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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: Completed NA study of Hypoxic Ischemic Encephalopathy and Neonatal Encephalopathy, sponsored by MaineHealth.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
To compare the change in the level of oxytocin in maternal saliva between two conditions; one assessing the difference between oxytocin levels before and immediately after a 30-minute period of holding during therapeutic hypothermia compared to the second condition in which pre and post-levels of salivary oxytocin surrounding a 30-minute period of "not holding" are obtained.
Conditions Studied
Interventions
- OTHER Saliva collection
- BEHAVIORAL Holding
- BEHAVIORAL No Holding
Study Locations (1)
Maine
- Maine Medical Center - Portland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2018-12-04 |
| Est. Completion | 2021-02-08 |
| Phase | NA |
What the finished NCT03837717 record still lists
NCT03837717 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 34 participants, a relatively small participant target, below the 80-participant average among 13 other Hypoxic Ischemic Encephalopathy trials with a reported enrollment target (57% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Where NCT03837717's enrollment target sits among peer trials
34 8th of 13 higher than 6 of 13 other Hypoxic Ischemic Encephalopathy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hypoxic Ischemic Encephalopathy 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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