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Family Nurture Intervention in the NICU at The Valley Hospital

NCT03267043 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2023-02-15

No results posted yet for this study

Summary

The purpose of this study is to compare neurodevelopment and activity in infants born preterm (25 to 34 1/7 weeks gestational age (GA)) receiving Standard Care (SC) or Family Nurture Intervention (FNI) in the neonatal intensive care unit (NICU).

The investigators hypothesize that FNI will improve: i) neonatal electroencephalographic activity ii) maternal caregiving and wellbeing (psychological and physiological, and iii) infant behavior and neurodevelopment at 18 months corrected age (CA).

The two-phase effectiveness study aims to:

* Phase 1 - Examine the existing Standard Care Approximately 35 infants and their mothers
* Phase 2 - Examine effectiveness by implementing FNI unit-wide so that every baby receives the intervention Approximately 35 infants and their mothers

Conditions

  • Premature Birth
  • Obstetric Labor, Premature

Interventions

BEHAVIORAL

Family Nurture Intervention (FNI)

Subjects will be guided by the nursing staff through an enhanced program of mother/infant interactions, which include skin-to-skin holding.

BEHAVIORAL

Standard Care

Established routine care provided on the NICU floor by specially trained health care professionals.

Sponsors & Collaborators

Principal Investigators

  • Martha G Welch, MD · Columbia University

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
SEQUENTIAL

Eligibility

Min Age
26 Weeks
Max Age
34 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-20
Primary Completion
2020-03-19
Completion
2020-07-01

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 NCT03267043 on ClinicalTrials.gov