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

Assistance Publique - Hôpitaux de Paris

Status and phase

Completed

Phase 4

Conditions

Enteral Nutrition

Low Birth Weight Infant

Treatments

Procedure: classical hydration via intravenous infusion

Procedure: Oral rehydration therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT00715000

P060208

Details and patient eligibility

About

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.

Full 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 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.

Enrollment

49 patients

Sex

All

Ages

32 to 34 weeks old

Volunteers

No Healthy Volunteers

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