- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
Delaware
-
Newark, Delaware, Forente stater, 19713
- Christiana Care Health Systems
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Enkeltgruppeoppdrag
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Annen: TAT vs. RT
This arm is comparing the Temporal Artery Thermometer (TAT) temperature to the Rectal Temperature (RT).
|
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.
Andre navn:
|
Annen: TAT vs. AT
This arm is comparing the Temporal Artery Thermometer (TAT) temperature to the Axillary Temperature (AT).
|
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.
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Accuracy of temporal artery temperature compared to rectal and axillary temperature measurements.
Tidsramme: All temperatures will be taken within 5 minutes of each other
|
All temperatures will be taken within 5 minutes of each other
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Michael F. Bruno, MD, Christiana Care Health Services
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- 28148
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
Kliniske studier på Newborn Infants
-
University of California, DavisEunice Kennedy Shriver National Institute of Child Health and Human Development...FullførtFekal mikroflora i Formula Fed Premature InfantForente stater
-
Michael HoelscherClinton Health Access Initiative Inc.; Instituto Nacional de Saúde (INS)... og andre samarbeidspartnereAktiv, ikke rekrutterendeHIV, neonatal HIV tidlig-infant-diagnose (EID), Point-of-Care-testing (PoC)Mosambik, Tanzania
-
Assiut UniversityHar ikke rekruttert ennåHDN - Hemolytic Disease of the Newborn
Kliniske studier på Temporal artery thermometer temperature
-
Ajou University School of MedicineRekrutteringGenerell anestesi | TemperaturKorea, Republikken
-
The Cleveland ClinicFullførtLaparoskopisk kirurgi | Kirurgi | Generell anestesi | PostoperativtForente stater