Family Integrated Care in the NICU

A Family Integrated Care Model For The Neonatal Intensive Care Unit: A Cluster Randomised Controlled Trial

Sponsors

Lead Sponsor: Mount Sinai Hospital, Canada

Collaborator: Foothills Medical Centre
Sunnybrook Health Sciences Centre
London Health Sciences Centre
St. Boniface Hospital
CHU de Quebec-Universite Laval
IWK Health Centre
Hamilton Health Sciences Corporation
The Hospital for Sick Children
Horizon Health Network
Regina General Hospital
Royal University Hospital Foundation
Windsor Regional Hospital
Centre de recherche du Centre hospitalier universitaire de Sherbrooke
The Moncton Hospital
Health Sciences Centre, Winnipeg, Manitoba
Kingston Health Sciences Centre
Victoria General Hospital
Janeway Hospital

Source Mount Sinai Hospital, Canada
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.

Overall Status Unknown status
Start Date 2013-03-01
Completion Date 2017-03-01
Primary Completion Date 2015-10-01
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Weight Gain Day 0-21
Secondary Outcome
Measure Time Frame
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
Resource Use Day 0 -week 16
Enrollment 720
Condition
Intervention

Intervention Type: Behavioral

Intervention Name: Family Integrated Care

Description: 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.

Arm Group Label: Family Integrated Care Arm

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).

Gender:

All

Minimum Age:

N/A

Maximum Age:

33 Weeks

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Shoo K Lee, FRCPC PhD Principal Investigator MOUNT SINAI HOSPITAL
Location
Facility:
Foothills Medical Centre | Calgary, Alberta, Canada
Health Sciences Centre, Winnipeg | Winnipeg, Manitoba, Canada
St. Boniface General Hospital | Winnipeg, Manitoba, Canada
The Moncton Hospital | Moncton, New Brunswick, Canada
Saint John Regional Hospital | Saint John, New Brunswick, Canada
IWK Health Centre | Halifax, Nova Scotia, Canada
Hamilton Health Sciences Centre | Hamilton, Ontario, Canada
London Health Sciences Centre | London, Ontario, Canada
Hospital for Sick Children | Toronto, Ontario, Canada
Sunnybrook Health Sciences Centre | Toronto, Ontario, Canada
Windsor Regional Hospital | Windsor, Ontario, Canada
Centre hospitalier universitaire de Québec | Laval, Quebec, Canada
Centre Hospitalier Universitaire de Sherbrooke | Sherbrooke, Quebec, Canada
Regina General Hospital | Regina, Saskatchewan, Canada
Royal University Hospital | Saskatoon, Saskatchewan, Canada
Location Countries

Canada

Verification Date

2015-10-01

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Family Integrated Care Arm

Type: Experimental

Description: 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.

Label: Control Arm

Type: No Intervention

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

Acronym FICare
Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Masking: None (Open Label)

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