Polyethylene Bag vs Prewarmed Blanket for Preventing Neonatal Hypothermia During Transfer

NCT07661511 | Completed

• 1 other identifier: COMBIOENF-006-2025-ME
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

Brief Summary

Premature babies can lose body heat quickly after birth, which can lead to serious health problems. This study compared two methods to keep premature babies warm while they were being moved from the delivery room to the neonatal intensive care unit (NICU): wrapping the baby in a plastic bag (polyethylene bag) versus wrapping the baby in a prewarmed blanket, which is the usual method used in many hospitals. Sixty-seven premature babies weighing 2000 grams or less were randomly assigned to receive one of these two methods. The researchers measured the babies' body temperature, heart rate, oxygen levels, and blood sugar at three points: right after birth, during the transfer, and after arriving at the NICU. The goal was to find out whether the plastic bag method was more effective than the blanket method at preventing low body temperature (hypothermia) in these vulnerable babies.

Conditions

Hypothermia Neonatal; Premature Birth; Neonatal

Keywords

Polyethylene Bag; Intrahospital Transfer; Thermoregulation; Neonatal Intensive Care; Very Low Birth Weight

Outcome Measures

Primary Outcomes (1)

• Frequency of Neonatal Hypothermia at NICU Admission

  Proportion of neonates with axillary body temperature below 36.5°C at NICU admission.

  At NICU admission, approximately 5 minutes after arrival

Secondary Outcomes (3)

• Change in Heart Rate from Baseline to NICU Admission

  From first minute of life to NICU admission

• Change in Oxygen Saturation from Baseline to NICU Admission

  From first minute of life to NICU admission

• Change in Capillary Blood Glucose from Baseline to NICU Admission

  From first minute of life to NICU admission

Study Arms (2)

Polyethylene Bag

EXPERIMENTAL

Premature neonates weighing ≤2000 g assigned to this arm were placed inside a neonatal polyethylene bag (Neohelp®, Vygon, France) immediately after birth, without prior drying, covering the body up to the neck with the integrated head cap adjusted. The bag was maintained throughout intrahospital transfer until NICU admission.

Device: Neonatal Polyethylene Bag

Prewarmed Blanket

ACTIVE COMPARATOR

Premature neonates weighing ≤2000 g assigned to this arm were dried immediately after birth and wrapped in a prewarmed blanket (37°C), in accordance with the unit's conventional thermal management protocol during intrahospital transfer to the NICU.

Other: Prewarmed Blanket

Interventions

Neonatal Polyethylene Bag DEVICE

A neonatal polyethylene bag (Neohelp®, Vygon, France) placed around the infant's body immediately after birth, without prior drying, to reduce evaporative and convective heat loss during intrahospital transfer to the neonatal intensive care unit.

Polyethylene Bag

Prewarmed Blanket OTHER

Standard thermal management consisting of drying the neonate immediately after birth and wrapping in a blanket prewarmed to 37°C, used as the unit's conventional approach during intrahospital transfer to the neonatal intensive care unit.

Prewarmed Blanket

Eligibility Criteria

• Age: 0 Days - 1 Day
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Premature neonates born before 37 weeks of gestation
• Birth weight ≤2000 grams
• Born in the obstetric-surgical unit of the participating public hospital and requiring immediate intrahospital transfer to the Neonatal Intensive Care Unit (NICU)
• Written informed consent provided by parents or legal guardians

You may not qualify if:

• Major congenital malformations
• Need for immediate resuscitation procedures incompatible with application of the assigned intervention
• Parents or legal guardians unable or unwilling to provide informed consent

Sponsors & Collaborators

• Mario Adrián Tienda Vázquez: lead

Study Sites (1)

Hospital de Especialidades del Niño y la Mujer

Querétaro, Mexico

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Professor

Model Details: Participants were randomly assigned to one of two parallel groups: polyethylene bag (intervention) or prewarmed blanket (control), with no crossover between groups.

Study Record Dates

• First Submitted: June 16, 2026
• First Posted: June 22, 2026
• Study Start: November 25, 2025
• Primary Completion: February 17, 2026
• Study Completion: February 17, 2026
• Last Updated: June 22, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)