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

Enteral Nutrition Clinical Trial

— SROPREMA  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00715000
• Other study ID #: P060208
• Status: Completed
• Phase: Phase 4
• First received: July 11, 2008
• Last updated: April 24, 2013
• Start date: July 2008
• Est. completion date: August 2011

Study information

• Verified date: April 2013
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: August 2011
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 32 Weeks to 34 Weeks

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Birth Weight
• Dehydration
• Enteral Nutrition
• Low Birth Weight Infant

Intervention

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

Locations

Country	Name	City	State
France	Assistance Publique - Hôpitaux de Paris Hôpital Antoine Béclère	Clamart

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

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