Holding, Stress, and Bonding During Therapeutic Hypothermia

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-20

Study Completion Date

2017-09-23

Brief Summary

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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.

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Detailed Description

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Conditions

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Hypoxic-Ischemic Encephalopathy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Holding Group

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.

Group Type EXPERIMENTAL

Holding during cooling

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

24 Hours

Maximum Eligible Age

3 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No