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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 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.

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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.

Interventions

  • BEHAVIORAL Skin-to-skin

Study Locations (1)

California

  • UCSF Benioff Children's Hospital San Francisco - San Francisco

Trial Details

FieldValue
Enrollment Target 8 participants
Start Date 2020-08-03
Est. Completion 2020-09-30
Phase NA

What the Registry Record Tells You About NCT04368767

The ClinicalTrials.gov registry entry for NCT04368767 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 8 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 86-participant average among 36 other Oxidative Stress trials with a reported enrollment target (91% lower). The listed sponsor is University of California, San Francisco, which has 1,713 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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