Evaluation of the efficacy of S-omeprazole alone and with baclofen in the treatment of neonatal reflux

Study of the effect of Esomeprazole and combination of Esomeprazole ppus Baclofen in the treatment of clinical signs of infants reflux

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT20130311012782N44

Enrollment

Registered

2020-03-16

Start date

2020-04-02

Completion date

Unknown

Last updated

2020-03-24

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

Conditions

Neonatal Reflux. Newborn esophageal reflux

Interventions

Intervention 1: Intervention group 1: Reflux treatment with Esomeprazole made by Rosa Darou Company as intra capsuls granules 1 mg/kg once daily for two weeks. Intervention 2: Intervention group 2:Tre

Eligibility

Sex/Gender

All

Age

3 Months to 12 Months

Inclusion criteria

Inclusion criteria: Range age 3 to 12 months Failure to respond to routine reflux treatments

Exclusion criteria

Exclusion criteria: History of hospitalization in neonatal intensive care unit Birth weight less than 2500 grams Having an underlying disease such as cerebral palsy

Design outcomes

Primary

Measure	Time frame
Newborn esophageal reflux. Timepoint: Before beginning intervention and the end of the first week, second week, first month, second month after intervention. Method of measurement: Investigation of clinical singes.;Restlessness. Timepoint: Before beginning intervention and the end of the first week, second week,. Method of measurement: Investigation of clinical singes.;Nausea. Timepoint: Before beginning intervention and the end of the first week, second week,. Method of measurement: Investigation of clinical singes.;Womitting. Timepoint: Before beginning intervention and the end of the first week, second week,. Method of measurement: Investigation of clinical singes.;Respiratory distress. Timepoint: Before beginning intervention and the end of the first week, second week,. Method of measurement: Investigation of clinical singes.;Cough. Timepoint: Before beginning intervention and the end of the first week, second week,. Method of measurement: Investigation of clinical singes.;Weight loss. Timepoint: Before beginning intervention and the end of the first week, second week,. Method of measurement: Investigation of clinical singes.	—

Measure

Time frame

Newborn esophageal reflux. Timepoint: Before beginning intervention and the end of the first week, second week, first month, second month after intervention. Method of measurement: Investigation of clinical singes.;Restlessness. Timepoint: Before beginning intervention and the end of the first week, second week,. Method of measurement: Investigation of clinical singes.;Nausea. Timepoint: Before beginning intervention and the end of the first week, second week,. Method of measurement: Investigation of clinical singes.;Womitting. Timepoint: Before beginning intervention and the end of the first week, second week,. Method of measurement: Investigation of clinical singes.;Respiratory distress. Timepoint: Before beginning intervention and the end of the first week, second week,. Method of measurement: Investigation of clinical singes.;Cough. Timepoint: Before beginning intervention and the end of the first week, second week,. Method of measurement: Investigation of clinical singes.;Weight loss. Timepoint: Before beginning intervention and the end of the first week, second week,. Method of measurement: Investigation of clinical singes.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactLeila Naderi

Ghoum University of Medical Sciences

fatemeh.naderi2010@yahoo.com+98 25 3665 1801

Outcome results

None listed

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