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

22 oktober 2021 uppdaterad 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.

Studieöversikt

Status

Indragen

Detaljerad beskrivning

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.

Studietyp

Interventionell

Fas

  • Inte tillämpbar

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

1 dag till 2 veckor (Barn)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Förebyggande
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / 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.
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-jämförare: 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.
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.

Vad mäter studien?

Primära resultatmått

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

Sekundära resultatmått

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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Utredare

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

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

11 juni 2019

Primärt slutförande (Faktisk)

27 september 2021

Avslutad studie (Faktisk)

27 september 2021

Studieregistreringsdatum

Först inskickad

14 november 2017

Först inskickad som uppfyllde QC-kriterierna

14 november 2017

Första postat (Faktisk)

17 november 2017

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

26 oktober 2021

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

22 oktober 2021

Senast verifierad

1 oktober 2021

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • UAB Neo 019

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

Nej

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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