NCT01852695

Brief Summary

In the highly technological environment of the modern neonatal intensive care unit (NICU), the infant is physically, psychologically and emotionally separated from its parents. Recognition that this impedes parent- infant interaction and is detrimental to the infant, led to the development of programs such as family centered care, kangaroo care and skin-to-skin care1-3. However, they are based on the common premise that only NICU professionals with special skills can provide care for the infant. Parents are relegated to a supportive role, and some have described themselves as voyeurs who are "allowed" to visit and hold their infants4. Many feel anxious and unprepared to care for their infants after discharge5. In 1979, a shortage of NICU nurses in Estonia prompted Levin1,6 to implement a "humane" care model in which parents provided nursing care for the infant (except for administration of IV fluid and medication), while nurses provided teaching and guidance to parents. This resulted in 30% improvement in weight gain1,30% reduction in infections, 20% reduction in NICU length of stay, 50% reduction in nurse utilization and overall improved satisfaction among parents and staff \[personal communication, Levin,A.\]. Building on the Estonian experience, we have developed a new Family Integrated Care (FIC) model that is adapted for the NICU environment in North America. In a pilot study at Mount Sinai Hospital, Toronto 46 infants and their families were enrolled in the study. Preliminary results and feedback from parents and healthcare providers (HCP) show that the FIC model is both feasible and safe, and may lead to improved outcomes including improved weight gain(paper submitted for publication). This study is a cluster randomized controlled trial in 16 tertiary level NICUs, to evaluate the efficacy of the FIC model in Canada.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
720

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

15 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 19, 2012

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2013

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 14, 2013

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

October 4, 2016

Status Verified

October 1, 2015

Enrollment Period

2.6 years

First QC Date

December 19, 2012

Last Update Submit

October 3, 2016

Conditions

Premature Birth

Keywords

Family integrated CareFamily centered careNICU family centered careNICU parent program

Outcome Measures

Primary Outcomes (1)

  • Weight Gain

    Change in weight from enrollment to day 21 following commencement of the intervention

    Day 0-21

Secondary Outcomes (6)

  • Weight gain velocity

    Day 0-21

  • Breastfeeding rate

    up to 16 weeks

  • Clinical outcomes (mortality and Nosocomial infection (NI), Necrotizing Enterocolitis (NEC), Bronchopulmonary Dysplasia(BPD), Retinopathy of prematurity(ROP) & Intraventricular haemorrhage(IVH)

    up to 16 weeks

  • Safety

    1000 patient days

  • Parental stress and anxiety

    Day 0 and when the infant reaches 35 weeks corrected gestational age

  • +1 more secondary outcomes

Study Arms (2)

Family Integrated Care Arm

EXPERIMENTAL

Parents are integrated into the care of their infants in the NICU. Parents consent to spending up to eight hours a day with their infant, attend special education sessions, participate in daily medical rounds, and do basic infant charting. This will enable parents to provide care for infants with nursing supervision in the areas of feeding, bathing, dressing and holding skin to skin.

Behavioral: Family Integrated Care

Control Arm

NO INTERVENTION

Regular care by nurse will be provided to patients admitted to control sites.

Interventions

Family Integrated CareBEHAVIORAL

Parents are integrated into the care of their infants in the NICU. Parents consent to spending up to eight hours a day with their infant, attend special education sessions, participate in daily medical rounds, and do basic infant charting. This will enable parents to provide care for infants with nursing supervision in the areas of feeding, bathing, dressing and holding skin to skin.

Family Integrated Care Arm

Eligibility Criteria

AgeUp to 33 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • \< 33 weeks gestational age at birth;
  • On no respiratory support or low level respiratory support (i.e., oxygen by cannula or mask, or continuous positive airway pressure (CPAP);
  • A primary caregiver parent who is willing and able to commit to spending at least 8 hours per day with her/his infant between the hours of 0700 and 2000;
  • Parental consent.

You may not qualify if:

  • Palliative care;
  • Major life threatening congenital anomaly;
  • Critical illness (unlikely to survive);
  • On high level of respiratory support (mechanical ventilator, high frequency oscillatory or jet ventilation, extra-corporeal membrane oxygenation)
  • Parental request for early transfer to another hospital;
  • Parental inability to participate (e.g., health, social or language issues that might inhibit their ability to communicate with the healthcare team).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Foothills Medical Centre

Calgary, Alberta, Canada

Location

Health Sciences Centre, Winnipeg

Winnipeg, Manitoba, Canada

Location

St. Boniface General Hospital

Winnipeg, Manitoba, Canada

Location

The Moncton Hospital

Moncton, New Brunswick, Canada

Location

Saint John Regional Hospital

Saint John, New Brunswick, Canada

Location

IWK Health Centre

Halifax, Nova Scotia, Canada

Location

Hamilton Health Sciences Centre

Hamilton, Ontario, Canada

Location

London Health Sciences Centre

London, Ontario, Canada

Location

Hospital for Sick Children

Toronto, Ontario, Canada

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Location

Windsor Regional Hospital

Windsor, Ontario, Canada

Location

Centre hospitalier universitaire de Québec

Laval, Quebec, Canada

Location

Centre Hospitalier Universitaire de Sherbrooke

Sherbrooke, Quebec, Canada

Location

Regina General Hospital

Regina, Saskatchewan, Canada

Location

Royal University Hospital

Saskatoon, Saskatchewan, Canada

Location

Related Publications (4)

  • Mclean MA, Scoten OC, Yu W, Ye XY, Petrie J, Church PT, Soraisham AS, Mirea LS, Weinberg J, Synnes AR, O'Brien K, Grunau RE. 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. 2022 Apr;243:107-115.e4. doi: 10.1016/j.jpeds.2021.12.055. Epub 2021 Dec 29.

    PMID: 34971651DERIVED

  • Synnes AR, Petrie J, Grunau RE, Church P, Kelly E, Moddemann D, Ye X, Lee SK, O'Brien K; Canadian Neonatal Network Investigators; Canadian Neonatal Follow-Up Network Investigators. Family integrated care: very preterm neurodevelopmental outcomes at 18 months. Arch Dis Child Fetal Neonatal Ed. 2022 Jan;107(1):76-81. doi: 10.1136/archdischild-2020-321055. Epub 2021 Jun 18.

    PMID: 34145042DERIVED

  • 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. 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. 2018 Apr;2(4):245-254. doi: 10.1016/S2352-4642(18)30039-7. Epub 2018 Feb 8.

    PMID: 30169298DERIVED

  • 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. Evaluation of the Family Integrated Care model of neonatal intensive care: a cluster randomized controlled trial in Canada and Australia. BMC Pediatr. 2015 Dec 15;15:210. doi: 10.1186/s12887-015-0527-0.

    PMID: 26671340DERIVED

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Shoo K Lee, FRCPC PhD

    MOUNT SINAI HOSPITAL

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 19, 2012

First Posted

May 14, 2013

Study Start

March 1, 2013

Primary Completion

October 1, 2015

Study Completion

March 1, 2017

Last Updated

October 4, 2016

Record last verified: 2015-10

Data Sharing

IPD Sharing
Will not share

Locations

CA(15)