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

NCT01450436 | Completed

• 1 other identifier: PROG/11/80
• Study Type: observational
• Target: 270
• Locations: 1 country
• Sites: 1

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.

Conditions

Other Preterm Infants

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• 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

Study Arms (1)

preterm infants (<35 weeks gestation)

Other: Peapod assessment

Interventions

Peapod assessment OTHER

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).

preterm infants (<35 weeks gestation)

Eligibility Criteria

• Age: 25 Weeks - 35 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Preterm infants (\< 35 weeks gestation)

You may qualify if:

• Preterm newborns (\< 35 weeks gestation).
• Final clinical discharge (No transfer)
• Oral Parental consent.
• Nantes NICU Neonatal management in the first 5 days of life

You may not qualify if:

• 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

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (1)

Nantes University Hospital

Nantes, 44093, France

Location

Related Publications (1)

• 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.

  PMID: 24808483 DERIVED

Study Officials

• FRONDAS-CHAUTY Anne, MD

  Nantes University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2011
• First Posted: October 12, 2011
• Study Start: September 1, 2011
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: February 21, 2020

Record last verified: 2020-02

Locations

FR (1)