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Completed

NCT Number: NCT07661511

Polyethylene Bag vs Prewarmed Blanket for Preventing Neonatal Hypothermia During Transfer

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.

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Key information

Age range

0 day–1 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital de Especialidades del Niño y la Mujer

Querétaro, Mexico

About this study

Neonatal hypothermia is a major contributor to morbidity and mortality in premature infants, particularly during the period immediately following birth and during intrahospital transfer to the neonatal intensive care unit (NICU). International guidelines, including those from the World Health Organization and the Neonatal Resuscitation Program of the American Academy of Pediatrics, recommend thermal protection strategies such as the use of polyethylene bags or wraps in very low birth weight infants. However, most prior studies evaluating this intervention have not clearly differentiated outcomes by birth weight, and have primarily focused on body temperature as an outcome, with limited evaluation of other physiological parameters such as heart rate, oxygen saturation, and capillary blood glucose.

This randomized, open-label, parallel-group pilot clinical trial was conducted in the obstetric-surgical unit of a public hospital in Querétaro, Mexico. Sixty-seven premature neonates born before 37 weeks of gestation and weighing 2000 grams or less, who required immediate transfer to the NICU, were randomly assigned to an intervention group (n=33), in which a neonatal polyethylene bag was applied immediately after birth and maintained throughout intrahospital transfer, or a control group (n=34), in which the neonate was dried and wrapped in a prewarmed blanket according to standard unit protocol.

Axillary body temperature, heart rate, oxygen saturation, and capillary blood glucose were measured at three time points: within the first minute of life (baseline), during intrahospital transfer, and five minutes after NICU admission. The primary outcome was the frequency of hypothermia, defined as axillary temperature below 36.5°C, at NICU admission. Secondary outcomes included changes in heart rate, oxygen saturation, and capillary blood glucose between baseline and NICU admission.

Statistical analyses included comparison of baseline characteristics between groups, repeated-measures ANOVA to assess temporal variation of physiological parameters, and binary logistic regression and ANCOVA models adjusted for birth weight and gestational age to account for baseline imbalances between groups. This pilot study aims to provide preliminary evidence on the effectiveness and safety of the polyethylene bag intervention to inform the design of future, larger confirmatory trials.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

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.

Primary outcomes

  1. Frequency of Neonatal Hypothermia at NICU Admission

    Time frame: At NICU admission, approximately 5 minutes after arrival

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

Secondary outcomes

  1. Change in Heart Rate from Baseline to NICU Admission

    Time frame: From first minute of life to NICU admission

    Difference in heart rate (beats per minute) between baseline measurement (first minute of life) and measurement at NICU admission.

  2. Change in Oxygen Saturation from Baseline to NICU Admission

    Time frame: From first minute of life to NICU admission

    Difference in peripheral oxygen saturation (%) between baseline measurement (first minute of life) and measurement at NICU admission.

  3. Change in Capillary Blood Glucose from Baseline to NICU Admission

    Time frame: From first minute of life to NICU admission

    Difference in capillary blood glucose level (mg/dL) between baseline measurement (first minute of life) and measurement at NICU admission.

Sponsors and collaborators

Lead sponsor

Mario Adrián Tienda Vázquez

Other

Registry information

Official study title

Effectiveness of the Polyethylene Bag Compared With a Prewarmed Blanket for Preventing Hypothermia During Intrahospital Transfer in Premature Neonates: A Randomized Pilot Clinical Trial

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 22, 2026
Registry last updated
Jun 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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