GUT ULTRASOUND-GUIDED VERSUS CONVENTIONAL CLINICAL PARAMETERS BASED FEEDING ADVANCEMENT TO REDUCE TIME TO FULL ENTERAL FEED IN PRETERM NEONATES (28-32 WEEKS OF GESTATIONAL AGE) ADMITTED IN TERTIARY CARE CENTER : A SUPERIORITY RANDOMIZED CONTROLLED TRIAL
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 248
- 试验地点
- 1
研究概览
简要总结
Background and Objectives: Feeding intolerance in sick preterm neonates often delays enteral nutrition, as standard advancement relies on subjective clinical signs. Gut ultrasound offers an objective alternative to assess bowel function and integrity. The primary objective is to evaluate if a gut ultrasound-guided feeding advancement protocol significantly reduces the time to achieve full enteral feeds (150 ml/kg) compared to a conventional clinical protocol in sick preterm neonates (28-32 weeks gestational age).
Methods: This single-center, prospective, superiority, stratified randomized controlled trial will be conducted at Tertiary care Neonatal unit of IPGME&R, Kolkata. It will enroll 248 sick preterm neonates initially on intravenous fluids. Subjects are randomized (1:1) to a control arm, using conventional clinical signs for feeding advancement, or an intervention arm. The intervention utilizes daily point-of-care ultrasound evaluating superior mesenteric artery perfusion, bowel wall thickness, peristalsis, and gastric emptying to guide feed advancement.
Expected Outcomes: The ultrasound-guided protocol is expected to reduce the time to full feeds by preventing unnecessary interruptions due to false clinical alarms. Furthermore, it aims to decrease intravenous fluid duration, reduce postnatal growth failure, and detect severe gut pathology earlier.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 1.00 Day(s) 至 3.00 Day(s)（—）
- 性别
- All
入选标准
- •a) Gestational Age (GA) at birth: Intramural neonates born between 28 weeks 0 days to 32 weeks 6 days of gestational age b) Age at enrolment: Within the first 72 hours of life.
- •c) Sick neonates initiated on full intravenous fluids d) Written informed consent obtained from the parent/legal guardian.
排除标准
- •Major congenital gastrointestinal anomalies (e.g., oesophageal atresia, intestinal atresia, gastroschisis, omphalocele).
- •Chromosomal anomalies (likeTrisomy 13, 18, 21).
- •Definite NEC (stage 2 or more ) or spontaneous intestinal perforation prior to randomization.
- •Features of multi organ dysfunction within first 72 hours of life ( any one of Gastro intestinal bleeding , shock requiring 2or more inotropes , acute renal failure ) e.
- •Need for immediate surgical intervention.
研究者
DR ANINDYA KUMAR SAHA
IPGMER AND SSKM HOSPITAL