Infant, Premature, DiseasesEPINUTRINCT01486173
Early Nutrition and Neurological Development of Very Preterm Infants
An observational study of Infant, Premature, Diseases and Infant Nutrition Disorders, run by Lapillonne, Alexandre, M.D. at 1 site in France.
Trial summary
The main goal of this study is to determine the association between: the quantity of mother's milk and duration of breastfeeding the intake of polyunsaturated fatty acids and iron during hospitalization and the development of preterm infants born with a GA < 32 weeks. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Infant, Premature, Diseases, Infant Nutrition Disorders, Development; Delayed, Mental
- How many people
- 260 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2011to Dec 2014
- Phase
- Observational
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Subsample of infants born very preterm (before 32 weeks of gestation) otherwise included in the French national cohort EPIPAGE 2
Who may be able to join
- infants with a gestational age < 32 weeks already included in the EPIPAGE2 study
- agreement of parents
Who cannot join
- death during hospitalisation
Trial locations and contacts
1 site in 1 country.
About this study
The main goal of this study is to determine the association between:
- the quantity of mother's milk and duration of breastfeeding
- the intake of polyunsaturated fatty acids and iron during hospitalization and the development of preterm infants born with a GA < 32 weeks.
- Keywords
- PUFA, Iron, Neurological development, Premature infant
- Medical subject headings
- Infant, Premature, Diseases, Infant Nutrition Disorders, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Premature infants with a GA < 32 Weeks | Not described | |
| New born with a GA > 37Weeks | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurological development at 2 years of age
Age and Stages Questionnaire at 2 years of age
Brunet Lezine test
Measured: 3 years
Secondary outcomes (1)
Nutritional status at time of discharge
Polyunsaturated fatty acids status
Iron status
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2011 (estimated)
- Study startJun 2011
- Primary completionDec 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant, Premature, DiseasesStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lapillonne, Alexandre, M.D.
- Responsible party
- Principal investigator, Alexandre Lapillonne, M.D., Ph.D., Lapillonne, Alexandre, M.D.
- Investigators
- Alexandre Lapillonne, M.D., Ph.D., Study director, Alexandre Lapillonne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01486173
- Sponsor's protocol ID
- 2011-mars-12551
- Acronym
- EPINUTRI
- Status last verified
- Apr 2013
- First submitted
- 2 Dec 2011
- Last updated
- 17 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Nutrition and Neurological Development of Very Preterm Infants
- ClinicalTrials.gov ID
- NCT01486173
- Acronym / sponsor ID
- EPINUTRI / 2011-mars-12551
- Keywords
- PUFA, Iron, Neurological development, Premature infant
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- Lapillonne, Alexandre, M.D.
- Study start
- Jun 2011
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 6 Dec 2011 (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.
The main goal of this study is to determine the association between:
- the quantity of mother's milk and duration of breastfeeding
- the intake of polyunsaturated fatty acids and iron during hospitalization and the development of preterm infants born with a GA < 32 weeks.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Premature infants with a GA < 32 Weeks | – | – |
| New born with a GA > 37Weeks | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subsample of infants born very preterm (before 32 weeks of gestation) otherwise included in the French national cohort EPIPAGE 2
Key inclusion criteria (2 listed)
- infants with a gestational age < 32 weeks already included in the EPIPAGE2 study
- agreement of parents
Key exclusion criteria (1 listed)
- death during hospitalisation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Neurological development at 2 years of age
Time frame: 3 years
Age and Stages Questionnaire at 2 years of age Brunet Lezine test
1 secondary outcome
Nutritional status at time of discharge
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 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.
Alexandre Lapillonne, M.D., Ph.D. study director
Alexandre Lapillonne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infant, Premature, Diseases and Infant Nutrition Disorders, run by Lapillonne, Alexandre, M.D. 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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 17 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.
Are results available for this study?
Results are not available in the source record.
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?
Neurological development at 2 years of age (time frame: 3 years). 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 17 Apr 2013.