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Family Nurture Intervention in the NICU

NCT02710474 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 461

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 very preterm (26 to 33 6/7 weeks gestational age (GA)) receiving Standard Care (SC) or Family Nurture Intervention (FNI) in the neonatal intensive care unit (NICU).

The study investigator hypothesizes 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 study aims to:

\- Replicate efficacy from an earlier trial by conducting the study at multiple sites to allow for greater generalizability.

* SC, approximately 90 infants plus the parents
* FNI, approximately 90 infants plus the parents
* Term Controls, approximately 25 infants plus the parents

Conditions

  • Premature Birth
  • Obstetric Labor, Premature

Interventions

BEHAVIORAL

Family Nurture Intervention

Family Nurture Intervention is facilitated by specially trained Nurture Specialists in a randomized controlled trial (RCT) model (Part I) or applied unit-wide (either through dedicated staff or bedside nurses in Part II). Under FNI, specialists or nurses will support the parents and facilitate contact between mother and baby during the infant's NICU stay. The intervention involves calming interactions between mother and infant in the isolette via odor exchange, firm sustained touch and vocal soothing, through calming interactions during holding and feeding via the Calming Cycle and through family sessions designed to engage the help and support of family members for the mother.

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 · CUMC

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2017-01-24
Primary Completion
2020-02-07
Completion
2022-12-31

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 NCT02710474 on ClinicalTrials.gov