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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00715000
First received: July 11, 2008
Last updated: April 24, 2013
Last verified: April 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Low Birth Weight Infant
Enteral Nutrition
 Procedure: Oral rehydration therapy
Procedure: classical hydration via intravenous infusion
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Weight [ Time Frame: Day 0 to day 16 or day of recovering original birth day ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 49
Study Start Date: July 2008
Study Completion Date: August 2011
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
SRO
 Procedure: Oral rehydration therapy
oral rehydration solution
Other Name: SRO
Active Comparator: 2
classical hydration via intravenous infusion
 Procedure: classical hydration via intravenous infusion
intravenous infusion
Other Name: IV

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.

  Eligibility

Ages Eligible for Study:   32 Weeks to 34 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00715000

Locations
France
Assistance Publique - Hôpitaux de Paris Hôpital Antoine Béclère
Clamart, France, 92141
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Hasini RAZAFIMAHEFA, MD Assistance Publique-Hôpitaux de Paris, Hôpital Antoine Béclère
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00715000     History of Changes
Other Study ID Numbers: P060208
Study First Received: July 11, 2008
Last Updated: April 24, 2013
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Preterm babies hydration
Oral rehydration solution
Continuous gastric drip
Fluid therapy
 Premature babies comfort
Infant care
Technical challenge for the nurses/doctors in charge

Additional relevant MeSH terms:
Birth Weight
Dehydration
Body Weight
Signs and Symptoms
 Water-Electrolyte Imbalance
Metabolic Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 23, 2013