Preterm InfantsPolynucaNCT00663572
Food Habit Programming: Influence of Genetics and Early Nutrition in a Population of Preterm Infants
An observational study of Preterm Infants, run by Nantes University Hospital at 1 site in France.
Trial summary
Influence of neonatal nutrition and growth on psychomotor development of 2 years preterm infants.-Joint influence of environmental factor (early nutrition) and genetics factors on feeding behaviour setting- up in a particular population of infants of whom nutrition and life conditions during first weeks of life were… Read more about this study
- Who is it for?
- Ages 2 years to 25 months
- Conditions the study is for
- Preterm Infants
- How many people
- 234 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2008to Jan 2011
- 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 2 years to 25 months
- All sexes
- No healthy volunteers
- Child
Study population: Preterm infants < 33 SA who stayed at least 2 weeks after birth in Nantes hospital, included in the " Grandir ensemble " network, 2 years old in 2008 and 2009
Who may be able to join
- Preterm infants < 33 SA who stayed at least 2 weeks after birth in Nantes hospital, included in the " Grandir ensemble " network, 2 years old in 2008 and 2009
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Influence of neonatal nutrition and growth on psychomotor development of 2 years preterm infants.-Joint influence of environmental factor (early nutrition) and genetics factors on feeding behaviour setting- up in a particular population of infants of whom nutrition and life conditions during first weeks of life were purely controlled.
- Conditions
- Preterm Infants
- Keywords
- Newborn, nutrition, genetic, feeding behaviour, psychomotor development, long-term effects, nutritional imprinting.
- Medical subject headings
- Feeding Behavior
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurodevelopmental evaluation by ASQ (Age and stages Questionnaire) at 2 years of age
Measured: 2 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 posted22 Apr 2008 (estimated)
- Study startMar 2008
- Primary completionJan 2011
- Study completionJan 2011
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 Preterm InfantsStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe 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
- Time perspective
- Prospective
- Enrolment
- 234 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00663572
- Sponsor's protocol ID
- BRD07/12-L
- Other IDs
- ID RCB 2007-A01432-51
- Acronym
- Polynuca
- Status last verified
- Sep 2013
- First submitted
- 18 Apr 2008
- Last updated
- 4 Sep 2013
- Results posted
- No
Publications
Migraine A, Nicklaus S, Parnet P, Lange C, Monnery-Patris S, Des Robert C, Darmaun D, Flamant C, Amarger V, Roze JC. Effect of preterm birth and birth weight on eating behavior at 2 y of age. Am J Clin Nutr. 2013 Jun;97(6):1270-7. doi: 10.3945/ajcn.112.051151. Epub 2013 Apr 24.
PubMed 23615831
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Food Habit Programming: Influence of Genetics and Early Nutrition in a Population of Preterm Infants
- ClinicalTrials.gov ID
- NCT00663572
- Acronym / sponsor ID
- Polynuca / BRD07/12-L
- Conditions
- Preterm Infants
- Keywords
- Newborn, nutrition, genetic, feeding behaviour, psychomotor development, long-term effects, nutritional imprinting.
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 234 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 22 Apr 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.
Influence of neonatal nutrition and growth on psychomotor development of 2 years preterm infants.-Joint influence of environmental factor (early nutrition) and genetics factors on feeding behaviour setting- up in a particular population of infants of whom nutrition and life conditions during first weeks of life were purely controlled.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 2 years to 25 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Preterm infants < 33 SA who stayed at least 2 weeks after birth in Nantes hospital, included in the " Grandir ensemble " network, 2 years old in 2008 and 2009
Key inclusion criteria (1 listed)
- Preterm infants < 33 SA who stayed at least 2 weeks after birth in Nantes hospital, included in the " Grandir ensemble " network, 2 years old in 2008 and 2009
Key exclusion criteria (0 listed)
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
Neurodevelopmental evaluation by ASQ (Age and stages Questionnaire) at 2 years of age
Time frame: 2 years of age
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2013.
- Derived from this study: PubMed 23615831Migraine A, Nicklaus S, Parnet P, Lange C, Monnery-Patris S, Des Robert C, Darmaun D, Flamant C, Amarger V, Roze JC. Effect of preterm birth and birth weight on eating behavior at 2 y of age. Am J Clin Nutr. 2013 Jun;97(6):1270-7. doi: 10.3945/ajcn.112.051151. Epub 2013 Apr 24.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Preterm Infants, run by Nantes University Hospital 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 1 inclusion and 0 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: stopped early, as of the sponsor's last update on 4 Sep 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?
The study was stopped early. 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?
Neurodevelopmental evaluation by ASQ (Age and stages Questionnaire) at 2 years of age (time frame: 2 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 NCT00663572, 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 4 Sep 2013.