The comparison of the efficacy of two different doses of lansoprazole in the treatment of gastroesophageal reflux disease in term neonates.

The comparison of the efficacy of two different doses of lansoprazole in the treatment of neonatal gastro esophageal reflux disease refractory to conservative therapy

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20160827029535N9

Enrollment

120

Registered

2022-01-03

Start date

2022-02-20

Completion date

Unknown

Last updated

2022-01-11

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 group1: Intervention group1:Lansoprazole 0.5/kg/dose /BID. Intervention 2: Intervention group2: Lansoprazole 0.75mg/kg/dose /BID.

Eligibility

Sex/Gender

All

Age

1 Days to 30 Days

Inclusion criteria

Inclusion criteria: Healthy term neonates aged 1–30days with GERD not responding to conservative therapy (including anti-reflux positioning, milk thickening and feeding with lower volume of milk and shorter interval).

Exclusion criteria

Exclusion criteria: 1-Neonates with any underlying diseases, including anomalies or gastrointestinal obstruction, neurological disorders, sepsis, NEC, etc.2-Using any sedative , relaxant or anticonvulsive medications .3-History of ventilation therapy.

Design outcomes

Primary

Measure	Time frame
The comparison of two different doses of lansoprazole in treatment of refractory neonatal GERD to conservative therapy. 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 dose of lansoprazole. Timepoint: After one week and one month of administration. Method of measurement: Clinical manifestations.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactTehran University of Medical Sciences

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