Enteral FeedingPhase 4NCT00213668
Effect of Glutamine on Gastric Emptying and Length of Parenteral Nutrition in Premature Neonates
A Phase 4 study testing glutamine (dipeptiven) in people with Enteral Feeding, run by University Hospital, Rouen at 1 site in France.
Trial summary
This study investigates the effects of enterally supplied glutamine on gastric emptying, intestinal transit, age of total enteral nutrition and age at the end of hospitalisation. Forty neonates, aged at least 2 days and free of acute illness participate in a prospective, randomised, double-blind study. Read more about this study
- Who is it for?
- Ages 2 to 10 days
- Conditions the study is for
- Enteral Feeding
- What is being tested?
- glutamine (dipeptiven)
- How many people
- Not given
- Where
- 1 siteFrance
- Study dates
- Apr 2002to 31 Dec 2005
- 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 2 to 10 days
- All sexes
- Child
Who may be able to join
- Premature neonates aged 30-33 weeks of gestational age
- Aged at least 2 days and no more than 10 days
- Free of acute illness
- Written informed consent is obtained from the parent prior to enrolment.
Who cannot join
- Premature infants with respiratory (fraction of inspired oxygen [FiO2] > 30%), or cardiovascular, liver, intestinal or acute diseases
- Premature infants with congenital syndrome
Trial locations and contacts
1 site in 1 country.
About this study
This study investigates the effects of enterally supplied glutamine on gastric emptying, intestinal transit, age of total enteral nutrition and age at the end of hospitalisation. Forty neonates, aged at least 2 days and free of acute illness participate in a prospective, randomised, double-blind study. All are fed with parenteral and enteral nutrition enriched with glutamine (0.7 g/kg/per day, group 1) or isonitrogenous control (group 2). Gastric emptying is analysed by sequential measure of intragastric residue by diluted polyethylene glycol (PEG) 4000. Intestinal transit is analysed by Rouge Carmin test.
- Conditions
- Enteral Feeding
- Being tested
- glutamine (dipeptiven)
- Keywords
- glutamine, premature neonate, gastric emptying
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
glutamine (dipeptiven)Dietary supplement
What is being measured
The primary outcome is the main question the study is designed to answer.
gastric emptying
Measured: at day 0, day 1, day 7 and day 14 of enteral nutrition enriched by glutamine or isonitrogenous product
Secondary outcomes (5)
intestinal transit
Measured: at day 1 and day 14 of enteral nutrition enriched by glutamine or isonitrogenous product
date and duration of arrest of nutrition if necessary
age of total enteral nutrition
age at the end of hospitalization
variation of cholescystokinin and gastrin postprandial concentration
Measured: at day 0 and day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startApr 2002
- Primary completion31 Dec 2005
- Study completion31 Dec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Enteral FeedingStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anne Mercier, MD, Principal investigator, CHU Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00213668
- Sponsor's protocol ID
- 2000/111/HP
- Status last verified
- Jun 2013
- First submitted
- 13 Sep 2005
- Last updated
- 30 Mar 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Glutamine on Gastric Emptying and Length of Parenteral Nutrition in Premature Neonates
- ClinicalTrials.gov ID
- NCT00213668
- Acronym / sponsor ID
- 2000/111/HP
- Conditions
- Enteral Feeding
- Keywords
- glutamine, premature neonate, gastric emptying
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- Apr 2002 (actual)
- Primary completion
- 31 Dec 2005 (actual)
- Study completion
- 31 Dec 2005 (actual)
- First posted
- 21 Sep 2005 (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 study investigates the effects of enterally supplied glutamine on gastric emptying, intestinal transit, age of total enteral nutrition and age at the end of hospitalisation. Forty neonates, aged at least 2 days and free of acute illness participate in a prospective, randomised, double-blind study. All are fed with parenteral and enteral nutrition enriched with glutamine (0.7 g/kg/per day, group 1) or isonitrogenous control (group 2). Gastric emptying is analysed by sequential measure of intragastric residue by diluted polyethylene glycol (PEG) 4000. Intestinal transit is analysed by Rouge Carmin test.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 2 to 10 days
- Sex
- All
- Age groups
- Child
Key inclusion criteria (4 listed)
- Premature neonates aged 30-33 weeks of gestational age
- Aged at least 2 days and no more than 10 days
- Free of acute illness
- Written informed consent is obtained from the parent prior to enrolment.
Key exclusion criteria (2 listed)
- Premature infants with respiratory (fraction of inspired oxygen [FiO2] > 30%), or cardiovascular, liver, intestinal or acute diseases
- Premature infants with congenital syndrome
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 |
|---|---|---|
| glutamine (dipeptiven) | Dietary supplement | – |
Primary outcome
gastric emptying
Time frame: at day 0, day 1, day 7 and day 14 of enteral nutrition enriched by glutamine or isonitrogenous product
5 secondary outcomes
intestinal transit
Time frame: at day 1 and day 14 of enteral nutrition enriched by glutamine or isonitrogenous product
date and duration of arrest of nutrition if necessary
age of total enteral nutrition
age at the end of hospitalization
variation of cholescystokinin and gastrin postprandial concentration
Time frame: at day 0 and day 14
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 30 Mar 2026.
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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.
Anne Mercier, MD principal investigator
CHU Rouen
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 glutamine (dipeptiven) in people with Enteral Feeding, run by University Hospital, Rouen 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 4 inclusion and 2 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 30 Mar 2026. 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?
gastric emptying (time frame: at day 0, day 1, day 7 and day 14 of enteral nutrition enriched by glutamine or isonitrogenous product). 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 30 Mar 2026.