Premature InfantEPINUTRI_3NCT02184650
Nutrition and Neurological Development of Very Preterm Infants
An observational study of Premature Infant and Infant Nutrition Disorders, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The main goal of this study is to determine, in preterm infants born with a GA < 32 weeks, the association between: the quantity of mother's milk and duration and breastfeeding the intake of polyunsaturated fatty acids and iron during hospitalizations Read more about this study
- Who is it for?
- Ages 3 to 3 years
- Conditions the study is for
- Premature Infant, Infant Nutrition Disorders, Delayed Mental Development
- What is being tested?
- Premature infants with a GA < 32 weeks
- How many people
- 206 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2014to 31 Dec 2017
- 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 3 to 3 years
- All sexes
- No healthy volunteers
- Child
Study population: Subsample of infants born very preterm (before 32 weeks of gestation), otherwise included in the French national cohort EPIPAGE 2, and previously included in EPINUTRI study.
Who may be able to join
- Premature infants previously included in EPINUTRI study
- Non opposition of the parents for the collection of clinical and nutritional data
Who cannot join
- Refusal of the parents to collect clinical and nutritional data
Trial locations and contacts
1 site in 1 country.
France1 site
Hôpital Necker Assistance Publique- Hôpitaux de Paris
Paris, 75015
About this study
Official title: Early Nutrition and Neurological Development of Very Preterm Infants
The main goal of this study is to determine, in preterm infants born with a GA < 32 weeks, the association between:
- the quantity of mother's milk and duration and breastfeeding
- the intake of polyunsaturated fatty acids and iron during hospitalizations
Read the detailed description
The main hypothesis of this study is that the intake of lipid during hospitalization in neonatology department is associated with neurological development of preterm infants born with a GA < 32 weeks. The other hypotheses are that iron intake and the duration of breastfeeding are also associated with the development of preterm infants.
In the previous study EPINUTRI (NCT01486173), the development of infants was evaluated until the age of 1 year. EPINUTRI_3 is the follow-up of EPINUTRI until the age of 3 years.
The aim of EPINUTRI_3 study is to determine the association between lipid intake during hospitalization in neonatology department of preterm infants born with a GA < 32 weeks.
The secondary objective is :
- to evaluate the association between these factors and communication, developmental and social-emotional delays with the test " Ages and Stages questionnaire " (ASQ) at 3 years of age.
- Being tested
- Premature infants with a GA < 32 weeks
- Keywords
- Premature infants, Nutritional status, Polyunsaturated fatty acids status
- Medical subject headings
- Premature Birth, Infant Nutrition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Premature infants with a GA < 32 weeksOther
At 3 years of age: ASQ (filled in by parents)
| Study group | Role | What they receive |
|---|---|---|
| Premature infants | Premature infants with a GA < 32 weeks Receives: Other: Premature infants with a GA < 32 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurological development
Age and Stages Questionnaire
Measured: At 3 years of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2014 (estimated)
- Study startJul 2014
- Primary completionJul 2015
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Premature 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 206 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Alexandre Lapillonne, M.D, Ph.D., Principal investigator, Hôpital Necker Assistance Publique-Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02184650
- Sponsor's protocol ID
- NI 13016
- Other IDs
- ID RCB 2014-A00941-46
- Acronym
- EPINUTRI_3
- Status last verified
- Sep 2025
- First submitted
- 3 Jul 2014
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Pierrat V, Marchand-Martin L, Marret S, Arnaud C, Benhammou V, Cambonie G, Debillon T, Dufourg MN, Gire C, Goffinet F, Kaminski M, Lapillonne A, Morgan AS, Roze JC, Twilhaar S, Charles MA, Ancel PY; EPIPAGE-2 writing group. Neurodevelopmental outcomes at age 5 among children born preterm: EPIPAGE-2 cohort study. BMJ. 2021 Apr 28;373:n741. doi: 10.1136/bmj.n741.
PubMed 33910920
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. 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
- NCT02184650
- Acronym / sponsor ID
- EPINUTRI_3 / NI 13016
- Keywords
- Premature infants, Nutritional status, Polyunsaturated fatty acids status
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 206 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- Jul 2014 (actual)
- Primary completion
- Jul 2015 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 9 Jul 2014 (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, in preterm infants born with a GA < 32 weeks, the association between:
- the quantity of mother's milk and duration and breastfeeding
- the intake of polyunsaturated fatty acids and iron during hospitalizations
Detailed description
The main hypothesis of this study is that the intake of lipid during hospitalization in neonatology department is associated with neurological development of preterm infants born with a GA < 32 weeks. The other hypotheses are that iron intake and the duration of breastfeeding are also associated with the development of preterm infants.
In the previous study EPINUTRI (NCT01486173), the development of infants was evaluated until the age of 1 year. EPINUTRI_3 is the follow-up of EPINUTRI until the age of 3 years.
The aim of EPINUTRI_3 study is to determine the association between lipid intake during hospitalization in neonatology department of preterm infants born with a GA < 32 weeks.
The secondary objective is :
- to evaluate the association between these factors and communication, developmental and social-emotional delays with the test " Ages and Stages questionnaire " (ASQ) at 3 years of age.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Premature infants | – | Other: Premature infants with a GA < 32 weeksPremature infants with a GA < 32 weeks |
Who may qualify
- Ages
- 3 to 3 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Subsample of infants born very preterm (before 32 weeks of gestation), otherwise included in the French national cohort EPIPAGE 2, and previously included in EPINUTRI study.
Key inclusion criteria (2 listed)
- Premature infants previously included in EPINUTRI study
- Non opposition of the parents for the collection of clinical and nutritional data
Key exclusion criteria (1 listed)
- Refusal of the parents to collect clinical and nutritional data
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 |
|---|---|---|
| Premature infants with a GA < 32 weeksAt 3 years of age: ASQ (filled in by parents) | Other | Premature infants |
Primary outcome
Neurological development
Time frame: At 3 years of age
Age and Stages Questionnaire
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 20 Nov 2025.
- Results publication: PubMed 33910920Pierrat V, Marchand-Martin L, Marret S, Arnaud C, Benhammou V, Cambonie G, Debillon T, Dufourg MN, Gire C, Goffinet F, Kaminski M, Lapillonne A, Morgan AS, Roze JC, Twilhaar S, Charles MA, Ancel PY; EPIPAGE-2 writing group. Neurodevelopmental outcomes at age 5 among children born preterm: EPIPAGE-2 cohort study. BMJ. 2021 Apr 28;373:n741. doi: 10.1136/bmj.n741.
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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. principal investigator
Hôpital Necker Assistance Publique-Hôpitaux de Paris
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 Premature Infant and Infant Nutrition Disorders, 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 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: finished, as of the sponsor's last update on 20 Nov 2025. 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?
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?
Neurological development (time frame: At 3 years of age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02184650, which also lists 1 linked publication.
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 20 Nov 2025.