- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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
Studieöversikt
Status
Betingelser
Intervention / Behandling
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
Fas
- Inte tillämpbar
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
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
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
Utredare
- Huvudutredare: Colm P Travers, MB BCh BAO, University of Alabama at Birmingham
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- UAB Neo 019
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
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 .