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
Objectives: The goal of this study is to compare the effectiveness of omeprazole and ranitidine in the treatment of GERD in preterm neonates who do not respond to conservative treatment.
Design: The study is designed as a double blind randomized controlled trial.
Setting and conduct: The study will be conducted on 60 otherwise healthy preterm neonates with symptomatic GER attending the neonatalogy clinic of Shariati Hospital. Elligible neonates will be randomly assigned (in blocks of two per site) to a double blind therapeutic trial in two groups recieving either ranitidine or omeprazole. Outcome will be assessed by an independent researcher blinded to assignation of neonates.
Major Inclusion and Exclusion criteria: Study subjects will include healthy and preterm neonates aged 1-28 days with symtoms and signs of GER not responding to to conservative therapies including anti-reflux positioning and hypo-allergen regimens.
Intervention: Neonates who meet the criteria will be randomly assigned to two groups to receive either ranitidine ,1 mg/ kg /dose two times per day or omoperazole 0 .5 mg/ kg / dose two times per day for one month.
Main outcome variables: Main outcome is defined as significant improvement in signs and symptoms of GER.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016030226876N1
Registration date:2016-09-04, 1395/06/14
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-09-04, 1395/06/14
Registrant information
Name
Zahra Akhavan
Name of organization / entity
Tehran University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 7706 8769
Email address
z_akhavan@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2013-09-23, 1392/07/01
Expected recruitment end date
2014-09-23, 1393/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
Comparing omeprazole and ranitidine in treatment of gasteroesophageal reflux disease in pretem neonates
Purpose
Treatment
Inclusion/Exclusion 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)
Age
From 1 day old to 28 days old
Gender
Both
Phase
4
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
block randomization
Secondary Ids
1
Registry name
-
Secondary trial Id
-
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Tehran university Of Medical Sciences, Pursina ُStreet, Ghods Av, Enghelab Square, Tehran, Iran
City
Tehran
Postal code
Approval date
2016-07-12, 1395/04/22
Ethics committee reference number
IR.TUMS.REC.1395.2766
Health conditions studied
1
Description of health condition studied
Gastroesophageal reflux in premature neonate
ICD-10 code
P78.8
ICD-10 code description
Other specified perinatal digestive system disorders
Primary outcomes
1
Description
GERD symptomps and signs
Timepoint
One week and one month after beginning of intervention