Status:
COMPLETED
Oral Versus Intravenous Rehydration for Prevention of Dehydration in Premature Babies, During the First Days of Life.
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Low Birth Weight Infant
Enteral Nutrition
Eligibility:
All Genders
32-34 years
Phase:
PHASE4
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 wee...
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 intravenous...
Eligibility Criteria
Inclusion
- 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
- suspicion of gastro-intestinal disease,
- severe digestive risks, and metabolic diseases in the family history,
- metabolic or hydro-electrolyte disorders
- other severe diseases
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT00715000
Start Date
July 1 2008
End Date
August 1 2011
Last Update
April 25 2013
Active Locations (1)
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1
Assistance Publique - Hôpitaux de Paris Hôpital Antoine Béclère
Clamart, France, 92141