- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00762489
Comparison of Three Methods of Taking Temperatures in the Well Baby Nursery
Comparison of Temporal Artery, Axillary, and Rectal Temperatures in Newborn Patients in the Well Baby Nursery.
Body temperature measurement is one of the standard vital sign measurements in newborn babies in order assess their health status. Temperatures are taken on a regular basis throughout the newborn's stay on the well-baby floor. A temperature that is elevated above the normal range for age or depressed below the normal range for age may be a sign of illness in a newborn. There are many methods that may be used to record this temperature. Traditionally, axillary (under the arm) and rectal (in the rectum) sites have been used. Recently, a new method of temperature measurement has become available. Temporal artery thermometers are a non-invasive method to measure the baby's temperature by means of a light that is shone on the forehead that can read your baby's temperature quickly. It is not clear whether this method is accurate in the newborn period.
The purpose of this study is to evaluate the accuracy of temporal artery temperature measurement. This will be achieved by observing the axillary measurement, rectal temperature measurement, and temporal artery temperature measurement taken at approximately the same time in each infant. These measurements will be compared to each other to determine if temporal artery thermometry is as reliable a measurement as rectal and / or axillary temperature measurements.
We plan to compare
Hypothesis: Temporal artery thermometry of the immediate newborn infant is an accurate measurement of temperature in this age group.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Delaware
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Newark, Delaware, Stati Uniti, 19713
- Christiana Care Health Systems
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- term newborns >/= 37 weeks gestational age
- late preterm infants >/= 35 weeks gestational age
- admitted to the well baby nursery following delivery
- < 24 hours of age
Exclusion Criteria:
- Infants < 35 weeks gestational age
- Infants currently under a radiant warmer or who have been under a radiant warmer < 1 hour prior to temperature measurement.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Assegnazione: Non randomizzato
- Modello interventistico: Assegnazione di gruppo singolo
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Altro: TAT vs. RT
This arm is comparing the Temporal Artery Thermometer (TAT) temperature to the Rectal Temperature (RT).
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Newborn infants had a temporal artery temperature taken within a few minutes of the axillary and rectal temperatures.
The axillary and rectal temperatures are taken via methods which are standard of care.
Altri nomi:
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Altro: TAT vs. AT
This arm is comparing the Temporal Artery Thermometer (TAT) temperature to the Axillary Temperature (AT).
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Newborn infants had a temporal artery temperature taken within a few minutes of the axillary and rectal temperatures.
The axillary and rectal temperatures are taken via methods which are standard of care.
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
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Accuracy of temporal artery temperature compared to rectal and axillary temperature measurements.
Lasso di tempo: All temperatures will be taken within 5 minutes of each other
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All temperatures will be taken within 5 minutes of each other
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Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Michael F. Bruno, MD, Christiana Care Health Services
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Inizio studio
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 (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- 28148
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