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

The University of Hong Kong (HKU)

Status: Enrolling

Conditions: Newborn; Hyperthermia

Treatments: Device: TechTrade Ready Heat Half Body Temperature Management Blankets; Other: Control

Study type: Interventional

Funder types: Other

Identifiers

NCT06532266

UW 22-695

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: Female

Ages: 10 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 2 patient groups, including a placebo group

Intervention

Active Comparator group

Treatment:

Device: TechTrade Ready Heat Half Body Temperature Management Blankets

Control

Placebo Comparator group

Treatment:

Other: Control