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Device

Intervention group for Hypothermia

N/A
Waitlist Available
Led By Pavan Parikh, MD
Research Sponsored by University of Oklahoma
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through hospital discharge up to 3 months
Awards & highlights

Study Summary

This trialwould study how preterm babies' risk of hypothermia could be reduced with a warm mattress and delayed umbilical cord clamping.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through hospital discharge up to 3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and through hospital discharge up to 3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Difference in temperature
Secondary outcome measures
Composite neonatal morbidity (if applicable)
Highest bilirubin level
Hyperthermia (>37.5 degrees C) (if applicable)
+8 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention groupExperimental Treatment2 Interventions
In the intervention group, the infant will be placed on the thermal mattress, then wrapped.
Group II: Control groupActive Control1 Intervention
In the non-intervention group, the infant will be delivered onto the sterile field as per standard of care.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Neonatal warming mattress
2020
N/A
~60
Sterile polyethylene wrap
2020
N/A
~60

Find a Location

Who is running the clinical trial?

University of OklahomaLead Sponsor
455 Previous Clinical Trials
97,559 Total Patients Enrolled
3 Trials studying Hypothermia
134 Patients Enrolled for Hypothermia
Pavan Parikh, MDPrincipal InvestigatorUniversity of Oklahoma HSC
1 Previous Clinical Trials
33 Total Patients Enrolled
Birju Shah, MDPrincipal InvestigatorUniversity of Oklahoma HSC

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Neonatal Warming to Prevent Hypothermia
2020. "Neonatal Warming to Prevent Hypothermia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04827394.
~12 spots leftby Apr 2025
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