Evaluation the effect of Simeticone on feeding tolerance and bowel habits in preterm newborns in 2024 at Kamali and Imam Ali Hospitals

Determining the effect of simethicone on feeding tolerance and intestinal habits of preterm infants 33-88 weeks (in 1403 in Kamali and Imam Ali Hospital)

Two arms parallel-group randomized single-blinded trial, with 50 patients sample size. The permuted balance block technique of Stata software was used for randomization.

This study will be conducted on the infants of Kamali and Imam Ali hospitals in Karaj, who are fully fed with the commonly used hospital brand (aptamil). Patients will be included after obtaining ethical consent from their parents and randomly divided into two groups. During the 7 days of the intervention, the information will be recorded and finally analyzed.

Preterm newborns (28-32-week) born in Imam Ali or Kamali hospitals with normal appearance according to gestational age and normal Apgar score at birth, fed full feed (at least 30 ml per kg) and weight at least 1000 grams are included in this study. Infants with congenital malformations, metabolic disorders at birth, sepsis and infection diagnosed with positive CRP, respiratory distress, or nausea and vomiting are excluded from the study. infants who are allergic to the drug will be excluded from the study.

Intervention group: recipient of Simethicone 0.3 ml (Simethicone, Iran, 6 drops every 6 hours) for 7 days. The reason for choosing 7 days of study is due to the limitation of hospitalization time. Case group: preterm babies who are under normal hospital nutrition (aptamil), but they will not receive simethicone.

After the intervention, information, including age, sex, Apgar score, weight, type of feeding, and food intolerance (frequency of regurgitation, vomiting, episodes of crying, defecation) will be recorded. The remaining stomach volume will be measured using a neonatal feeding tube.

In this study, randomization of patients will be done in standard time using the permuted balance block randomization technique. Blocks in this study, are quadruple. The preparation of the random allocation sequences of the intervention and control groups and placing them in sealed envelopes and numbering with a 5-digit serial number is done by a third party who has no role in the design of the study. All envelopes have It is a 5-digit serial number that is opened immediately after entering the study and patients are divided into two intervention and treatment groups.

This is a single-blinded study, which the researcher team is not informed about control and intervention groups.

All data is potentially shareable after de-identifying individuals.

Access starts from 2026

Researchers working in academic and scientific institutions

People who are researching in the field of the medical industry can email to access it.

It is possible to receive data by email to the researcher and project manager.

Considering that the data gathering of this study is sponsored byAlborz University of Medical Sciences, the use of the data will only be possible through the administrative procedures of the Research Deputy of Alborz University of Medical Sciences.