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Glutamine-enriched enteral feeding in very low birth weight infants.


- candidate number1374
- NTR NumberNTR205
- ISRCTNISRCTN73254583
- Date ISRCTN created9-aug-2004
- date ISRCTN requested
- Date Registered NTR12-sep-2005
- Secondary IDsN/A 
- Public TitleGlutamine-enriched enteral feeding in very low birth weight infants.
- Scientific TitleGlutamine-enriched enteral feeding in very low birth weight infants.
- ACRONYMGEEF study
- hypothesisVLBW 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.
- Healt Condition(s) or Problem(s) studiedPreterm neonates, Low birth weight infants
- Inclusion criteriaInfants with a gestational age < 32 weeks and/or a birth weight < 1500 grams.
- Exclusion criteriaMajor chromosomal or congenital anomalies.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 16-sep-2001
- planned closingdate19-okt-2004
- Target number of participants107
- InterventionsEnteral glutamine supplementation in a dose of 0.3 g/kg/day between days 3 and 30 of life versus isonitrogenous placebo supplementation (alanine).
- Primary outcomePrimary outcome of the study is time to full enteral feeding, defined as a feeding volume 120 mL/kg/day.
- Secondary outcomeFurthermore, other parameters of feeding tolerance, infectious morbidity, and short-term outcome are evaluated. In addition to clinical outcome, intestinal permeability, faecal flora, plasma Th1/Th2 cytokine concentrations and plasma amino acid profiles are determined during the 30 day study period.
- TimepointsN/A
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESDr. A. Berg, van den
- CONTACT for SCIENTIFIC QUERIESProf. W.P.F. Fetter
- Sponsor/Initiator VU University Medical Center, Department of Paediatrics and Neonatology
- Funding
(Source(s) of Monetary or Material Support)
VU University Medical Center, Nutricia Nederland B.V.
- Publications1. Glutamine-enriched enteral nutrition in very low birth weight infants. Design of a double-blind randomised controlled trial. Anemone van den Berg, Ruurd M. van Elburg, Jos W.R. Twisk, Willem P.F. Fetter. Biomed Central Pediatrics 2004;4:17.


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.


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.


4. JPEN J Parenter Enteral Nutr. 2006 Sep-Oct;30(5):408-14.
- Brief summaryBackground:
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 120 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.
- Main changes (audit trail)
- RECORD5-sep-2005 - 16-jun-2008


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