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NCT03837717 · ClinicalTrials.gov registry record · NA

The Impact of Holding on Stress and Bonding in Mother-Infant Pairs During Therapeutic Hypothermia

A NA study of Hypoxic Ischemic Encephalopathy and Neonatal Encephalopathy, sponsored by MaineHealth.

Completed
Registry status
NA
Development phase
34
Enrollment target
1
Study location

NCT03837717 is a NA study of Hypoxic Ischemic Encephalopathy and Neonatal Encephalopathy that has completed, run by MaineHealth. The registered enrollment target is 34 participants, below the 80-participant average among 13 other Hypoxic Ischemic Encephalopathy trials with a reported enrollment target (57% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT03837717, a NA study of Hypoxic Ischemic Encephalopathy and Neonatal Encephalopathy, has completed, sponsored by MaineHealth.

COMPLETED
Registry status
NA
Development phase
34 participants
Enrollment target
1
Study location

Study Summary

This research is being done to try to improve the experience of mothers and babies during therapeutic hypothermia. Currently, mothers are not able to hold their baby during hypothermia treatment. Mothers have reported that not being able to hold their baby during this time is stressful. Additionally, it is known that holding has many benefits for mothers' and babies' psychological and physical health. Therapeutic hypothermia is the standard of care. The experimental interventions of this study are to have mothers hold their babies during this treatment, collect saliva samples from mothers and babies, and test the saliva samples for the hormones cortisol and oxytocin. The investigators will test saliva of infants and their mothers before and after holding. The investigators hope to demonstrate decreased cortisol, a marker for stress, and increased oxytocin, a marker for bonding, in infants and mothers while they are held during therapeutic hypothermia.

Conditions Studied

Hypoxic Ischemic Encephalopathy Neonatal Encephalopathy

Interventions

  • OTHER Saliva collection
  • BEHAVIORAL Holding
  • BEHAVIORAL No Holding

Study Locations (1)

Maine

  • Maine Medical Center - Portland

Trial Details

FieldValue
Enrollment Target 34 participants
Start Date 2018-12-04
Est. Completion 2021-02-08
Phase NA

Sponsor

MaineHealth

26 total trials

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What the Registry Record Tells You About NCT03837717

The ClinicalTrials.gov registry entry for NCT03837717 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 34 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 80-participant average among 13 other Hypoxic Ischemic Encephalopathy trials with a reported enrollment target (57% lower). The listed sponsor is MaineHealth, which has 26 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Hypoxic Ischemic Encephalopathy appearing as the primary indexed condition, and to 3 interventions - of which Saliva collection is the first listed.

NCT03837717 reports 1 study location spanning 1 distinct geographic area - top geographies include Maine.

Frequently Asked Questions

What is clinical trial NCT03837717 about?

NCT03837717 is a clinical study titled "The Impact of Holding on Stress and Bonding in Mother-Infant Pairs During Therapeutic Hypothermia". This research is being done to try to improve the experience of mothers and babies during therapeutic hypothermia. Currently, mothers are not able to hold their baby during hypothermia treatment. Mothers have reported that not being able to hold their baby during this time is stressful. Additionally...

What is the current status of trial NCT03837717?

This trial is currently completed. It is a NA study. The enrollment target is 34 participants. The study started on 2018-12-04. Estimated completion is 2021-02-08.

What conditions does trial NCT03837717 study?

This clinical trial studies the following conditions: Hypoxic Ischemic Encephalopathy, Neonatal Encephalopathy.

What interventions are being tested in trial NCT03837717?

The interventions under investigation include: Saliva collection (OTHER), Holding (BEHAVIORAL), No Holding (BEHAVIORAL).

Who is sponsoring clinical trial NCT03837717?

This trial is sponsored by MaineHealth, which has 26 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03837717 being conducted?

This trial has 1 study location across Maine. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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