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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | SRO |
|
| 2 | Active Comparator | classical hydration via intravenous infusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral rehydration therapy | Procedure | oral rehydration solution |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Weight | Day 0 to day 16 or day of recovering original birth day |
| 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hasini RAZAFIMAHEFA, MD | Assistance Publique-Hôpitaux de Paris, Hôpital Antoine Béclère | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Assistance Publique - Hôpitaux de Paris Hôpital Antoine Béclère | Clamart | 92141 | France |
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| classical hydration via intravenous infusion | Procedure | intravenous infusion |
|
|
| 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 |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D005440 | Fluid Therapy |
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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