Low Birth Weight InfantPhase 4SROPREMANCT00715000
Oral Versus Intravenous Rehydration for Prevention of Dehydration in Premature Babies, During the First Days of Life.
A Phase 4 study testing Oral rehydration therapy and classical hydration via intravenous infusion in people with Low Birth Weight Infant and Enteral Nutrition, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 32 to 34 weeks
- Conditions the study is for
- Low Birth Weight Infant, Enteral Nutrition
- What is being tested?
- Oral rehydration therapy and classical hydration via intravenous infusion
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2008to Aug 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 32 to 34 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- suspicion of gastro-intestinal disease,
- severe digestive risks, and metabolic diseases in the family history,
- metabolic or hydro-electrolyte disorders
- other severe diseases
Trial locations and contacts
1 site in 1 country.
France1 site
Assistance Publique - Hôpitaux de Paris Hôpital Antoine Béclère
Clamart, 92141
About this study
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
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.
Read the 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
- Being tested
- Oral rehydration therapy, classical hydration via intravenous infusion
- 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
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral rehydration therapyProcedure or surgery
Also called SRO
oral rehydration solution
classical hydration via intravenous infusionProcedure or surgery
Also called IV
intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | SRO Receives: Procedure: Oral rehydration therapy |
| 2 | Active comparator | classical hydration via intravenous infusion Receives: Procedure: classical hydration via intravenous infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight
Measured: Day 0 to day 16 or day of recovering original birth day
Secondary outcomes (10)
Weight, length, head circumference and brachial circumference
Measured: day 3, 15 of life, and at 37 GA.
Weight, Height/length, head circumference and brachial circumference
Measured: 6 and 12 months
pathologic digestive diseases (enteropathy, NEC…)
Measured: J0 to J16
metabolic tolerance during the first week of life: - hypoglycemia - fructose intolerance - bilirubin, electrolytes and creatinin level in blood
Measured: during the first week of life
pain and discomfort score (EDIN) evaluated 3 times a day
Measured: Day 0 to day 16
secondary IV infusion effects
Measured: Day 0 to day 8
number of failure to pick and to perfuse a baby
Measured: Day 0 to day 8
ORS culture
Measured: in case of infection
Adverse Events
Measured: Up to 12 months
Intestinal motility: - gastric residue - first meconium - first normal stool - number of stools during the first days of life
Measured: the first two weeks of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2008 (estimated)
- Study startJul 2008
- Primary completionAug 2010
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Birth Weight InfantStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hasini RAZAFIMAHEFA, MD, Principal investigator, Assistance Publique-Hôpitaux de Paris, Hôpital Antoine Béclère
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00715000
- Sponsor's protocol ID
- P060208
- Acronym
- SROPREMA
- Status last verified
- Apr 2013
- First submitted
- 11 Jul 2008
- Last updated
- 25 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00715000
- Acronym / sponsor ID
- SROPREMA / P060208
- Conditions
- 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
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Jul 2008
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 14 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: Oral rehydration therapySRO |
| 2 | Active comparator | Procedure: classical hydration via intravenous infusionclassical hydration via intravenous infusion |
Who may qualify
- Ages
- 32 to 34 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- suspicion of gastro-intestinal disease,
- severe digestive risks, and metabolic diseases in the family history,
- metabolic or hydro-electrolyte disorders
- other severe diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral rehydration therapyAlso: SROoral rehydration solution | Procedure or surgery | 1 |
| classical hydration via intravenous infusionAlso: IVintravenous infusion | Procedure or surgery | 2 |
Primary outcome
Weight
Time frame: Day 0 to day 16 or day of recovering original birth day
10 secondary outcomes
Weight, length, head circumference and brachial circumference
Time frame: day 3, 15 of life, and at 37 GA.
Weight, Height/length, head circumference and brachial circumference
Time frame: 6 and 12 months
pathologic digestive diseases (enteropathy, NEC…)
Time frame: J0 to J16
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
pain and discomfort score (EDIN) evaluated 3 times a day
Time frame: Day 0 to day 16
secondary IV infusion effects
Time frame: Day 0 to day 8
number of failure to pick and to perfuse a baby
Time frame: Day 0 to day 8
ORS culture
Time frame: in case of infection
Adverse Events
Time frame: Up to 12 months
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hasini RAZAFIMAHEFA, MD principal investigator
Assistance Publique-Hôpitaux de Paris, Hôpital Antoine Béclère
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Oral rehydration therapy and classical hydration via intravenous infusion in people with Low Birth Weight Infant and Enteral Nutrition, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight (time frame: Day 0 to day 16 or day of recovering original birth day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2013.