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Improving Preterm Infant Outcomes With Family Integrated Care and Mobile Technology

NCT03418870 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 347

Last updated 2021-03-23

No results posted yet for this study

Summary

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.

Conditions

  • Premature Birth of Newborn

Interventions

BEHAVIORAL

Family Integrated Care

Parents of infants assigned to mFI-Care will be trained and treated as primary caregivers for their infants and participate in daily medical rounds, with mFI-Care-trained nurses serving as teachers and coaches.

Sponsors & Collaborators

Principal Investigators

  • Linda Franck, RN, PhD · Dept of Family Care Nursing, California Preterm Birth Initiative, UCSF

Study Design

Allocation
NON_RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
SEQUENTIAL

Eligibility

Max Age
33 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-03
Primary Completion
2021-01-31
Completion
2021-03-15

Countries

  • United States

Study Locations

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Entities

Companies

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 NCT03418870 on ClinicalTrials.gov