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

NCT ID: NCT00715000

Last Updated: 2013-04-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-07-31
• Study Completion Date: 2011-08-31

Brief 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.

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.

Conditions

Low Birth Weight Infant; Enteral Nutrition

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

SRO

Group Type: EXPERIMENTAL

Oral rehydration therapy

Intervention Type: PROCEDURE

oral rehydration solution

2

classical hydration via intravenous infusion

Group Type: ACTIVE_COMPARATOR

classical hydration via intravenous infusion

Intervention Type: PROCEDURE

intravenous infusion

Interventions

Oral rehydration therapy

oral rehydration solution

Intervention Type: PROCEDURE

classical hydration via intravenous infusion

intravenous infusion

Intervention Type: PROCEDURE

Other Intervention Names

SRO; IV

Eligibility 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

• Minimum Eligible Age: 32 Weeks
• Maximum Eligible Age: 34 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hasini RAZAFIMAHEFA, MD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique-Hôpitaux de Paris, Hôpital Antoine Béclère

Locations

Assistance Publique - Hôpitaux de Paris Hôpital Antoine Béclère

Clamart, , France

Countries

France

Other Identifiers

P060208

Identifier Type: -

Identifier Source: org_study_id