VLBW infants may be susceptible to glutamine depletion as nutritional supply of glutamine is limited in the first weeks after birth. Glutamine depletion has negative effects on functional integrity of the gut and leads to immunosuppression. This…
ID
Bron
Verkorte titel
Aandoening
Gut adaptation and modulation of the immune response in very low birth weight infants.
Ondersteuning
Department of Pediatrics
Division of Neonatology
De Boelelaan 1117
1081 HV Amsterdam
Netherlands
Tel: +31 20 4442413
Fax: +31 20 4443045
Email: w.fetter@vumc.nl
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Primary outcome of the study is time to full enteral feeding, defined as a feeding volume ¡Ý120 mL/kg/day.
Achtergrond van het onderzoek
Background:
Enteral feeding of very low birth weight (VLBW) infants is a challenge, since metabolic demands are high and administration of enteral nutrition is limited by immaturity of the gastrointestinal tract. The amino acid glutamine plays an important role in maintaining functional integrity of the gut. In addition, glutamine is utilised at a high rate by cells of the immune system. In critically ill patients, glutamine is considered a conditionally essential amino acid. VLBW infants may be especially susceptible to glutamine depletion as nutritional supply of glutamine is limited in the first weeks after birth. Glutamine depletion has negative effects on functional integrity of the gut and leads to immunosuppression.
This double-blind randomised controlled trial is designed to investigate the effect of glutamine-enriched enteral nutrition on feeding tolerance, infectious morbidity and short-term outcome in VLBW infants. Furthermore, an attempt is made to elucidate the role of glutamine in postnatal adaptation of the gut and modulation of the immune response.
Methods:
VLBW infants (gestational age <32 weeks and/or birth weight <1500 g) are randomly allocated to receive enteral glutamine supplementation (0.3 g/kg/day) or isonitrogenous placebo supplementation between day 3 and 30 of life. Primary outcome is time to full enteral feeding (defined as a feeding volume ¡Ý120 mL/kg/day). Furthermore, incidence of serious infections and short-term outcome are evaluated. The effect of glutamine on postnatal adaptation of the gut is investigated by measuring intestinal permeability and determining faecal microflora. The role of glutamine in modulation of the immune response is investigated by determining plasma Th1/Th2 cytokine concentrations following in vitro whole blood stimulation.
Doel van het onderzoek
VLBW infants may be susceptible to glutamine depletion as nutritional supply of glutamine is limited in the first weeks after birth. Glutamine depletion has negative effects on functional integrity of the gut and leads to immunosuppression. This double-blind randomised controlled trial is designed to investigate the effect of glutamine-enriched enteral nutrition on feeding tolerance, infectious morbidity and short-term outcome in VLBW infants. Furthermore, an attempt is made to elucidate the role of glutamine in postnatal adaptation of the gut and modulation of the immune response.
Onderzoeksopzet
N/A
Onderzoeksproduct en/of interventie
Enteral glutamine supplementation in a dose of 0.3 g/kg/day between days 3 and 30 of life versus isonitrogenous placebo supplementation (alanine).
Algemeen / deelnemers
De Boelelaan 1117
A. Berg, van den
De Boelelaan 1117
Amsterdam 1081 HV
The Netherlands
+31 (0)20 4442413
a.vandenberg@vumc.nl
Wetenschappers
De Boelelaan 1117
A. Berg, van den
De Boelelaan 1117
Amsterdam 1081 HV
The Netherlands
+31 (0)20 4442413
a.vandenberg@vumc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
Infants with a gestational age < 32 weeks and/or a birth weight < 1500 grams.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
Major chromosomal or congenital anomalies.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
Register | ID |
---|---|
NTR-new | NL169 |
NTR-old | NTR205 |
Ander register | : N/A |
ISRCTN | ISRCTN73254583 |
Samenvatting resultaten
Anemone van den Berg, Ruurd M. van Elburg, Jos W.R. Twisk, Willem P.F. Fetter. Biomed Central Pediatrics 2004;4:17.<br>
<br><br>
2. Glutamine-enriched enteral nutrition in very-low-birth-weight infants and effects on feeding tolerance and infectious morbidity: a randomized controlled trial.
Anemone van den Berg, Ruurd M. van Elburg, Elisabeth A.M. Westerbeek, Jos W.R. Twisk, Willem P.F. Fetter. American Journal of Clinical Nutrition 2005;81:1397-1404.<br>
<br><br>
3. A randomized controlled trial of enteral glutamine supplementation in very low birth weight infants: Plasma amino acid concentrations.
Anemone van den Berg, Ruurd M. van Elburg, Tom Teerlink, Harrie N. Lafeber, Jos W.R. Twisk, Willem P.F. Fetter. Journal of Pediatric Gastroenterology and Nutrition 2005;41:66-71. <br>
<br><br>
4. JPEN J Parenter Enteral Nutr. 2006 Sep-Oct;30(5):408-14.<br>