- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Fase
- Non applicabile
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Comparatore attivo: 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.
|
Comparatore placebo: 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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
---|---|
Moderate (32.0-35.9° C) or Severe (<32.0° C) Hypothermia at discharge per axillary Temperature
Lasso di tempo: Up to 14 days
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Up to 14 days
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Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
---|---|
Hypothermia (< 36.0° C) throughout the duration of the intervention measured by axillary temperature
Lasso di tempo: Up to14 days
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Up to14 days
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Mean Axillary Temperatures on All Infants Weaned to Cardboard Cots
Lasso di tempo: 4 months
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4 months
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Mean Axillary Temperatures on All Infants Weaned to Open Cribs
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 14 days
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14 days
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Rate of Normothermia (>36.5° C) at discharge measured by axillary temperature
Lasso di tempo: Up to 14 days
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Up to 14 days
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Collaboratori e investigatori
Investigatori
- Investigatore principale: Colm P Travers, MB BCh BAO, University of Alabama at Birmingham
Studiare le date dei record
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Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- UAB Neo 019
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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