Hypoxic-Ischemic Encephalopathy
Conditions
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
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
Study design
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of Adverse Events (Safety) | 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
| Measure | Time frame | Description |
|---|---|---|
| Qualitative Experience of Mothers: After Holding my Baby, I Feel Our Bond is: | 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 |
| Qualitative Experience of Mothers: Before Holding my Baby, my Stress Level Was: | 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 |
| Qualitative Experience of Mothers: After Holding my Baby, I Feel: | 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 |
| Qualitative Experience of Mothers: I am Glad I Had the Opportunity to Hold my Baby During Treatment With Hypothermia | 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 |
| Qualitative Experience of Mothers: I Think Other Parents Would Benefit From Holding Their Babies During Treatment With Hypothermia, Provided They Are Medically Stable | 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 |
| Qualitative Experience of Nurses: Therapeutic Hypothermia is Emotionally Challenging to the Parents of the Infant. | 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 |
| Qualitative Experience of Mothers: Before I Could Hold my Baby, I Would Describe Our Ability to Bond as: | 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 |
| Qualitative Experience of Nurses: After Assisting With the Holding Protocol, the Mother's Emotional Response to Her Infant's Treatment is... | 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 |
| Qualitative Experience of Nurses: After Seeing the Mother Hold Her Infant, the Maternal-infant Bond is a... | 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 |
| Qualitative Experience of Nurses: After Assisting With the Holding Protocol, I Feel That Holding During Cooling is Safe. | 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 |
| 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 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 |
| Qualitative Experience of Nurses: After Having Been Held, the Infant Has Become… | 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 |
| Qualitative Experience of Nurses: Treatment With Therapeutic Hypothermia Makes it Difficult for Parents to Bond With Their Infant. | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 |
| Total | 10 |
Baseline characteristics
| Characteristic | Holding 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 type | EG000 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
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Holding Group | Frequency of Adverse Events (Safety) | 0 Participants |
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
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Holding Group | Qualitative Experience of Mothers: After Holding my Baby, I Feel: | Much more stressed | 0 Participants |
| Holding Group | Qualitative Experience of Mothers: After Holding my Baby, I Feel: | More stressed | 0 Participants |
| Holding Group | Qualitative Experience of Mothers: After Holding my Baby, I Feel: | No change | 0 Participants |
| Holding Group | Qualitative Experience of Mothers: After Holding my Baby, I Feel: | Less stressed Less stressed | 3 Participants |
| Holding Group | Qualitative Experience of Mothers: After Holding my Baby, I Feel: | Much less stressed | 7 Participants |
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
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Holding Group | Qualitative Experience of Mothers: After Holding my Baby, I Feel Our Bond is: | Much stronger | 6 Participants |
| Holding Group | Qualitative Experience of Mothers: After Holding my Baby, I Feel Our Bond is: | Stronger | 4 Participants |
| Holding Group | Qualitative Experience of Mothers: After Holding my Baby, I Feel Our Bond is: | No change | 0 Participants |
| Holding Group | Qualitative Experience of Mothers: After Holding my Baby, I Feel Our Bond is: | Weaker | 0 Participants |
| Holding Group | Qualitative Experience of Mothers: After Holding my Baby, I Feel Our Bond is: | Much weaker | 0 Participants |
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
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Holding Group | Qualitative Experience of Mothers: Before Holding my Baby, my Stress Level Was: | Very high | 6 Participants |
| Holding Group | Qualitative Experience of Mothers: Before Holding my Baby, my Stress Level Was: | High | 3 Participants |
| Holding Group | Qualitative Experience of Mothers: Before Holding my Baby, my Stress Level Was: | Low | 1 Participants |
| Holding Group | Qualitative Experience of Mothers: Before Holding my Baby, my Stress Level Was: | Very low | 0 Participants |
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
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Holding Group | Qualitative Experience of Mothers: Before I Could Hold my Baby, I Would Describe Our Ability to Bond as: | Very easy to bond | 0 Participants |
| Holding Group | Qualitative Experience of Mothers: Before I Could Hold my Baby, I Would Describe Our Ability to Bond as: | Easy to bond | 2 Participants |
| Holding Group | Qualitative Experience of Mothers: Before I Could Hold my Baby, I Would Describe Our Ability to Bond as: | Hard to bond | 5 Participants |
| Holding Group | Qualitative Experience of Mothers: Before I Could Hold my Baby, I Would Describe Our Ability to Bond as: | Very hard to bond | 3 Participants |
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
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Holding Group | Qualitative Experience of Mothers: I am Glad I Had the Opportunity to Hold my Baby During Treatment With Hypothermia | Strongly agree | 10 Participants |
| Holding Group | Qualitative Experience of Mothers: I am Glad I Had the Opportunity to Hold my Baby During Treatment With Hypothermia | Agree | 0 Participants |
| Holding Group | Qualitative Experience of Mothers: I am Glad I Had the Opportunity to Hold my Baby During Treatment With Hypothermia | Disagree | 0 Participants |
| Holding Group | Qualitative Experience of Mothers: I am Glad I Had the Opportunity to Hold my Baby During Treatment With Hypothermia | Strongly 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
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
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Holding Group | 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 |
| Holding Group | 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 |
| Holding Group | 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 |
| Holding Group | 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 |
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
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Holding Group | Qualitative Experience of Nurses: After Assisting With the Holding Protocol, I Feel That Holding During Cooling is Safe. | Strongly agree | 6 Participants |
| Holding Group | Qualitative Experience of Nurses: After Assisting With the Holding Protocol, I Feel That Holding During Cooling is Safe. | Agree | 2 Participants |
| Holding Group | Qualitative Experience of Nurses: After Assisting With the Holding Protocol, I Feel That Holding During Cooling is Safe. | Disagree | 0 Participants |
| Holding Group | Qualitative Experience of Nurses: After Assisting With the Holding Protocol, I Feel That Holding During Cooling is Safe. | Strongly disagree | 0 Participants |
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
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Holding Group | 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 |
| Holding Group | 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 |
| Holding Group | 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 |
| Holding Group | 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 |
| Holding Group | 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 |
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
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Holding Group | Qualitative Experience of Nurses: After Having Been Held, the Infant Has Become… | Easier to care for | 3 Participants |
| Holding Group | Qualitative Experience of Nurses: After Having Been Held, the Infant Has Become… | Much easier to care for | 1 Participants |
| Holding Group | Qualitative Experience of Nurses: After Having Been Held, the Infant Has Become… | No change | 4 Participants |
| Holding Group | Qualitative Experience of Nurses: After Having Been Held, the Infant Has Become… | Harder to care for | 0 Participants |
| Holding Group | Qualitative Experience of Nurses: After Having Been Held, the Infant Has Become… | Much harder to care for | 0 Participants |
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
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Holding Group | Qualitative Experience of Nurses: After Seeing the Mother Hold Her Infant, the Maternal-infant Bond is a... | Weaker bond | 2 Participants |
| Holding Group | Qualitative Experience of Nurses: After Seeing the Mother Hold Her Infant, the Maternal-infant Bond is a... | Much stronger bond | 4 Participants |
| Holding Group | Qualitative Experience of Nurses: After Seeing the Mother Hold Her Infant, the Maternal-infant Bond is a... | Stronger bond | 2 Participants |
| Holding Group | Qualitative Experience of Nurses: After Seeing the Mother Hold Her Infant, the Maternal-infant Bond is a... | No change | 0 Participants |
| Holding Group | Qualitative Experience of Nurses: After Seeing the Mother Hold Her Infant, the Maternal-infant Bond is a... | Much weaker bond | 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.
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
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Holding Group | 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 |
| Holding Group | 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 |
| Holding Group | 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 |
| Holding Group | 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 |
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
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Holding Group | Qualitative Experience of Nurses: Therapeutic Hypothermia is Emotionally Challenging to the Parents of the Infant. | Strongly agree | 1 Participants |
| Holding Group | Qualitative Experience of Nurses: Therapeutic Hypothermia is Emotionally Challenging to the Parents of the Infant. | Agree | 7 Participants |
| Holding Group | Qualitative Experience of Nurses: Therapeutic Hypothermia is Emotionally Challenging to the Parents of the Infant. | Disagree | 0 Participants |
| Holding Group | Qualitative Experience of Nurses: Therapeutic Hypothermia is Emotionally Challenging to the Parents of the Infant. | Strongly disagree | 0 Participants |
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
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Holding Group | Qualitative Experience of Nurses: Treatment With Therapeutic Hypothermia Makes it Difficult for Parents to Bond With Their Infant. | Strongly agree | 3 Participants |
| Holding Group | Qualitative Experience of Nurses: Treatment With Therapeutic Hypothermia Makes it Difficult for Parents to Bond With Their Infant. | Agree | 5 Participants |
| Holding Group | Qualitative Experience of Nurses: Treatment With Therapeutic Hypothermia Makes it Difficult for Parents to Bond With Their Infant. | Disagree | 0 Participants |
| Holding Group | Qualitative Experience of Nurses: Treatment With Therapeutic Hypothermia Makes it Difficult for Parents to Bond With Their Infant. | Strongly disagree | 0 Participants |