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

This study is currently recruiting participants.
Verified November 2012 by Nantes University Hospital
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT01450436
First received: September 28, 2011
Last updated: November 16, 2012
Last verified: November 2012

September 28, 2011
November 16, 2012
September 2011
June 2013   (final data collection date for primary outcome measure)
  • Fatty mass percentage at discharge by PEAPOD measurement [ Time Frame: PEAPOD measurement will be done at newborns discharge, at an expected average of 6.4 weeks hospitalization ] [ Designated as safety issue: No ]
    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) [ Time Frame: ASQ/BLR Neurodevelopmental assesmment at 2 years old. ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01450436 on ClinicalTrials.gov Archive Site
  • body composition of preterm infants at discharge and full term newborns at 3 days of life [ Time Frame: PEAPOD measurement will be done at newborns discharge, at an expected average of 6.4 weeks hospitalization ] [ Designated as safety issue: No ]
  • Relationship between body composition at discharge and that at 2 years [ Time Frame: PEAPOD measurement will be done at newborns discharge, at an expected average of 6.4 weeks hospitalization ] [ Designated as safety issue: No ]
  • Impact of fatty mass percentage at preterm newborns discharge on neurologic outcome assessed by a revised Brunet-Lezine test at 2 years. [ Time Frame: PEAPOD measurement will be done at newborns discharge, at an expected average of 6.4 weeks hospitalization ] [ Designated as safety issue: No ]
  • Preterm infants feeding behavior at 2 years [ Time Frame: At 2 years old ] [ Designated as safety issue: No ]
  • Factors (both intrinsic and nutritional) influencing body composition of preterm infants (<35 weeks gestation), at discharge [ Time Frame: factors influencing body composition report will be done at newborns discharge, at an expected average of 6.4 weeks hospitalization ] [ Designated as safety issue: No ]
Same as current
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Not Provided
 
Impact of Preterm Body Composition at Discharge on 2 Years Neurological Development (ASQ Evaluation)
Impact of Preterm Body Composition at Discharge on 2 Years Neurological Development (ASQ Evaluation)

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
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Non-Probability Sample

Preterm infants (< 35 weeks gestation)

Other Preterm Infants
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).

preterm infants (<35 weeks gestation)
Intervention: Other: Peapod assessment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
189
September 2013
June 2013   (final data collection date for primary outcome measure)

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
Both
25 Weeks to 35 Weeks
No
Contact: FRONDAS-CHAUTY Anne, MD + 33 2 40 08 76 79 Anne.chauty@chu-nantes.fr
France
 
NCT01450436
PROG/11/80
No
Nantes University Hospital
Nantes University Hospital
Not Provided
Study Director: FRONDAS-CHAUTY Anne, MD Nantes University Hospital
Nantes University Hospital
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP