NCT04233489

Clinical Interventions to Mitigate Neurodevelopmental Risk

Terminated NA Last updated 13 October 2022

What this trial tests

NA trial testing Family Nurture Intervention (FNI) in Child Development in 4 participants. Terminated before completion.

Timeline

3 January 2020

Primary endpoint
13 March 2020

13 March 2020

Quick facts

Lead sponsor	Columbia University
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	4
Start date	3 January 2020
Primary completion	13 March 2020
Estimated completion	13 March 2020
Sites	1 location across United States

Drugs / interventions tested

• Family Nurture Intervention (FNI)

Conditions studied

• Child Development — all drugs for Child Development →
• Mother-Infant Interaction — all drugs for Mother-Infant Interaction →
• Diabetes Mellitus, Gestational — all drugs for Diabetes Mellitus, Gestational →

Sponsor

Columbia University

Who can join

Adults 12 Hours to 3 Days, any sex, with Child Development or Mother-Infant Interaction. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.