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Researchers are proposing a pilot randomized controlled trial evaluating the benefit of immediately warming preterm babies using a warming mattress and a plastic wrap, while delaying clamping the umbilical cord at the time of c-section in babies born between 32 and 36 weeks to determine if it reduces the risk of hypothermia.
The trial will be advertised and introduced to patients admitted to the OU Children's Hospital labor and delivery or antepartum units by research nurses. Interested participants will be consented. Researchers are choosing to only include patients undergoing non-emergent cesarean in order to improve their ability to control parameters such as room temperature and labor-related clinical or subclinical maternal infection, which are known confounders. Further, they are limiting their investigation to fetuses 32-36 weeks gestation, since this population represents the largest preterm delivery population. Recruitment and randomization will be stratified by gestational age with an aim to enroll at least 44 pregnancies at 32-34 weeks and 6 days and 20 pregnancies between 35-36 weeks and 6 days. Last, it is impossible to recruit patients outside of the inpatient setting for a study investigating preterm delivery, as such deliveries are rarely predictable in the outpatient setting. There will only be one site for this study, the OU Children's Hospital labor and delivery and antepartum units.
The proposed study is a pragmatic randomized controlled pilot trial of neonatal warming techniques with participants allocated in a 1:1 ratio using a random block allocation table using blocks of size 4 and 6 that are stratified by gestational age ranges of 35-36 weeks and 6 days and 32-34 weeks and 6 days. Since there cannot be a placebo intervention, neither the patient nor the neonatal team will be blinded to the group assignment. The group assignments will be made and coded by a third party at the time of randomization. Patients will be randomized to their respective groups immediately prior to surgery.
The surgical technician will be provided with the necessary neonatal wraps and mattresses in a sterile fashion, and they will ensure these are available on the surgical field once the cesarean has begun. In the intervention group, the thermal mattress will be activated immediately prior to hysterotomy and placed on the sterile field with delivery of the infant directly onto the mattress. The infant will be dried, stimulated and bulb suctioned as deemed necessary per standard of care followed by wrapping. In the non-intervention group, the infant will be delivered onto the sterile field, dried and suctioned as deemed necessary per OU standard. Cord clamping will be delayed for 60 seconds in all infants under the supervision of both the obstetrician and the neonatal resuscitation team. If either team believes delayed cord clamping is no longer considered safe, as is usual protocol, the cord will be clamped and cut and the baby will be handed off to the neonatology team. After the infant is handed to the neonatology team along with all group assignment specific materials (neonatal wrap and thermal mattress, if in the intervention group), neonatal temperature will be assessed immediately upon arrival to the resuscitation warmer using a digital thermometer placed in the axillary space. Infant temperature will be recorded at 1) arrival to the warmer, 2) after the neonatologist deems that in-room resuscitation is complete and 3) at admission to the Neonatal Intensive Care Unit (NICU), Mother Baby Unit (MBU) or Post-Anesthesia Care Unit (PACU) depending on the baby's needs; determined by the resuscitating physicians. These measurements will be recorded by research nurses in a data collection sheet. Further, the research nurse will record the time from delivery to the time it takes for the infant to arrive at the warmer. Upon arrival at the warmer, the mattress and wrap will be removed as neonatal evaluation takes place.
As immediate neonatal temperature is not generally discussed with patients unless there is an issue such as concern for infection, neonatal temperature will not be routinely discussed with all participants. Only if there is concern for neonatal infection or if there is hyperthermia (>37.5 degrees C) will the study results be discussed with the patient.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | In the intervention group, the infant will be placed on the thermal mattress, then wrapped. |
|
| Control group | No Intervention | In the non-intervention group, the infant will be delivered onto the sterile field as per standard of care. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neonatal warming mattress | Device | Babies will be warmed with a standard neonatal transport warming mattress immediately after birth. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Temperature at Arrival to Warmer | Temperature at arrival to the Warmer | 3 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Temperature at Exit | The temperature at exit is only available for n=21 in treatment groups and n=19 in control group. | 3 minutes |
| Temperature at NICU/Recovery | Temperature at admission to NICU/Recovery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Birju Shah, MD | University of Oklahoma HSC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73104 | United States |
No plans to share data
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The values reported reflect the total number of unique participants (mothers) assigned to each Arm.
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| ID | Title | Description |
|---|---|---|
| FG000 | Warming Mattress and Sterile Polyethylene Wrap Group | In the intervention group, the infant was placed on the thermal mattress, then wrapped. Neonatal warming mattress: Babies will be warmed with a standard neonatal transport warming mattress immediately after birth. Sterile polyethylene wrap: Babies will be wrapped in a sterile polyethylene wrap prior to arrival at the warmer. |
| FG001 | Standard of Care Group | In the non-intervention group, the infant will be delivered onto the sterile field as per standard of care. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention Group | In the intervention group, the infant will be placed on the thermal mattress, then wrapped. Neonatal warming mattress: Babies will be warmed with a standard neonatal transport warming mattress immediately after birth. Sterile polyethylene wrap: Babies will be wrapped in a sterile polyethylene wrap prior to arrival at the warmer. |
| 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 | Temperature at Arrival to Warmer | Temperature at arrival to the Warmer | Posted | Median | Full Range | degrees Celsius | 3 minutes |
|
Through discharge, assessed up to 3 months per participant
Adverse events were collected for participants throughout their participation in the study, up to their hospital or NICU discharge.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Warming Mattress and Sterile Polyethylene Wrap Group-Mothers | In the intervention group, the infant will be placed on the thermal mattress, then wrapped. Neonatal warming mattress: Babies will be warmed with a standard neonatal transport warming mattress immediately after birth. Sterile polyethylene wrap: Babies will be wrapped in a sterile polyethylene wrap prior to arrival at the warmer. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Elevated temperature | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Birju Shah, MD | University of Oklahoma Health Sciences Center | 405-271-5215 | 42167 | birju-shah@ouhsc.edu |
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| 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 | Feb 18, 2022 | Mar 5, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007035 | Hypothermia |
| ID | Term |
|---|---|
| D001832 | Body Temperature Changes |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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1:1 using a block randomization scheme stratified by gestational age
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| Sterile polyethylene wrap | Device | Babies will be wrapped in a sterile polyethylene wrap prior to arrival at the warmer. |
|
| 24 hours |
| Peak Bilirubin | Highest bilirubin level of infant based on blood test | Through hospital discharge up to 3 months |
| Duration of Respiratory Support | Duration of respiratory support in the form of intubation or continuous positive airway pressure (if applicable) | Through hospital discharge up to 3 months |
| Length of Delayed Cord Clamp | Length of delayed cord clamp in seconds | Up to 60 seconds after birth |
| Length of Hospital Stay | Length of hospital stay in days | Through hospital discharge up to 3 months |
| Age to Wean to Crib | Age to wean to crib in days | Through hospital discharge up to 3 months |
| Hypothermia at Warmer | Number of infants with hypothermia at time of arrival to warmer | Immediately after cord clamping (up to 60 seconds after birth) |
| Hypothermia at Completion of Resuscitation | Hypothermia at the Completion of Resuscitation | Through hospital discharge up to 3 months |
| Hypothermia at NICU/Recovery | Hypothermia at NICU admission /Recovery | Through hospital discharge up to 3 months |
| Hyperthermia (>37.5C) at Warmer | Hyperthermia (>37.5C) at arrival to Warmer | Through hospital discharge up to 3 months |
| Hypoglycemia | Hypoglycemia (less than 30mg/dL in the first 24 hours) | 24 hours |
| Need for NICU Admission | Whether or not infant was admitted to NICU | 24 hours |
| Composite | Composite neonatal morbidity (if applicable) | Through hospital discharge up to 3 months |
| BG001 |
| Control Group |
In the non-intervention group, the infant will be delivered onto the sterile field as per standard of care. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Due to the nature of the study, only females (mothers) were enrolled. The sex of the newborns was not collected. | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Maternal Age | Mean | Standard Deviation | years |
|
| Gestational age | Mean | Standard Deviation | days |
|
| Number of prenatal visits | Mean | Standard Deviation | visits |
|
| Body Mass Index (kg/m2) | Median | Full Range | kg/m2 |
|
| Payor Status | Number | participants |
|
| Recevied Prenatal Care | Number | participants |
|
| Maternal Labor | Number | participants |
|
| Rupture of Membranes | Number | participants |
|
| Meconium Stain | Number | participants |
|
| Maternal Complications | Number | participants |
|
| NICU Admission | Number | participants |
|
| Fetal Complications | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Temperature at Exit | The temperature at exit is only available for n=21 in treatment groups and n=19 in control group. | Posted | Median | Full Range | degrees Celsius | 3 minutes |
|
|
|
| Secondary | Temperature at NICU/Recovery | Temperature at admission to NICU/Recovery | Posted | Median | Full Range | degrees Celsius | 24 hours |
|
|
|
| Secondary | Peak Bilirubin | Highest bilirubin level of infant based on blood test | Posted | Median | Full Range | mg/dl | Through hospital discharge up to 3 months |
|
|
|
| Secondary | Duration of Respiratory Support | Duration of respiratory support in the form of intubation or continuous positive airway pressure (if applicable) | Posted | Median | Full Range | hours | Through hospital discharge up to 3 months |
|
|
|
| Secondary | Length of Delayed Cord Clamp | Length of delayed cord clamp in seconds | Posted | Median | Full Range | seconds | Up to 60 seconds after birth |
|
|
|
| Secondary | Length of Hospital Stay | Length of hospital stay in days | Posted | Median | Full Range | days | Through hospital discharge up to 3 months |
|
|
|
| Secondary | Age to Wean to Crib | Age to wean to crib in days | Posted | Median | Full Range | days | Through hospital discharge up to 3 months |
|
|
|
| Secondary | Hypothermia at Warmer | Number of infants with hypothermia at time of arrival to warmer | Posted | Number | participants | Immediately after cord clamping (up to 60 seconds after birth) |
|
|
|
| Secondary | Hypothermia at Completion of Resuscitation | Hypothermia at the Completion of Resuscitation | Posted | Number | participants | Through hospital discharge up to 3 months |
|
|
|
| Secondary | Hypothermia at NICU/Recovery | Hypothermia at NICU admission /Recovery | Posted | Number | participants | Through hospital discharge up to 3 months |
|
|
|
| Secondary | Hyperthermia (>37.5C) at Warmer | Hyperthermia (>37.5C) at arrival to Warmer | Posted | Number | participants | Through hospital discharge up to 3 months |
|
|
|
| Secondary | Hypoglycemia | Hypoglycemia (less than 30mg/dL in the first 24 hours) | Posted | Number | participants | 24 hours |
|
|
|
| Secondary | Need for NICU Admission | Whether or not infant was admitted to NICU | Posted | Number | participants | 24 hours |
|
|
|
| Secondary | Composite | Composite neonatal morbidity (if applicable) | Posted | Number | participants | Through hospital discharge up to 3 months |
|
|
|
| 0 |
| 25 |
| 0 |
| 25 |
| 0 |
| 25 |
| EG001 | Standard of Care Group-Mothers | In the non-intervention group, the infant will be delivered onto the sterile field as per standard of care. | 0 | 25 | 0 | 25 | 0 | 25 |
| EG002 | Warming Mattress and Sterile Polyethylene Wrap Group-Infants | In the intervention group, the infant will be placed on the thermal mattress, then wrapped. Neonatal warming mattress: Babies will be warmed with a standard neonatal transport warming mattress immediately after birth. Sterile polyethylene wrap: Babies will be wrapped in a sterile polyethylene wrap prior to arrival at the warmer. | 1 | 25 | 0 | 25 | 2 | 25 |
| EG003 | Standard of Care Group-Infants | In the non-intervention group, the infant will be delivered onto the sterile field as per standard of care. | 1 | 25 | 0 | 25 | 1 | 25 |
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