- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT01818518
Neonatal Outcome by Reason for Delivery
Neonatal Outcome by Reason for Delivery - A Prospective, Observational Study
Studienübersicht
Status
Bedingungen
Detaillierte Beschreibung
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).
Studientyp
Einschreibung (Tatsächlich)
Kontakte und Standorte
Studienorte
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Arizona
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Mesa, Arizona, Vereinigte Staaten, 85210
- Banner Desert Medical Center
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Phoenix, Arizona, Vereinigte Staaten, 85006
- Banner Good Samaritan Medical Center
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Scottsdale, Arizona, Vereinigte Staaten, 85260
- Scottsdale Healthcare-Shea Medical Center
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California
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Laguna Hills, California, Vereinigte Staaten, 92653
- Saddleback Memorial Medical Center
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San Jose, California, Vereinigte Staaten, 95008
- Good Samaritan Hospital
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Colorado
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Denver, Colorado, Vereinigte Staaten, 80218
- Presbyterian/St Luke's Hospital
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Missouri
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Kansas City, Missouri, Vereinigte Staaten, 64111
- Saint Luke's Hospital, Kansas City
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Saint Louis, Missouri, Vereinigte Staaten, 63141
- Mercy Hospital of St. Louis
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Texas
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Fort Worth, Texas, Vereinigte Staaten, 76104
- Harris Methodist Hospital - Fort Worth
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Washington
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Seattle, Washington, Vereinigte Staaten, 98122-4307
- Swedish Medical Center
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
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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
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Composite Perinatal Morbidity
Zeitfenster: Infants from birth until discharge or until infant reaches 28 days of life.
|
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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Mitarbeiter und Ermittler
Sponsor
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- OBX0022
Plan für individuelle Teilnehmerdaten (IPD)
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Beschreibung des IPD-Plans
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