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

N

Nantes University Hospital (NUH)

Status

Completed

Conditions

Other Preterm Infants

Treatments

Other: Peapod assessment

Study type

Observational

Funder types

Other

Identifiers

NCT01450436
PROG/11/80

Details and patient eligibility

About

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.

Enrollment

270 patients

Sex

All

Ages

25 to 35 weeks old

Volunteers

No Healthy Volunteers

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

Trial design

270 participants in 1 patient group

preterm infants (<35 weeks gestation)
Treatment:
Other: Peapod assessment

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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