CompletedNot Applicable

Impact of Preterm Body Composition at Discharge on 2 Years Neurological Development (ASQ Evaluation)

France270 participantsStarted 2011-09

Plain-language summary

Neonatal nutritional management consists in reproducing miming uteri growth kinetic. Since the seventies, NICU (Neonatal Intensive Care Unit) strategy consists in a high proteidic input (apport) supposed to allow optimal neurodevelopment. However, nutritional practices and strategies have significantly evolved during these last years, influenced by Baker nutritional imprinting concept (2002). Actually, neonatal high proteidic exposition could perturb metabolism and hormonal systems of newborns conducting to a reinforcement of obesity and cardio-vascular pathology prevalence in this target population at adulthood. In this context many studies emerged since 2000 and try to assess the trade-off between neurodevelopment and growth under nutrition conditions. EPIPOD try to focus the link between heterogenous proteic input dispensed in our NICU (described by tercil methods on population) and fat mass phenotype variations at discharge (described by tercil methods); and its consequences on neurodevelopmental growth. Understanding how particular nutritional exposition could determine "fatty" phenotype and impact neurodevelopment is clearly our main goal.

Who can participate

Age range

25 Weeks – 35 Weeks

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Preterm newborns (\< 35 weeks gestation). * Final clinical discharge (No transfer) * Oral Parental consent. * Nantes NICU Neonatal management in the first 5 days of life Exclusion Criteria: * Congenital pathology inconsistent with PEAPOD investigation (Beckwith-Wiedemann syndrome, lipodystrophia with abnormal constitutional fat mass level). * Pathology inducing neurodevelopment troubles. * Transfer in an other hospital before discharge * Hemodynamic or cardiovascular instability requiring continuous monitoring or perfusion, incompatible with PEAPOD measurement

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

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Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Fatty mass percentage at discharge by PEAPOD measurement

Timeframe: PEAPOD measurement will be done at newborns discharge, at an expected average of 6.4 weeks hospitalization

Children neurological development at 2 years old evaluated by Ages and stages questionnaires (ASQ)

Timeframe: ASQ/BLR Neurodevelopmental assesmment at 2 years old.

Trial details

NCT IDNCT01450436

SponsorNantes University Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2014-10

View on ClinicalTrials.gov More Other Preterm Infants trials