CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 765 enrolled
Drug / intervention
Implement Family Integrated Careother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02879799
NCT02879799N/ACompleted

Family Integrated Care (FICare) in Level II NICUs: An Innovative Program for Alberta

University of Calgary·interventional·Posted Aug 26, 2016·Updated Sep 26, 2019

In Brief

A clinical study evaluating Implement Family Integrated Care for Premature Birth. Completed, enrolled 765 participants across 10 sites.

Detailed Summary

In Alberta, nearly one in every twelve babies is born too soon (preterm). Preterm babies are at greater risk for breathing and feeding problems, as well as infections, than babies born on their due date (full term). As a result, parents must leave their preterm babies in the hospital to fully develop and become healthy enough to take home. When it is time for discharge, parents are often not ready to look after their baby because they may have limited involvement in the care of their baby in hospital. In addition to the distress and costs to parents of having a baby in hospital, health system costs are also increased the longer a baby is in hospital. The purpose of this project is to test a new way to integrate parents into the care of their baby through a program called Family Integrated Care (FICare). In FICare, parents are educated and supported by nurses to provide care for their baby; nurses and doctors still provide intravenous medications and medical procedures. FICare has been tested in Ontario and shows promise as a better model of care for the small percentage of babies born more than 8 weeks early, who have to spend a long time in hospital. Now the investigators want to test FICare with the greater percentage of preterm babies who are born 4 to 8 weeks early to see if parents are able to take their baby home sooner, and if their babies are healthier. The investigators also want to know if FICare can reduce distress for parents. The investigators propose to test FICare in Level II Neonatal Intensive Care Units (NICUs) in Alberta by implementing FICare in half the Level II NICUs and comparing the outcomes with the other Level II NICUs who do not use FICare. If FICare improves outcomes for preterm babies and their parents, the investigators will implement it in all Level II NICUs. In Alberta, the investigators want the best quality care for our most vulnerable babies and their parents. This project is aligned with Alberta's Health Research and Innovation Strategy priority of wellness at every age (child and maternal health), and with Alberta Health Services' quality of care goals to increase efficiency, effectiveness, appropriateness, and acceptability of health care services delivery.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPremature Birth
CountriesCanada
Collaborators--

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedAug 26, 2016
Enrollment StartSep 1, 2015
Primary CompletionJul 26, 2018
Study CompletionDec 10, 2018
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 9.8 years ago

Interventions

Implement Family Integrated Careother

Specially trained FICare nurses will provide education and support for families to provide care for the baby while they are present in the NICU. Study mothers will meet with veteran parents for additional support. Families will keep a log of their activities and costs.