Holding, Stress, and Bonding During Therapeutic Hypothermia

Not Applicable

Completed

Conditions: Hypoxic-Ischemic Encephalopathy

Interventions: Other: Holding during cooling

Registration Number: NCT03079284

Lead Sponsor: Alexa Craig

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 10

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Holding Group	Holding during cooling	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.

Primary Outcome Measures

Name	Time	Method
Frequency of Adverse Events (Safety)	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

Name	Time	Method
Qualitative Experience of Mothers: Before I Could Hold my Baby, I Would Describe Our Ability to Bond as:	3 days	A novel tool was developed to assess the mothers' subjective level of stress and bonding with her infant after holding by a questionnaire. 1. Before I could hold my baby, I would describe our ability to bond as: 1. Very easy to bond 2. Easy to bond 3. Hard to bond 4. Very hard to bond
Qualitative Experience of Mothers: I am Glad I Had the Opportunity to Hold my Baby During Treatment With Hypothermia	3 days	5. I am glad I had the opportunity to hold my baby during treatment with hypothermia 1. Strongly agree 2. Agree 3. Disagree 4. Strongly disagree
Qualitative Experience of Nurses: Therapeutic Hypothermia is Emotionally Challenging to the Parents of the Infant.	3 days	A novel tool was developed by the investigator to assess the nurses' subjective level of comfort with mothers holding their infants during the cooling protocol. Therapeutic hypothermia is emotionally challenging to the parents of the infant. A. Strongly agree B. Agree C. Disagree D. Strongly Disagree
Qualitative Experience of Nurses: After Assisting With the Holding Protocol, I Feel That Holding During Cooling is Safe.	3 days	A novel tool was developed by the investigator to assess the nurses' subjective level of comfort with mothers holding their infants during the cooling protocol. After seeing the mother hold her infant, the maternal-infant bond is a... A. Strongly agree B. Agree C. Disagree D. Strongly disagree
Qualitative Experience of Mothers: After Holding my Baby, I Feel Our Bond is:	3 days	A novel tool was developed to assess the mothers' subjective level of stress and bonding with her infant after holding by a questionnaire. 2. After holding my baby, I feel our bond is: 1. Much stronger 2. Stronger 3. No change 4. Weaker 5. Much weaker
Qualitative Experience of Nurses: Treatment With Therapeutic Hypothermia Makes it Difficult for Parents to Bond With Their Infant.	3 days	A novel tool was developed by the investigator to assess the nurses' subjective level of comfort with mothers holding their infants during the cooling protocol. Treatment with therapeutic hypothermia makes it difficult for parents to bond with their infant. A. Strongly agree B. Agree C. Disagree D. Strongly Disagree
Qualitative Experience of Nurses: After Having Been Held, the Infant Has Become…	3 days	A novel tool was developed by the investigator to assess the nurses' subjective level of comfort with mothers holding their infants during the cooling protocol. I would like to see holding during cooling become a standard practice in our NICU, so long as the infant is otherwise medically stable. A. Much easier to care for B. Easier to care for C. No change D. Harder to care for E. Much harder to care for
Qualitative Experience of Mothers: Before Holding my Baby, my Stress Level Was:	3 days	A novel tool was developed to assess the mothers' subjective level of stress and bonding with her infant after holding by a questionnaire. 3. Before holding my baby, my stress level was: 1. Very high 2. High 3. Low 4. Very low
Qualitative Experience of Mothers: After Holding my Baby, I Feel:	3 days	4. After holding my baby, I feel: 1. Much more stressed 2. More stressed 3. No change 4. Less stressed 5. Much less stressed
Qualitative Experience of Nurses: After Assisting With the Holding Protocol, the Mother's Emotional Response to Her Infant's Treatment is...	3 days	A novel tool was developed by the investigator to assess the nurses' subjective level of comfort with mothers holding their infants during the cooling protocol. After assisting with the holding protocol, the mother's emotional response to her infant's treatment is... A. Strongly more positive B. More positive C. No change D. More negative E. Strongly more negative
Qualitative Experience of Nurses: I Would Like to See Holding During Cooling Become a Standard Practice in Our NICU, so Long as the Infant is Otherwise Medically Stable.	3 days	A novel tool was developed by the investigator to assess the nurses' subjective level of comfort with mothers holding their infants during the cooling protocol. I would like to see holding during cooling become a standard practice in our NICU, so long as the infant is otherwise medically stable. A. Strongly agree B. Agree C. Disagree D. Strongly disagree
Qualitative Experience of Nurses: After Seeing the Mother Hold Her Infant, the Maternal-infant Bond is a...	3 days	A novel tool was developed by the investigator to assess the nurses' subjective level of comfort with mothers holding their infants during the cooling protocol. After seeing the mother hold her infant, the maternal-infant bond is a... A. Much stronger bond B. Stronger bond C. No change D. Weaker bond E. Much weaker bond
Qualitative Experience of Mothers: I Think Other Parents Would Benefit From Holding Their Babies During Treatment With Hypothermia, Provided They Are Medically Stable	3 days	6. I think other parents would benefit from holding their babies during treatment with hypothermia, provided they are medically stable 1. Strongly agree 2. Agree 3. Disagree 4. Strongly Disagree