The comparison of the efficacy of two therapeutic regimens in the treatment of gastroesophageal reflux disease in term neonates.

The comparison of the efficacy of omeprazole with lansoprazole in the recovery rate of neonatal gastro esophageal reflux disease refractory to conservative therapy

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT20160827029535N10

Enrollment

120

Registered

2022-02-02

Start date

2022-02-20

Completion date

Unknown

Last updated

2022-02-07

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

Conditions

Gastroesophageal Reflux. Gastro-oesophageal reflux disease

Interventions

Intervention 1: Intervention group: Intervention group1:Omeprazole 0.5mg/kg/dose /BID. Intervention 2: Intervention group: Lansoprazole 0.5mg/kg/dose /BID.

Eligibility

Sex/Gender

All

Age

1 Days to 30 Days

Inclusion criteria

Inclusion criteria: Term neonates aged 1–30 days with gastro esophageal reflux disease

Exclusion criteria

Exclusion criteria: Neonates with any underlying diseases, including anomalies or gastrointestinal obstruction, neurological disorders, sepsis, NEC, etc. History of using any sedative , relaxant or anticonvulsive medications History of ventilation therapy.

Design outcomes

Primary

Measure	Time frame
The comparison of omeprazole with lansoprazole in neonatal GERD. Timepoint: One week and one month after using each drug. Method of measurement: using (I-GERDQ-R) and related scoring.	—

Secondary

Measure	Time frame
The side effects of each drug. Timepoint: After one week and one month of administration. Method of measurement: Clinical manifestations.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactPeymaneh Alizadeh Taheri

Tehran University of Medical Sciences

p.alizadet@yahoo.com+98 73013413

Outcome results

None listed

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