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NCT04368767 · ClinicalTrials.gov registry record · NA
A Pilot Randomized Controlled Trial of the Effects of Daily Skin-to-skin Contact (PRCTS2S)
A NA study of Oxidative Stress and Mother-Infant Interaction, sponsored by University of California, San Francisco.
- Completed
- Registry status
- NA
- Development phase
- 8
- Enrollment target
- 1
- Study location
NCT04368767: Completed NA study of Oxidative Stress and Mother-Infant Interaction, sponsored by University of California, San Francisco.
NCT04368767 is a NA study of Oxidative Stress and Mother-Infant Interaction that has completed, run by University of California, San Francisco. The registered enrollment target is 8 participants, below the 86-participant average among 36 other Oxidative Stress trials with a reported enrollment target (91% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04368767, a NA study of Oxidative Stress and Mother-Infant Interaction, has completed, sponsored by University of California, San Francisco.
- COMPLETED
- Registry status
- NA
- Development phase
- 8 participants
- Enrollment target
- 1
- Study location
Study Summary
Late preterm infants are at risk of experiencing inadequate glycogen stores with immature glucose metabolism and increased adenosine triphosphate (ATP) degradation, which indicates cellular increased and stress. Processes mediating infant acute/chronic stress symptoms and their biochemical effects have not been adequately investigated. Skin-to-skin contact (SSC), also known as Kangaroo Mother Care (KMC), is as an intervention that activates mechanisms of energy preservation that decrease stress in preterm infants. SSC has been shown in numerous clinical trials to reduce mortality and morbidity by stabilization of breathing, thermal regulation, oxygen saturation, and heart rate. SSC also reduces behavioral distress during painful and stressful procedures and improves breast-feeding parent bonding. However, little is known about how SSC affects biomarkers of stress and energy expenditure in late preterm infants in the first week of life. The aim of this pilot randomized controlled trial is to evaluate changes in biomarkers of stress, stress modulation and energy expenditure in late preterm infants who receive two hours of continuous SSC care or two hours of lying undisturbed in an incubator administered daily for 3 consecutive days in the first week of life, and to provide preliminary data for future research comparing the effects of usual incubator care with prolonged SSC on stress biomarkers in preterm infants.
Primary Outcome
Compare group differences in measures of stress (i.e., salivary cortisol, urinary biomarkers of Hx, Xa, UA, and allantoin, and stress buffering (i.e., salivary oxytocin) between the intervention and usual care groups.
Conditions Studied
Interventions
- BEHAVIORAL Skin-to-skin
Study Locations (1)
California
- UCSF Benioff Children's Hospital San Francisco - San Francisco
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2020-08-03 |
| Est. Completion | 2020-09-30 |
| Phase | NA |
What the finished NCT04368767 record still lists
NCT04368767 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 86-participant average among 36 other Oxidative Stress trials with a reported enrollment target (91% lower).
The record links to 3 conditions, with Oxidative Stress appearing as the primary indexed condition, and to 1 intervention - of which Skin-to-skin is the first listed.
NCT04368767 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT04368767 about?
NCT04368767 is a clinical study titled "A Pilot Randomized Controlled Trial of the Effects of Daily Skin-to-skin Contact (PRCTS2S)". Late preterm infants are at risk of experiencing inadequate glycogen stores with immature glucose metabolism and increased adenosine triphosphate (ATP) degradation, which indicates cellular increased and stress. Processes mediating infant acute/chronic stress symptoms and their biochemical effects h...
What is the current status of trial NCT04368767?
This trial is currently completed. It is a NA study. The enrollment target is 8 participants. The study started on 2020-08-03. Estimated completion is 2020-09-30.
What conditions does trial NCT04368767 study?
This clinical trial studies the following conditions: Oxidative Stress, Mother-Infant Interaction, Premature Baby 33 to 36 Weeks.
What interventions are being tested in trial NCT04368767?
The interventions under investigation include: Skin-to-skin (BEHAVIORAL).
Who is sponsoring clinical trial NCT04368767?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04368767 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04368767's enrollment target sits among peer trials
8 36th of 36 higher than 1 of 36 other Oxidative Stress trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Oxidative 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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