No registrations found.
ID
Source
Brief title
Health condition
neonates, preterms, LBWI, nutrition, amino acids
neonaten, prematuren, voeding, aminozuren
Sponsors and support
SHS International
Intervention
Outcome measures
Primary outcome
The mean requirement of threonine in preterm neonates by breakpoint estimation. This will be determined by applying a two-phase linear regression crossover model.
Secondary outcome
N/A
Background summary
The 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.
Study objective
The 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.
Study design
Baseline 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.
Intervention
The 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.
Boelelaan 1117
Hans Goudoever, van
Amsterdam 1081 HV
The Netherlands
+31 (0)20 444444
Boelelaan 1117
Hans Goudoever, van
Amsterdam 1081 HV
The Netherlands
+31 (0)20 444444
Inclusion criteria
Preterm 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 criteria
1. Congenital anomalies;
2. Sepsis;
3. Gastro-intestinal pathology;
4. No informed consent.
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
NTR-new | NL3031 |
NTR-old | NTR3179 |
CCMO | NL31220.000.10 |
ISRCTN | ISRCTN wordt niet meer aangevraagd. |
OMON | NL-OMON36663 |
Summary results
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.