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Pre op lower body forced air warming (32˚C) for Neonatal Hypothermia

N/A

Recruiting

Led By Stacy Norrell, MD

Research Sponsored by The University of Texas Health Science Center, Houston

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 10 minutes after birth

Awards & highlights

Study Summary

This trial is trying to find the best way to keep mothers warm during surgery and how temperature changes affect the mother and baby.

Eligible Conditions

Hypothermia
Neonatal Hypothermia

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 10 minutes after birth

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~10 minutes after birth

This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 minutes after birth for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in maternal core body temperature

Blood Coagulation Disorders

Neonate status as determined by Appearance, Pulse, Grimace, Activity, and Respiration (APGAR) score

+2 more

Secondary outcome measures

Shivering

Hospital Length of Stay

Number of patients that need meperidine

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: TreatmentExperimental Treatment9 Interventions

Preop: Use of full body forced air warming pre-operative at ambient (32˚C) for at least 30 minutes and fluids from warmed cabinet set at 45˚C Intraop: Use of upper body and lower forced air warming intra-operative at 32 and 42˚C respectively and IV fluids with hotline fluid warmer set at 42˚C

Group II: Control GroupActive Control6 Interventions

Preop: Use of full body forced air warming pre-operative at ambient (32˚C) for at least 30 minutes and fluids from warmed cabinet set at 45˚C Intraop: Use of upper body forced air warming intra-operative at ambient (32˚C) and IV fluids at room temperature

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Find a Location

Who is running the clinical trial?

The University of Texas Health Science Center, HoustonLead Sponsor

903 Previous Clinical Trials

320,877 Total Patients Enrolled

Stacy Norrell, MDPrincipal InvestigatorThe University of Texas Health Science Center, Houston

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still openings in this experiment for participants?

"True, according to clinicaltrials.gov this medical trial is actively recruiting volunteers. It was initially posted on August 23rd 2021 and recently updated on January 6th 2023; the researchers are searching for 100 patients from a single location."

Answered by AI

What is the aggregate amount of individuals participating in this experiment?

"Affirmative, the listing on clinicaltrials.gov demonstrates that this study is currently recruiting volunteers. This trial was initially posted on August 23rd 2021 and has since had its information updated as recently as January 6th 2023. At present, 100 individuals are needed at 1 medical centre."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Perioperative Warming Measures in Cesarean Delivery

Stacy Lynn Norrell 2021. "Perioperative Warming Measures in Cesarean Delivery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05015582.