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The Impact of Holding on Stress and Bonding in Mother-Infant Pairs During Therapeutic Hypothermia
NCT03837717 · View on ClinicalTrials.gov ↗
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
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03837717
The ClinicalTrials.gov registry entry for NCT03837717 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 34 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is MaineHealth, which has 10 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03837717 reports 1 study location spanning 1 distinct geographic area — top geographies include Maine. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03837717?
The interventions under investigation include: Saliva collection (OTHER), Holding (BEHAVIORAL), No Holding (BEHAVIORAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03837717?
This trial is sponsored by MaineHealth, which has 10 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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