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NCT03267043 · ClinicalTrials.gov registry record · NA
Family Nurture Intervention in the NICU at The Valley Hospital
A NA study, sponsored by Columbia University.
- Completed
- Registry status
- NA
- Development phase
- 150
- Enrollment target
NCT03267043: Completed NA study, sponsored by Columbia University.
NCT03267043 is a NA study that has completed, run by Columbia University. The registered enrollment target is 150 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03267043, a NA study, has completed, sponsored by Columbia University.
- COMPLETED
- Registry status
- NA
- Development phase
- 150 participants
- Enrollment target
Study Summary
The purpose of this study is to compare neurodevelopment and activity in infants born preterm (25 to 34 1/7 weeks gestational age (GA)) receiving Standard Care (SC) or Family Nurture Intervention (FNI) in the neonatal intensive care unit (NICU). The investigators hypothesize that FNI will improve: i) neonatal electroencephalographic activity ii) maternal caregiving and wellbeing (psychological and physiological, and iii) infant behavior and neurodevelopment at 18 months corrected age (CA). The two-phase effectiveness study aims to: * Phase 1 - Examine the existing Standard Care Approximately 35 infants and their mothers * Phase 2 - Examine effectiveness by implementing FNI unit-wide so that every baby receives the intervention Approximately 35 infants and their mothers
Primary Outcome
Measured in microvolts (µV)\^2 for infants.
Interventions
- BEHAVIORAL Standard Care
- BEHAVIORAL Family Nurture Intervention (FNI)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2017-10-20 |
| Est. Completion | 2020-07-01 |
| Phase | NA |
What the finished NCT03267043 record still lists
NCT03267043 is an interventional study that assigns participants to a tested intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (89% lower).
The record links to 0 conditions, and to 2 interventions - of which Standard Care is the first listed.
NCT03267043 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03267043 about?
NCT03267043 is a clinical study titled "Family Nurture Intervention in the NICU at The Valley Hospital". The purpose of this study is to compare neurodevelopment and activity in infants born preterm (25 to 34 1/7 weeks gestational age (GA)) receiving Standard Care (SC) or Family Nurture Intervention (FNI) in the neonatal intensive care unit (NICU). The investigators hypothesize that FNI will improve: ...
What is the current status of trial NCT03267043?
This trial is currently completed. It is a NA study. The enrollment target is 150 participants. The study started on 2017-10-20. Estimated completion is 2020-07-01.
What interventions are being tested in trial NCT03267043?
The interventions under investigation include: Standard Care (BEHAVIORAL), Family Nurture Intervention (FNI) (BEHAVIORAL).
Who is sponsoring clinical trial NCT03267043?
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 NCT03267043's enrollment target sits among peer trials
150 661st of 2000 higher than 1,299 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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