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

Other Preterm Infants Clinical Trial

— EPIPOD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01450436
• Other study ID #: PROG/11/80
• Status: Completed
• Start date: September 2011
• Est. completion date: October 2014

Study information

• Verified date: February 2020
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 270
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Weeks to 35 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Other Preterm Infants
• Premature Birth

Intervention

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).

Locations

Country	Name	City	State
France	Nantes University Hospital	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Children neurological development at 2 years old evaluated by Ages and stages questionnaires (ASQ)		ASQ/BLR Neurodevelopmental assesmment at 2 years old.
Secondary	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
Secondary	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
Secondary	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
Secondary	Preterm infants feeding behavior at 2 years		At 2 years old
Secondary	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