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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Low Birth Weight Infant, Enteral Nutrition

Intervention / Treatment
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* Procedure: Oral rehydration therapy
* Procedure: classical hydration via intravenous infusion


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 32 Weeks
Maximum Age: 34 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>SRO | Procedure: Oral rehydration therapy<br>* oral rehydration solution<br>* Other names: SRO;|
| Active Comparator: 2<br>classical hydration via intravenous infusion | Procedure: classical hydration via intravenous infusion<br>* intravenous infusion<br>* Other names: IV;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight |  | Day 0 to day 16 or day of recovering original birth day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| pathologic digestive diseases (enteropathy, NEC…) |  | J0 to J16 | 
| metabolic tolerance during the first week of life: - hypoglycemia - fructose intolerance - bilirubin, electrolytes and creatinin level in blood |  | during the first week of life | 
| pain and discomfort score (EDIN) evaluated 3 times a day |  | Day 0 to day 16 | 
| secondary IV infusion effects |  | Day 0 to day 8 | 
| number of failure to pick and to perfuse a baby |  | Day 0 to day 8 | 
| ORS culture |  | in case of infection | 
| Adverse Events |  | Up to 12 months | 
| Intestinal motility: - gastric residue - first meconium - first normal stool - number of stools during the first days of life |  | the first two weeks of life | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fluid therapy, Preterm babies hydration, Oral rehydration solution, Continuous gastric drip, Premature babies comfort, Infant care, Technical challenge for the nurses/doctors in charge