Family Integrated Care in the NICU

NCT01852695 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 720

Last updated 2016-10-04

No results posted yet for this study

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.

Conditions

  • Premature Birth

Interventions

BEHAVIORAL

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.

Sponsors & Collaborators

  • Foothills Medical Centre

    collaborator OTHER
  • Sunnybrook Health Sciences Centre

    collaborator OTHER
  • London Health Sciences Centre

    collaborator OTHER
  • St. Boniface Hospital

    collaborator OTHER
  • CHU de Quebec-Universite Laval

    collaborator OTHER
  • IWK Health Centre

    collaborator OTHER
  • Hamilton Health Sciences Corporation

    collaborator OTHER
  • The Hospital for Sick Children

    collaborator OTHER
  • Horizon Health Network

    collaborator OTHER
  • Regina General Hospital

    collaborator OTHER
  • Royal University Hospital Foundation

    collaborator OTHER
  • Windsor Regional Hospital

    collaborator OTHER
  • Centre de recherche du Centre hospitalier universitaire de Sherbrooke

    collaborator OTHER
  • The Moncton Hospital

    collaborator UNKNOWN
  • Health Sciences Centre, Winnipeg, Manitoba

    collaborator OTHER
  • Kingston Health Sciences Centre

    collaborator OTHER
  • Victoria General Hospital

    collaborator UNKNOWN
  • Janeway Hospital

    collaborator UNKNOWN
  • Mount Sinai Hospital, Canada

    lead OTHER

Principal Investigators

  • Shoo K Lee, FRCPC PhD · MOUNT SINAI HOSPITAL

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
33 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-03-31
Primary Completion
2015-10-31
Completion
2017-03-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01852695 on ClinicalTrials.gov