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The effect of Erythromycin on feeding intolerance in premature infants

Evaluating the effect of intermediate dose of oral Erythromycin on feeding intolerance in premature infants

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20120614010026N10
Enrollment
84
Registered
2018-01-14
Start date
2016-03-20
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

feeding intolerance. Underfeeding of newborn

Interventions

Intervention 1: in intervention group: erythromycin syrup, 20 mg/kg/ day, every 6 hours. for 8 days in control group: distilled water, 20 cc/kg/day, every 6 hours, for 8 days. Intervention 2: Control
Treatment - Drugs
in intervention group: erythromycin syrup, 20 mg/kg/ day, every 6 hours. for 8 days in control group: distilled water, 20 cc/kg/day, every 6 hours, for 8 days
Control group: distilled water equal volume of erythromycin for 8 days

Sponsors

Esfahan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
14 Days to 1 Months

Inclusion criteria

Inclusion criteria: premature infants weight lower than 1800 grams feeding volume less than 75 cc/kg/ day in the 14th day after birth frequent lavage (i.e. => 2 times lavage; >50% of milk volume) parents willingness

Exclusion criteria

Exclusion criteria: presence of sepsis gastrointestinal anomalies cyanotic heart disease history of operation on gastrointestinal system in the first 14 days after birth consumption of medication effective in erythromycin metabolism in the same time incidence of arrhythmia or prolonged QT interval parents unwillingness

Design outcomes

Primary

MeasureTime frame
Time duration to reach to 75, 110 and 150 cc/kg/ day feeding volume. Timepoint: daily, during intervention. Method of measurement: observation.

Secondary

MeasureTime frame
Time duration of oxygen dependency. Timepoint: during intervention. Method of measurement: observation.;Time duration of hospitalization. Timepoint: during intervention. Method of measurement: observation.;Sepsis incidence. Timepoint: during intervention. Method of measurement: physical examination.;Necrotizing enterocolitis incidence. Timepoint: during intervention. Method of measurement: physical examination.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAmir-mohammad Armanian

Esfahan University of Medical Sciences

armanian@med.mui.ac.ir+98 31 3621 0008

Outcome results

None listed

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