Oral Versus Intravenous Rehydration for Prevention of Dehydration in Premature Babies, During the First Days of Life.

Phase 4

Completed

Interventions: Procedure: Oral rehydration therapy
Procedure: classical hydration via intravenous infusion

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Inclusion Criteria

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

Exclusion Criteria

Arm && Interventions

Group	Intervention	Description
1	Oral rehydration therapy	SRO
2	classical hydration via intravenous infusion	classical hydration via intravenous infusion

Primary Outcome Measures

Name	Time	Method
Weight	Day 0 to day 16 or day of recovering original birth day

Secondary Outcome Measures

Name	Time	Method
ORS culture	in case of infection
Weight, length, head circumference and brachial circumference	day 3, 15 of life, and at 37 GA.
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

Locations (1): Assistance Publique - Hôpitaux de Paris Hôpital Antoine Béclère
🇫🇷
Clamart, France

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