Clinical trial NCT01450436: Impact of Preterm Body Composition at Discharge on 2 Years Neurological Development (ASQ Evaluation)
Official title: Impact of Preterm Body Composition at Discharge on 2 Years Neurological Development (ASQ Evaluation)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Other Preterm Infants
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2011-10-12
Enrollment: 270
Sex: ALL
Minimum age (years): 25
Maximum age (years): 35
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Preterm infants (\< 35 weeks gestation)

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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
measure: Children neurological development at 2 years old evaluated by Ages and stages questionnaires (ASQ)
timeFrame: ASQ/BLR Neurodevelopmental assesmment at 2 years old.
Secondary outcomes:
measure: body composition of preterm infants at discharge and full term newborns at 3 days of life
timeFrame: PEAPOD measurement will be done at newborns discharge, at an expected average of 6.4 weeks hospitalization
measure: Relationship between body composition at discharge and that at 2 years
timeFrame: PEAPOD measurement will be done at newborns discharge, at an expected average of 6.4 weeks hospitalization
measure: Impact of fatty mass percentage at preterm newborns discharge on neurologic outcome assessed by a revised Brunet-Lezine test at 2 years.
timeFrame: PEAPOD measurement will be done at newborns discharge, at an expected average of 6.4 weeks hospitalization
measure: Preterm infants feeding behavior at 2 years
timeFrame: At 2 years old
measure: Factors (both intrinsic and nutritional) influencing body composition of preterm infants (<35 weeks gestation), at discharge
timeFrame: factors influencing body composition report will be done at newborns discharge, at an expected average of 6.4 weeks hospitalization
Other outcomes:
Locations:
city: Nantes
country: France
facility: Nantes University Hospital
Study officials:
affiliation: Nantes University Hospital
name: FRONDAS-CHAUTY Anne, MD
role: STUDY_DIRECTOR
References:
citation: Simon L, Frondas-Chauty A, Senterre T, Flamant C, Darmaun D, Roze JC. Determinants of body composition in preterm infants at the time of hospital discharge. Am J Clin Nutr. 2014 Jul;100(1):98-104. doi: 10.3945/ajcn.113.080945. Epub 2014 May 7.