- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01818518
Neonatal Outcome by Reason for Delivery
Neonatal Outcome by Reason for Delivery - A Prospective, Observational Study
연구 개요
상태
정황
상세 설명
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).
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Arizona
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Mesa, Arizona, 미국, 85210
- Banner Desert Medical Center
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Phoenix, Arizona, 미국, 85006
- Banner Good Samaritan Medical Center
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Scottsdale, Arizona, 미국, 85260
- Scottsdale Healthcare-Shea Medical Center
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California
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Laguna Hills, California, 미국, 92653
- Saddleback Memorial Medical Center
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San Jose, California, 미국, 95008
- Good Samaritan Hospital
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Colorado
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Denver, Colorado, 미국, 80218
- Presbyterian/St Luke's Hospital
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Missouri
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Kansas City, Missouri, 미국, 64111
- Saint Luke's Hospital, Kansas City
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Saint Louis, Missouri, 미국, 63141
- Mercy Hospital of St. Louis
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Texas
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Fort Worth, Texas, 미국, 76104
- Harris Methodist Hospital - Fort Worth
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Washington
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Seattle, Washington, 미국, 98122-4307
- Swedish Medical Center
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Composite Perinatal Morbidity
기간: 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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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
조산에 대한 임상 시험
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University Hospitals Cleveland Medical CenterThe Cleveland Clinic; MetroHealth Medical Center모병조산 | 임신 조산 | 무도회(임신) | 임신 프롬 | PROM, 조산아(임신) | 파열/분만 사이의 기간에 대한 Premat Rupture Membranes Preterm Unspec미국