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Effects of lactase supplement in breast milk on feeding tolerance and time to achieve full enteral nutrition in preterm infants less than 32 weeks gestational age.A clinical trial at Kamali hospital.

Effects of lactase supplement in breast milk on feeding tolerance and time to achieve full enteral nutrition in preterm infants less than 32 weeks gestational age.A clinical trial at Kamali hospital.

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20240727062559N1
Enrollment
180
Registered
2025-08-06
Start date
2025-08-23
Completion date
Unknown
Last updated
2025-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Condition 1: In this study, infants will be compared in terms of incidence of NEC. Condition 2: In this study, infants will be compared in terms of the incidence of sepsis. Condition 3: In this study, infants will be compared in terms of time to reach maximum enteral feeding (150 cc/kg), weight gain at 40 weeks, number of days of parenteral nutrition (TPN), time to reach birth weight, and length of hospitalization. Necrotizing enterocolitis in newborn, unspecified Bacterial sepsis of newborn,

Interventions

Intervention 1: Intervention group: In the intervention group, from the beginning of feeding, feeding with breast milk along with lactase (4 drops of lactase solution Under the trade name Milkazyme fr

Sponsors

Karaj University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 224 Days

Inclusion criteria

Inclusion criteria: infants born less than 32 weeks hospitalized in Kamali hospital.

Exclusion criteria

Exclusion criteria: A type of sepsis that leads to nutritional intolerance NEC not feeding tolerance digestive anomaly

Design outcomes

Primary

MeasureTime frame
Time to reach maximum enteral nutrition. Timepoint: Time to feed150cc/kg. Method of measurement: the watch.

Secondary

MeasureTime frame
Days of intravenous nutrition (TPN). Timepoint: in the course of study. Method of measurement: the watch.;Weight gain at 40 weeks. Timepoint: 40 weeks. Method of measurement: scale.;Time to reach birth weight. Timepoint: daily. Method of measurement: scale.;Hospitalization period. Timepoint: Discharge time. Method of measurement: the watch.;Incidence of necrotizing enterocolitis (NEC). Timepoint: daily. Method of measurement: Clinical.;Incidence of sepsis. Timepoint: daily. Method of measurement: clinical.;Sepsis with nutritional intolerance. Timepoint: Daily. Method of measurement: clinical.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactKamran Behrozi

Karaj University of Medical Sciences

daneshpoor371@gmail.com+98 26 3226 6851

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026