Clinical trial NCT00715000: Oral Versus Intravenous Rehydration for Prevention of Dehydration in Premature Babies, During the First Days of Life.
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Low Birth Weight Infant
Enteral Nutrition
Keywords: Preterm babies hydration
Oral rehydration solution
Continuous gastric drip
Fluid therapy
Premature babies comfort
Infant care
Technical challenge for the nurses/doctors in charge
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2008-07-14
Enrollment: 49
Sex: ALL
Minimum age (years): 32
Maximum age (years): 34
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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:

* suspicion of gastro-intestinal disease,
* severe digestive risks, and metabolic diseases in the family history,
* metabolic or hydro-electrolyte disorders
* other severe diseases

Primary outcomes:
measure: Weight
timeFrame: Day 0 to day 16 or day of recovering original birth day
Secondary outcomes:
measure: Weight, length, head circumference and brachial circumference
timeFrame: day 3, 15 of life, and at 37 GA.
measure: Weight, Height/length, head circumference and brachial circumference
timeFrame: 6 and 12 months
measure: pathologic digestive diseases (enteropathy, NEC…)
timeFrame: J0 to J16
measure: metabolic tolerance during the first week of life: - hypoglycemia - fructose intolerance - bilirubin, electrolytes and creatinin level in blood
timeFrame: during the first week of life
measure: pain and discomfort score (EDIN) evaluated 3 times a day
timeFrame: Day 0 to day 16
measure: secondary IV infusion effects
timeFrame: Day 0 to day 8
measure: number of failure to pick and to perfuse a baby
timeFrame: Day 0 to day 8
measure: ORS culture
timeFrame: in case of infection
measure: Adverse Events
timeFrame: Up to 12 months
measure: Intestinal motility: - gastric residue - first meconium - first normal stool - number of stools during the first days of life
timeFrame: the first two weeks of life
Other outcomes:
Locations:
city: Clamart
country: France
facility: Assistance Publique - Hôpitaux de Paris Hôpital Antoine Béclère
Study officials:
affiliation: Assistance Publique-Hôpitaux de Paris, Hôpital Antoine Béclère
name: Hasini RAZAFIMAHEFA, MD
role: PRINCIPAL_INVESTIGATOR
References: