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

This study is currently recruiting participants. (see Contacts and Locations)
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
  Purpose

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.


Condition Intervention
Other Preterm Infants
Other: Peapod assessment

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Impact of Preterm Body Composition at Discharge on 2 Years Neurological Development (ASQ Evaluation)

Further study details as provided by Nantes University Hospital:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 189
Study Start Date: September 2011
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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).


  Eligibility

Ages Eligible for Study:   25 Weeks to 35 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Preterm infants (< 35 weeks gestation)

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01450436

Contacts
Contact: FRONDAS-CHAUTY Anne, MD + 33 2 40 08 76 79 Anne.chauty@chu-nantes.fr

Locations
France
Nantes University Hospital Recruiting
Nantes, France, 44093
Contact: FRONDAS-CHAUTY Anne, MD    + 33 2 40 08 76 79    Anne.chauty@chu-nantes.fr   
Sponsors and Collaborators
Nantes University Hospital
Investigators
Study Director: FRONDAS-CHAUTY Anne, MD Nantes University Hospital
  More Information

No publications provided

Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT01450436     History of Changes
Other Study ID Numbers: PROG/11/80
Study First Received: September 28, 2011
Last Updated: November 16, 2012
Health Authority: France: Institutional Ethical Committee

ClinicalTrials.gov processed this record on September 16, 2014