Status:
COMPLETED
Neonatal Warming to Prevent Hypothermia
Lead Sponsor:
University of Oklahoma
Conditions:
Hypothermia
Eligibility:
FEMALE
Up to 55 years
Phase:
NA
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 umbi...
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. Res...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 21 2023
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT04827394
Start Date
December 1 2020
End Date
February 21 2023
Last Update
May 1 2024
Active Locations (1)
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1
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104