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

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.

Study Overview

• Status: Completed
• Conditions: Other Preterm Infants
• Intervention / Treatment: Other: Peapod assessment

• Study Type: Observational
• Enrollment (Actual): 270

Contacts and Locations

Study Locations

• France
  • Nantes, France, 44093
    • Nantes University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 months to 8 months (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Preterm infants (< 35 weeks gestation)

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

preterm infants (<35 weeks gestation)

Other: Peapod 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fatty mass percentage at discharge by PEAPOD measurement	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).	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)		ASQ/BLR Neurodevelopmental assesmment at 2 years old.

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Nantes University Hospital
• Investigators: Study Director: FRONDAS-CHAUTY Anne, MD, Nantes University Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (ACTUAL): October 1, 2014
• Study Completion (ACTUAL): October 1, 2014

Study Registration Dates

• First Submitted: September 28, 2011
• First Submitted That Met QC Criteria: October 11, 2011
• First Posted (ESTIMATE): October 12, 2011

Study Record Updates

• Last Update Posted (ACTUAL): February 21, 2020
• Last Update Submitted That Met QC Criteria: February 20, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth
• Other Study ID Numbers: PROG/11/80