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Clinical Interventions to Mitigate Neurodevelopmental Risk

NCT04233489 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2022-10-13

No results posted yet for this study

Summary

Family Nurture Intervention (FNI) has been shown to facilitate emotional connection and long-term child developmental progress in the NICU population. It has been theorized that FNI also promotes autonomic co-regulation and physiological synchrony between the mother-child dyad. The goal of the pilot study is to assess how a short one-time FNI session between at-risk mother and child dyads in the Well Baby Nursery (WBN) influences physiological synchrony, emotional connection, and developmental changes both short and long-term.

Conditions

  • Child Development
  • Mother-Infant Interaction
  • Diabetes Mellitus, Gestational

Interventions

BEHAVIORAL

Family Nurture Intervention (FNI)

FNI is a family based intervention that facilitates and strengthens the mother-infant emotional connection through a structured guided interaction by a physician. The mother is asked to sit with her baby in her arms so that they are face-to-face, and when the baby becomes restless, the physician will coach the mom to bring the baby back to a calm state. The mother will also be encouraged to verbalize her feelings to her baby. Mother-infant emotional connection is known to affect various developmental processes and improve overall health. FNI was previously shown to be efficacious in improving several long-term health outcomes in preterm infants in the neonatal intensive care unit (NICU).

Sponsors & Collaborators

Principal Investigators

  • Dani Dumitriu, MD/PhD · Columbia University

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Hours
Max Age
3 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-01-03
Primary Completion
2020-03-13
Completion
2020-03-13

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 NCT04233489 on ClinicalTrials.gov