The comparison of the efficacy of two different doses of lansoprazole in the treatment of neonatal gastro esophageal reflux disease refractory to conservative therapy
The comparison of the efficacy of two different doses of lansoprazole in the treatment of GERD in term neonates refractory to conservative therapy.
Design
A randomized 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 120 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 of 60 patients receiving two different doses of lansoprazole.
The participants, the medical clinician, the researcher who collect data and the statist who analyzes the data, are blind .
Participants/Inclusion and exclusion criteria
Major Inclusion Criteria: Healthy term neonates aged 1–30days with GERD not responding to conservative therapy (including anti-reflux positioning, milk thickening and feeding with lower volume of milk and shorter interval).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 lansoprazole with 0 .5 mg/ kg / dose two times per day or lansoprazole 0 .75 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 lansoprazole in each group.
General information
Reason for update
Acronym
Neonatal GERD
IRCT registration information
IRCT registration number:IRCT20160827029535N9
Registration date:2022-01-03, 1400/10/13
Registration timing:prospective
Last update:2022-01-03, 1400/10/13
Update count:0
Registration date
2022-01-03, 1400/10/13
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
2022-02-20, 1400/12/01
Expected recruitment end date
2022-12-22, 1401/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of the efficacy of two different doses of lansoprazole in the treatment of neonatal gastro esophageal reflux disease refractory to conservative therapy
Public title
The comparison of the efficacy of two different doses of lansoprazole 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 therapy (including anti-reflux positioning, milk thickening and feeding with lower volume of milk and shorter interval).
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
2-3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
120
More than 1 sample in each individual
Number of samples in each individual:
60
Each patient receives 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
Blinding (investigator's opinion)
Double blinded
Blinding description
The participants, the medical clinician, the researcher who
collect data and the statist who analyzes the data are blind.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
کمیته اخلاق دانشگاه علوم پزشکی تهران
Street address
میدان انقلاب-خیابان قدس-خیابان پورسینا- دانشگاه علوم پزشکی
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2021-11-03, 1400/08/12
Ethics committee reference number
IR.TUMS.CHMC.REC.1400.173
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 two different doses of lansoprazole in treatment of refractory neonatal GERD to conservative therapy