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

• Weight, length, head circumference and brachial circumference [ Time Frame: day 3, 15 of life, and at 37 GA. ] [ Designated as safety issue: Yes ]
• Weight, Height/length, head circumference and brachial circumference [ Time Frame: 6 and 12 months ] [ Designated as safety issue: Yes ]
• pathologic digestive diseases (enteropathy, NEC…) [ Time Frame: J0 to J16 ] [ Designated as safety issue: Yes ]
• metabolic tolerance during the first week of life: - hypoglycemia - fructose intolerance - bilirubin, electrolytes and creatinin level in blood [ Time Frame: during the first week of life ] [ Designated as safety issue: Yes ]
• pain and discomfort score (EDIN) evaluated 3 times a day [ Time Frame: Day 0 to day 16 ] [ Designated as safety issue: Yes ]
• secondary IV infusion effects [ Time Frame: Day 0 to day 8 ] [ Designated as safety issue: Yes ]
• number of failure to pick and to perfuse a baby [ Time Frame: Day 0 to day 8 ] [ Designated as safety issue: Yes ]
• ORS culture [ Time Frame: in case of infection ] [ Designated as safety issue: Yes ]
• Adverse Events [ Time Frame: Up to 12 months ] [ Designated as safety issue: Yes ]
• Intestinal motility: - gastric residue - first meconium - first normal stool - number of stools during the first days of life [ Time Frame: the first two weeks of life ] [ Designated as safety issue: Yes ]

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.

• Low Birth Weight Infant
• Enteral Nutrition

• Procedure: Oral rehydration therapy
  oral rehydration solution
  Other Name: SRO
• Procedure: classical hydration via intravenous infusion
  intravenous infusion
  Other Name: IV

• Experimental: 1
  SRO
  Intervention: Procedure: Oral rehydration therapy
• Active Comparator: 2
  classical hydration via intravenous infusion
  Intervention: Procedure: classical hydration via intravenous infusion

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:

• suspicion of gastro-intestinal disease,
• severe digestive risks, and metabolic diseases in the family history,
• metabolic or hydro-electrolyte disorders
• other severe diseases