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Holding hope: study tests Skin-to-Skin contact during infant cooling therapy

NCT ID NCT03079284

Symptom relief Sponsor: Alexa Craig Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study looked at whether mothers can safely hold their infants while they undergo therapeutic hypothermia (cooling) for a brain injury called hypoxic-ischemic encephalopathy (HIE). Ten infants were enrolled, and mothers held them for 30 minutes under careful monitoring. The goal was to see if holding increased risks like accidental rewarming or tube dislodgement, and to measure how it affected maternal stress and bonding.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Holding during cooling (a procedure where mothers hold their infants during hypothermia treatment)
What this could lead to
If successful, this could show that holding is safe and may reduce stress and improve bonding for mothers and infants during cooling treatment.
What could go wrong
This is a very small safety study with only 10 infants, so results may not apply to all. There is a risk of accidental rewarming or dislodged medical tubes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

10 people

The number who actually took part.

Started

Mar 2017

Finished

Sep 2017

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

24 hours to 3 days

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Infant must have a gestational age of greater than or equal to 35 weeks * Infant must be undergoing treatment with therapeutic hypothermia * Infant must be without seizures in the first 24 hours of treatment based on EEG * Infant must be clinically stable on bubble CPAP, nasal cannula, or no respiratory support. * Informed consent must be signed by the mother at Maine Medical Center Exclusion Criteria: * Infant is intubated * Infant is being treated with inhaled nitric oxide * Presence of Persistent Pulmonary Hypertension of the Newborn * Presence of seizure on EEG * Use of vasopressors or paralytic agents * Presence of chest tubes, wound vacuums, or drains * Neonatal abstinence syndrome

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Conditions

The condition(s) this trial relates to.

brain hypoxia - ischemia perinatal asphyxia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hypoxic-ischemic encephalopathy

Contacts and locations

Locations

  • Maine Medical Center

    Portland, Maine, 04102, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.