Neonatal Outcome by Reason for Delivery
Ključne riječi
Sažetak
Opis
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).
Datumi
| Posljednja provjera: | 05/31/2019 |
| Prvo podneseno: | 03/20/2013 |
| Predviđena prijava predata: | 03/20/2013 |
| Prvo objavljeno: | 03/25/2013 |
| Zadnje ažuriranje poslato: | 06/05/2019 |
| Posljednje ažuriranje objavljeno: | 06/17/2019 |
| Datum prvog dostavljanja rezultata: | 05/06/2018 |
| Datum prvog podnošenja rezultata QC: | 03/04/2019 |
| Datum prvog objavljivanja rezultata: | 06/06/2019 |
| Stvarni datum početka studija: | 06/30/2013 |
| Procijenjeni datum primarnog završetka: | 05/02/2016 |
| Predviđeni datum završetka studije: | 07/24/2016 |
Stanje ili bolest
Faza
Grupe ruku
| Arm | Intervencija / liječenje |
|---|---|
| Preterm Labor Group who goes into labor prior to 32 weeks of gestation | |
| 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. | |
| Premature birth before 32 weeks gestation Premature birth before 32 weeks gestation not including PTL or PROM |
Kriteriji prihvatljivosti
| Uzrast podoban za studiranje | 18 Years To 18 Years |
| Polovi podobni za studiranje | Female |
| Metoda uzorkovanja | Non-Probability Sample |
| Prihvaća zdrave volontere | Da |
| Kriterijumi | Inclusion Criteria: - Delivery at participating hospitals at less than 32weeks of gestation based on best obstetrical dating - Singleton pregnancy - Delivery where the baby is: 1. Stillborn OR 2. 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. |
Ishod
Primarne mjere ishoda
1. Composite Perinatal Morbidity [Infants from birth until discharge or until infant reaches 28 days of life.]
