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Clinical Trials/NCT01852695
NCT01852695
Unknown
Not Applicable

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

Mount Sinai Hospital, Canada15 sites in 1 country720 target enrollmentMarch 2013
ConditionsPremature Birth

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Premature Birth
Sponsor
Mount Sinai Hospital, Canada
Enrollment
720
Locations
15
Primary Endpoint
Weight Gain
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 2013
End Date
March 2017
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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).

Outcomes

Primary Outcomes

Weight Gain

Time Frame: Day 0-21

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

Secondary Outcomes

  • Weight gain velocity(Day 0-21)
  • Resource Use(Day 0 -week 16)
  • Breastfeeding rate(up to 16 weeks)
  • Parental stress and anxiety(Day 0 and when the infant reaches 35 weeks corrected gestational age)
  • 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)

Study Sites (15)

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