Impact of Preterm Body Composition at Discharge on 2 Years Neurological Development (ASQ Evaluation) (EPIPOD)
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| First Received Date ICMJE | September 28, 2011 | ||||
| Last Updated Date | November 16, 2012 | ||||
| Start Date ICMJE | September 2011 | ||||
| Estimated Primary Completion Date | June 2013 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01450436 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Impact of Preterm Body Composition at Discharge on 2 Years Neurological Development (ASQ Evaluation) | ||||
| Official Title ICMJE | Impact of Preterm Body Composition at Discharge on 2 Years Neurological Development (ASQ Evaluation) | ||||
| 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Preterm infants (< 35 weeks gestation) |
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| Condition ICMJE | Other Preterm Infants | ||||
| Intervention ICMJE | 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). |
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| Study Group/Cohort (s) | preterm infants (<35 weeks gestation)
Intervention: Other: Peapod assessment |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 189 | ||||
| Estimated Completion Date | September 2013 | ||||
| Estimated Primary Completion Date | June 2013 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 25 Weeks to 35 Weeks | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | France | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01450436 | ||||
| Other Study ID Numbers ICMJE | PROG/11/80 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Nantes University Hospital | ||||
| Study Sponsor ICMJE | Nantes University Hospital | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Nantes University Hospital | ||||
| Verification Date | November 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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