- ICH GCP
- US-Register für klinische Studien
- Klinische Studie 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
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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Querétaro, Mexiko
- Hospital de Especialidades del Niño y la Mujer
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-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Kind
Akzeptiert gesunde Freiwillige
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
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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Aktiver Komparator: 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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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Frequency of Neonatal Hypothermia at NICU Admission
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Change in Heart Rate from Baseline to NICU Admission
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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.
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From first minute of life to NICU admission
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Mitarbeiter und Ermittler
Sponsor
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- COMBIOENF-006-2025-ME
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