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NCT02352142 · ClinicalTrials.gov registry record · NA
Family Nurture Intervention in the CHoNJ NICU
A NA study, sponsored by Columbia University.
- Terminated
- Registry status
- NA
- Development phase
- 54
- Enrollment target
NCT02352142 is a NA study that was terminated before completion, run by Columbia University. The registered enrollment target is 54 participants.
The verdict
NCT02352142, a NA study, was terminated before completion, sponsored by Columbia University.
- TERMINATED
- Registry status
- NA
- Development phase
- 54 participants
- Enrollment target
Study Summary
The purpose of this proposal is to conduct a replication study of Family Nurture Intervention (FNI) at CHoNJ. FNI facilitates mother-infant interactions that are vital to early development. These include early and repeated mother/infant calming interactions during the NICU stay, such as interactive touch with vocal soothing, sustained reciprocal olfactory exposure and family practice in comforting, and systematically implemented skin to skin holding. This has already been studied at CHONY. Findings reveal that infants who receive FNI have significant increases in EEG power, a measure of brain activity, near to term age, when compared with those who receive Standard Care. There will be two groups; STANDARD CARE (SC) and INTERVENTION (FNI). In addition, 10 pilot subjects will be enrolled to train the staff involved in the procedures used in this Randomized Control Trial (RCT). The pilot patients will be enrolled identical to study patients and will be encouraged to participate fully. They will not be included in the analysis of the RCT. The STANDARD CARE group will receive current standard of care in NICU. The INTERVENTION group, in addition to the standard care, will receive the FNI intervention, which will be facilitated by our Nurture Specialists. In addition to the SC and FNI groups, there will be a third non-randomized group of infants born at term age who will receive standard care for newborns at CHoNJ. Assessments in the NICU will include physiological measures (ECG EEG), measures of maternal sensitivity through recorded mother-infant interactions and a variety of specimen collections (saliva, blood, and breast milk samples). The investigators will be conducting two follow up studies, at 4 months corrected age and at 12 months corrected age. The investigators will test the immediate and long-term effects of this approach to the development of preterm infants. The investigators hypothesize that this intervention will alter a wide range of indices of physiolo
Interventions
- OTHER Full Term EEG
- BEHAVIORAL Facilitated Infant Care
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 54 participants |
| Start Date | 2015-01 |
| Est. Completion | 2016-05 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02352142
The ClinicalTrials.gov registry entry for NCT02352142 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 54 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Columbia University, which has 958 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Full Term EEG is the first listed.
NCT02352142 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02352142 about?
NCT02352142 is a clinical study titled "Family Nurture Intervention in the CHoNJ NICU". The purpose of this proposal is to conduct a replication study of Family Nurture Intervention (FNI) at CHoNJ. FNI facilitates mother-infant interactions that are vital to early development. These include early and repeated mother/infant calming interactions during the NICU stay, such as interactive ...
What is the current status of trial NCT02352142?
This trial is currently terminated. It is a NA study. The enrollment target is 54 participants. The study started on 2015-01. Estimated completion is 2016-05.
What interventions are being tested in trial NCT02352142?
The interventions under investigation include: Full Term EEG (OTHER), Facilitated Infant Care (BEHAVIORAL).
Who is sponsoring clinical trial NCT02352142?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
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