Preterm infants commonly experience feeding intolerance, which can delay advancement of enteral feeding and impair early growth. This randomized double-blind controlled trial evaluated whether lactase enzyme supplementation could improve feeding tolerance and growth in Egyptian preterm infants born before 34 weeks of gestation. Infants were assigned to receive either feeds supplemented with lactase enzyme or standard feeds without lactase for 2 weeks from the start of enteral feeding. The study hypothesized that lactase supplementation would reduce signs of feeding intolerance and improve weight gain. Outcomes included feeding intolerance symptoms, stool markers of carbohydrate malabsorption, feeding progression, growth parameters, and selected clinical outcomes including necrotizing enterocolitis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
124
Lactase enzyme was administered with enteral feeds for 2 weeks from initiation of feeding in preterm infants. For bottle feeds, 1 drop was added to each 20 mL of breast milk or formula and incubated for 30 minutes at room temperature before administration. For directly breastfed infants, 5 drops were given before each breastfeed.
Cairo University Children's Hospitals
Cairo, Cairo Governorate, Egypt
Weight Gain
Mean weight gain rate in grams per day during the 2-week study period.
Time frame: From initiation of enteral feeding to the end of week 2
Feeding Intolerance During Week 1
Incidence of feeding intolerance signs during the first week of observation, including gastric residuals, abdominal distension, emesis, and diarrhea.
Time frame: End of week 1 after initiation of enteral feeding
Feeding Intolerance During Week 2
Incidence of feeding intolerance signs during the second week of observation, including gastric residuals, abdominal distension, emesis, and diarrhea.
Time frame: End of week 2 after initiation of enteral feeding
Stool Reducing Substances
Presence and degree of reducing substances in stool assessed by Benedict's test as an indicator of carbohydrate malabsorption.
Time frame: End of week 1 and end of week 2
Stool pH
Fecal pH measured in fresh stool samples as an indicator of carbohydrate malabsorption.
Time frame: End of week 1 and end of week 2
Feeding Increment
Daily amount of feeding increment achieved during the study period.
Time frame: Throughout the 2-week observation period
Days to Full Feeding
Number of days required to reach full enteral feeding.
Time frame: From initiation of enteral feeding until achievement of full enteral feeding, assessed up to 2 weeks
Hospital Stay
Duration of hospital stay in days.
Time frame: From hospital admission until hospital discharge, assessed up to 3 months
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