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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01450436
Acronym
EPIPOD
Enrollment
270
Registered
2011-10-12
Start date
2011-09-30
Completion date
2014-10-31
Last updated
2020-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Other Preterm Infants

Brief 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.

Interventions

OTHERPeapod assessment

EPIPOD consists in a Non-Interventional Research according to French regulations. Actually, Peapod examination at discharge takes part of current clinical practice and patient management in Nantes Neonatal Intensive Care Unit since 2008. After checking inclusion and non-inclusion criteria and obtaining oral informed consent from newborn legal authority or parents, PEAPOD assessment was leaded in the last week of hospitalization. Consisting in 2 repeated measurement, body composition estimation was completed by clinical and demographic data as neonatal nutrition (Parenteral nutrition pattern at Day 5, 10 and 21, and ASQ/BLR Neurodevelopmental assessment at 2 years old).

Sponsors

Nantes University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
25 Weeks to 35 Weeks
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Fatty mass percentage at discharge by PEAPOD measurementPEAPOD measurement will be done at newborns discharge, at an expected average of 6.4 weeks hospitalizationAfter checking inclusion and non-inclusion criteria and obtaining oral informed consent from newborn legal authority or parents, PEAPOD assessment was leaded in the last week of hospitalization. Consisting in 2 repeated measurement, body composition estimation was completed by clinical and demographic data as neonatal nutrition (Parenteral nutrition pattern at Day 5, 10 and 21, and ASQ/BLR Neurodevelopmental assesmment at 2 years old).
Children neurological development at 2 years old evaluated by Ages and stages questionnaires (ASQ)ASQ/BLR Neurodevelopmental assesmment at 2 years old.

Secondary

MeasureTime frame
Impact of fatty mass percentage at preterm newborns discharge on neurologic outcome assessed by a revised Brunet-Lezine test at 2 years.PEAPOD measurement will be done at newborns discharge, at an expected average of 6.4 weeks hospitalization
body composition of preterm infants at discharge and full term newborns at 3 days of lifePEAPOD measurement will be done at newborns discharge, at an expected average of 6.4 weeks hospitalization
Factors (both intrinsic and nutritional) influencing body composition of preterm infants (<35 weeks gestation), at dischargefactors influencing body composition report will be done at newborns discharge, at an expected average of 6.4 weeks hospitalization
Preterm infants feeding behavior at 2 yearsAt 2 years old
Relationship between body composition at discharge and that at 2 yearsPEAPOD measurement will be done at newborns discharge, at an expected average of 6.4 weeks hospitalization

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 20, 2026