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van CCT (UK)

The threonine requirement in preterm neonates. De behoefte aan threonine in de voeding van de preterm geboren neonaat.

- candidate number10630
- NTR NumberNTR3179
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR6-dec-2011
- Secondary IDsNL31220 CCMO
- Public TitleThe threonine requirement in preterm neonates. De behoefte aan threonine in de voeding van de preterm geboren neonaat.
- Scientific TitleThreonine requirement in preterm neonates by using the IAAO method.
- ACRONYMThreonine requirement in preterm neonates
- hypothesisThe aim of the study is to quantify the mean requirement of threonine in preterm infants. We hypothesize that the current estimations for preterms are too high.
- Healt Condition(s) or Problem(s) studiedPremature infants, Nutrition, Neonates, Amino acids
- Inclusion criteriaPreterm infants with a gestational age of 30-35 weeks, a postnatal age of 28 days and a birth weight of less than 2200 gram.
- Exclusion criteria1. Congenital anomalies;
2. Sepsis;
3. Gastro-intestinal pathology;
4. No informed consent.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlNot applicable
- groupParallel
- TypeSingle arm
- Studytypeintervention
- planned startdate 8-dec-2011
- planned closingdate1-jan-2013
- Target number of participants35
- InterventionsThe subjects will adapt 24 hours to the study diet. An elemental diet (Neocate®, Danone) will be used to provide the infants with different amino acid intakes.
On the study day subjects will receive a primed (15 µmol/(kg) continuous (10 µmol/(kg•h)) enteral infusion of [13C]bicarbonate by the nasogastric tube for 2.5 h to quantify individual CO2 production. The labeled sodium bicarbonate infusion will be directly followed by a primed (40 µmol/(kg)) continuous (30 µmol/(kg•h)) enteral infusion of [1-13C]-lysine for four hours. 30 minutes before start of the oxidation study the feeding regimen will be changed into continuous drip-feeding. Enterally infused tracer will be mixed with the study formula and infused continuously by an infusion pump via the nasogastric tube. Breath samples will be obtained using the direct sampling method described by Van der Schoor et al.
- Primary outcomeThe mean requirement of threonine in preterm neonates by breakpoint estimation. This will be determined by applying a two-phase linear regression crossover model.
- Secondary outcomeN/A
- TimepointsBaseline samples will be obtained 15 and 5 minutes before starting tracer infusion. During the experiment duplicate 13C-enriched breath samples will be collected every 10 minutes during the last 45 minutes of the [13C]bicarbonate infusion and the last hour of the [1-13C]lysine infusion.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESProf. dr. Hans Goudoever, van
- CONTACT for SCIENTIFIC QUERIESProf. dr. Hans Goudoever, van
- Sponsor/Initiator Erasmus Medical Center, Sophia Children's Hospital
- Funding
(Source(s) of Monetary or Material Support)
Danone Research B.V. , SHS international
- PublicationsLysine requirement of the enterally fed term neonate in the first month of life.
Huang L, Hogewind-Schoonenboom JE, de Groof F, Twisk JW, Voortman GJ, Dorst K, Schierbeek H, Boehm G, Huang Y, Chen C, van Goudoever JB Am J Clin Nutr. 2011 Dec;94(6):1496-503.
- Brief summaryThe exact requirement of essential amino acids for term and preterm neonates is not known. So far, requirements have been estimated either from the composition of human milk or are derived using nitrogen balance studies which are known to be imprecise. By using a new method, the indicator amino acid oxidation (IAAO), we are able to 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)
- RECORD6-dec-2011 - 17-dec-2011

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