NCT03079284

Holding, Stress, and Bonding During Therapeutic Hypothermia

The Effects of Holding on Stress and Bonding in Mother-Infant Dyads During Therapeutic Hypothermia

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Alexa Craig · Academic / Other
• Sex: All
• Age: 24 Hours – 3 Days
• Healthy volunteers: Not accepted

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.

Conditions

• Hypoxic-Ischemic Encephalopathy

Interventions

Type	Name	Description
OTHER	Holding during cooling	An initial set of vital sings will be recorded before the infant is removed from the isolette. The mother will sit in a reclining chair next to the isolette and place a thermal barrier over her chest and abdomen. The infant will be transferred to the mother by placing the hands under the cooling blanket so as to move the infant and cooling blanket together as one unit. The mother will be allowed to hold for thirty minutes provided that the infant's temperature does not increase by greater than one degree centigrade and the oxygen saturation does not drop below 90%. After thirty minutes, the infant will be returned to the isolette.

Timeline

• Start date: 2017-03-20
• Primary completion: 2017-09-23
• Completion: 2017-09-23
• First posted: 2017-03-14
• Last updated: 2025-09-04
• Results posted: 2022-01-26

Locations

1 site across 1 country: United States