Neonatal Warming to Prevent Hypothermia

NCT04827394 | Completed Results DMC FDA Device

• 1 other identifier: 12752
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypothermia

Outcome Measures

Primary Outcomes (1)

• Temperature at Arrival to Warmer

  Temperature at arrival to the Warmer

  3 minutes

Secondary Outcomes (14)

• Temperature at Exit

  3 minutes

• Temperature at NICU/Recovery

  24 hours

• Peak Bilirubin

  Through hospital discharge up to 3 months

• Duration of Respiratory Support

  Through hospital discharge up to 3 months

• Length of Delayed Cord Clamp

  Up to 60 seconds after birth

Study Arms (2)

Intervention group

EXPERIMENTAL

In the intervention group, the infant will be placed on the thermal mattress, then wrapped.

Device: Neonatal warming mattress; Device: Sterile polyethylene wrap

Control group

NO INTERVENTION

In the non-intervention group, the infant will be delivered onto the sterile field as per standard of care.

Interventions

Neonatal warming mattress DEVICE

Babies will be warmed with a standard neonatal transport warming mattress immediately after birth.

Intervention group

Sterile polyethylene wrap DEVICE

Babies will be wrapped in a sterile polyethylene wrap prior to arrival at the warmer.

Intervention group

Eligibility Criteria

• Age: Up to 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Oklahoma: lead

Study Sites (1)

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

MeSH Terms

Conditions

Hypothermia

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Birju Shah, MD
• Organization: University of Oklahoma Health Sciences Center

birju-shah@ouhsc.edu

405-271-5215

Study Officials

• Birju Shah, MD

  University of Oklahoma HSC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 1:1 using a block randomization scheme stratified by gestational age

Study Record Dates

• First Submitted: March 4, 2021
• First Posted: April 1, 2021
• Study Start: December 1, 2020
• Primary Completion: February 21, 2023
• Study Completion: February 21, 2023
• Last Updated: May 1, 2024
• Results First Posted: May 1, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)