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Sponsored by: |
Assistance Publique - Hôpitaux de Paris |
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Information provided by: | Assistance Publique - Hôpitaux de Paris |
ClinicalTrials.gov Identifier: | NCT00715000 |
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.
Condition | Intervention | Phase |
---|---|---|
Low Birth Weight Infant Enteral Nutrition |
Procedure: Oral rehydration therapy Procedure: classical hydration via intravenous infusion |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 350 |
Study Start Date: | July 2008 |
Estimated Study Completion Date: | January 2012 |
Estimated Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
SRO
|
Procedure: Oral rehydration therapy
oral rehydration solution
|
2: Active Comparator
classical hydration via intravenous infusion
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Procedure: classical hydration via intravenous infusion
intravenous infusion
|
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.
Ages Eligible for Study: | 32 Weeks to 34 Weeks |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Hasinirina RAZAFIMAHEFA, MD | +33(0)-1 4537 4074 | Hasinirina.razafimahefa@abc.aphp.fr |
France | |
Assistance Publique - Hôpitaux de Paris Hôpital Antoine Béclère | |
Clamart, France, 92141 |
Principal Investigator: | Hasini RAZAFIMAHEFA, MD | Assistance Publique-Hôpitaux de Paris, Hôpital Antoine Béclère |
Responsible Party: | Department Clinical Research Delegation ( Saliha Djane ) |
Study ID Numbers: | P060208 |
Study First Received: | July 11, 2008 |
Last Updated: | July 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00715000 |
Health Authority: | France: Ministry of Health |
Preterm babies hydration Oral rehydration solution Continuous gastric drip Fluid therapy |
Premature babies comfort Infant care Technical challenge for the nurses/doctors in charge |
Body Weight Birth Weight Signs and Symptoms Metabolic Diseases |
Water-Electrolyte Imbalance Metabolic disorder Dehydration |
Pathologic Processes |