Overview

This trial is active, not recruiting.

Condition premature birth
Treatment family integrated care
Sponsor Mount Sinai Hospital, Canada
Collaborator Foothills Medical Centre
Start date March 2013
End date October 2015
Trial size 720 participants
Trial identifier NCT01852695, 122173

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
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.
family integrated care
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.
(No Intervention)
Regular care by nurse will be provided to patients admitted to control sites.

Primary Outcomes

Measure
Weight Gain
time frame: Day 0-21

Secondary Outcomes

Measure
Weight gain velocity
time frame: Day 0-21
Breastfeeding rate
time frame: up to 16 weeks
Clinical outcomes (mortality and Nosocomial infection (NI), Necrotizing Enterocolitis (NEC), Bronchopulmonary Dysplasia(BPD), Retinopathy of prematurity(ROP) & Intraventricular haemorrhage(IVH)
time frame: up to 16 weeks
Safety
time frame: 1000 patient days
Parental stress and anxiety
time frame: Day 0 and when the infant reaches 35 weeks corrected gestational age
Resource Use
time frame: Day 0 -week 16

Eligibility Criteria

Male or female participants up to 33 weeks old.

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).

Additional Information

Official title A Family Integrated Care Model For The Neonatal Intensive Care Unit: A Cluster Randomised Controlled Trial
Principal investigator Shoo K Lee, FRCPC PhD
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Mount Sinai Hospital, Canada.