Neonatal Warming to Prevent Hypothermia

Preventing Hypothermia in Moderate and Late Preterm Neonates - a Pilot Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Hypothermia
• Intervention / Treatment: Device: Neonatal warming mattress; Device: Sterile polyethylene wrap

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • University of Oklahoma Health Sciences Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 55 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients who have non-emergent cesarean deliveries (defined as at least 2 hours prior to planned cesarean)
• Gestational age between 32 weeks and 0 days and 36 weeks and 6 days determined per usual clinical parameters

Exclusion Criteria:

• Fetal anomalies or death
• Maternal diabetes
• Neonates with blistering skin conditions
• Reversed end diastolic umbilical artery flow
• Placental abruption
• Chorioamnionitis
• Monochorionic multifetal pregnancies
• Inability to provide consent
• Provider perception that patient is in significant pain and provider perceived contraindications to delayed cord clamping.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; In the intervention group, the infant will be placed on the thermal mattress, then wrapped.	Device: Neonatal warming mattress; Babies will be warmed with a standard neonatal transport warming mattress immediately after birth.; Device: Sterile polyethylene wrap; Babies will be wrapped in a sterile polyethylene wrap prior to arrival at the warmer.
No Intervention: Control group; In the non-intervention group, the infant will be delivered onto the sterile field as per standard of care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Temperature at Arrival to Warmer	Temperature at arrival to the Warmer	3 minutes

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: University of Oklahoma
• Investigators: Principal Investigator: Birju Shah, MD, University of Oklahoma HSC

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2020
• Primary Completion (Actual): February 21, 2023
• Study Completion (Actual): February 21, 2023

Study Registration Dates

• First Submitted: March 4, 2021
• First Submitted That Met QC Criteria: March 29, 2021
• First Posted (Actual): April 1, 2021

Study Record Updates

• Last Update Posted (Actual): May 1, 2024
• Last Update Submitted That Met QC Criteria: April 30, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Temperature Changes; Hypothermia
• Other Study ID Numbers: 12752

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No plans to share data

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No