Prevention of Dehydration in Premature Babies Between 32 and 34+6 Gestational Age, Weighing Between 1700 and 2200 g, During the First Days of Life, Using Oral Rehydration Solution in Alternative to Intravenous Infusion
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 2
- 主要终点
- Weight
研究概览
简要总结
This prospective randomised study comparing administration of a hypo-osmolar oral hydration solution with the classical hydration via IV (intravenous) infusion in premature infants of more than 32 weeks GA (gestational age) aims to determine whether administration of a hypo-osmolar oral hydration solution is as efficient as intravenous infusion.
详细描述
In order to prevent dehydration of the premature infant during the first days of life, enteral nutrition with milk must be complemented by an additional fluid supply, commonly administered intravenously. We propose to perform a prospective randomised multi-centric study comparing administration of a hypo-osmolar oral hydration solution with the classical hydration via IV (intravenous) infusion in premature infants of more than 30 weeks GA (gestational age).
We define success as a weight loss inferior to 15 % of birth weight and a weight at day 15 superior to birth weight. Failure was defined hence as a weight loss superior to 15% of birth weight or a weight at day 15 inferior to birth weight or a severe complication or death. Major violations of the protocol in the study group will be counted as failures. The other objectives were to determine whether oral hydration demonstrates practical advantages: less complications in initial management, more comfort for the baby and less technical challenges for the nurses/doctors in charge. Furthermore to evaluate the clinical tolerance of oral hydration from a nutritional point of view and to examine it's effects on intestinal function (defecation, gastric residues), signs of intestinal inflammation and GI flora.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 32 Weeks 至 34 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Premature babies between 32 to 34 + 6 weeks of gestation, with a birth weight greater than 1700g and less than 2200g under exclusion of SGA (small for gestational age) babies with a BW < 10th percentile.
- •Infants must be included within the first 12 to 24 hours of life
- •Good tolerance to nasogastric milk feeding
- •Necessity of additional fluid supply
- •Any suspicion of gastro intestinal or metabolic disease
- •Maximal humidity in incubator
- •Parental consent form
排除标准
- •suspicion of gastro-intestinal disease,
- •severe digestive risks, and metabolic diseases in the family history,
- •metabolic or hydro-electrolyte disorders
- •other severe diseases
结局指标
主要结局
Weight
时间窗: Day 0 to day 16 or day of recovering original birth day
次要结局
- Weight, length, head circumference and brachial circumference(day 3, 15 of life, and at 37 GA.)
- ORS culture(in case of infection)
- Weight, Height/length, head circumference and brachial circumference(6 and 12 months)
- secondary IV infusion effects(Day 0 to day 8)
- Intestinal motility: - gastric residue - first meconium - first normal stool - number of stools during the first days of life(the first two weeks of life)
- pathologic digestive diseases (enteropathy, NEC…)(J0 to J16)
- pain and discomfort score (EDIN) evaluated 3 times a day(Day 0 to day 16)
- metabolic tolerance during the first week of life: - hypoglycemia - fructose intolerance - bilirubin, electrolytes and creatinin level in blood(during the first week of life)
- number of failure to pick and to perfuse a baby(Day 0 to day 8)
- Adverse Events(Up to 12 months)