Lactase Enzyme Supplementation for Growth and Feeding Tolerance in Preterm Infants

Cairo University (CU)

Status: Completed

Conditions: Prematurity; Feeding Intolerance; Lactose Intolerance

Treatments: Dietary Supplement: Lactase Enzyme Supplementation

Study type: Interventional

Funder types: Other

Identifiers

NCT07494123

MD-33-2022

Details and patient eligibility

About

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.

Enrollment: 124 patients

Sex: All

Ages: Under 28 days old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Preterm infants born before 34 weeks of gestation
• Infants prescribed to start enteral feeding
• Absence of gastrointestinal disorders at enrollment, including necrotizing enterocolitis

Exclusion criteria

• Congenital heart disease
• Other serious congenital malformations
• Cow's milk protein allergy symptoms such as abdominal distension or increased exhaust
• Diagnosed necrotizing enterocolitis
• Neonatal sepsis
• Legal guardian unwilling to provide informed consent

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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124 participants in 2 patient groups

Lactase Enzyme Supplementation

Experimental group

Description:

Preterm infants received enteral feeding with lactase enzyme supplementation for 2 weeks from the start of feeding. For bottle feeds, 1 drop of lactase enzyme was added to every 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.

Treatment:

Dietary Supplement: Lactase Enzyme Supplementation

Standard Feeding Control

No Intervention group

Description:

Preterm infants received breast milk or formula without lactase enzyme supplementation for 2 weeks from initiation of enteral feeding.