Clinical trial NCT01852695: Family Integrated Care in the NICU
Official title: A Family Integrated Care Model For The Neonatal Intensive Care Unit: A Cluster Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Premature Birth
Keywords: Family integrated Care
Family centered care
NICU family centered care
NICU parent program
Lead sponsor: Mount Sinai Hospital, Canada
Sponsor class: OTHER
Collaborators: name: Foothills Medical Centre
name: Sunnybrook Health Sciences Centre
name: London Health Sciences Centre
name: St. Boniface Hospital
name: CHU de Quebec-Universite Laval
name: IWK Health Centre
name: Hamilton Health Sciences Corporation
name: The Hospital for Sick Children
name: Horizon Health Network
name: Regina General Hospital
name: Royal University Hospital Foundation
name: Windsor Regional Hospital
name: Centre de recherche du Centre hospitalier universitaire de Sherbrooke
name: The Moncton Hospital
name: Health Sciences Centre, Winnipeg, Manitoba
name: Kingston Health Sciences Centre
name: Victoria General Hospital
name: Janeway Hospital
First posted: 2013-05-14
Enrollment: 720
Sex: ALL
Maximum age (years): 33
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.


Eligibility criteria: Inclusion Criteria:

* \< 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.

Exclusion Criteria:

* 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).

Primary outcomes:
measure: Weight Gain
timeFrame: Day 0-21
Secondary outcomes:
measure: Weight gain velocity
timeFrame: Day 0-21
measure: Breastfeeding rate
timeFrame: up to 16 weeks
measure: Clinical outcomes (mortality and Nosocomial infection (NI), Necrotizing Enterocolitis (NEC), Bronchopulmonary Dysplasia(BPD), Retinopathy of prematurity(ROP) & Intraventricular haemorrhage(IVH)
timeFrame: up to 16 weeks
measure: Safety
timeFrame: 1000 patient days
measure: Parental stress and anxiety
timeFrame: Day 0 and when the infant reaches 35 weeks corrected gestational age
measure: Resource Use
timeFrame: Day 0 -week 16
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Foothills Medical Centre
state: Alberta
city: Winnipeg
country: Canada
facility: Health Sciences Centre, Winnipeg
state: Manitoba
city: Winnipeg
country: Canada
facility: St. Boniface General Hospital
state: Manitoba
city: Moncton
country: Canada
facility: The Moncton Hospital
state: New Brunswick
city: Saint John
country: Canada
facility: Saint John Regional Hospital
state: New Brunswick
city: Halifax
country: Canada
facility: IWK Health Centre
state: Nova Scotia
city: Hamilton
country: Canada
facility: Hamilton Health Sciences Centre
state: Ontario
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: Hospital for Sick Children
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Windsor
country: Canada
facility: Windsor Regional Hospital
state: Ontario
city: Laval
country: Canada
facility: Centre hospitalier universitaire de Québec
state: Quebec
city: Sherbrooke
country: Canada
facility: Centre Hospitalier Universitaire de Sherbrooke
state: Quebec
city: Regina
country: Canada
facility: Regina General Hospital
state: Saskatchewan
city: Saskatoon
country: Canada
facility: Royal University Hospital
state: Saskatchewan
Study officials:
affiliation: MOUNT SINAI HOSPITAL
name: Shoo K Lee, FRCPC PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.