun 5;44(1):65. doi: 10.1186/s13052-018-0506-9.PMID: 29871689 Free PMC article. Clinical Trial.

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

O’Brien K, Robson K, Bracht M, Cruz M, Lui K, Alvaro R, da Silva O, Monterrosa L, Narvey M, Ng E, Soraisham A, Ye XY, Mirea L, Tarnow-Mordi W, Lee SK; FICare Study Group and FICare Parent Advisory Board.

Lancet Child Adolesc Health. 2018 Apr;2(4):245-254. doi: 10.1016/S2352-4642(18)30039-7. Epub 2018 Feb 8.PMID: 30169298 Clinical Trial.

Breastfeeding data in the Family Integrated Care trial.

O’Brien K, Lui K, Tarnow-Mordi W, Lee SK.Lancet Child Adolesc Health. 2018 Apr;2(4):e5. doi: 10.1016/S2352-4642(18)30072-5. Epub 2018 Mar 13.PMID: 30169303 No abstract available.

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

O’Brien K, Robson K, Bracht M, Cruz M, Lui K, Alvaro R, da Silva O, Monterrosa L, Narvey M, Ng E, Soraisham A, Ye XY, Mirea L, Tarnow-Mordi W, Lee SK; FICare Study Group and FICare Parent Advisory Board.Lancet Child Adolesc Health. 2018 Apr;2(4):245-254. doi: 10.1016/S2352-4642(18)30039-7. Epub 2018 Feb 8.PMID: 30169298 Clinical Trial.

Family Integrated Care: changing the culture in the neonatal unit.

Patel N, Ballantyne A, Bowker G, Weightman J, Weightman S; Helping Us Grow Group (HUGG).Arch Dis Child. 2018 May;103(5):415-419. doi: 10.1136/archdischild-2017-313282. Epub 2017 Nov 9.PMID: 29122741 No abstract available.

 

2019:

Evaluating the effect of Family Integrated Care on maternal stress and anxiety in neonatal intensive care units. Cheng C, Franck LS, Ye XY, Hutchinson SA, Lee SK, O’Brien K.J Reprod Infant Psychol. 2019 Sep 10:1-14. doi: 10.1080/02646838.2019.1659940. Online ahead of print.

The evolution of family-centered care: From supporting parent-delivered interventions to a model of family integrated care.

Franck LS, O’Brien K.Birth Defects Res. 2019 Sep 1;111(15):1044-1059. doi: 10.1002/bdr2.1521. Epub 2019 May 21.PMID: 31115181 Review.

A multilayered approach is needed in the NICU to support parents after the preterm birth of their infant.Treyvaud K, Spittle A, Anderson PJ, O’Brien K.

Early Hum Dev . 2019 Dec;139:104838. doi: 10.1016/j.earlhumdev.2019.104838. Epub 2019 Aug 27. Review

  

2020: 

Family Integrated Care for Preterm Infants.

Franck LS, Waddington C, O’Brien K.Crit Care Nurs Clin North Am. 2020 Jun;32(2):149-165. doi: 10.1016/j.cnc.2020.01.001. Epub 2020 Mar 31.

Hospitalising preterm infants in single family rooms versus open bay units: A systematic review and meta-analysis of impact on parents.

van Veenendaal NR, van Kempen AAMW, Franck LS, O’Brien K, Limpens J, van der Lee JH, van Goudoever JB, van der Schoor SRD.

EClinicalMedicine. 2020 Jun 6;23:100388. doi: 10.1016/j.eclinm.2020.100388. eCollection 2020 Jun Free PMC article

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

O’Brien K, Robson K, Bracht M, Cruz M, Lui K, Alvaro R, da Silva O, Monterrosa L, Narvey M, Ng E, Soraisham A, Ye XY, Mirea L, Tarnow-Mordi W, Lee SK; FICare Study Group and FICare Parent Advisory Board.Lancet Child Adolesc Health. 2018 Apr;2(4):245-254. doi: 10.1016/S2352-4642(18)30039-7. Epub 2018 Feb 8.PMID: 30169298 Clinical Trial.