このページは自動翻訳されたものであり、翻訳の正確性は保証されていません。を参照してください。 英語版 ソーステキスト用。

Polyethylene Bag vs Prewarmed Blanket for Preventing Neonatal Hypothermia During Transfer

2026年6月16日 更新者: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.

調査の概要

詳細な説明

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.

研究の種類

介入

入学 (実際)

67

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

      • Querétaro、メキシコ
        • Hospital de Especialidades del Niño y la Mujer

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 子

健康ボランティアの受け入れ

いいえ

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:防止
  • 割り当て:ランダム化
  • 介入モデル:並列代入
  • マスキング:なし(オープンラベル)

武器と介入

参加者グループ / アーム
介入・治療
実験的: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.
アクティブコンパレータ: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.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Frequency of Neonatal Hypothermia at NICU Admission
時間枠: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

二次結果の測定

結果測定
メジャーの説明
時間枠
Change in Heart Rate from Baseline to NICU Admission
時間枠: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
時間枠: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
時間枠: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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2025年11月25日

一次修了 (実際)

2026年2月17日

研究の完了 (実際)

2026年2月17日

試験登録日

最初に提出

2026年6月16日

QC基準を満たした最初の提出物

2026年6月16日

最初の投稿 (実際)

2026年6月22日

学習記録の更新

投稿された最後の更新 (実際)

2026年6月22日

QC基準を満たした最後の更新が送信されました

2026年6月16日

最終確認日

2026年6月1日

詳しくは

本研究に関する用語

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

購読する