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NCT04233489 · ClinicalTrials.gov registry record · NA
Clinical Interventions to Mitigate Neurodevelopmental Risk
A NA study, sponsored by Columbia University.
- Terminated
- Registry status
- NA
- Development phase
- 4
- Enrollment target
NCT04233489: Clinical Trial NA study, sponsored by Columbia University.
NCT04233489 is a NA study that was terminated before completion, run by Columbia University. The registered enrollment target is 4 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04233489, a NA study, was terminated before completion, sponsored by Columbia University.
- TERMINATED
- Registry status
- NA
- Development phase
- 4 participants
- Enrollment target
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.
Primary Outcome
The Welch Emotional Connection Screen (WECS) is a validated scale for quantitative assessment of the emotional connection between infant and mother by scoring the interaction of the dyad in four domains: attraction, vocal communication, facial communication and sensitivity/reciprocity. Each domain is scored on a scale from 1.0 to 3.0 in 0.25 point increments, with higher scores indicating stronger emotional connection. The WECS will be measured at baseline for the FNI groups during the intervent
Interventions
- BEHAVIORAL Family Nurture Intervention (FNI)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2020-01-03 |
| Est. Completion | 2020-03-13 |
| Phase | NA |
Why NCT04233489 stopped before completion
NCT04233489 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower).
The record links to 0 conditions, and to 1 intervention - of which Family Nurture Intervention (FNI) is the first listed.
NCT04233489 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04233489 about?
NCT04233489 is a clinical study titled "Clinical Interventions to Mitigate Neurodevelopmental Risk". 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...
What is the current status of trial NCT04233489?
This trial is currently terminated. It is a NA study. The enrollment target is 4 participants. The study started on 2020-01-03. Estimated completion is 2020-03-13.
What interventions are being tested in trial NCT04233489?
The interventions under investigation include: Family Nurture Intervention (FNI) (BEHAVIORAL).
Who is sponsoring clinical trial NCT04233489?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04233489's enrollment target sits among peer trials
4 1996th of 2000 higher than 5 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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