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De behoefte aan essentiele aminozuren in pasgeborenen.


- candidate number4738
- NTR NumberNTR1588
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR16-dec-2008
- Secondary IDs2007-392 
- Public TitleDe behoefte aan essentiele aminozuren in pasgeborenen.
- Scientific TitleEssential Amino acid requirement in preterm and term neonates.
- ACRONYMN/A
- hypothesisThe current estimations of the essential amino acids in neonates are inadequate. We hypothese these are too low.
- Healt Condition(s) or Problem(s) studiedPreterm neonates, term neonates
- Inclusion criteriaPreterm: GA 28-36 weeks, BW< 2200 g, growth > 10 g/kg/d over the last 5 days.

Term: GA 37-42 weeks, BW > 2500 g, growth > 5 g/kg/d over the last 5 days.
- Exclusion criteria1. Gastro-intestinal pathology;
2. sepsis;
3. syndromes;
4. no informed consent.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlNot applicable
- group[default]
- Type[default]
- Studytype[default]
- planned startdate 15-okt-2008
- planned closingdate1-jan-2011
- Target number of participants400
- InterventionsIndicator Amino Acid Oxidation(IAAO).

Method: In short:
stable isotope by nasogastric tube test essential amino acid in wide range of intake for 24 hours adaptation and 8 hours on study day.
Breath sampling for labelled CO2.
- Primary outcomeRequirement of the 9 essential amino acids determined by the breakpoint.
- Secondary outcome1. Length of adaptation time;
2. validation of the breath sampling compared to urine and blood sampling.
- TimepointsOn the studyday breath sampling at start of the study and at isotopic plateau every 15 minutes.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESProf. MD. PhD. J.B. Goudoever, van
- CONTACT for SCIENTIFIC QUERIESProf. MD. PhD. J.B. Goudoever, van
- Sponsor/Initiator Erasmus Sophia BV
- Funding
(Source(s) of Monetary or Material Support)
Danone Research B.V. , SHS international, Numico
- Publicationsnone
- Brief summary
- Main changes (audit trail)
- RECORD16-dec-2008 - 23-jan-2009


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