Comparing omeprazole and ranitidine in treatment of gasteroesophageal reflux disease in pretem neonates

Comparing the effectiveness of omeprazole and ranitidine in the control of signs and symptoms of gastroesophageal reflux disease in preterm neonates unresponsive to conservativel therapy

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

IRCT

Registry ID

IRCT2016030226876N1

Enrollment

Registered

2016-09-04

Start date

2013-09-23

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 premature neonate. Other specified perinatal digestive system disorders

Interventions

Intervention 1: Intervention Group 2:Ranitidine1mg/kg/dose/BID. Intervention 2: Intervention Group1: Omeprazole 0.5mg/kg/dose /BID.

Treatment - Drugs

Intervention Group 2:Ranitidine1mg/kg/dose/BID

Intervention Group1: Omeprazole 0.5mg/kg/dose /BID

Eligibility

Sex/Gender

All

Age

1 Days to 28 Days

Inclusion criteria

Inclusion criteria: Inclusion criteria: Healthy preterm infants with troublesome clinical manifestations of gasteroesophageal reflux disease (including wheezing, pneumonia, chronic cough, apnea, stridor, failure to thrive, seizure, anemia, sandifer syndrome, irritability, regurgitation, vomiting, rumination); non-resposive to conservative treatment including antireflux positioning and hypo-allergen regimen. Exclusion criteria : Abnormality of GI tract (volvulus, atresia); Drug abuse (morphine, phenobarbital); Mechanical ventilation; Underlying disease (necrotizing enterocolitis, sepsis); Central nervous system abnormalities; Pripheral nervous system abnormalities, Neuro-muscular abnormalities (Myastenia gravis,Werdnig-Hoffmann disease)

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
GERD symptomps and signs. Timepoint: One week and one month after beginning of intervention. Method of measurement: Questionnaire.	—

Secondary

Measure	Time frame
Complications of ranitidine & omeprazole. Timepoint: One week and one month after intervention. Method of measurement: Questionnaire.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactNegar Sajjadian

Tehran University of Medical Sciences-Shariati Hospita

nsajjadian@yahoo.com+98 21 8822 0000

Outcome results

None listed

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