Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| MaineHealth | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Holding during cooling | Other | An initial set of vital sings will be recorded before the infant is removed from the isolette. The mother will sit in a reclining chair next to the isolette and place a thermal barrier over her chest and abdomen. The infant will be transferred to the mother by placing the hands under the cooling blanket so as to move the infant and cooling blanket together as one unit. The mother will be allowed to hold for thirty minutes provided that the infant's temperature does not increase by greater than one degree centigrade and the oxygen saturation does not drop below 90%. After thirty minutes, the infant will be returned to the isolette. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
| 3 days |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Alexa Craig, MD, MSc | MaineHealth | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maine Medical Center | Portland | Maine | 04102 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30721531 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | 3 days |
|
Adverse events were tracked for the three days of therapeutic hypothermia.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Alexa Craig | Maine Medical Center | 207-396-7337 | craiga@mmc.org |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 28, 2017 | Feb 24, 2020 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D020925 | Hypoxia-Ischemia, Brain |
| ID | Term |
|---|---|
| D002545 | Brain Ischemia |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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:
| 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. 3. Before holding my baby, my stress level was:
| 3 days |
| Qualitative Experience of Mothers: After Holding my Baby, I Feel: | 4. After holding my baby, I feel:
| 3 days |
| 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
| 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 | 6. I think other parents would benefit from holding their babies during treatment with hypothermia, provided they are medically stable
| 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. A. Strongly agree B. Agree C. Disagree D. Strongly Disagree | 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. A. Strongly agree B. Agree C. Disagree D. Strongly Disagree | 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... A. Strongly more positive B. More positive C. No change D. More negative E. Strongly more negative | 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 | 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. A. Strongly agree B. Agree C. Disagree D. Strongly disagree | 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. A. Strongly agree B. Agree C. Disagree D. Strongly disagree | 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. 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 | 3 days |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | 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:
| Posted | Count of Participants | Participants | 3 days |
|
|
|
| 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:
| Posted | Count of Participants | Participants | 3 days |
|
|
|
| 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:
| Posted | Count of Participants | Participants | 3 days |
|
|
|
| Secondary | Qualitative Experience of Mothers: After Holding my Baby, I Feel: | 4. After holding my baby, I feel:
| Posted | Count of Participants | Participants | 3 days |
|
|
|
| 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
| Posted | Count of Participants | Participants | 3 days |
|
|
|
| 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
| Posted | Count of Participants | Participants | 3 days |
|
|
|
| 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 | Posted | Count of Participants | Participants | 3 days |
|
|
|
| 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 | Posted | Count of Participants | Participants | 3 days |
|
|
|
| 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 | Posted | Count of Participants | Participants | 3 days |
|
|
|
| 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 | Posted | Count of Participants | Participants | 3 days |
|
|
|
| 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 | Posted | Count of Participants | Participants | 3 days |
|
|
|
| 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 | Posted | Count of Participants | Participants | 3 days |
|
|
|
| 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 | Posted | Count of Participants | Participants | 3 days |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
Not provided
Not provided
| D009422 | Nervous System Diseases |
| D002534 | Hypoxia, Brain |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D000860 | Hypoxia |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Very hard to bond |
|
| Weaker |
|
| Much weaker |
|
| Very low |
|
| Less stressed Less stressed |
|
| Much less stressed |
|
| Strongly disagree |
|
| Strongly disagree |
|
| Strongly disagree |
|
| Strongly disagree |
|
| More negative |
|
| Strongly more negative |
|
| Weaker bond |
|
| Much weaker bond |
|
| Strongly disagree |
|
| Strongly disagree |
|
| Harder to care for |
|
| Much harder to care for |
|