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- Ensaio Clínico NCT07661511
Polyethylene Bag vs Prewarmed Blanket for Preventing Neonatal Hypothermia During Transfer
Effectiveness of the Polyethylene Bag Compared With a Prewarmed Blanket for Preventing Hypothermia During Intrahospital Transfer in Premature Neonates: A Randomized Pilot Clinical Trial
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
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
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Querétaro, México
- Hospital de Especialidades del Niño y la Mujer
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
Aceita Voluntários Saudáveis
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
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 |
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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.
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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.
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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.
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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.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Frequency of Neonatal Hypothermia at NICU Admission
Prazo: At NICU admission, approximately 5 minutes after arrival
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Proportion of neonates with axillary body temperature below 36.5°C at NICU admission.
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At NICU admission, approximately 5 minutes after arrival
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change in Heart Rate from Baseline to NICU Admission
Prazo: From first minute of life to NICU admission
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Difference in heart rate (beats per minute) between baseline measurement (first minute of life) and measurement at NICU admission.
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From first minute of life to NICU admission
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Change in Oxygen Saturation from Baseline to NICU Admission
Prazo: From first minute of life to NICU admission
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Difference in peripheral oxygen saturation (%) between baseline measurement (first minute of life) and measurement at NICU admission.
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From first minute of life to NICU admission
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Change in Capillary Blood Glucose from Baseline to NICU Admission
Prazo: From first minute of life to NICU admission
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Difference in capillary blood glucose level (mg/dL) between baseline measurement (first minute of life) and measurement at NICU admission.
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From first minute of life to NICU admission
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Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
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Conclusão Primária (Real)
Conclusão do estudo (Real)
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Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
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Palavras-chave
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Outros números de identificação do estudo
- COMBIOENF-006-2025-ME
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