Holding, Stress, and Bonding During Therapeutic Hypothermia
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|ClinicalTrials.gov Identifier: NCT03079284|
Recruitment Status : Completed
First Posted : March 14, 2017
Last Update Posted : November 9, 2017
|Condition or disease||Intervention/treatment||Phase|
|Hypoxic-Ischemic Encephalopathy||Other: Holding during cooling||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Effects of Holding on Stress and Bonding in Mother-Infant Dyads During Therapeutic Hypothermia|
|Actual Study Start Date :||March 20, 2017|
|Actual Primary Completion Date :||September 23, 2017|
|Actual Study Completion Date :||September 23, 2017|
Experimental: 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.
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.
- Frequency of adverse events (Safety) [ Time Frame: 3 days ]Assess the frequency of adverse events during the holding intervention including unintentional rewarming of the infant, dislodged infant catheters (umbilical arterial/venous lines, urinary catheter, iv) or infant intolerance of holding due to vital sign instability.
- Qualitative experience of mothers [ Time Frame: 3 days ]Assess the mothers' subjective level of stress and bonding with her infant after holding by administration of a questionnaire utilizing the Likert scale
- Qualitative experience of nurses [ Time Frame: 3 days ]Assess the nurses' subjective level of comfort with mothers holding their infants during the cooling protocol. Nurses will be given a survey with multiple choice (Likert scale) questions and open ended questions
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03079284
|United States, Maine|
|Maine Medical Center|
|Portland, Maine, United States, 04102|
|Principal Investigator:||Alexa Craig, MD, MSc||MaineHealth|