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NCT01439269 · ClinicalTrials.gov registry record · NA
Family Nurture Intervention (FNI) in Neonatal Intensive Care Unit (NICU)
A NA study, sponsored by Columbia University.
- Completed
- Registry status
- NA
- Development phase
- 394
- Enrollment target
NCT01439269: Completed NA study, sponsored by Columbia University.
NCT01439269 is a NA study that has completed, run by Columbia University. The registered enrollment target is 394 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (72% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01439269, a NA study, has completed, sponsored by Columbia University.
- COMPLETED
- Registry status
- NA
- Development phase
- 394 participants
- Enrollment target
Study Summary
The purpose of this study is to test the efficacy of a family nurture intervention in the neonatal intensive care unit (NICU). Infants receiving enhanced mother-infant and family nurture are compared to infants receiving standard NICU care. The intervention enhances mother/infant interactions that are vital to early development in the infant. The main goal is to get the mother and infant into biological synchrony, emotional attunement and mutual calm through an activity referred to as a "calming cycle". Mother's are encouraged to engage in the calming cycle activities as much as possible. Her increased effectiveness in calming her infant is hypothesized to improve the mother's view of her baby, reduce negative emotions about having delivered a baby prematurely, and help her gain confidence in her care-taking abilities, which in other studies predicted shorter length of stay and fewer re-hospitalizations. Another goal is to assist mothers in repeating the calming cycle activities providing appropriate types of stimulation for their babies that are important for social, emotional, and neurobehavioral development. Since preterm babies are often easily upset, mothers will be taught how to comfort and calm their babies. Assessments in the NICU and in follow-up visits for two years will test the immediate and long-term effects of this new approach to the nurture of prematurely born infants.
Primary Outcome
Length of stay will be determined based on the infant's number of days as an inpatient at the Children's Hospital of New York (CHONY) NICU.
Interventions
- BEHAVIORAL Family Nurture Intervention
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 394 participants |
| Start Date | 2008-06 |
| Est. Completion | 2018-01-09 |
| Phase | NA |
What the finished NCT01439269 record still lists
NCT01439269 is an interventional study that assigns participants to a tested intervention. The registered 394 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 (72% lower).
The record links to 0 conditions, and to 1 intervention - of which Family Nurture Intervention is the first listed.
NCT01439269 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01439269 about?
NCT01439269 is a clinical study titled "Family Nurture Intervention (FNI) in Neonatal Intensive Care Unit (NICU)". The purpose of this study is to test the efficacy of a family nurture intervention in the neonatal intensive care unit (NICU). Infants receiving enhanced mother-infant and family nurture are compared to infants receiving standard NICU care. The intervention enhances mother/infant interactions that a...
What is the current status of trial NCT01439269?
This trial is currently completed. It is a NA study. The enrollment target is 394 participants. The study started on 2008-06. Estimated completion is 2018-01-09.
What interventions are being tested in trial NCT01439269?
The interventions under investigation include: Family Nurture Intervention (BEHAVIORAL).
Who is sponsoring clinical trial NCT01439269?
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 NCT01439269's enrollment target sits among peer trials
394 268th of 2000 higher than 1,732 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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