Evaluation of the Clinical and Growth-related Effects of Probiotics in Preterm Infants: A Randomized, Placebo Controlled Clinical Trial.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 249
- 试验地点
- 1
- 主要终点
- Necrotizing enterocolitis (NEC)
研究概览
简要总结
The goal of this randomized control clinical trial is to determine if probiotics can prevent mortality and morbidity in preterm neonates. It also evaluates effects of probiotics on feeding pattern and growth. It will also learn about the comparative effects of single vs multiple strain probiotics.
It aims to answer:
Does probiotics improve the health and growth outcomes in preterm neonates in our population? Does single vs multiple strain of probiotics have difference in effects?
Participants will:
Participants given either single strain or multiple strain probiotics for 28 days post birth.
Data about mortality, morbidity, feeding pattern and growth (weight, height, head circumference gain) recorded on daily basis.
详细描述
This trial is single-centered, parallel, multi-arm, 1:1:1 randomized, blinded, placebo controlled clinical trial. It compares 3 groups; Group P1 (Placebo), Group P2-Single Strain probiotic (Lactobacillus rhamnosus GG) and Group P3- Multiple strains probiotic ( Bifidobacterium BB-12, Lactobacillus paracasei, L casei-431, Streptococcus thermophilus TH-4) for preventing preterm neonatal morbidities, improving feeding tolerance and overall growth.
Primary objective: The primary objective of our trial will be to compare the incidence and severity of Necrotizing enterocolitis (NEC) from the time of trial participation till the end of trial treatment (28 days) according to Bell's grading criteria.
Secondary objectives:
All these outcomes will be measured from the day intervention started to the end of supplementation (28 days)
- To evaluate incidence of sepsis, intracerebral haemorrhage and periventricular leukomalacia, retinopathy of prematurity and bronchopulmonary dysplasia)
- To estimate the time to full enteral feeding (i.e., ≥150 ml/kg/day) and feeding tolerance based on Davy's Neonatal Feeding Assessment Scale (NFAS).
- To determine the effect of probiotics on growth (weight, height, and head circumference) of premature babies
- To assess comparative efficacy of single strain vs combination probiotics for aforementioned objectives
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 36 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preterm babies of gestational age <35+6days, birth weight <2500 grams, received and tolerated at-least one feed within 72 hours of birth and informed consent from parents or guardian.
排除标准
- •Neonates with major congenital malformations, gastrointestinal anomalies, early onset sepsis (C-reactive protein (CRP) >10 mg/L in the first 72 h of life) and renal insufficiency
研究组 & 干预措施
P1
1 ml of 10% dextrose water will be dispensed in 5cc syringe and administered orally or via feeding tube for 28 days.
干预措施: Dextrose 10% (Dietary Supplement)
P2
Single strain probiotic- Lactobacillus rhamnosus GG. The single dose 1.5×109 CFU/day as 1 mL of the reconstituted solution will be given every day via the feeding tube or orally as applicable until reaching feeds of 50 mL/kg/day. It will be increased thereafter to 3×109 CFU/day once feeds exceed 50mL/kg/day.
干预措施: Lactobacillus Rhamnosus GG (Drug)
P3
Multiple strain probiotic-Bifidobacterium BB-12, Lactobacillus paracasei, L casei-431, Streptococcus thermophilus TH-4.
The single dose 1.5×109 CFU/day as 1 mL of the reconstituted solution will be given every day via the feeding tube or orally as applicable until reaching feeds of 50 mL/kg/day. It will be increased thereafter to 3×109 CFU/day once feeds exceed 50mL/kg/day.
干预措施: Bifidobacterium BB-12, Lactobacillus paracasei, L casei-431, Streptococcus thermophilus TH-4 (Drug)
结局指标
主要结局
Necrotizing enterocolitis (NEC)
时间窗: From the day intervention started to day 28 of supplementation
Bell's classification used for grading and diagnosis
次要结局
- Neonatal Sepsis(From the day intervention started to day 28 of supplementation)
- Head Circumference(From the day study started to day 28 of supplementation)
- Feeding Intolerance(From the day intervention started to day 28 of supplementation)
- Weight(From the day intervention started to day 28 of supplementation)
- Body length(From the day intervention started to day 28 of supplementation)
研究者
Madiha, MPhil
Co-investigator
The Islamia University of Bahawalpur, Khawaja Fareed CampusDr