Generic Database: A Survey of Morbidity and Mortality in Very Low Birth Weight Infants
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80,000
- 试验地点
- 31
- 主要终点
- To maintain a registry of baseline and outcome data for VLBW infants with data collected in a uniform manner
研究概览
简要总结
The Generic Database (GDB) is a registry of very low birth weight infants born alive in NICHD Neonatal Research Network (NRN) centers. The GDB collects observational baseline data on both mothers and infants, and the therapies used and outcomes of the infants. The information collected is not specific to a disease or treatment (i.e., it is "generic"). Data are analyzed to find associations and trends between baseline information, treatments, and infant outcome, and to develop future NRN trials.
详细描述
The Generic Database (GDB) is a registry of very low birth weight infants born alive in NICHD Neonatal Research Network (NRN) centers. The purpose is to collect baseline and outcome data in a uniform manner on a large cohort of VLBW and other sick infants admitted to neonatal intensive care units.
The GDB collects observational baseline data on both mothers and infants, and the therapies used and outcomes of the infants. The information collected is not specific to a disease or treatment (i.e., it is "generic"). Baseline data is collected soon after admission to the NICU; outcome data is collected at the time of death or discharge from the hospital. The data collected includes information on:
- Demographics of mother and infant
- Mother's health (e.g., pregnancy history and complications)
- Labor and deliver (e.g., rupture of the membranes, steroids and antibiotics given, mode of delivery)
- Infant's health (gestational age, Apgar scores, weight, length, delivery room resuscitation, respiratory support, etc.)
- Infant's medical outcome (heart, lung, nervous system, gastrointestinal system, hearing, and vision, known infections, and major malformations/syndromes, and mortality or number of days hospitalized).
These data are used: to examine associations between baseline characteristics, treatments, and outcomes; to track trends in incidences of disease and effectiveness of therapies; and to identify questions requiring additional in-depth research.
Informed Consent: As required by local IRBs.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 14 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants inborn at NICHD NRN centers that are:
- •401-1000 grams birth weight, and/or
- •20 0/7 to 28 6/7 weeks (<29 weeks) gestational age
- •Infants enrolled in one or more additional NICHD NRN interventional trials or time-limited observational studies. For infants that do not meet the inclusion criteria above, inclusion and
排除标准
- •for the Generic Database are determined by the criteria for the additional trial(s). In these cases, infants that are larger than 1,000 grams and/or older than 29 weeks may be included in the GDB.
- •Exclusion Criteria:
- •Infants >1,000 grams birth weight and/or >29 weeks gestational age
- •Note: These inclusion criteria were changed as of 1/1/
- •Prior to this date, all infants with birth weights between 401 and 1500 grams who are admitted to NRN NICUs within 14 days of birth were included in the database.
研究组 & 干预措施
Registry Cohort
Registry Cohort
干预措施: No Intervention (Other)
结局指标
主要结局
To maintain a registry of baseline and outcome data for VLBW infants with data collected in a uniform manner
时间窗: Longitudinal database currently funded through 3/31/2030
To maintain a registry of baseline and outcome data for VLBW infants with data collected
次要结局
未报告次要终点