CompletedNot Applicable

Holding, Stress, and Bonding During Therapeutic Hypothermia

United States10 participantsStarted 2017-03-20

Plain-language summary

Ten infants undergoing therapeutic hypothermia for hypoxic-ischemic encephalopathy will be enrolled in a new protocol that will allow mothers to hold their infants during the hypothermia treatment period. This is a safety study that will assess whether or not there is an increase in adverse event frequency in infants that are held during hypothermia. Parents and NICU nurses will be given a questionnaire after holding is complete investigating their feelings on maternal-infant bonding and safety of the holding protocol.

Who can participate

Age range

24 Hours – 3 Days

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Frequency of Adverse Events (Safety)

Timeframe: 3 days

Trial details

NCT IDNCT03079284

SponsorAlexa Craig

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-09-23

Results submitted2019-05-29

View on ClinicalTrials.gov More Hypoxic-Ischemic Encephalopathy trials