Evaluation of the efficacy of Esomeprazole and combination of baclofen plus Esomeprazole in the treatment of clinical symptoms of infantile reflux
Design
In this double-blind clinical trial study, 50 neonates with reflux disease were randomly divided into two groups by using Random Allocation Software. The fist group is treated with Esomprazole and the second group is treated with Es-omperazole plus Baclofen and the outcome of treatment was compared between the two groups. In this study, the patient's parents and the physician examining the patients were unaware of the type of medication received.
Settings and conduct
This study was carried out in 2020 at Hazrat Zeinab Hospital in Qom. 50 neonates with reflux were randomly divided into two groups receiving Es-omperazole and Esomperazol with Baclofen and compared the recovery status in the two groups. The study was double-blind and the parents of the patients were unaware of the type of drug being administered. The medication is also prescribed by the researcher, but the child examination and reflux treatment are performed by another pediatrician who is not in the study.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age range 3 to 12 months, suffer to reflux, failure to respond to routine reflux treatments.
Not inclusion criteria: history of hospitalization in neonatal intensive care unit, birth weight less than 2500, underlying disease such as cerebral palsy
Intervention groups
Patients in the first intervention group will be treated with intra capsular granules of Esomeprazole at a dose of 1 mg / kg once daily for two weeks. Patients in the second intervention group received granules intra capsular administered with Esomeprazole 1 mg / kg once daily plus baclofen 0.2 mg / kg once daily for 14 days.
Main outcome variables
Reflux, restlessness, nausea, vomiting, respiratory distress, cough, weight loss
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130311012782N44
Registration date:2020-03-16, 1398/12/26
Registration timing:prospective
Last update:2020-03-16, 1398/12/26
Update count:0
Registration date
2020-03-16, 1398/12/26
Registrant information
Name
Ali Mehrabi kushki
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3629 1510
Email address
mehrabi@mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-02, 1399/01/14
Expected recruitment end date
2020-09-20, 1399/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of the effect of Esomeprazole and combination of Esomeprazole ppus Baclofen in the treatment of clinical signs of infants reflux
Public title
Evaluation of the efficacy of S-omeprazole alone and with baclofen in the treatment of neonatal reflux
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Range age 3 to 12 months
Failure to respond to routine reflux treatments
Exclusion criteria:
History of hospitalization in neonatal intensive care unit
Birth weight less than 2500 grams
Having an underlying disease such as cerebral palsy
Age
From 3 months old to 12 months old
Gender
Both
Phase
1
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization of patients between the two intervention groups was done using random Allocation Software. In the mentioned software, the sample size is first entered into software for two groups. Then the number of study groups is entered. At the output of the software, a list of two columns is seen, with numbers 1 to 50 (total sample size) distributed in two columns randomly. Patients are divided into two groups according to the time of referral, which is the first patient number 1 and the last patient number 50.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is done by double blind method . The blinds included in this study include parents of children and person of responsible for data collection . Parents are unaware of the type of drug they are receiving.Also the drugs is prescribed by the researcher for the patients, but the outcome of the study is evaluated by another pediatrician who is unaware of the type of medication the patient is receiving.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Qom University of Medical Sciences
Street address
Research faculty, Qom University ofMedical Sciences, Shahi Lavasani street
City
Isfahan
Province
Isfehan
Postal code
3713649373
Approval date
2019-10-21, 1398/07/29
Ethics committee reference number
IR.MUQ.REC.1398.039
Health conditions studied
1
Description of health condition studied
Neonatal Reflux
ICD-10 code
P78.83
ICD-10 code description
Newborn esophageal reflux
Primary outcomes
1
Description
Newborn esophageal reflux
Timepoint
Before beginning intervention and the end of the first week, second week, first month, second month after intervention
Method of measurement
Investigation of clinical singes
2
Description
Restlessness
Timepoint
Before beginning intervention and the end of the first week, second week,
Method of measurement
Investigation of clinical singes
3
Description
nausea
Timepoint
Before beginning intervention and the end of the first week, second week,
Method of measurement
Investigation of clinical singes
4
Description
womitting
Timepoint
Before beginning intervention and the end of the first week, second week,
Method of measurement
Investigation of clinical singes
5
Description
respiratory distress
Timepoint
Before beginning intervention and the end of the first week, second week,
Method of measurement
Investigation of clinical singes
6
Description
cough
Timepoint
Before beginning intervention and the end of the first week, second week,
Method of measurement
Investigation of clinical singes
7
Description
weight loss
Timepoint
Before beginning intervention and the end of the first week, second week,
Method of measurement
Investigation of clinical singes
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Reflux treatment with Esomeprazole made by Rosa Darou Company as intra capsuls granules 1 mg/kg once daily for two weeks
Category
Treatment - Drugs
2
Description
Intervention group 2:Treatment of reflux with Esomeprazole as intra capsuls granules made by Roz Darou company, 1 mg / kg daily dose plus baclofen tablet (made by Roz darou company) 0.2 mg / kg once daily for 14 days:
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Hazrate Masoumeh hospital
Full name of responsible person
Leila Naderi
Street address
Imam Khomini street, Qom
City
Qom
Province
Ghoum
Postal code
3713649373
Phone
+98 25 3665 1801
Email
fatemeh_naderi2010@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Ehsan Sharifipour
Street address
No. 83, 4 Alley, 1/1 street, Safashahr
City
Qom
Province
Ghoum
Postal code
3713649373
Phone
+98 25 3665 1801
Email
sharifipour.e@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ghoum University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Leila Naderi
Position
Resident of pediatric
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
No. 83, 4 alley, 1/1 street, Safashahr
City
Qom
Province
Ghoum
Postal code
3713649373
Phone
+98 25 3665 1801
Email
fatemeh.naderi2010@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Hojatollah Jafari
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Imam Khomini street, Hazrate Masoumeh hospital
City
Qom
Province
Ghoum
Postal code
3713649373
Phone
+98 25 3665 1801
Email
ahw_2704@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ali Mehrabi
Position
Statistical Consultant
Latest degree
Master
Other areas of specialty/work
Epidemiology
Street address
Research faculty of medical school, Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
8434193474
Phone
+98 31 3356 3466
Email
al.mehrabi@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
The plan is owned by the government agency and data cannot be published.