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The effect of Lactolose on premature infants

lactulose effectiveness on incidence of suspected NEC in VLBW infants in Al_zahra and shahid baheshti hospitals in Isfahan

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT2015020110026N6
Enrollment
50
Registered
2015-03-06
Start date
2014-01-01
Completion date
Unknown
Last updated
2018-02-22

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

Conditions

NEC. Necrotizing enterocolitis of fetus and newborn

Interventions

Intervention 1: In the lactulose given group after consideration the inclusion and exclusion criteria for premature infant <1500gr that their milk begin lactulose 1%added and it continued on till the
Treatment - Drugs
Placebo
In the lactulose given group after consideration the inclusion and exclusion criteria for premature infant <1500gr that their milk begin lactulose 1%added and it continued on till the milk volume 150
In the control group after consideration the inclusion and exclusion criteria for premature infant<1500 gr that their milk begin water injectin added and it cntinues to till the milk volume to 150 cc

Sponsors

Isfahan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 30 Days

Inclusion criteria

Inclusion criteria: Inclusion criteria: prematurity; birth weight equal and lower than 1500 gr; at the time of beginning milk. Exclusion criteria: major congenital anomalies; asphyxia; GI anomalies; congenital cyanotic heart disease.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
GI microbial changes. Timepoint: 30 days. Method of measurement: Stool exam.;NEC. Timepoint: 30 days. Method of measurement: Patient examination and observation.

Secondary

MeasureTime frame
Hospital stay. Timepoint: 30 days. Method of measurement: Daily recorded sheets.;Death. Timepoint: During hospital stay. Method of measurement: Daily recorded sheets.;Being NPO. Timepoint: 30 days. Method of measurement: Daily recorded sheets.;Milk intolerance. Timepoint: 30 days. Method of measurement: Daily recorded sheets.;Time of becoming full volume. Timepoint: 30 days. Method of measurement: Daily recorded sheets.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Elahe Shirani

Isfahan University of Medical Sciences

shirani_elahe@yahoo.com+98 31 3335 3034

Outcome results

None listed

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