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Completed

NCT Number: NCT01450436

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.

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Key information

Conditions

Other Preterm Infants

Age range

25 week–35 week

Sex eligibility

All sexes

Study type

Observational

Primary location

Nantes University Hospital

Nantes, 44093, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

Primary outcomes

  1. 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

    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).

  2. Children neurological development at 2 years old evaluated by Ages and stages questionnaires (ASQ)

    Time frame: ASQ/BLR Neurodevelopmental assesmment at 2 years old.

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. Preterm infants feeding behavior at 2 years

    Time frame: At 2 years old

  5. 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

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Acronym: EPIPOD

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Oct 12, 2011
Registry last updated
Feb 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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