Randomised Controlled Trial on Using Active Warming to Prevent Newborn Hypothermia After Caesarean Delivery

A Randomised Controlled Trial Using Active Warming in Prevention of Newborn Hypothermia After Caesarean Delivery Without Interruption to Skin-to-skin Contact

Despite the enormous advantages that skin-to-skin contact (STSC) and Delaying Cord Clamping (DCC) bring, newborns can lose heat quickly if they are not thermally protected. In the first 10-20 minutes after birth, newborns can experience a body temperature drop of between 2°C to 4°C if they are not properly dried and covered. In 2014, Horn et al. published a research paper regarding the incidence and prevention of newborn hypothermia after Caesarean delivery. The findings showed up to 80% of newborns become hypothermic if only warm towels (passive insulation) were used during STSC after Caesarean delivery. Evidence also shows higher hypothermia rates in infants born by Caesarean section than vaginal birth.

STSC will begin while Caesarean section continues. Newborns will be clothed in a cotton hat and diaper. Newborns will be placed on bare chest of mother, horizontally, in prone position. The head of the newborn will turn laterally, making the nose and mouth unobstructed. Newborns' hands are not swaddled and are free to move to allow exploration to facilitate first feeding. In both groups, infants will be covered from head-to-toe with 3 layers of 100% cotton woven blankets, taken from a 70°C heating cabinet. For the "intervention group", thermal blanket will be placed on top of the cotton blanket. Newborn will be first covered with conventional warm blanket then adding the thermal blanket on top. The thermal blanket will be placed inside a "pillowcase" like cotton blanket to avoid direct contact with mother or newborn.

Study Overview

• Status: Recruiting
• Conditions: Newborn; Hyperthermia
• Intervention / Treatment: Device: TechTrade Ready Heat Half Body Temperature Management Blankets; Other: Control

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ka Wang Cheung, MD; Phone Number: 22554567; Email: kelvincheung82@hotmail.com

Study Locations

• China
  • Hong Kong
    • Hong Kong, Hong Kong, China, 852
      • Recruiting
      • Department of Obstetrics and Gynaecology
      • Contact: Ka Wang Cheung; Phone Number: (852) 22553111; Email: kelvincheung82@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• All women scheduled for elective Caesarean section under spinal anaesthesia during study period.

Exclusion Criteria:

• Multiple pregnancy
• Gestation <37week or >42 week
• Placenta previa or abruptio placenta
• Abnormal Cardiotocogram or fetal heart rate immediately prior to Caesarean section
• Suspected or known fetal congenital abnormality

• Immediate newborn condition that prevents STSC

  • Newborn birth weight <2.5kg
  • Newborn rectal temperature >38°C
  • Maternal tympanic temperature >38°C

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control	Other: Control; 3 layers of 100% cotton woven blankets
Active Comparator: Intervention	Device: TechTrade Ready Heat Half Body Temperature Management Blankets; The thermal blanket will be placed on top of the cotton blanket. Newborn will be first covered with conventional warm blanket then adding the thermal blanket on top. The thermal blanket will be placed inside a "pillowcase" like cotton blanket to avoid direct contact with mother or newborn.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Newborn hypothermia	Body temperature below 36.5°C	after 20 minutes of skin to skin contact after Caesarean delivery or at the cessation of using active or conventional warming method before completion of 20 minutes of STSC, whichever happens first.

Collaborators and Investigators

• Sponsor: The University of Hong Kong
• Investigators: Study Director: Ka Wang Cheung, MD, The University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2023
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: July 29, 2024
• First Submitted That Met QC Criteria: July 29, 2024
• First Posted (Actual): August 1, 2024

Study Record Updates

• Last Update Posted (Actual): August 1, 2024
• Last Update Submitted That Met QC Criteria: July 29, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Body Temperature Changes; Heat Stress Disorders; Hyperthermia; Hypothermia
• Other Study ID Numbers: UW 22-695

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No