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

Overview

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 Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 2010

Detailed 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.

Interventions

  • Procedure: Oral rehydration therapy
    • oral rehydration solution
  • Procedure: classical hydration via intravenous infusion
    • intravenous infusion

Arms, Groups and Cohorts

  • Experimental: 1
    • SRO
  • Active Comparator: 2
    • classical hydration via intravenous infusion

Clinical Trial Outcome Measures

Primary Measures

  • Weight
    • Time Frame: Day 0 to day 16 or day of recovering original birth day

Secondary Measures

  • Weight, length, head circumference and brachial circumference
    • Time Frame: day 3, 15 of life, and at 37 GA.
  • Weight, Height/length, head circumference and brachial circumference
    • Time Frame: 6 and 12 months
  • pathologic digestive diseases (enteropathy, NEC…)
    • Time Frame: J0 to J16
  • 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
  • pain and discomfort score (EDIN) evaluated 3 times a day
    • Time Frame: Day 0 to day 16
  • secondary IV infusion effects
    • Time Frame: Day 0 to day 8
  • number of failure to pick and to perfuse a baby
    • Time Frame: Day 0 to day 8
  • ORS culture
    • Time Frame: in case of infection
  • Adverse Events
    • Time Frame: Up to 12 months
  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 32 Weeks

Maximum Age: 34 Weeks

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Assistance Publique – Hôpitaux de Paris
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Hasini RAZAFIMAHEFA, MD, Principal Investigator, Assistance Publique-Hôpitaux de Paris, Hôpital Antoine Béclère

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