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Completed

NCT Number: NCT00715000

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

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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Key information

Age range

32 week–34 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Assistance Publique - Hôpitaux de Paris Hôpital Antoine Béclère

Clamart, 92141, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oral rehydration therapy

Procedure

oral rehydration solution

Other names: SRO

classical hydration via intravenous infusion

Procedure

intravenous infusion

Other names: IV

Primary outcomes

  1. Weight

    Time frame: Day 0 to day 16 or day of recovering original birth day

Secondary outcomes

  1. Weight, length, head circumference and brachial circumference

    Time frame: day 3, 15 of life, and at 37 GA.

  2. Weight, Height/length, head circumference and brachial circumference

    Time frame: 6 and 12 months

  3. pathologic digestive diseases (enteropathy, NEC…)

    Time frame: J0 to J16

  4. 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

  5. pain and discomfort score (EDIN) evaluated 3 times a day

    Time frame: Day 0 to day 16

  6. secondary IV infusion effects

    Time frame: Day 0 to day 8

  7. number of failure to pick and to perfuse a baby

    Time frame: Day 0 to day 8

  8. ORS culture

    Time frame: in case of infection

  9. Adverse Events

    Time frame: Up to 12 months

  10. 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

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2010
Study completion
2011
First posted
Jul 14, 2008
Registry last updated
Apr 25, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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