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Comparison of erythromycin and metoclopramide on gastrointestinal disorders in premature infants

Comparison of erythromycin and metoclopramide in the treatment of dysmotility in premature neonates

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20220524054983N1
Enrollment
60
Registered
2024-01-10
Start date
2024-01-09
Completion date
Unknown
Last updated
2024-01-22

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

Conditions

Gastrointestinal dysmotility. Feeding problem of newborn, unspecified

Interventions

Intervention 1: Intervention group: metoclopramide drops, made in Iran, Abidi company, one drop every 8 hours, oral. Intervention 2: Intervention group: erythromycin syrup, made in Iran, Loghman compa

Sponsors

Karaj University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
8 Months to No maximum

Inclusion criteria

Inclusion criteria: Neonates with gestational age of more than 32 weeks and postnatal ago of more than 2 weeks Signs and symptoms of dysmotility; vomiting, abdominal distention, failure to defecate for more than 3 days Absence of gastrointestinal anomaly; malrotation, intestinal atresia, necrotizing enterocolitis Neonates with minimum weight of 800 grams and maximum of 1500 grams

Exclusion criteria

Exclusion criteria: Drug reactions Worsening of dysmotility signs and symptoms Positive CRP in laboratory tests or any suspicion about gastrointestinal anomalies including intestinal malrotation, necrotizing enterocolitis and intestinal atresia The impossibility of assessing the outcome due to transfer to another center or the loss of the infant. Dissatisfaction with participation in the study

Design outcomes

Primary

MeasureTime frame
The improvement in clinical symptoms of dysmotility in premature neonate after a course of treatment. Timepoint: Measuring the frequency of daily feeding and lavage until the end of the treatment period. Method of measurement: Daily enteral feeding volume.

Secondary

MeasureTime frame
Time of administration of the drugs under study. Timepoint: At the beginning of the study and then daily. Method of measurement: Insertion in data query form including date and hour.;Lavage frequency. Timepoint: Each lavage. Method of measurement: Nasogastric tube.;Duration of intravenous feeding. Timepoint: Initiation and termination of Intravenous nutrition. Method of measurement: Patient information file.;Enteral nutrition initiation time. Timepoint: At the beginning of the study. Method of measurement: Patient information file.;Enteral nutrition intake. Timepoint: At the beginning of the study and then daily. Method of measurement: Patient information file.;Vomiting frequency. Timepoint: Each time vomiting. Method of measurement: Patient information file.;Frequency of defecation. Timepoint: Daily. Method of measurement: Frequency of diaper change.;Gender. Timepoint: At the beginning of the study. Method of measurement: Patient information file.;Time of admission. Timepoint: At the beginning of the study. Method of measurement: Patient information file.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactKamran Behrouzi

Karaj University of Medical Sciences

zahraarabiaan@gmail.com+98 26 3252 3121

Outcome results

None listed

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