Holding, Stress, and Bonding During Therapeutic Hypothermia

Completed · Not applicable

Conditions studied: Hypoxic-Ischemic Encephalopathy

In brief

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.

Key facts

Study ID

NCT03079284

Run by

Alexa Craig

People needed

10

Starts

2017-03-20

Expected to finish

2017-09-23

Last updated by the study team

2025-09-04

Who can join

Age: 0 and older, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Maine Medical Center — Portland, Maine, United States

Full record on ClinicalTrials.gov

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