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NCT04531618 · ClinicalTrials.gov registry record · NA
Mother-infant Bonding During COVID-19
A NA study of Child Development and Mother-Infant Interaction, sponsored by Columbia University.
- Active
- Registry status
- NA
- Development phase
- 132
- Enrollment target
- 1
- Study location
NCT04531618 is a NA study of Child Development and Mother-Infant Interaction that is active but no longer recruiting, run by Columbia University. The registered enrollment target is 132 participants, below the 1,089-participant average among 32 other Child Development trials with a reported enrollment target (88% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04531618, a NA study of Child Development and Mother-Infant Interaction, is active but no longer recruiting, sponsored by Columbia University.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 132 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Conditions Studied
Interventions
- BEHAVIORAL Emotional Exchange (EE)
- OTHER Newborn Care (NC)
Study Locations (1)
New York
- Morgan Stanley Children's Hospital - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 132 participants |
| Start Date | 2024-02-14 |
| Est. Completion | 2028-06-30 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04531618
The ClinicalTrials.gov registry entry for NCT04531618 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 132 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,089-participant average among 32 other Child Development trials with a reported enrollment target (88% lower). The listed sponsor is Columbia University, which has 958 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Child Development appearing as the primary indexed condition, and to 2 interventions - of which Emotional Exchange (EE) is the first listed.
NCT04531618 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.
Frequently Asked Questions
What is clinical trial NCT04531618 about?
NCT04531618 is a clinical study titled "Mother-infant Bonding During COVID-19". 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 i...
What is the current status of trial NCT04531618?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 132 participants. The study started on 2024-02-14. Estimated completion is 2028-06-30.
What conditions does trial NCT04531618 study?
This clinical trial studies the following conditions: Child Development, Mother-Infant Interaction, Relation, Parent-Child.
What interventions are being tested in trial NCT04531618?
The interventions under investigation include: Emotional Exchange (EE) (BEHAVIORAL), Newborn Care (NC) (OTHER).
Who is sponsoring clinical trial NCT04531618?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04531618 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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