Skip to main content
OpenTrials
Completed

NCT Number: NCT03079284

Holding, Stress, and Bonding During Therapeutic Hypothermia

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hypoxic-Ischemic Encephalopathy Brain Diseases Brain Ischemia Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Hypoxia Hypoxia, Brain Hypoxia-Ischemia, Brain Nervous System Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Respiratory Vascular Diseases

Age range

24 hour–3 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maine Medical Center

Portland, Maine, 04102, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Holding during cooling

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.

Primary outcomes

  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 outcomes

  1. Qualitative Experience of Mothers: Before I Could Hold my Baby, I Would Describe Our Ability to Bond as:

    Time frame: 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.

    • 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

  2. Qualitative Experience of Mothers: After Holding my Baby, I Feel Our Bond is:

    Time frame: 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.

    • After holding my baby, I feel our bond is:
    • Much stronger
    • Stronger
    • No change
    • Weaker
    • Much weaker

  3. Qualitative Experience of Mothers: Before Holding my Baby, my Stress Level Was:

    Time frame: 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.

    • Before holding my baby, my stress level was:
    • Very high
    • High
    • Low
    • Very low

  4. Qualitative Experience of Mothers: After Holding my Baby, I Feel:

    Time frame: 3 days

    • After holding my baby, I feel:
    • Much more stressed
    • More stressed
    • No change
    • Less stressed
    • Much less stressed

  5. Qualitative Experience of Mothers: I am Glad I Had the Opportunity to Hold my Baby During Treatment With Hypothermia

    Time frame: 3 days

    • I am glad I had the opportunity to hold my baby during treatment with hypothermia
    • Strongly agree
    • Agree
    • Disagree
    • Strongly disagree

  6. Qualitative Experience of Mothers: I Think Other Parents Would Benefit From Holding Their Babies During Treatment With Hypothermia, Provided They Are Medically Stable

    Time frame: 3 days

    • 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

  7. Qualitative Experience of Nurses: Therapeutic Hypothermia is Emotionally Challenging to the Parents of the Infant.

    Time frame: 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

  8. Qualitative Experience of Nurses: Treatment With Therapeutic Hypothermia Makes it Difficult for Parents to Bond With Their Infant.

    Time frame: 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

  9. Qualitative Experience of Nurses: After Assisting With the Holding Protocol, the Mother's Emotional Response to Her Infant's Treatment is...

    Time frame: 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

  10. Qualitative Experience of Nurses: After Seeing the Mother Hold Her Infant, the Maternal-infant Bond is a...

    Time frame: 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

  11. Qualitative Experience of Nurses: After Assisting With the Holding Protocol, I Feel That Holding During Cooling is Safe.

    Time frame: 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, I feel that holding during cooling is safe.

    A. Strongly agree B. Agree C. Disagree D. Strongly disagree

  12. 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.

    Time frame: 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

  13. Qualitative Experience of Nurses: After Having Been Held, the Infant Has Become…

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Alexa Craig

Other

Collaborators

  • MaineHealth

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Mar 14, 2017
Registry last updated
Sep 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.