|- candidate number||5006|
|- NTR Number||NTR1610|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||7-jan-2009|
|- Secondary IDs||2007-392 METC Erasmus MC|
|- Public Title||The requirement of the essential amino acids in the Asian and Caucasian newborn.
De behoefte van de essentiele aminozuren in de voeding van de pasgeborene.|
|- Scientific Title||Essential amino acid requirements of term and preterm Asian and Caucasian neonates determined by the IAAO method.|
|- ACRONYM||Essential amino acid requirement of term and preterm Asian and Caucasian neonates|
|- hypothesis||Our hypothesis is that the current recommendations based upon nitrogen balance and weight gain rates are too low.|
|- Healt Condition(s) or Problem(s) studied||Neonates|
|- Inclusion criteria||Term: |
1. Gestational age 37-42 weeks;
2. growth > 5 g/kg/d in the last 5 d;
3. birthweight > 2200 g;
1. Gestational age 28-37 weeks;
2. growth > 10 g/kg/d in the last 5d;
3. birthweight < 2200.
|- Exclusion criteria||1. Gastro-intestinal pathology;|
3. congenital abnormalities;
4. no informed consent.
|- mec approval received||yes|
|- multicenter trial||yes|
|- control||Not applicable|
|- Type||Single arm|
|- planned startdate ||15-okt-2008|
|- planned closingdate||31-dec-2014|
|- Target number of participants||300|
|- Interventions||24 hours adaptation to study formula.|
On the studyday ( 8 hours): studyformula, an intragastric tube with orally infused tracer ( stable isotope).
Sampling by breath sampling at the start of the studyday and every 10-15 minutes of the plateau of the tracers.
|- Primary outcome||The requirement of all 9 essential amino acids in preterm and term neonates by determination of a breakpoint (by biphase regression analysis).|
|- Secondary outcome||Time needed for adaptation to the study formula.|
Validation of the breath sampling method by comparing it with blood and urine.
|- Timepoints||On the studyday we will take breath samples before start of the tracer and after 2 hours when a plateau of the tracer is achieved. We will take breathsamples every 10-15 minutes for 1.5 hours.|
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Prof. MD. PhD. J.B. Goudoever, van|
|- CONTACT for SCIENTIFIC QUERIES||Prof. MD. PhD. J.B. Goudoever, van|
|- Sponsor/Initiator ||Erasmus Sophia BV|
(Source(s) of Monetary or Material Support)
|Danone Research B.V. , SHS international, Numico|
|- Brief summary||The exact requirement of essential amino acids for term and preterm neonates is not known. So far, they have been estimated either from the composition of the human milk proteins or are derived using nitrogen balance studies which are known to be imprecise. By using a new method, the indicator amino acid oxidation, we will determine the exact individual requirement for all essential amino acids in both term and preterm infants. This will improve our knowledge on how to feed infants and might improve functional outcome in these vulnerable patient groups.|
|- Main changes (audit trail)|
|- RECORD||7-jan-2009 - 21-okt-2011|