- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Querétaro, Mexico
- Hospital de Especialidades del Niño y la Mujer
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
Tager imod sunde frivillige
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: 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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Aktiv 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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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Frequency of Neonatal Hypothermia at NICU Admission
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Change in Heart Rate from Baseline to NICU Admission
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- COMBIOENF-006-2025-ME
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