Survival and nEonatal outComes of veRy Low Birth wEight Infants in Türkiye: Turkish Neonatal Society SECRETS-TR Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 3,150
- 试验地点
- 1
- 主要终点
- mortality rate
研究概览
简要总结
The aim of this multi-center study was to evaluate the mortality rate and early neonatal outcomes of very low birth weight (VLBW) infants hospitalized in neonatal intensive care units (NICUs) in Türkiye. It was promoted by the Turkish Neonatology Society (TNS) and research was approved by the Cam and Sakura City Hospital Ethical Committee.
It was conducted between 28 April 2021 and 02 January 2023 and written informed consents from the families of included patients were obtained.
A total of 74 level III and IV NICUs participated to the study. All the centers had an oppurtunity to follow-up these high risk premature infants in terms of their medical staff, equipment and other neonatology sources.
The inclusion criteria consisted of preterm infants with birth weight (BW)≤1500 grams and with gestational age (GA) of 24 0/7 weeks to 31 6/7 weeks, all inborn and outborn infants admitted to NICU within the first 24 hours of life and approval of parental consent.The survival status, maternal, perinatal and neonatal characteristics, risk factors and early neonatal outcomes of all infants were recorded.
详细描述
The study includes the selected cohort of approximately 3000 very low birth weight preterm infants born in one year period in Turkey in level III/IV neonatal intensive care units (NICUs). Detailed information on antenatal (growth, infection), natal (neonatal resuscitation, non-invasive/invasive ventilation and surfactant administration in the delivery room) and postnatal clinical course in NICUs (ventilatory support, circulation, intestinal and cranial event status,growth, exitus) were recorded. The mortality and overall spesific morbidities of the study population will be evaluated. Also, subgroup analysis for extremely low birth weight infants, micropremies, gray zone infants (22 to 24 weeks of gestational age) will also be performed for local data of Turkey and will be used for development of local guidelines and improvements in the care of preterm infants.
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
- 60 Minutes 至 1 Day（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preterm infants with BW≤1500 grams and with gestational age (GA) of 24 0/7 weeks to 31 6/7 weeks,
- •All inborn and outborn infants admitted to NICU within the first 24 hours of life
- •Presence of parental consent
排除标准
- •The larger infants than inclusion criteria,
- •Infants who died in the delivery room,
- •Infants admitted to NICU after first 24 hours of life,
- •Infants with major congenital/chromosomal abnormalities
- •Refusal of parental consent
结局指标
主要结局
mortality rate
时间窗: during hospitalization period, with an average of 6 months.
mortality rate of infants participated to the study
rate of prematurity-related morbidities
时间窗: during hospitalization period or at the time of discharge whichever came first, assessed through study completion, an average of 6 months
rates of prematurity-related morbidities in infants participated to the study
次要结局
- Duration of hospitalization(at the time of discharge of the Neonatal Intensive Care Unit (NICU), an average of 1 year.)
研究者
Merih CETINKAYA
Professor, MD, PhD
Başakşehir Çam & Sakura City Hospital