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

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

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.

Study Overview

• Status: Completed
• Conditions: Enteral Nutrition; Low Birth Weight Infant
• Intervention / Treatment: Procedure: Oral rehydration therapy; Procedure: classical hydration via 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.

• Study Type: Interventional
• Enrollment (Actual): 49
• Phase: Phase 4

Contacts and Locations

Study Locations

• France
  • Clamart, France, 92141
    • Assistance Publique - Hôpitaux de Paris Hôpital Antoine Béclère

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 months to 7 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; SRO	Procedure: Oral rehydration therapy; oral rehydration solution; Other Names: SRO
Active Comparator: 2; classical hydration via intravenous infusion	Procedure: classical hydration via intravenous infusion; intravenous infusion; Other Names: IV

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Weight	Day 0 to day 16 or day of recovering original birth day

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Hasini RAZAFIMAHEFA, MD, Assistance Publique-Hôpitaux de Paris, Hôpital Antoine Béclère

Study record dates

Study Major Dates

• Study Start: July 1, 2008
• Primary Completion (Actual): August 1, 2010
• Study Completion (Actual): August 1, 2011

Study Registration Dates

• First Submitted: July 11, 2008
• First Submitted That Met QC Criteria: July 11, 2008
• First Posted (Estimate): July 14, 2008

Study Record Updates

• Last Update Posted (Estimate): April 25, 2013
• Last Update Submitted That Met QC Criteria: April 24, 2013
• Last Verified: April 1, 2013

More Information

Terms related to this study

• Keywords: Fluid therapy; Infant care; Preterm babies hydration; Oral rehydration solution; Continuous gastric drip; Premature babies comfort; Technical challenge for the nurses/doctors in charge
• Additional Relevant MeSH Terms: Pathologic Processes; Metabolic Diseases; Body Weight; Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Water-Electrolyte Imbalance; Premature Birth; Birth Weight; Dehydration
• Other Study ID Numbers: P060208