The comparison of the efficacy of ranitidine with esoprazole in the recovery rate of signs and symptoms of neonatal gastro esophageal reflux disease ________________________________________
The comparison of the efficacy of esomeprazole with ranitidine in the treatment of GERD in term neonates.
Design
A randomised double blinded clinical trial with two arm parallel group and simple randomization at the individual level and using random number table with allocation concealment by sequentially numbered sealed opaque envelop.
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Settings and conduct
The study will be conducted on 60 otherwise healthy term neonates with symptomatic GERD attending to the neonatal clinic of Bahrami Hospital. Eligible neonates will be randomly assigned to a double blind therapeutic trial in two groups receiving either ranitidine or esomeprazole. The physician who cares the patients, the researcher who collects the data and the person who analyses the data are blind.
Participants/Inclusion and exclusion criteria
Major Inclusion Criteria: Study subjects will include healthy and term neonates aged 1-30 days with symptoms and signs of GERD not responding to conservative therapies including anti-reflux positioning, milk thickening and hypo-allergen regimen.Major Exclusion Criteria:1-Neonates with any underlying diseases, including anomalies or gastrointestinal obstruction, neurological diseases, sepsis, NEC, etc .2-Using any sedative , relaxant or anticonvulsive medications .3- History of ventilation therapy.
Intervention groups
Neonates who meet the criteria will be randomly assigned to two groups to receive either ranitidine 2 mg/ kg /dose three times per day or esomeprazole 0 .5 mg/ kg / dose two times per day for one month.
Main outcome variables
En Primary outcome variable includes: The recovery rate in signs and symptoms of GERD. Secondary outcome variable includes: Complications of ranitidine and esomeprazole in each group.
General information
Reason for update
Acronym
Neonatal GERD
IRCT registration information
IRCT registration number:IRCT20160827029535N5
Registration date:2019-08-21, 1398/05/30
Registration timing:prospective
Last update:2019-08-21, 1398/05/30
Update count:0
Registration date
2019-08-21, 1398/05/30
Registrant information
Name
Peymaneh Alizadeh Taheri
Name of organization / entity
Tehran University of Medical Sciences, Bahrami Hospital
Country
Iran (Islamic Republic of)
Phone
+98 21 7301 3420
Email address
alizadep@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-23, 1398/07/01
Expected recruitment end date
2020-03-19, 1398/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of the efficacy of ranitidine with esoprazole in the recovery rate of signs and symptoms of neonatal gastro esophageal reflux disease ________________________________________
Public title
The comparison of the efficacy of two therapeutic regimens in the treatment of gastroesophageal reflux disease in term neonates.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Healthy term neonates aged 1–30days with GERD .
Exclusion criteria:
Healthy term neonates aged 1–30days with GERD not responding to conservative therapies including antireflux positioning, milk thickening, hypoallergic regimens and monotherapy
Age
From 1 day old to 30 days old
Gender
Both
Phase
N/A
Groups that have been masked
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
90
More than 1 sample in each individual
Number of samples in each individual:
1
Each patient recieves the defined drug of his group.
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization at the individual level and using random number table with allocation concealment by sequentially numbered sealed opaque envelop
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Blinding (investigator's opinion)
Double blinded
Blinding description
The participants,the medicl clinician,the researcher who collect data and the who analyze the data are blind.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
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
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2019-06-23, 1398/04/02
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1398.251
Health conditions studied
1
Description of health condition studied
Gastroesophageal Reflux
ICD-10 code
K21
ICD-10 code description
Gastro-oesophageal reflux disease
Primary outcomes
1
Description
the comparison of ranitidine with esomeprazole in neonatal GERD
Timepoint
One week and one month after using each drug
Method of measurement
using (I-GERDQ-R) and related scoring
Secondary outcomes
1
Description
The side effects of each drug
Timepoint
After one week and one month of administering
Method of measurement
Clinical manifestations
Intervention groups
1
Description
Intervention group1: Ranitidine:2mg/kg/dose/TDS
Category
Treatment - Drugs
2
Description
Intervention group 2: Esomeprazole 0.5mg/kg/dose /BID