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Completed Not applicable Interventional Accepts healthy volunteers

Mother-infant Bonding During COVID-19

ClinicalTrials.gov ID: NCT04531618

Public ClinicalTrials.gov record NCT04531618. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 6, 2026, 12:31 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Randomized Controlled Trial (RCT) of Two Programs Supporting Early Infant Development Beginning in the Well Baby Nursery Through 4 Months of Age

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This study will assess whether the promotion of emotional exchange between mother and infant during the first four months of life improves primarily mother-child early relational health (ERH) and secondarily child neurodevelopmental and maternal mental health outcomes. In prior research on preterm infants, a similar intervention demonstrated increased quality of maternal caregiving behaviors and significant improvements in premature infants' neurodevelopment across multiple domains, including social-relatedness and attention problems. The goal of the emotional exchange intervention is to help mothers provide appropriate stimulation crucial for social, emotional, and neurobehavioral development, by helping the mother and child become attuned, or 'in sync', with each other. Measures of ERH, such as bonding, maternal sensitivity, and mother-child emotional connection will be compared between two groups: one receiving newborn parenting education and the other undergoing facilitated emotional exchange. Assessments will involve videos of mother-infant interactions during each intervention session and follow-up surveys conducted as part of a linked Institutional Review Board-approved study. Data collected in this study will contribute to understanding the underlying mechanisms of mother-infant interactions and their role in shaping optimal neurodevelopmental trajectories for infants and maternal mental health.

Study identification

NCT ID
NCT04531618
Recruitment status
Completed
Study type
Interventional
Phase
Not applicable
Lead sponsor
Columbia University
Other
Enrollment
132 participants

Conditions and interventions

Eligibility (public fields only)

Age range
12 Hours to 72 Hours
Sex
All
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Feb 13, 2024
Primary completion
Aug 5, 2025
Completion
Sep 16, 2025
Last update posted
Jun 8, 2026

2024 – 2025

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
Morgan Stanley Children's Hospital New York New York 10032

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04531618, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jun 8, 2026 · Synced Sep 6, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT04531618 live on ClinicalTrials.gov.

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