Hypoxic-Ischemic EncephalopathyNCT03079284
Holding, Stress, and Bonding During Therapeutic Hypothermia
A study testing Holding during cooling in people with Hypoxic-Ischemic Encephalopathy, run by Alexa Craig at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 24 hours to 3 days
- Conditions the study is for
- Hypoxic-Ischemic Encephalopathy
- What is being tested?
- Holding during cooling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Mar 2017to 23 Sep 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 hours to 3 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Holding on Stress and Bonding in Mother-Infant Dyads 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.
- Conditions
- Hypoxic-Ischemic Encephalopathy
- Being tested
- Holding during cooling
- Medical subject headings
- Hypoxia-Ischemia, Brain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Holding during coolingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Holding Group | Experimental | 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. Receives: Other: Holding during cooling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 days
Secondary outcomes (13)
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.
- 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
Measured: 3 days
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.
- After holding my baby, I feel our bond is:
- Much stronger
- Stronger
- No change
- Weaker
- Much weaker
Measured: 3 days
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.
- Before holding my baby, my stress level was:
- Very high
- High
- Low
- Very low
Measured: 3 days
Qualitative Experience of Mothers: After Holding my Baby, I Feel:
- After holding my baby, I feel:
- Much more stressed
- More stressed
- No change
- Less stressed
- Much less stressed
Measured: 3 days
Qualitative Experience of Mothers: I am Glad I Had the Opportunity to Hold my Baby During Treatment With Hypothermia
- I am glad I had the opportunity to hold my baby during treatment with hypothermia
- Strongly agree
- Agree
- Disagree
- Strongly disagree
Measured: 3 days
Qualitative Experience of Mothers: I Think Other Parents Would Benefit From Holding Their Babies During Treatment With Hypothermia, Provided They Are Medically Stable
- 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
Measured: 3 days
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.
- Strongly agree B. Agree C. Disagree D. Strongly Disagree
Measured: 3 days
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.
- Strongly agree B. Agree C. Disagree D. Strongly Disagree
Measured: 3 days
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...
- Strongly more positive B. More positive C. No change D. More negative E. Strongly more negative
Measured: 3 days
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
Measured: 3 days
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.
- Strongly agree B. Agree C. Disagree D. Strongly disagree
Measured: 3 days
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.
- Strongly agree B. Agree C. Disagree D. Strongly disagree
Measured: 3 days
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.
- Much easier to care for B. Easier to care for C. No change D. Harder to care for E. Much harder to care for
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2017
- Study start20 Mar 2017
- Primary completion23 Sep 2017
- Study completion23 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hypoxic-Ischemic EncephalopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexa Craig
- Sponsor type
- University, hospital or other
- Collaborators
- MaineHealth
- Responsible party
- Sponsor-investigator, Alexa Craig, MaineHealth
- Investigators
- Alexa Craig, MD, MSc, Principal investigator, MaineHealth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03079284
- Sponsor's protocol ID
- 1015281-1
- Status last verified
- Aug 2025
- First submitted
- 6 Mar 2017
- Last updated
- 4 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Craig A, Deerwester K, Fox L, Jacobs J, Evans S. Maternal holding during therapeutic hypothermia for infants with neonatal encephalopathy is feasible. Acta Paediatr. 2019 Sep;108(9):1597-1602. doi: 10.1111/apa.14743. Epub 2019 Mar 5.
PubMed 30721531
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Holding on Stress and Bonding in Mother-Infant Dyads During Therapeutic Hypothermia
- ClinicalTrials.gov ID
- NCT03079284
- Acronym / sponsor ID
- 1015281-1
- Conditions
- Hypoxic-Ischemic Encephalopathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Alexa CraigUniversity, hospital or other
- Collaborators
- MaineHealth
- Study start
- 20 Mar 2017 (actual)
- Primary completion
- 23 Sep 2017 (actual)
- Study completion
- 23 Sep 2017 (actual)
- First posted
- 14 Mar 2017 (actual)
- Results
- Posted 26 Jan 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Holding Group | Experimental | Other: Holding during coolingAfter 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. |
Who may qualify
- Ages
- 24 hours to 3 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Holding during coolingAn 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. | Other | Holding Group |
Primary outcome
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.
13 secondary outcomes
Qualitative Experience of Mothers: Before I Could Hold my Baby, I Would Describe Our Ability to Bond as:
Time frame: 3 days
Qualitative Experience of Mothers: After Holding my Baby, I Feel Our Bond is:
Time frame: 3 days
Qualitative Experience of Mothers: Before Holding my Baby, my Stress Level Was:
Time frame: 3 days
Qualitative Experience of Mothers: After Holding my Baby, I Feel:
Time frame: 3 days
Qualitative Experience of Mothers: I am Glad I Had the Opportunity to Hold my Baby During Treatment With Hypothermia
Time frame: 3 days
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
Qualitative Experience of Nurses: Therapeutic Hypothermia is Emotionally Challenging to the Parents of the Infant.
Time frame: 3 days
Qualitative Experience of Nurses: Treatment With Therapeutic Hypothermia Makes it Difficult for Parents to Bond With Their Infant.
Time frame: 3 days
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
Qualitative Experience of Nurses: After Seeing the Mother Hold Her Infant, the Maternal-infant Bond is a...
Time frame: 3 days
Qualitative Experience of Nurses: After Assisting With the Holding Protocol, I Feel That Holding During Cooling is Safe.
Time frame: 3 days
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
Qualitative Experience of Nurses: After Having Been Held, the Infant Has Become…
Time frame: 3 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30721531Craig A, Deerwester K, Fox L, Jacobs J, Evans S. Maternal holding during therapeutic hypothermia for infants with neonatal encephalopathy is feasible. Acta Paediatr. 2019 Sep;108(9):1597-1602. doi: 10.1111/apa.14743. Epub 2019 Mar 5.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexa Craig, MD, MSc principal investigator
MaineHealth
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Holding during cooling in people with Hypoxic-Ischemic Encephalopathy, run by Alexa Craig at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Jan 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of Adverse Events (Safety) (time frame: 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03079284, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2025.