Oral Versus Intravenous Rehydration for Prevention of Dehydration in Premature Babies, During the First Days of Life. (SROPREMA)
Primary Purpose
Low Birth Weight Infant, Enteral Nutrition
Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Oral rehydration therapy
classical hydration via intravenous infusion
Sponsored by
About this trial
This is an interventional treatment trial for Low Birth Weight Infant focused on measuring Preterm babies hydration, Oral rehydration solution, Continuous gastric drip, Fluid therapy, Premature babies comfort, Infant care, Technical challenge for the nurses/doctors in charge
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
Sites / Locations
- Assistance Publique - Hôpitaux de Paris Hôpital Antoine Béclère
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
SRO
classical hydration via intravenous infusion
Outcomes
Primary Outcome Measures
Weight
Secondary Outcome Measures
Weight, length, head circumference and brachial circumference
Weight, Height/length, head circumference and brachial circumference
pathologic digestive diseases (enteropathy, NEC…)
metabolic tolerance during the first week of life: - hypoglycemia - fructose intolerance - bilirubin, electrolytes and creatinin level in blood
pain and discomfort score (EDIN) evaluated 3 times a day
secondary IV infusion effects
number of failure to pick and to perfuse a baby
ORS culture
Adverse Events
Intestinal motility: - gastric residue - first meconium - first normal stool - number of stools during the first days of life
Full Information
NCT ID
NCT00715000
First Posted
July 11, 2008
Last Updated
April 24, 2013
Sponsor
Assistance Publique - Hôpitaux de Paris
1. Study Identification
Unique Protocol Identification Number
NCT00715000
Brief Title
Oral Versus Intravenous Rehydration for Prevention of Dehydration in Premature Babies, During the First Days of Life.
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
August 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Birth Weight Infant, Enteral Nutrition
Keywords
Preterm babies hydration, Oral rehydration solution, Continuous gastric drip, Fluid therapy, Premature babies comfort, Infant care, Technical challenge for the nurses/doctors in charge
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
49 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
SRO
Arm Title
2
Arm Type
Active Comparator
Arm Description
classical hydration via intravenous infusion
Intervention Type
Procedure
Intervention Name(s)
Oral rehydration therapy
Other Intervention Name(s)
SRO
Intervention Description
oral rehydration solution
Intervention Type
Procedure
Intervention Name(s)
classical hydration via intravenous infusion
Other Intervention Name(s)
IV
Intervention Description
intravenous infusion
Primary Outcome Measure Information:
Title
Weight
Time Frame
Day 0 to day 16 or day of recovering original birth day
Secondary Outcome Measure Information:
Title
Weight, length, head circumference and brachial circumference
Time Frame
day 3, 15 of life, and at 37 GA.
Title
Weight, Height/length, head circumference and brachial circumference
Time Frame
6 and 12 months
Title
pathologic digestive diseases (enteropathy, NEC…)
Time Frame
J0 to J16
Title
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
Title
pain and discomfort score (EDIN) evaluated 3 times a day
Time Frame
Day 0 to day 16
Title
secondary IV infusion effects
Time Frame
Day 0 to day 8
Title
number of failure to pick and to perfuse a baby
Time Frame
Day 0 to day 8
Title
ORS culture
Time Frame
in case of infection
Title
Adverse Events
Time Frame
Up to 12 months
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
32 Weeks
Maximum Age & Unit of Time
34 Weeks
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hasini RAZAFIMAHEFA, MD
Organizational Affiliation
Assistance Publique-Hôpitaux de Paris, Hôpital Antoine Béclère
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assistance Publique - Hôpitaux de Paris Hôpital Antoine Béclère
City
Clamart
ZIP/Postal Code
92141
Country
France
12. IPD Sharing Statement
Learn more about this trial
Oral Versus Intravenous Rehydration for Prevention of Dehydration in Premature Babies, During the First Days of Life.
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