Time Limited Observational Study of the Moderately Preterm Infant (29 0/7 - 33 6/7 Weeks)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 7,057
- 试验地点
- 19
- 主要终点
- Number of infants born moderately preterm
研究概览
简要总结
This is a registry of moderate preterm infants, born alive at 29-33 weeks gestational age, in NICHD Neonatal Research Network (NRN) centers. The registry 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 Moderate Preterm Registry is a registry of moderate preterm infants (29-33 weeks gestational age) born alive in NICHD Neonatal Research Network (NRN) centers. The purpose is to collect baseline and outcome data in a uniform manner on a cohort of infants.
The registry 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
- 29 Weeks 至 33 Weeks(Child)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Gestational age 29-33 weeks
- •Inborn infants and outborn infants admitted by 72 hours.
排除标准
- 未提供
结局指标
主要结局
Number of infants born moderately preterm
时间窗: up to 2 years
Number of infants born between 29-33 weeks gestational age at 18 participating NRN centers.
次要结局
未报告次要终点
