Trial Outcomes & Findings for Holding, Stress, and Bonding During Therapeutic Hypothermia (NCT NCT03079284)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

10 participants

Primary outcome timeframe

3 days

Results posted on

2025-09-04

Participant Flow

Participant milestones

Participant milestones
Measure	Holding Group Intervention was mothers being able to hold their infants for 30 minutes during therapeutic hypothermia. 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.
Overall Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Holding, Stress, and Bonding During Therapeutic Hypothermia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Holding Group n=10 Participants 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.
Age, Categorical <=18 years	10 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	10 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Holding Group n=10 Participants 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.
Frequency of Adverse Events (Safety)	0 Participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Holding Group n=10 Participants 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.
Qualitative Experience of Mothers: Before I Could Hold my Baby, I Would Describe Our Ability to Bond as: Easy to bond	2 Participants
Qualitative Experience of Mothers: Before I Could Hold my Baby, I Would Describe Our Ability to Bond as: Hard to bond	5 Participants
Qualitative Experience of Mothers: Before I Could Hold my Baby, I Would Describe Our Ability to Bond as: Very easy to bond	0 Participants
Qualitative Experience of Mothers: Before I Could Hold my Baby, I Would Describe Our Ability to Bond as: Very hard to bond	3 Participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Holding Group n=10 Participants 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.
Qualitative Experience of Mothers: After Holding my Baby, I Feel Our Bond is: Much stronger	6 Participants
Qualitative Experience of Mothers: After Holding my Baby, I Feel Our Bond is: Stronger	4 Participants
Qualitative Experience of Mothers: After Holding my Baby, I Feel Our Bond is: No change	0 Participants
Qualitative Experience of Mothers: After Holding my Baby, I Feel Our Bond is: Weaker	0 Participants
Qualitative Experience of Mothers: After Holding my Baby, I Feel Our Bond is: Much weaker	0 Participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Holding Group n=10 Participants 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.
Qualitative Experience of Mothers: Before Holding my Baby, my Stress Level Was: Very high	6 Participants
Qualitative Experience of Mothers: Before Holding my Baby, my Stress Level Was: High	3 Participants
Qualitative Experience of Mothers: Before Holding my Baby, my Stress Level Was: Low	1 Participants
Qualitative Experience of Mothers: Before Holding my Baby, my Stress Level Was: Very low	0 Participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Holding Group n=10 Participants 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.
Qualitative Experience of Mothers: After Holding my Baby, I Feel: Much more stressed	0 Participants
Qualitative Experience of Mothers: After Holding my Baby, I Feel: More stressed	0 Participants
Qualitative Experience of Mothers: After Holding my Baby, I Feel: No change	0 Participants
Qualitative Experience of Mothers: After Holding my Baby, I Feel: Less stressed Less stressed	3 Participants
Qualitative Experience of Mothers: After Holding my Baby, I Feel: Much less stressed	7 Participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Holding Group n=10 Participants 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.
Qualitative Experience of Mothers: I am Glad I Had the Opportunity to Hold my Baby During Treatment With Hypothermia Strongly agree	10 Participants
Qualitative Experience of Mothers: I am Glad I Had the Opportunity to Hold my Baby During Treatment With Hypothermia Agree	0 Participants
Qualitative Experience of Mothers: I am Glad I Had the Opportunity to Hold my Baby During Treatment With Hypothermia Disagree	0 Participants
Qualitative Experience of Mothers: I am Glad I Had the Opportunity to Hold my Baby During Treatment With Hypothermia Strongly disagree	0 Participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Holding Group n=10 Participants 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.
Qualitative Experience of Mothers: I Think Other Parents Would Benefit From Holding Their Babies During Treatment With Hypothermia, Provided They Are Medically Stable Strongly agree	10 Participants
Qualitative Experience of Mothers: I Think Other Parents Would Benefit From Holding Their Babies During Treatment With Hypothermia, Provided They Are Medically Stable Agree	0 Participants
Qualitative Experience of Mothers: I Think Other Parents Would Benefit From Holding Their Babies During Treatment With Hypothermia, Provided They Are Medically Stable Disagree	0 Participants
Qualitative Experience of Mothers: I Think Other Parents Would Benefit From Holding Their Babies During Treatment With Hypothermia, Provided They Are Medically Stable Strongly disagree	0 Participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Holding Group n=8 Participants 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.
Qualitative Experience of Nurses: Therapeutic Hypothermia is Emotionally Challenging to the Parents of the Infant. Agree	7 Participants
Qualitative Experience of Nurses: Therapeutic Hypothermia is Emotionally Challenging to the Parents of the Infant. Disagree	0 Participants
Qualitative Experience of Nurses: Therapeutic Hypothermia is Emotionally Challenging to the Parents of the Infant. Strongly disagree	0 Participants
Qualitative Experience of Nurses: Therapeutic Hypothermia is Emotionally Challenging to the Parents of the Infant. Strongly agree	1 Participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Holding Group n=8 Participants 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.
Qualitative Experience of Nurses: Treatment With Therapeutic Hypothermia Makes it Difficult for Parents to Bond With Their Infant. Strongly agree	3 Participants
Qualitative Experience of Nurses: Treatment With Therapeutic Hypothermia Makes it Difficult for Parents to Bond With Their Infant. Agree	5 Participants
Qualitative Experience of Nurses: Treatment With Therapeutic Hypothermia Makes it Difficult for Parents to Bond With Their Infant. Disagree	0 Participants
Qualitative Experience of Nurses: Treatment With Therapeutic Hypothermia Makes it Difficult for Parents to Bond With Their Infant. Strongly disagree	0 Participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Holding Group n=8 Participants 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.
Qualitative Experience of Nurses: After Assisting With the Holding Protocol, the Mother's Emotional Response to Her Infant's Treatment is... Strongly more positive	5 Participants
Qualitative Experience of Nurses: After Assisting With the Holding Protocol, the Mother's Emotional Response to Her Infant's Treatment is... More positive	1 Participants
Qualitative Experience of Nurses: After Assisting With the Holding Protocol, the Mother's Emotional Response to Her Infant's Treatment is... No change	2 Participants
Qualitative Experience of Nurses: After Assisting With the Holding Protocol, the Mother's Emotional Response to Her Infant's Treatment is... More negative	0 Participants
Qualitative Experience of Nurses: After Assisting With the Holding Protocol, the Mother's Emotional Response to Her Infant's Treatment is... Strongly more negative	0 Participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Holding Group n=8 Participants 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.
Qualitative Experience of Nurses: After Seeing the Mother Hold Her Infant, the Maternal-infant Bond is a... Much stronger bond	4 Participants
Qualitative Experience of Nurses: After Seeing the Mother Hold Her Infant, the Maternal-infant Bond is a... Stronger bond	2 Participants
Qualitative Experience of Nurses: After Seeing the Mother Hold Her Infant, the Maternal-infant Bond is a... No change	0 Participants
Qualitative Experience of Nurses: After Seeing the Mother Hold Her Infant, the Maternal-infant Bond is a... Weaker bond	2 Participants
Qualitative Experience of Nurses: After Seeing the Mother Hold Her Infant, the Maternal-infant Bond is a... Much weaker bond	0 Participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Holding Group n=8 Participants 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.
Qualitative Experience of Nurses: After Assisting With the Holding Protocol, I Feel That Holding During Cooling is Safe. Strongly agree	6 Participants
Qualitative Experience of Nurses: After Assisting With the Holding Protocol, I Feel That Holding During Cooling is Safe. Agree	2 Participants
Qualitative Experience of Nurses: After Assisting With the Holding Protocol, I Feel That Holding During Cooling is Safe. Disagree	0 Participants
Qualitative Experience of Nurses: After Assisting With the Holding Protocol, I Feel That Holding During Cooling is Safe. Strongly disagree	0 Participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Holding Group n=8 Participants 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.
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. Strongly agree	6 Participants
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. Agree	2 Participants
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. Disagree	0 Participants
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. Strongly disagree	0 Participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Holding Group n=8 Participants 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.
Qualitative Experience of Nurses: After Having Been Held, the Infant Has Become… Much easier to care for	1 Participants
Qualitative Experience of Nurses: After Having Been Held, the Infant Has Become… Easier to care for	3 Participants
Qualitative Experience of Nurses: After Having Been Held, the Infant Has Become… No change	4 Participants
Qualitative Experience of Nurses: After Having Been Held, the Infant Has Become… Harder to care for	0 Participants
Qualitative Experience of Nurses: After Having Been Held, the Infant Has Become… Much harder to care for	0 Participants

Adverse Events

Holding Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Alexa Craig

Maine Medical Center

Phone: 207-396-7337

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place