Determining the effect of erythromycin and metoclopramide in improving gastrointestinal symptoms in infants with dysmotility
Determining the time required for total parenteral nutrition in premature infants treated with erythromycin and metoclopramide
Comparison of side effects of erythromycin and metoclopramide on premature infants
Comparison of hospitalization duration of infants treated with erythromycin and metoclopramide
Comparison of the duration of receiving antibiotics in infants treated with erythromycin and metoclopramide
Design
A comparative clinical trial, parallel groups, no blinding, randomized with non-equivalent blocks with pilot method, phase 3 on 60 patients, randomization will be done with the website sealedenvelope.com
Settings and conduct
Premature babies hospitalized in the Kamali Hospital NICU included in criteria are examined by the responsible researcher and their clinical evaluation is performed by another researcher who is not aware of the randomized list
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1. Infant with gestational age of under 32 weeks and postnatal age of more than 2 weeks
2. Signs of dysmotility; vomiting, no defecation for more than three days, abdominal distention
3. Absence of gastrointestinal anomaly; Necrotizing enterocolitis(NEC), malrotation, intestinal atresia
Exclusion criteria:
1. Drug sensitivity
2. Parental dissatisfaction with participation in the study
3. Aggravation of dysmotility symptoms
4.The impossibility of assessing outcome due to transfer to another center or loss of the infant
5. Positive CRP or symptoms of gastrointestinal anomalies; NEC, malrotation, intestinal atresia
Intervention groups
Infants are divided into two groups. one group is treated with erythromycin and other with metoclopramide.
Comparison of erythromycin and metoclopramide in the treatment of dysmotility in premature neonates
Public title
Comparison of erythromycin and metoclopramide on gastrointestinal disorders in premature infants
Purpose
Treatment
Inclusion/Exclusion 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:
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
Age
From 8 months old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
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.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Alborz University of Medical Sciences