Holding, Stress, and Bonding During Therapeutic Hypothermia

Hypoxic-Ischemic Encephalopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03079284
• Other study ID #: 1015281-1
• Status: Completed
• Phase: N/A
• Start date: March 20, 2017
• Est. completion date: September 23, 2017

Study information

• Verified date: March 2020
• Source: MaineHealth
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: September 23, 2017
• Est. primary completion date: September 23, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 3 Days

Eligibility

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

Related Conditions & MeSH terms

• Brain Diseases
• Brain Ischemia
• Hypothermia
• Hypoxia-Ischemia, Brain
• Hypoxic-Ischemic Encephalopathy

Intervention

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.

Locations

Country	Name	City	State
United States	Maine Medical Center	Portland	Maine

Sponsors (2)

Lead Sponsor	Collaborator
Alexa Craig	MaineHealth

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of Adverse Events (Safety)	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.	3 days
Secondary	Qualitative Experience of Mothers: Before I Could Hold my Baby, I Would Describe Our Ability to Bond as:	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: Very easy to bond; Easy to bond; Hard to bond; Very hard to bond	3 days
Secondary	Qualitative Experience of Mothers: After Holding my Baby, I Feel Our Bond is:	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: Much stronger; Stronger; No change; Weaker; Much weaker	3 days
Secondary	Qualitative Experience of Mothers: Before Holding my Baby, my Stress Level Was:	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: Very high; High; Low; Very low	3 days
Secondary	Qualitative Experience of Mothers: After Holding my Baby, I Feel:	4. After holding my baby, I feel: Much more stressed; More stressed; No change; Less stressed; Much less stressed	3 days
Secondary	Qualitative Experience of Mothers: I am Glad I Had the Opportunity to Hold my Baby During Treatment With Hypothermia	5. I am glad I had the opportunity to hold my baby during treatment with hypothermia; Strongly agree; Agree; Disagree; Strongly disagree	3 days
Secondary	Qualitative Experience of Mothers: I Think Other Parents Would Benefit From Holding Their Babies During Treatment With Hypothermia, Provided They Are Medically Stable	6. I think other parents would benefit from holding their babies during treatment with hypothermia, provided they are medically stable; Strongly agree; Agree; Disagree; Strongly Disagree	3 days
Secondary	Qualitative Experience of Nurses: Therapeutic Hypothermia is Emotionally Challenging to the Parents of the Infant.	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	3 days
Secondary	Qualitative Experience of Nurses: Treatment With Therapeutic Hypothermia Makes it Difficult for Parents to Bond With Their Infant.	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	3 days
Secondary	Qualitative Experience of Nurses: After Assisting With the Holding Protocol, the Mother's Emotional Response to Her Infant's Treatment is...	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	3 days
Secondary	Qualitative Experience of Nurses: After Seeing the Mother Hold Her Infant, the Maternal-infant Bond is a...	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	3 days
Secondary	Qualitative Experience of Nurses: After Assisting With the Holding Protocol, I Feel That Holding During Cooling is Safe.	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	3 days
Secondary	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.	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	3 days
Secondary	Qualitative Experience of Nurses: After Having Been Held, the Infant Has Become…	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	3 days