Relation Between Prostaglandin E2 Metabolite Levels and the Development of Hemodynamically Significant Patent Ductus Arteriosus in Preterm Neonates
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Explore the relationship between PGE2 metabolite levels and the development of hemodynamically significant PDA in preterm neonates.
研究概览
简要总结
prospective observational cohort study to explore the relationship between PGE2 metabolite levels and the development of hemodynamically significant PDA in preterm neonates.
详细描述
Regulation of ductus arteriosus involves (PGE2), produced by the placenta and DA itself, that promotes ductal patency by relaxing smooth muscle.
Prostaglandins are pluripotent lipid mediators derived from membrane glycerophospholipid metabolism. They are synthesized via a multienzyme cascade involving the actions of phospholipases and COX isoforms. Prostanoids, such as prostaglandin E2 and prostaglandin D2 metabolite (PGDM), are produced by various structural and inflammatory cells.
Cyclooxygenase inhibitors restrict the PDA by inhibiting the prostaglandin synthase enzyme, which prevents arachidonic acid from converting to prostaglandin. Acetaminophen is also believed to inhibit the prostaglandin synthesis enzyme's peroxidase portion, resulting in the PDA narrowing.
A significant decrease in serum PGE2 levels was observed following COX inhibitor treatment.
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
- 1 Day 至 7 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preterm neonates with gestational age ≤ 32 weeks, admitted to the NICU and diagnosed with patent ductus arteriosus by echocardiography on day 3 of life.
排除标准
- •Preterm neonates with evidence of any of the following will be excluded:
- •Chromosomal anomaly or Congenital malformations Progressive intraventricular hemorrhage Congenital heart defect other than PDA and/or patent foramen ovale Pulmonary hypertension with right to left shunt on PDA Contraindications to the use of Ibuprofen: [1] Urine output <1 mL/kg/hour during preceding 8 hours. Serum creatinine >1.6 mg/dL. Platelet count <50 000/mm
- •Abnormal coagulation profile. Necrotizing enterocolitis (NEC) or intestinal perforation
研究组 & 干预措施
group1, hemodynamically significant PDA
fulfilling the following criteria PDA measuring > 1.5 mm and predominantly left-to-right shunt. LA/Ao ratio between 1.4 and 1.6 in moderate PDA and >1.6 in large PDA. Left pulmonary artery (LPA) diastolic flow velocity of >0.25 m/sec. Systemic hypo perfusion: absent or reversed diastolic flow in the Aorta Group1will receive anti-PGE; Ibuprofen (IBU) (brufen)® syrup will be given for 3 days enterally either orally or via a gastric tube with an initial dose of 10mg/kg/day, followed by 5mg/kg/day for the next 2 days
干预措施: Ibuprofen (Brufen®) (Drug)
group2, hemodynamically insignificant PDA
Spontaneous closure group by echocardiography
结局指标
主要结局
Explore the relationship between PGE2 metabolite levels and the development of hemodynamically significant PDA in preterm neonates.
时间窗: initial PGE2 level on the first day of life and follow up the level after 3 days of treatment
correlating the initial levels of PGE2 with the significance of PDA
次要结局
未报告次要终点