Feeding Intolerance, Lactose Intolerance, Prematurity
Conditions
Keywords
Preterm infant, Premature infant, Lactase enzyme supplementation, Feeding tolerance, Growth promotion, Necrotizing enterocolitis, Enteral feeding
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTLactase Enzyme Supplementation
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.
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
This was a prospective double-blind controlled trial. Randomization codes were generated by a person not directly involved in the study. Feeding bottles were prepared and labeled using coded assignment to maintain blinding. Parents, study investigators, and outcome assessors were blinded to treatment allocation throughout the study period.
Intervention model description
Preterm infants were assigned in parallel to 1 of 2 groups from the start of enteral feeding for 2 weeks: lactase enzyme supplementation added to feeds or standard feeds without lactase supplementation.
Eligibility
Sex/Gender
ALL
Age
No minimum to 28 Days
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weight Gain | From initiation of enteral feeding to the end of week 2 | Mean weight gain rate in grams per day during the 2-week study period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Feeding Intolerance During Week 1 | End of week 1 after initiation of enteral feeding | Incidence of feeding intolerance signs during the first week of observation, including gastric residuals, abdominal distension, emesis, and diarrhea. |
| Feeding Intolerance During Week 2 | End of week 2 after initiation of enteral feeding | Incidence of feeding intolerance signs during the second week of observation, including gastric residuals, abdominal distension, emesis, and diarrhea. |
| Stool Reducing Substances | End of week 1 and end of week 2 | Presence and degree of reducing substances in stool assessed by Benedict's test as an indicator of carbohydrate malabsorption. |
| Stool pH | End of week 1 and end of week 2 | Fecal pH measured in fresh stool samples as an indicator of carbohydrate malabsorption. |
| Feeding Increment | Throughout the 2-week observation period | Daily amount of feeding increment achieved during the study period. |
| Days to Full Feeding | From initiation of enteral feeding until achievement of full enteral feeding, assessed up to 2 weeks | Number of days required to reach full enteral feeding. |
| Hospital Stay | From hospital admission until hospital discharge, assessed up to 3 months | Duration of hospital stay in days. |
Countries
Egypt
Outcome results
None listed