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

Completed

• Conditions: Other Preterm Infants
• Interventions: Other: Peapod assessment

• Registration Number: NCT01450436
• Lead Sponsor: Nantes University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2011-09-28
• Study First Submitted QC: 2011-10-11
• Study First Posted: 2011-10-12
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-20
• Last Update Posted: 2020-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 270

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
preterm infants (<35 weeks gestation)	Peapod assessment	-

Primary Outcome Measures

Name	Time	Method
Fatty mass percentage at discharge by PEAPOD measurement	PEAPOD measurement will be done at newborns discharge, at an expected average of 6.4 weeks hospitalization	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 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 Outcome Measures

Name	Time	Method
body composition of preterm infants at discharge and full term newborns at 3 days of life	PEAPOD measurement will be done at newborns discharge, at an expected average of 6.4 weeks hospitalization
Relationship between body composition at discharge and that at 2 years	PEAPOD measurement will be done at newborns discharge, at an expected average of 6.4 weeks hospitalization
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
Preterm infants feeding behavior at 2 years	At 2 years old
Factors (both intrinsic and nutritional) influencing body composition of preterm infants (<35 weeks gestation), at discharge	factors influencing body composition report will be done at newborns discharge, at an expected average of 6.4 weeks hospitalization

Trial Locations

Locations (1)

Nantes University Hospital; 🇫🇷 Nantes, France