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- Klinische proef NCT03344991
Cardboard Cot: Prevention of Moderate or Severe Hypothermia in Preterm Infants Assigned to Open Crib
Cardboard Cot in Neonatal Thermoregulation: Prevention of Moderate or Severe Hypothermia in Preterm Infants Assigned to Open Crib
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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
Fase
- Niet toepasbaar
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Actieve vergelijker: 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.
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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.
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Placebo-vergelijker: 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.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
|
Moderate (32.0-35.9° C) or Severe (<32.0° C) Hypothermia at discharge per axillary Temperature
Tijdsspanne: Up to 14 days
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Up to 14 days
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Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
|
Hypothermia (< 36.0° C) throughout the duration of the intervention measured by axillary temperature
Tijdsspanne: Up to14 days
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Up to14 days
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Mean Axillary Temperatures on All Infants Weaned to Cardboard Cots
Tijdsspanne: 4 months
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4 months
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Mean Axillary Temperatures on All Infants Weaned to Open Cribs
Tijdsspanne: 4 months
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4 months
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Moderate Hypothermia (32.0-35.9° C) after placement in warming device measured by axillary Temperature
Tijdsspanne: 1 hour after placement in warming device
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1 hour after placement in warming device
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Moderate Hypothermia (32.0-35.9° C) after placement in warming device measured by axillary temperature
Tijdsspanne: 6 hours
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6 hours
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Moderate Hypothermia (32.0-35.9° C) after placement in warming device measured by axillary temperature
Tijdsspanne: 24 hours after placement in warming device
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24 hours after placement in warming device
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Severe (<32.0° C) Hypothermia after placement in the warming device measured by axillary temperature
Tijdsspanne: 1 hour after placement in warming device
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1 hour after placement in warming device
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Severe (<32.0° C) Hypothermia after placement in the warming device measured by axillary temperature
Tijdsspanne: 6 hours after placement in warming device
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6 hours after placement in warming device
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Severe (<32.0° C) Hypothermia after placement in the warming device measured by axillary temperature
Tijdsspanne: 24 hours after placement in warming device
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24 hours after placement in warming device
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Rate of Hyperthemia (>38° C) measured by axillary temperature
Tijdsspanne: 14 days
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14 days
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Rate of Normothermia (>36.5° C) at discharge measured by axillary temperature
Tijdsspanne: Up to 14 days
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Up to 14 days
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Medewerkers en onderzoekers
Onderzoekers
- Hoofdonderzoeker: Colm P Travers, MB BCh BAO, University of Alabama at Birmingham
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- UAB Neo 019
Plan Individuele Deelnemersgegevens (IPD)
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