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[Influence of the lactose free and lactose containing diet on prevalence of gram-negative sepsis and feeding intolerance in very low birth weight infants: double-blind randomized trial].

OBJECTIVE
VLBW infants have a developmental lactase deficiency in the gut. The aim of the study was to evaluate the influence of lactose containing and lactose free diets on prevalence of feeding intolerance and Gram negative sepsis in VLBW infants.


METHODS
80 newborns with mean (+/- SEM) birth weight 1091 +/- 25 g and gestational age 28.5 +/- 0.24 wks were randomized into 2 groups fed during 1st month of life with 1) formula containing lactose (Bebilon Nenatal--BN group; n = 40) or 2) lactose free formula (Pregestimil--PG group; n = 40). The end points of the study were: feeding intolerance episodes, Gram negative sepsis, weight gain and the length of parenteral nutrition.


RESULTS
The birthweight (1112 vs 1114 g), gestational age (28.8 vs 28.3 wks), 5th min. Apgar score (5 vs 6 pts), sex (52% vs 55% male), type of delivery (65 vs 58% vaginal delivery) did not differ between the groups. Thirty (75%) newborns of the BN group and 31 (77.5%) newborns of the PG group completed the study (RR = 1.11; 95% CI: 0.54-2.44). The prevalence of Gram negative sepsis were similar in both groups (2/40 vs. 3/40; RR = 0.67; 95% CI: 0.12-3.78). Also a comparable number of children had at least one episode of feeding intolerance (14/40 vs. 12/40; RR = 1.17; 95% CI: 0.69-2.20) The weight gain (11.7 vs 10.9 g/day) and the length of parenteral nutrition did not differ between the groups (16 vs 15 days).


CONCLUSION
The inclusion of lactose into feeding formula does not influence feeding tolerance in VLBW infants.