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

The comparison of the efficacy of ranitidine plus metoclopramide with lansoprazole plus metoclopramide in the recovery rate of signs and symptoms of neonatal gastro esophageal reflux disease unresponsive to conservative and monotherapy.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT20160827029535N3
Enrollment
60
Registered
2018-01-30
Start date
2018-03-21
Completion date
Unknown
Last updated
2018-02-22

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

Conditions

Gastroesophageal reflux in mature neonate. Other specified perinatal digestive system disorders

Interventions

Intervention 1: In group 1 intervention: Ranitidine 2 mg/kg TDS plus metoclopramide 0/15 mg/kg TDS for one month. Intervention 2: In group 2 intervention: lansoprazole 0/7 mg/kg/BID plus metoclopramid
Treatment - Drugs
In group 1 intervention: Ranitidine 2 mg/kg TDS plus metoclopramide 0/15 mg/kg TDS for one month
In group 2 intervention: lansoprazole 0/7 mg/kg/BID plus metoclopramide 0/15 mg/kg TDS for one month.

Sponsors

Investigator
Lead Sponsor

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 therapies including antireflux positioning, milk thickening, hypoallergic regimens and monotherapy.

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

Secondary

MeasureTime frame
The rate of complications of ranitidine , lanzoprasole and omeprazole in each group of intervention. Timepoint: One week and one month after beginning of intervention. Method of measurement: Questionnaire.

Primary

MeasureTime frame
The response rate of GERD symptoms and signs in each intervention group. Timepoint: One week and one month after beginning of intervention. Method of measurement: Questionnaire.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Peymaneh Alizadeh Taheri

Tehran University of Medical Sciences, Bahrami Hospital

p.alizadet@yahoo.com+98 73013420

Outcome results

None listed

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