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Holding, Stress, and Bonding During Therapeutic Hypothermia

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03079284
Enrollment
10
Registered
2017-03-14
Start date
2017-03-20
Completion date
2017-09-23
Last updated
2025-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypoxic-Ischemic Encephalopathy

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.

Interventions

OTHERHolding 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.

Sponsors

MaineHealth
CollaboratorOTHER
Alexa Craig
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
24 Hours to 3 Days
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

Design outcomes

Primary

MeasureTime frameDescription
Frequency of Adverse Events (Safety)3 daysAssess 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

MeasureTime frameDescription
Qualitative Experience of Mothers: After Holding my Baby, I Feel Our Bond is:3 daysA 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 Mothers: Before Holding my Baby, my Stress Level Was:3 daysA 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 days4\. 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 Mothers: I am Glad I Had the Opportunity to Hold my Baby During Treatment With Hypothermia3 days5\. 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 Mothers: I Think Other Parents Would Benefit From Holding Their Babies During Treatment With Hypothermia, Provided They Are Medically Stable3 days6\. 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
Qualitative Experience of Nurses: Therapeutic Hypothermia is Emotionally Challenging to the Parents of the Infant.3 daysA 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 Mothers: Before I Could Hold my Baby, I Would Describe Our Ability to Bond as:3 daysA 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 Nurses: After Assisting With the Holding Protocol, the Mother's Emotional Response to Her Infant's Treatment is...3 daysA 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: After Seeing the Mother Hold Her Infant, the Maternal-infant Bond is a...3 daysA 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 Nurses: After Assisting With the Holding Protocol, I Feel That Holding During Cooling is Safe.3 daysA 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
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 daysA 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 Having Been Held, the Infant Has Become…3 daysA 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 Nurses: Treatment With Therapeutic Hypothermia Makes it Difficult for Parents to Bond With Their Infant.3 daysA 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

Countries

United States

Participant flow

Participants by arm

ArmCount
Holding Group
Inclusion criteria were gestational age at birth of 35 weeks or greater, absence of clinical or electrographic seizures during the first 24 hours of TH, and designation as clinically stable by the attending neonatologist with the infant on room air, nasal cannula, or continuous positive airway pressure (CPAP). Exclusion criteria were intubation, use of inhaled nitric oxide for persistent pulmonary hypertension of the newborn, presence of seizures on EEG, use of vasopressors or paralytic agents, presence of chest tubes, wound vacuums, or drains, and in utero opiate exposure. Written informed consent was obtained from the mother for all patients.
10
Total10

Baseline characteristics

CharacteristicHolding Group
Age, Categorical
<=18 years
10 Participants
Age, Categorical
>=65 years
0 Participants
Age, Categorical
Between 18 and 65 years
0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
0 Participants
Race (NIH/OMB)
Black or African American
0 Participants
Race (NIH/OMB)
More than one race
0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
10 Participants
Race (NIH/OMB)
White
0 Participants
Region of Enrollment
United States
10 participants
Sex: Female, Male
Female
4 Participants
Sex: Female, Male
Male
6 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 10
other
Total, other adverse events
0 / 10
serious
Total, serious adverse events
0 / 10

Outcome results

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.

Time frame: 3 days

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Holding GroupFrequency of Adverse Events (Safety)0 Participants
Secondary

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

4\. After holding my baby, I feel: 1. Much more stressed 2. More stressed 3. No change 4. Less stressed 5. Much less stressed

Time frame: 3 days

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Holding GroupQualitative Experience of Mothers: After Holding my Baby, I Feel:Much more stressed0 Participants
Holding GroupQualitative Experience of Mothers: After Holding my Baby, I Feel:More stressed0 Participants
Holding GroupQualitative Experience of Mothers: After Holding my Baby, I Feel:No change0 Participants
Holding GroupQualitative Experience of Mothers: After Holding my Baby, I Feel:Less stressed Less stressed3 Participants
Holding GroupQualitative Experience of Mothers: After Holding my Baby, I Feel:Much less stressed7 Participants
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: 1. Much stronger 2. Stronger 3. No change 4. Weaker 5. Much weaker

Time frame: 3 days

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Holding GroupQualitative Experience of Mothers: After Holding my Baby, I Feel Our Bond is:Much stronger6 Participants
Holding GroupQualitative Experience of Mothers: After Holding my Baby, I Feel Our Bond is:Stronger4 Participants
Holding GroupQualitative Experience of Mothers: After Holding my Baby, I Feel Our Bond is:No change0 Participants
Holding GroupQualitative Experience of Mothers: After Holding my Baby, I Feel Our Bond is:Weaker0 Participants
Holding GroupQualitative Experience of Mothers: After Holding my Baby, I Feel Our Bond is:Much weaker0 Participants
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: 1. Very high 2. High 3. Low 4. Very low

Time frame: 3 days

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Holding GroupQualitative Experience of Mothers: Before Holding my Baby, my Stress Level Was:Very high6 Participants
Holding GroupQualitative Experience of Mothers: Before Holding my Baby, my Stress Level Was:High3 Participants
Holding GroupQualitative Experience of Mothers: Before Holding my Baby, my Stress Level Was:Low1 Participants
Holding GroupQualitative Experience of Mothers: Before Holding my Baby, my Stress Level Was:Very low0 Participants
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: 1. Very easy to bond 2. Easy to bond 3. Hard to bond 4. Very hard to bond

Time frame: 3 days

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Holding GroupQualitative Experience of Mothers: Before I Could Hold my Baby, I Would Describe Our Ability to Bond as:Very easy to bond0 Participants
Holding GroupQualitative Experience of Mothers: Before I Could Hold my Baby, I Would Describe Our Ability to Bond as:Easy to bond2 Participants
Holding GroupQualitative Experience of Mothers: Before I Could Hold my Baby, I Would Describe Our Ability to Bond as:Hard to bond5 Participants
Holding GroupQualitative Experience of Mothers: Before I Could Hold my Baby, I Would Describe Our Ability to Bond as:Very hard to bond3 Participants
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 1. Strongly agree 2. Agree 3. Disagree 4. Strongly disagree

Time frame: 3 days

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Holding GroupQualitative Experience of Mothers: I am Glad I Had the Opportunity to Hold my Baby During Treatment With HypothermiaStrongly agree10 Participants
Holding GroupQualitative Experience of Mothers: I am Glad I Had the Opportunity to Hold my Baby During Treatment With HypothermiaAgree0 Participants
Holding GroupQualitative Experience of Mothers: I am Glad I Had the Opportunity to Hold my Baby During Treatment With HypothermiaDisagree0 Participants
Holding GroupQualitative Experience of Mothers: I am Glad I Had the Opportunity to Hold my Baby During Treatment With HypothermiaStrongly disagree0 Participants
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 1. Strongly agree 2. Agree 3. Disagree 4. Strongly Disagree

Time frame: 3 days

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Holding GroupQualitative Experience of Mothers: I Think Other Parents Would Benefit From Holding Their Babies During Treatment With Hypothermia, Provided They Are Medically StableStrongly agree10 Participants
Holding GroupQualitative Experience of Mothers: I Think Other Parents Would Benefit From Holding Their Babies During Treatment With Hypothermia, Provided They Are Medically StableAgree0 Participants
Holding GroupQualitative Experience of Mothers: I Think Other Parents Would Benefit From Holding Their Babies During Treatment With Hypothermia, Provided They Are Medically StableDisagree0 Participants
Holding GroupQualitative Experience of Mothers: I Think Other Parents Would Benefit From Holding Their Babies During Treatment With Hypothermia, Provided They Are Medically StableStrongly disagree0 Participants
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 assisting with the holding protocol, I feel that holding during cooling is safe. A. Strongly agree B. Agree C. Disagree D. Strongly disagree

Time frame: 3 days

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Holding GroupQualitative Experience of Nurses: After Assisting With the Holding Protocol, I Feel That Holding During Cooling is Safe.Strongly agree6 Participants
Holding GroupQualitative Experience of Nurses: After Assisting With the Holding Protocol, I Feel That Holding During Cooling is Safe.Agree2 Participants
Holding GroupQualitative Experience of Nurses: After Assisting With the Holding Protocol, I Feel That Holding During Cooling is Safe.Disagree0 Participants
Holding GroupQualitative Experience of Nurses: After Assisting With the Holding Protocol, I Feel That Holding During Cooling is Safe.Strongly disagree0 Participants
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

Time frame: 3 days

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Holding GroupQualitative Experience of Nurses: After Assisting With the Holding Protocol, the Mother's Emotional Response to Her Infant's Treatment is...Strongly more positive5 Participants
Holding GroupQualitative Experience of Nurses: After Assisting With the Holding Protocol, the Mother's Emotional Response to Her Infant's Treatment is...More positive1 Participants
Holding GroupQualitative Experience of Nurses: After Assisting With the Holding Protocol, the Mother's Emotional Response to Her Infant's Treatment is...No change2 Participants
Holding GroupQualitative Experience of Nurses: After Assisting With the Holding Protocol, the Mother's Emotional Response to Her Infant's Treatment is...More negative0 Participants
Holding GroupQualitative Experience of Nurses: After Assisting With the Holding Protocol, the Mother's Emotional Response to Her Infant's Treatment is...Strongly more negative0 Participants
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

Time frame: 3 days

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Holding GroupQualitative Experience of Nurses: After Having Been Held, the Infant Has Become…Easier to care for3 Participants
Holding GroupQualitative Experience of Nurses: After Having Been Held, the Infant Has Become…Much easier to care for1 Participants
Holding GroupQualitative Experience of Nurses: After Having Been Held, the Infant Has Become…No change4 Participants
Holding GroupQualitative Experience of Nurses: After Having Been Held, the Infant Has Become…Harder to care for0 Participants
Holding GroupQualitative Experience of Nurses: After Having Been Held, the Infant Has Become…Much harder to care for0 Participants
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

Time frame: 3 days

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Holding GroupQualitative Experience of Nurses: After Seeing the Mother Hold Her Infant, the Maternal-infant Bond is a...Weaker bond2 Participants
Holding GroupQualitative Experience of Nurses: After Seeing the Mother Hold Her Infant, the Maternal-infant Bond is a...Much stronger bond4 Participants
Holding GroupQualitative Experience of Nurses: After Seeing the Mother Hold Her Infant, the Maternal-infant Bond is a...Stronger bond2 Participants
Holding GroupQualitative Experience of Nurses: After Seeing the Mother Hold Her Infant, the Maternal-infant Bond is a...No change0 Participants
Holding GroupQualitative Experience of Nurses: After Seeing the Mother Hold Her Infant, the Maternal-infant Bond is a...Much weaker bond0 Participants
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

Time frame: 3 days

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Holding GroupQualitative 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.Strongly agree6 Participants
Holding GroupQualitative 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.Agree2 Participants
Holding GroupQualitative 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.Disagree0 Participants
Holding GroupQualitative 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.Strongly disagree0 Participants
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

Time frame: 3 days

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Holding GroupQualitative Experience of Nurses: Therapeutic Hypothermia is Emotionally Challenging to the Parents of the Infant.Strongly agree1 Participants
Holding GroupQualitative Experience of Nurses: Therapeutic Hypothermia is Emotionally Challenging to the Parents of the Infant.Agree7 Participants
Holding GroupQualitative Experience of Nurses: Therapeutic Hypothermia is Emotionally Challenging to the Parents of the Infant.Disagree0 Participants
Holding GroupQualitative Experience of Nurses: Therapeutic Hypothermia is Emotionally Challenging to the Parents of the Infant.Strongly disagree0 Participants
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

Time frame: 3 days

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Holding GroupQualitative Experience of Nurses: Treatment With Therapeutic Hypothermia Makes it Difficult for Parents to Bond With Their Infant.Strongly agree3 Participants
Holding GroupQualitative Experience of Nurses: Treatment With Therapeutic Hypothermia Makes it Difficult for Parents to Bond With Their Infant.Agree5 Participants
Holding GroupQualitative Experience of Nurses: Treatment With Therapeutic Hypothermia Makes it Difficult for Parents to Bond With Their Infant.Disagree0 Participants
Holding GroupQualitative Experience of Nurses: Treatment With Therapeutic Hypothermia Makes it Difficult for Parents to Bond With Their Infant.Strongly disagree0 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026