The effect of simethicone on food intolerance of preterm infants

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

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20240623062230N1

Enrollment

Registered

2024-07-04

Start date

2024-07-22

Completion date

Unknown

Last updated

2024-07-22

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

Conditions

Food intolerance in premature newborns. Malabsorption due to intolerance, not elsewhere classified

Interventions

Intervention 1: Intervention group: Recipient of Simethicone 0.3 ml (Simethicone, Iran, 6 drops every 6 hours) for 7 days. Intervention 2: Control group: Preterm babies who are under normal hospital n

Eligibility

Sex/Gender

All

Age

1 Days to 7 Days

Inclusion criteria

Inclusion criteria: Preterm newborns (28-32 weeks) in Imam Ali or Kamali hospitals Normal appearance according to gestational age and normal Apgar score at birth Under full feeding (at least 30 ml per kg) Weight more than 1000 grams

Exclusion criteria

Exclusion criteria: Newborns with congenital malformations, metabolic disorders at birth Sepsis and infection diagnosed according to positive CRP, having respiratory distress or nausea and vomiting Allergic reaction to the drug

Design outcomes

Primary

Measure	Time frame
Weight. Timepoint: End of intervention. Method of measurement: The weight of infants without diapers.;Average regurgitation volume. Timepoint: It will be measured every day and averaged at the end. Method of measurement: Measurement according to the volume of the gavage syringe.;Frequency of vomiting. Timepoint: It will be measured every day. Method of measurement: Expulsion of the stomach contents from the mouth.;Average duration of crying per day. Timepoint: It will be measured every day and averaged at the end. Method of measurement: The duration of the baby's restlessness during the day.;Average frequency of defecation per day. Timepoint: It will be measured every day and averaged at the end. Method of measurement: The number of times the patient defecates during the day.;Side effects. Timepoint: It will be measured every day. Method of measurement: Digestive problems such as increased belching and flatulence, allergic symptoms such as itching, hives or burning, inflammation of the face, throat, mouth or tongue and the occurrence of nasal congestion and respiratory system problems.	—

Measure

Time frame

Weight. Timepoint: End of intervention. Method of measurement: The weight of infants without diapers.;Average regurgitation volume. Timepoint: It will be measured every day and averaged at the end. Method of measurement: Measurement according to the volume of the gavage syringe.;Frequency of vomiting. Timepoint: It will be measured every day. Method of measurement: Expulsion of the stomach contents from the mouth.;Average duration of crying per day. Timepoint: It will be measured every day and averaged at the end. Method of measurement: The duration of the baby's restlessness during the day.;Average frequency of defecation per day. Timepoint: It will be measured every day and averaged at the end. Method of measurement: The number of times the patient defecates during the day.;Side effects. Timepoint: It will be measured every day. Method of measurement: Digestive problems such as increased belching and flatulence, allergic symptoms such as itching, hives or burning, inflammation of the face, throat, mouth or tongue and the occurrence of nasal congestion and respiratory system problems.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactSalimeh Yosefi

Karaj University of Medical Sciences

dr.salimehyousefi@gmail.com+98 26 3250 0123

Outcome results

None listed

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