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Neonatal Warming to Prevent Hypothermia

NCT04827394 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2024-05-01

Study results available
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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

Interventions

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.

Sponsors & Collaborators

  • University of Oklahoma

    lead OTHER

Principal Investigators

  • Birju Shah, MD · University of Oklahoma HSC

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
55 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-01
Primary Completion
2023-02-21
Completion
2023-02-21
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04827394 on ClinicalTrials.gov