- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01818518
Neonatal Outcome by Reason for Delivery
Neonatal Outcome by Reason for Delivery - A Prospective, Observational Study
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
This is a prospective, observational study that will use information from the medical records of mothers and their newborns. This study seeks to determine the rate of Composite Neonatal Morbidity for very preterm babies delivered secondary to preterm labor (PTL) vs. prelabor rupture of membranes (PROM). Composite neonatal morbidity is defined as ≥ 1 of the following: Respiratory Distress Syndrome (RDS) (oxygen requirement, clinical diagnosis, and consistent chest radiograph), bronchopulmonary dysplasia (BPD) (requirement for oxygen support at 28 days of life), severe intraventricular hemorrhage (IVH) (grades III or IV), periventricular leukomalacia (PVL), blood culture-proven sepsis, necrotizing enterocolitis (NEC), or perinatal death (stillbirth or death before neonatal hospital discharge.
Secondary Objectives: 1) Difference in mortality between the PTL and PROM groups, composite morbidity differences for other reasons for premature delivery, and individual morbidities including IVH, PVL, RDS, sepsis, seizures, BPD and NEC
Study Population: All babies from singleton pregnancies delivering in each of the involved hospitals who deliver at less than 32 weeks of gestation who are stillborn, who die in the delivery room and who are cared for in the Neonatal Intensive Care Unit (NICU) will be included.
Planned Sample Size: We plan a two year study and estimate based on historical data for the institutions to be included in the study, which should yield approximately 6000 babies less than (<) 32w0d gestation. For a 10% difference in composite morbidity (assuming 90% power and two-sided alpha=0.05) assuming a rate of 60% at least 661 patients are needed in each of the 3 groups (PTL, PROM, and other).
Tipo di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
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Arizona
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Mesa, Arizona, Stati Uniti, 85210
- Banner Desert Medical Center
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Phoenix, Arizona, Stati Uniti, 85006
- Banner Good Samaritan Medical Center
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Scottsdale, Arizona, Stati Uniti, 85260
- Scottsdale Healthcare-Shea Medical Center
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California
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Laguna Hills, California, Stati Uniti, 92653
- Saddleback Memorial Medical Center
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San Jose, California, Stati Uniti, 95008
- Good Samaritan Hospital
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Colorado
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Denver, Colorado, Stati Uniti, 80218
- Presbyterian/St Luke's Hospital
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Missouri
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Kansas City, Missouri, Stati Uniti, 64111
- Saint Luke's Hospital, Kansas City
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Saint Louis, Missouri, Stati Uniti, 63141
- Mercy Hospital of St. Louis
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Texas
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Fort Worth, Texas, Stati Uniti, 76104
- Harris Methodist Hospital - Fort Worth
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Washington
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Seattle, Washington, Stati Uniti, 98122-4307
- Swedish Medical Center
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-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
Inclusion Criteria:
- Delivery at participating hospitals at less than 32weeks of gestation based on best obstetrical dating
- Singleton pregnancy
Delivery where the baby is:
- Stillborn OR
- Born alive and:
- expires before it leaves the delivery room OR
- is cared for in the Neonatal Intensive Care Unit or an Intermediate Care Nursery
Exclusion Criteria:
- Patient less than 18 years of age
- Pregnancies that had previously been multiple gestations but where one or more fetuses had died after 12weeks of gestation
- Deliveries where the baby is born alive, does not expire in the delivery room but the baby does not get admitted to the NICU.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
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Preterm Labor
Group who goes into labor prior to 32 weeks of gestation
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Prelabor rupture of membranes
Group who have prelabor rupture of membranes are those who break their bag of water prior to 32 weeks gestation in the absence of labor.
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Premature birth before 32 weeks gestation
Premature birth before 32 weeks gestation not including PTL or PROM
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Composite Perinatal Morbidity
Lasso di tempo: Infants from birth until discharge or until infant reaches 28 days of life.
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The primary outcome is Composite Perinatal Morbidity.
Composite morbidity refers to the newborns born to the female participants enrolled in the study.
Composite Morbidity is defined as ≥ 1 of the following: respiratory distress syndrome (RDS) (oxygen requirement, clinical diagnosis, and consistent chest radiograph), bronchopulmonary dysplasia (BPD) (requirement for oxygen support at 28 days of life), severe intraventricular hemorrhage (IVH) (grades III or IV), periventricular leukomalacia (PVL), blood culture-proven sepsis present within 72 hours of birth, necrotising enterocolitis (NEC), or perinatal death (stillbirth or neonatal death prior to hospital discharge).
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Infants from birth until discharge or until infant reaches 28 days of life.
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Collaboratori e investigatori
Sponsor
Studiare le date dei record
Studia le date principali
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 (Stima)
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
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- OBX0022
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
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 .