Assistance Publique - Hôpitaux de Paris Hôpital Antoine Béclère
Clamart, 92141, France
NCT Number: 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.
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Notify Me32 week–34 week
All sexes
Interventional
Phase 4
Clamart, 92141, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
oral rehydration solution
Other names: SRO
intravenous infusion
Other names: IV
Time frame: Day 0 to day 16 or day of recovering original birth day
Time frame: day 3, 15 of life, and at 37 GA.
Time frame: 6 and 12 months
Time frame: J0 to J16
Time frame: during the first week of life
Time frame: Day 0 to day 16
Time frame: Day 0 to day 8
Time frame: Day 0 to day 8
Time frame: in case of infection
Time frame: Up to 12 months
Time frame: the first two weeks of life
Assistance Publique - Hôpitaux de Paris
Other
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
Acronym: SROPREMA
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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