Holding, Stress, and Bonding During Therapeutic Hypothermia

Alexa Craig

Status: Completed

Conditions: Hypoxic-Ischemic Encephalopathy

Treatments: Other: Holding during cooling

Study type: Interventional

Funder types: Other

Identifiers

NCT03079284

1015281-1

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: All

Ages: 24 hours to 3 days old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Holding Group

Experimental group

Description:

After meeting inclusion criteria and consenting to participation, mothers of infants who have completed at least 24 hours of therapeutic hypothermia treatment will be allowed to hold their infant who will remain on the cooling blanket for a 30-minute period with the use of a thermal barrier. Vital signs will be measured before holding begins, during holding and following completion of holding. Temperature will be recorded every two minutes during holding. Afterwards, a Likert scale questionnaire to assess the mother's and nurse's reactions will be administered.

Treatment:

Other: Holding during cooling