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IRCT20220524054983N1 IRCT 2024-01-10 Karaj University of Medical Sciences Comparison of erythromycin and metoclopramide on gastrointestinal disorders in premature infants Comparison of erythromycin and metoclopramide in the treatment of dysmotility in premature neonates 2024-01-09 anticipated 60 Complete https://irct.ir/trial/63928 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Premature neonates hospitalized in the NICU are examined based on the entry and exit criteria, and with the individual block randomization method, we separate the neonates by statistical software and the neonates will be evaluated by the responsible researcher. Also, the size of the blocks will be unmatched to hide the allocation. 3 Gastrointestinal dysmotility. 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 company, 10 mg per kilogram of weight, every 6 hours, oral. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is I don't intent to explain at the moment
public Kamran Behrouzi
No. 34.1, 6th Boustan Ave., North Neda blvd., Mehran Sq., Azimieh
Karaj Iran (Islamic Republic of) 3155716911 +98 26 3252 3121 zahraarabiaan@gmail.com Karaj University of Medical Sciences scientific Kamran Behrouzi
No. 34.1, 6th Boustan Ave., North Neda blvd., Mehran Sq., Azimieh
Karaj Iran (Islamic Republic of) 3155716913 +98 26 3252 3121 zahraarabiaan@gmail.com Karaj University of Medical Sciences Iran (Islamic Republic of) 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 8 months no limit Both 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 P92.9 Feeding problem of newborn, unspecified Treatment - Drugs Treatment - Drugs Intervention group: metoclopramide drops, made in Iran, Abidi company, one drop every 8 hours, oral Intervention group: erythromycin syrup, made in Iran, Loghman company, 10 mg per kilogram of weight, every 6 hours, oral 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. 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. Karaj University of Medical Sciences Approved 2023-11-18 Ethics committee of Alborz University of Medical Sciences No. 34.1, 6th Boostan Ave., North Neda Blvd., Mehran Sq., Azimieh karaj Alborz Iran (Islamic Republic of)