Trial of Indomethacin Prophylaxis in Preterm Infants (TIPP)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,202
- 试验地点
- 9
- 主要终点
- Death or Neurodevelopment Impairment
研究概览
简要总结
This trial was to determine whether giving low-dose indomethacin to infants weight 500 to 999 grams (approximately 1 to 2 pounds) at birth improves their survival without cerebral palsy or developmental problems at 18 to 22 months of age.
详细描述
Prophylactic indomethacin reduces patent ductus arteriosus (PDA) and intraventricular hemorrhage in very low birth weight infants. However, the effects of early indomethacin on long-term neurodevelopment remain uncertain. There is also insufficient evidence to rule out serious adverse effects, such as increases in the risk of necrotizing enterocolitis (NEC) and retinopathy of prematurity (ROP). The aim of this trial was to determine if prophylactic administration of indomethacin improves survival without neurosensory impairments in extremely-low-birth-weight infants. Infants (n=1202) with birthweights 500 to 999 grams were randomized between 2 and 6 hours after birth to receive either intravenous indomethacin (0.1 mg/kg) or equal volumes of normal saline placebo, daily for 3 days. The primary outcomes at a corrected age of 18 months was a composite of death, cerebral palsy, cognitive delay, deafness, or blindness. Secondary long-term outcomes were hydrocephalus necessitating the placement of a shunt, seizure disorder, and microcephaly. Secondary short-term outcomes were patent ductus arteriosus, pulmonary hemorrhage, chronic lung disease, cranial ultrasonographic abnormalities, nectrotizing enterocolitis and retinopathy. Infants were evaluated in follow-up at 18-22 months corrected age.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 2 Hours 至 6 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Birth weight 500 to 999 grams;
- •Postnatal age greater than 2 hours;
排除标准
- •Unable to administer study drug within 6 hours of birth;
- •Structural heart disease and/or renal disease;
- •Dysmorphic features or congenital abnormalities;
- •Tocolytic therapy with indomethacin or other prostaglandin inhibitor within 72 hours prior to delivery;
- •Overt clinical bleeding from more than one site;
- •Platelet count less than 50 x 109/L;
- •Not considered viable
研究组 & 干预措施
Indomethacin
Indocid P.D.A., Merck Frosst, Kirkland, Que., Canada, and Merck, West Point, Pa.
干预措施: Indomethacin (Drug)
Placebo
Saline solution
干预措施: Placebo (Drug)
结局指标
主要结局
Death or Neurodevelopment Impairment
时间窗: 18-22 Months Corrected Age
次要结局
- Pulmonary hemorrhage(120 Days of Life)
- Bronchopulmonary Dysplasia (BPD)(120 Days of Life)
- Necrotizing enterocolitis (NEC)(120 Days of Life)
- Intracranial abnormalities(120 Days of Life)
- Retinopathy of Prematurity (ROP)(18-22 Months Corrected Age)
- Patent ductus arteriosus(120 Days of Life)