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 range24 Hours – 3 Days

SexALL

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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

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