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

NCT06532266 | Recruiting

• 1 other identifier: UW 22-695
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Newborn; Hyperthermia

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

Intervention

ACTIVE COMPARATOR

Device: TechTrade Ready Heat Half Body Temperature Management Blankets

Control

PLACEBO COMPARATOR

Other: Control

Interventions

TechTrade Ready Heat Half Body Temperature Management Blankets DEVICE

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.

Intervention

Control OTHER

3 layers of 100% cotton woven blankets

Control

Eligibility Criteria

• Age: 10 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

Department of Obstetrics and Gynaecology

Hong Kong, Hong Kong, 852, China

RECRUITING

MeSH Terms

Conditions

Hyperthermia

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Heat Stress Disorders; Wounds and Injuries

Study Officials

• Ka Wang Cheung, MD

  The University of Hong Kong

  STUDY DIRECTOR

Central Study Contacts

Ka Wang Cheung, MD

CONTACT

22554567; kelvincheung82@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2024
• First Posted: August 1, 2024
• Study Start: November 1, 2023
• Primary Completion: December 31, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: August 1, 2024

Record last verified: 2024-07

Locations

CN (1)