Improving Preterm Infant Outcomes With Family Integrated Care and Mobile Technology

Conditions:Women's Studies
Therapuetic Areas:Reproductive
Age Range:Any
Start Date:April 3, 2017
End Date:July 2019
Contact:Rebecca Kriz, MS

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The purpose of this study is to compare the standard of care in the neonatal intensive care
unit (NICU), known as Family Centered Care, to a new model of care, called mobile enhanced
Family Integrated Care. This exploratory two-group comparison study will examine the
feasibility, acceptability and effectiveness, providing the first United States (US)
information about outcomes of a new NICU care model that better integrates parents into all
aspects of their baby's care. The use of mobile technology as part of this new model of care
could improve access and equity in family integration for the many US families who face
barriers to NICU involvement.

Poor growth during neonatal intensive care unit (NICU) hospitalization is a modifiable risk
factor contributing to mortality and serious long-term morbidity for many of the nearly
400,000 preterm infants born each year in the United States (US). Active parent involvement
in preterm infant caregiving promotes parent-infant attachment and leads to higher
breastfeeding rates, earlier discharge, and improved long-term neurodevelopment. Despite
decades of evidence of the positive effects of parental involvement, parents remain for the
most part passive bystanders in the NICU setting. Even with many NICUs adopting a
Family-Centered Care (FCC) approach, parent-infant contact and parenting skills remain well
below desired levels.

Family Integrated Care (FI-Care) is a novel intervention that differs from FCC because it
formally teaches and supports parents to be primary caregivers for their infants and
restructures the relationship between parents and clinicians so that parents are fully
integrated into the care team. There is strong evidence from a large, well-designed cluster
randomized trial conducted in Canada and Australia that FI-Care improves infant growth and
breastfeeding rates and reduces maternal stress. However, these findings cannot be
generalized to US NICUs where parents face many barriers to involvement in their infant's
NICU care. The research team has developed a secure, HIPAA-compliant, mobile application to
capture high quality data about parent involvement in NICU caregiving and to deliver
essential elements of the FI-Care program remotely. This mobile-enhanced FI-Care (mFI-Care)
may improve involvement of parents who cannot be present in the NICU during daytime hours due
to distance, employment or other responsibilities and family commitments. Increasing access
and equity in family-integrated care may improve outcomes for US preterm infants.

This exploratory two-group, multi-site comparison study will compare usual FCC with mFI-Care
on growth and clinical outcomes of preterm infants < 33 weeks gestational age, as well as the
stress, competence and self-efficacy of their parents. The feasibility and acceptability of
using mobile technology to gather data about parent involvement in the care of preterm
infants receiving FCC or mFICare as well as of the mFI-Care intervention will be evaluated
(Aim 1). The effect sizes for infant growth (primary outcome) and for secondary infant and
parent outcomes at NICU discharge and three months after discharge will be estimated (Aim 2).
This study will provide important new information on innovative approaches to increasing
parent involvement in NICU infant caregiving, including the use of a novel mobile
application. The findings will be used to develop a future US cluster-randomized trial of
mFI-Care with the aim of improving outcomes for preterm infants and their parents.

Inclusion Criteria:

- Infant ≤ 33 weeks and their parent or guardian

Exclusion Criteria:

- Infant has a life-threatening congenital anomaly, is unlikely to survive or is
receiving palliative care

- Parent is not English literate

- Parent < 18 years of age

- Parent does not have access to hand-held computer (smartphone or tablet)
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