- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00428038
Assessment of the Pulmonary Diffusion Capacity in Healthy Infants and Infants With Chronic Lung Disease
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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Indiana
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Indianapolis, Indiana, Forenede Stater, 46202
- Riley Hospital for Children
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- Group 1 Infants born at < 32 weeks gestation with Chronic lung disease
- Group 2 Infants born at <32 weeks gestation without Chronic lung disease
- Group 3 Infants born full term at >37 weeks
Exclusion Criteria:
- Group 1 and Group 2--No heart disease, no oxygen requirement
- Group 3--No hospitalization for respiratory illness, No asthma, No heart disease, No history of wheezing, asthma or treatment with asthma medications.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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1
Group 1: Infants born prematurely at a gestational age < 32 weeks with a diagnosis of chronic lung disease. Subjects will be evaluated at a corrected-age between 1 month and 24 months when they are clinically stable and free of acute respiratory symptoms for > 3 weeks. Subjects will be excluded for the following reasons:
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2
Group 2: Infants born prematurely at a gestational age < 32 weeks without a diagnosis of chronic lung disease. Subjects will be evaluated at a corrected-age between 1 month and 24 months when they are clinically stable and free of acute respiratory symptoms for > 3 weeks. Subjects will be excluded for the following reasons:
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3
Group 3: Infants born full term at a gestational age > 37 weeks. Subjects will be evaluated at a corrected-age between 1 month and 24 months when they are clinically stable and free of acute respiratory symptoms for > 3 weeks. Subjects will be excluded for the following reasons:
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Robert S Tepper, MD, PhD, Indiana University
Datoer for undersøgelser
Studer store datoer
Studiestart
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
- 0309-15
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