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Polyethylene Bag vs Prewarmed Blanket for Preventing Neonatal Hypothermia During Transfer

16 de junho de 2026 atualizado por: Mario Adrián Tienda Vázquez

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

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.

Visão geral do estudo

Descrição detalhada

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.

Tipo de estudo

Intervencional

Inscrição (Real)

67

Estágio

  • Não aplicável

Contactos e Locais

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Locais de estudo

      • Querétaro, México
        • Hospital de Especialidades del Niño y la Mujer

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Filho

Aceita Voluntários Saudáveis

Não

Descrição

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

Plano de estudo

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Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Prevenção
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Polyethylene Bag
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.
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.
Comparador Ativo: Prewarmed Blanket
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.
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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Frequency of Neonatal Hypothermia at NICU Admission
Prazo: At NICU admission, approximately 5 minutes after arrival
Proportion of neonates with axillary body temperature below 36.5°C at NICU admission.
At NICU admission, approximately 5 minutes after arrival

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Change in Heart Rate from Baseline to NICU Admission
Prazo: 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.
From first minute of life to NICU admission
Change in Oxygen Saturation from Baseline to NICU Admission
Prazo: 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.
From first minute of life to NICU admission
Change in Capillary Blood Glucose from Baseline to NICU Admission
Prazo: 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.
From first minute of life to NICU admission

Colaboradores e Investigadores

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Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

25 de novembro de 2025

Conclusão Primária (Real)

17 de fevereiro de 2026

Conclusão do estudo (Real)

17 de fevereiro de 2026

Datas de inscrição no estudo

Enviado pela primeira vez

16 de junho de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

16 de junho de 2026

Primeira postagem (Real)

22 de junho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

22 de junho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

16 de junho de 2026

Última verificação

1 de junho de 2026

Mais Informações

Termos relacionados a este estudo

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

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