Abstract
BackgroundEnteral 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.MethodsVLBW 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.
Highlights
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
Experimental studies have shown that the amino acid glutamine plays an important role in maintaining functional integrity of the gut [2,3,4,5]
The effect of glutamine-enriched enteral nutrition on the immune response is investigated by determining plasma T-helper type 1 (Th1) and T-helper type 2 (Th2) cytokine concentrations following in vitro whole blood stimulation
Summary
The study is designed as a double-blind randomised clinical trial. The national central committee on research involving human subjects and the medical ethical review board of our hospital approved the study protocol. Feeding tolerance Enteral feeding >120 mL/kg/day Age at finishing parenteral nutrition Days of no enteral feeding during study period Necrotising enterocolitis Infectious morbidity Serious infections Number of infectious episodes Cultured micro-organisms Short-term outcome Weight z scores at birth, day 30 and at discharge Patent ductus arteriosus Ventilatory support Use of oxygen at postmenstrual age of 36 weeks Intraventricular hemorrhage Retinopathy of prematurity Death Age at discharge from NICU and at discharge home. 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 (Table 2). During the study period actual intake of enteral and parenteral nutrition, powder supplementation and type of feeding (breast milk or preterm formula) are recorded daily. SPSS 9.0 (SPSS Inc., Chicago, IL, USA) and STAT 7.0 (StatCorp LP, College Station, TX, USA) are used for data analysis
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