Clinical trial NCT01818518: Neonatal Outcome by Reason for Delivery
Official title: Neonatal Outcome by Reason for Delivery - A Prospective, Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Preterm Delivery
Keywords: Preterm delivery
Premature delivery
Premature birth
Lead sponsor: Pediatrix
Sponsor class: OTHER
First posted: 2013-03-26
Enrollment: 995
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All babies from singleton pregnancies delivering in each of the involved hospitals who delivered at less than 32 weeks of gestation and who are stillborn, who die in the delivery room and who are cared for in the Neonatal Intensive Care Unit (NICU) will be included.

Brief summary: 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.

Detailed description: 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).

Eligibility criteria: 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.

Primary outcomes:
measure: Composite Perinatal Morbidity
timeFrame: Infants from birth until discharge or until infant reaches 28 days of life.
Secondary outcomes:
Other outcomes:
Locations:
city: Mesa
country: United States
facility: Banner Desert Medical Center
state: Arizona
city: Phoenix
country: United States
facility: Banner Good Samaritan Medical Center
state: Arizona
city: Scottsdale
country: United States
facility: Scottsdale Healthcare-Shea Medical Center
state: Arizona
city: Laguna Hills
country: United States
facility: Saddleback Memorial Medical Center
state: California
city: San Jose
country: United States
facility: Good Samaritan Hospital
state: California
city: Denver
country: United States
facility: Presbyterian/St Luke's Hospital
state: Colorado
city: Kansas City
country: United States
facility: Saint Luke's Hospital, Kansas City
state: Missouri
city: Saint Louis
country: United States
facility: Mercy Hospital of St. Louis
state: Missouri
city: Fort Worth
country: United States
facility: Harris Methodist Hospital - Fort Worth
state: Texas
city: Seattle
country: United States
facility: Swedish Medical Center
state: Washington
Study officials:
affiliation: Obstetrix Medical Group
name: Thomas Garite, MD
role: PRINCIPAL_INVESTIGATOR
References: