- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret 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.
Undersøgelsestype
Fase
- Ikke anvendelig
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
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
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 |
|---|---|
|
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 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.
|
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.
|
Hvad måler undersøgelsen?
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
|
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Mean Axillary Temperatures on All Infants Weaned to Open Cribs
Tidsramme: 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
Tidsramme: 1 hour after placement in warming device
|
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
Tidsramme: 6 hours
|
6 hours
|
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Moderate Hypothermia (32.0-35.9° C) after placement in warming device measured by axillary temperature
Tidsramme: 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
Tidsramme: 1 hour after placement in warming device
|
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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 14 days
|
14 days
|
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Rate of Normothermia (>36.5° C) at discharge measured by axillary temperature
Tidsramme: Up to 14 days
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Up to 14 days
|
Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Colm P Travers, MB BCh BAO, University of Alabama at Birmingham
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
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Plan for individuelle deltagerdata (IPD)
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