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.
The comparison of the efficacy of lansoprazole plus metoclopramide with ranitidine plus metoclopramide in the treatment of GERD in term neonates who do not respond to conservative and monotherapy.
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.
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 plus metoclopramide or lansoprazole plus metoclopramide. 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 lansoprazole 0 .7 mg/ kg / dose two times per day for one month.
Main outcome variables
Primary outcome variable includes: The recovery rate in signs and symptoms of GERD. Secondary outcome variable includes: Complications of ranitidine , lansoprazole and metoclopramide in each group.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160827029535N3
Registration date:2018-01-30, 1396/11/10
Registration timing:prospective
Last update:2018-01-30, 1396/11/10
Update count:0
Registration date
2018-01-30, 1396/11/10
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
Investigator
Expected recruitment start date
2018-03-21, 1397/01/01
Expected recruitment end date
2019-03-21, 1398/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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.
Public title
The comparison of the efficacy of two combined 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 not responding to conservative therapies including antireflux positioning, milk thickening, hypoallergic regimens and monotherapy.
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.
Age
From 1 day old to 30 days old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
60
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
Blinding (investigator's opinion)
Double blinded
Blinding description
The participants; the physicians who care the participants; the researcher who collects the data and the person who analyses the data are blind to the study.
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 Avenue, Enghelab Square Tehran Tehran Iran, Islamic Republic Of Iran
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2017-10-15, 1396/07/23
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1396.3714
Health conditions studied
1
Description of health condition studied
Gastroesophageal reflux in mature neonate
ICD-10 code
P78.8
ICD-10 code description
Other specified perinatal digestive system disorders
Primary outcomes
1
Description
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
Secondary outcomes
1
Description
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
Intervention groups
1
Description
In group 1 intervention: Ranitidine 2 mg/kg TDS plus metoclopramide 0/15 mg/kg TDS for one month
Category
Treatment - Drugs
2
Description
In group 2 intervention: lansoprazole 0/7 mg/kg/BID plus metoclopramide 0/15 mg/kg TDS for one month.