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NCT03664154 · ClinicalTrials.gov registry record · NA
Stress and Feeding (SAFE): A Pilot Intervention for Mothers and Their Preterm Infants
A NA study of Stress and Feeding Behavior, sponsored by Virginia Commonwealth University.
- Completed
- Registry status
- NA
- Development phase
- 10
- Enrollment target
- 1
- Study location
NCT03664154: Completed NA study of Stress and Feeding Behavior, sponsored by Virginia Commonwealth University.
NCT03664154 is a NA study of Stress and Feeding Behavior that has completed, run by Virginia Commonwealth University. The registered enrollment target is 10 participants, below the 786-participant average among 152 other Stress trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03664154, a NA study of Stress and Feeding Behavior, has completed, sponsored by Virginia Commonwealth University.
- COMPLETED
- Registry status
- NA
- Development phase
- 10 participants
- Enrollment target
- 1
- Study location
Study Summary
A majority of mothers experience high stress levels and associated symptoms of anxiety, depressive symptoms, and sleep disruption during the NICU hospitalization and continuing after hospital discharge. Given preterm infant feeding is one of the most stressful things the new mother will face and given the harmful nature of stress on maternal and infant health, it is important an intervention focuses on both of these concerns: infant feeding and maternal stress. Therefore, the purpose of this research study is two-fold. First, the investigators will examine how practical and acceptable it is for mothers of preterm infants to participate in Stress And FEeding (SAFE) intervention and collect biological stress measures from mothers and their preterm infant's saliva (spit). The intervention is designed to reduce stress and improve maternal feeding interaction. The second purpose of this study is to examine changes before and after using the intervention on mother and infant outcomes over 16-weeks.
Primary Outcome
Number of mother-infant dyads recruited, with a goal of 15
Conditions Studied
Interventions
- BEHAVIORAL Stress and Feeding (SAFE)
Study Locations (1)
Virginia
- Virginia Commonwealth University - Richmond
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2019-05-15 |
| Est. Completion | 2020-12-14 |
| Phase | NA |
What the finished NCT03664154 record still lists
NCT03664154 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 786-participant average among 152 other Stress trials with a reported enrollment target (99% lower).
The record links to 4 conditions, with Stress appearing as the primary indexed condition, and to 1 intervention - of which Stress and Feeding (SAFE) is the first listed.
NCT03664154 reports a single indexed study location in Virginia.
Frequently Asked Questions
What is clinical trial NCT03664154 about?
NCT03664154 is a clinical study titled "Stress and Feeding (SAFE): A Pilot Intervention for Mothers and Their Preterm Infants". A majority of mothers experience high stress levels and associated symptoms of anxiety, depressive symptoms, and sleep disruption during the NICU hospitalization and continuing after hospital discharge. Given preterm infant feeding is one of the most stressful things the new mother will face and giv...
What is the current status of trial NCT03664154?
This trial is currently completed. It is a NA study. The enrollment target is 10 participants. The study started on 2019-05-15. Estimated completion is 2020-12-14.
What conditions does trial NCT03664154 study?
This clinical trial studies the following conditions: Stress, Feeding Behavior, Mother-Infant Interaction, Preterm Infant.
What interventions are being tested in trial NCT03664154?
The interventions under investigation include: Stress and Feeding (SAFE) (BEHAVIORAL).
Who is sponsoring clinical trial NCT03664154?
This trial is sponsored by Virginia Commonwealth University, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03664154 being conducted?
This trial has 1 study location across Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Stress
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03664154's enrollment target sits among peer trials
10 150th of 152 higher than 2 of 152 other Stress trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Stress 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.
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