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Holding, Stress, and Bonding During Therapeutic Hypothermia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03079284
Recruitment Status : Completed
First Posted : March 14, 2017
Last Update Posted : November 9, 2017
Information provided by (Responsible Party):
Alexa Craig, MaineHealth

Brief 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.

Condition or disease Intervention/treatment Phase
Hypoxic-Ischemic Encephalopathy Other: Holding during cooling Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hypothermia

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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

  2. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 3 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT03079284

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United States, Maine
Maine Medical Center
Portland, Maine, United States, 04102
Sponsors and Collaborators
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Principal Investigator: Alexa Craig, MD, MSc MaineHealth
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Alexa Craig, Associate Professor of Pediatrics, MaineHealth Identifier: NCT03079284    
Other Study ID Numbers: 1015281-1
First Posted: March 14, 2017    Key Record Dates
Last Update Posted: November 9, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Brain Diseases
Brain Ischemia
Hypoxia-Ischemia, Brain
Central Nervous System Diseases
Nervous System Diseases
Body Temperature Changes
Signs and Symptoms, Respiratory
Cerebrovascular Disorders
Vascular Diseases
Cardiovascular Diseases
Hypoxia, Brain