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Cardboard Cot: Prevention of Moderate or Severe Hypothermia in Preterm Infants Assigned to Open Crib

22. oktober 2021 oppdatert av: Colm Travers, University of Alabama at Birmingham

Cardboard Cot in Neonatal Thermoregulation: Prevention of Moderate or Severe Hypothermia in Preterm Infants Assigned to Open Crib

Infants with an estimated gestational age < 36 6/7 weeks at delivery who have been in an incubator in the newborn ICU for at least 24 hours in settings where an incubator is available, or who are delivered in a setting where an incubator is not available, will be randomized to either standard protocol of open crib or mylar-lined cardboard cot for the duration of the hospital stay. Axillary temperatures will be taken 1 hr, 6 hrs, and 24 hours after being placed in the cot or crib, and then once every 24 hours. All other care is provided as standard of care.

Studieoversikt

Status

Tilbaketrukket

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Following parental consent, preterm infants with an estimated gestational age < 36 6/7 weeks at delivery who have been in an incubator in the newborn ICU for at least 24 hours in settings where an incubator is available, or who are in the newborn ICU in a setting where an incubator is not available, will be randomized to to transfer either standard protocol of open crib or mylar-lined cardboard cot when their temperatures are stable for transfer. The infants will remain in the cot or crib for the duration of the hospital stay. Axillary temperatures will be taken 1 hr, 6 hrs, and 24 hours after being placed in the cot or crib, and then once every 24 hours. All other care is provided as standard of care, including WHO warm chain thermoregulation guidelines of early and exclusive breastfeeding, appropriate bundling and Kangaroo Mother Care as continuously as possible.

If at any point a babies becomes moderately (32.0-35.9° C) or severely hypothermic (< 32.0° C), an extra blanket will be added to their bodies and a hat placed on their heads.

Studietype

Intervensjonell

Fase

  • Ikke aktuelt

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

1 dag til 2 uker (Barn)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Estimated gestational age < 36 6/7 weeks
  • Hospitalized in the newborn ICU at University Teaching Hospital
  • Nursed in an incubator for at least 24 hours
  • Thought to be ready to be weaned from incubator by the clinical staff

Exclusion Criteria:

  • Major congenital anomalies
  • Requiring ongoing respiratory support
  • Suspected sepsis

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: Cardboard Cot Care
Stable infant will be transferred to cardboard cot, lined with reflective film for duration of hospital stay following weaning from radiant warmer. Infant's axillary temperature will be taken at 1 hour, 6 hours, 24 hours after being placed in the cot or crib, and then once every 24 hours until discharge.
Annen: Cardboard Cot Care
When ready to be weaned from radiant warmer, infant will be placed in a reflective film-lined cot for the duration of hospitalization. Axillary temperatures will be taken at 1 hour, 6 hours, and 24 hours after placement in cot, and every 24 hours thereafter until discharge. If temperatures found < 36.0 at any time, an additional blanket and hat will be added to infant to improve temperature. All other care will be standard of care at University Teaching Hospital, including early and exclusive breastfeeding, appropriate bundling, and Kangaroo Mother Care as continuously as possible.
Placebo komparator: Open Crib
Stable infant will be transferred to standard of care open crib for duration of hospital stay following weaning from radiant warmer. Infant's axillary temperature will be taken at 1 hour, 6 hours, 24 hours after being placed in the cot or crib, and then once every 24 hours until discharge.
Annen: Open Crib
When ready to be weaned from radiant warmer, infant will be placed in a standard of care open crib for the duration of hospitalization. Axillary temperatures will be taken at 1 hour, 6 hours, and 24 hours after placement in cot, and every 24 hours thereafter until discharge. If temperatures found < 36.0 at any time, an additional blanket and hat will be added to infant to improve temperature. All other care will be standard of care at University Teaching Hospital, including early and exclusive breastfeeding, appropriate bundling, and Kangaroo Mother Care as continuously as possible.

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Moderate (32.0-35.9° C) or Severe (<32.0° C) Hypothermia at discharge per axillary Temperature
Tidsramme: Up to 14 days
Up to 14 days

Sekundære resultatmål

Resultatmål
Tidsramme
Hypothermia (< 36.0° C) throughout the duration of the intervention measured by axillary temperature
Tidsramme: Up to14 days
Up to14 days
Mean Axillary Temperatures on All Infants Weaned to Cardboard Cots
Tidsramme: 4 months
4 months
Mean Axillary Temperatures on All Infants Weaned to Open Cribs
Tidsramme: 4 months
4 months
Moderate Hypothermia (32.0-35.9° C) after placement in warming device measured by axillary Temperature
Tidsramme: 1 hour after placement in warming device
1 hour after placement in warming device
Moderate Hypothermia (32.0-35.9° C) after placement in warming device measured by axillary temperature
Tidsramme: 6 hours
6 hours
Moderate Hypothermia (32.0-35.9° C) after placement in warming device measured by axillary temperature
Tidsramme: 24 hours after placement in warming device
24 hours after placement in warming device
Severe (<32.0° C) Hypothermia after placement in the warming device measured by axillary temperature
Tidsramme: 1 hour after placement in warming device
1 hour after placement in warming device
Severe (<32.0° C) Hypothermia after placement in the warming device measured by axillary temperature
Tidsramme: 6 hours after placement in warming device
6 hours after placement in warming device
Severe (<32.0° C) Hypothermia after placement in the warming device measured by axillary temperature
Tidsramme: 24 hours after placement in warming device
24 hours after placement in warming device
Rate of Hyperthemia (>38° C) measured by axillary temperature
Tidsramme: 14 days
14 days
Rate of Normothermia (>36.5° C) at discharge measured by axillary temperature
Tidsramme: Up to 14 days
Up to 14 days

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University of Alabama at Birmingham

Etterforskere

  • Hovedetterforsker: Colm P Travers, MB BCh BAO, University of Alabama at Birmingham

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

11. juni 2019

Primær fullføring (Faktiske)

27. september 2021

Studiet fullført (Faktiske)

27. september 2021

Datoer for studieregistrering

Først innsendt

14. november 2017

Først innsendt som oppfylte QC-kriteriene

14. november 2017

Først lagt ut (Faktiske)

17. november 2017

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

26. oktober 2021

Siste oppdatering sendt inn som oppfylte QC-kriteriene

22. oktober 2021

Sist bekreftet

1. oktober 2021

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • UAB Neo 019

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

Nei

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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