- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02003846
Comparing Bubble and Ventilator Nasal CPAP in Preterm Infants
Comparing the Effects of Bubble Nasal CPAP Versus Ventilator Nasal CPAP in Preterm Infants
There are various methods to generate the pressure needed for Nasal CPAP. Some neonatal intensive care units (NICU) use an underwater bubbling system and others use a ventilator to generate the pressure. There is no right or wrong way to generate the pressure and both methods are approved and accepted.
The aim of this study is to compare the two systems of Nasal CPAP by placing the baby on each for a defined time period and reviewing the infant's vital signs. The investigators expect that the pressure generated by bubble CPAP will be better and lead to improved vital signs.
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
There are various methods to generate the pressure needed for Nasal CPAP. Some neonatal intensive care units (NICU) use an underwater bubbling system and others use a ventilator to generate the pressure. There is no right or wrong way to generate the pressure and both methods are approved and accepted.
The aim of this study is to compare the two systems of Nasal CPAP by placing the baby on each for a defined time period and reviewing the infant's vital signs. The investigators expect that the pressure generated by bubble CPAP will be better and lead to improved vital signs.
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
-
-
New York
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Brooklyn, New York, Forenede Stater, 11219
- Maimonides Medical Center
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- Neonates between 26-32 weeks gestational age who have been on Nasal CPAP for at least 48hrs on fraction of inspired oxygen (FiO2) of < or = 0.3. Parental consent will be obtained prior to enrollment.
Exclusion Criteria:
- Infants with severe congenital anomalies, such as airway or chest wall deformities, pulmonary hypoplasia, congenital heart disease, neurologic abnormalities including severe intraventricular hemorrhage (IVH) and need for surgery eg. for necrotizing enterocolitis will be excluded from the study. Any infants with genetic/chromosomal abnormalities will be excluded.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
---|
Premature infant
Each premature infant will be on bubble nasal CPAP for 2 hours and on ventilator nasal CPAP for 2 hours
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Physiologic parameters
Tidsramme: 2 hours
|
heart rate, respiratory rate, oxygen saturation
|
2 hours
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Physiologic parameters
Tidsramme: 2 hours
|
cerebral oxygen tissue extraction
|
2 hours
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Shantanu Rastogi, MD, Maimonides Medical Center
Publikationer og nyttige links
Generelle publikationer
- Gregory GA, Kitterman JA, Phibbs RH, Tooley WH, Hamilton WK. Treatment of the idiopathic respiratory-distress syndrome with continuous positive airway pressure. N Engl J Med. 1971 Jun 17;284(24):1333-40. doi: 10.1056/NEJM197106172842401. No abstract available.
- Lee KS, Dunn MS, Fenwick M, Shennan AT. A comparison of underwater bubble continuous positive airway pressure with ventilator-derived continuous positive airway pressure in premature neonates ready for extubation. Biol Neonate. 1998;73(2):69-75. doi: 10.1159/000013962.
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- MMC 2013-02-10 (Anden identifikator: Maimonides Medical Center)
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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