This single center study aims to assess the relieving effects of glucose administration in neonates with infantile colic (IC). A double-blinded randomized controlled trial is designed. Seventy-six neonates who fulfill IC diagnosis (based on the Wessel criteria) are randomly assigned to one of the two groups (36 neonates per group) of daily administrated oral glucose solution (either 30% or 25%, 2.5 mg/kg) or simethicone (2.5 mg/kg) groups. Randomization is carried out by creating a random sequence of numbers using on an line randomizer tool (https://www.randomizer.org). Neonates with systemic disorders and those who have history of receiving medication for IC are excluded. Treatments continue for 28 days. The primary and secondary outcomes are reduction in crying times and improvement of general conditions of the neonates as perceived by mothers respectively. The data is recorded using a questionnaire filling by mothers.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017092636423N1
Registration date:2017-10-28, 1396/08/06
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-10-28, 1396/08/06
Registrant information
Name
Mahvash Ebrahimi
Name of organization / entity
Zabol University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 54 3223 0764
Email address
ebrahimimahvash@zbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Deputy of Zabol University of Medical Sciences
Expected recruitment start date
2017-12-22, 1396/10/01
Expected recruitment end date
2018-06-22, 1397/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A clinical trial study for comparison the effects of glucose and Simeticone administration on reducing crying times in newborns with infantile colic
Public title
The effects of glucose administration on the improvement of infantile colic
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Diagnosis of infantile colic (IC) based on the Wessel criteria; the age of 3 weeks to 6 months
Exclusion criteria: Neonates with systemic disorders; history of taking medications for IC
Age
From 21 days old to 6 months old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
76
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Simethicone is administrated to the control group.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Zabol University of Medical Sciences
Street address
Rajaee street, Deputy of Education of the University, First floor, Zabol
City
Zabol
Postal code
9861615881
Approval date
2017-06-21, 1396/03/31
Ethics committee reference number
Zbmu.1.REC..1396.95
Health conditions studied
1
Description of health condition studied
Infantile colic
ICD-10 code
R10.4
ICD-10 code description
Other and unspecified abdominal pain
Primary outcomes
1
Description
Reduction in crying times
Timepoint
One week before the initiation of the intervention, and at the end of the intervention
Method of measurement
Questionnaire filled by mothers
Secondary outcomes
1
Description
Improvement of general conditions of the neonates as perceived by mothers
Timepoint
One week before initiation of the intervention, and at the end of intervention
Method of measurement
Questionnaire filled by mothers
Intervention groups
1
Description
Control group: Simethicone (2.5 mg/kg per day) is administrated for 28 days.
Category
Treatment - Drugs
2
Description
Intervention group: Oral glucose is administrated as 25% or 30% solution (2.5 mg/kg per day) for 28 days.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Zabol University of Medical Sciences
Full name of responsible person
Dr Iraj Shahramian
Street address
Amir-Al-Momenin Hospital, Zabol
City
Zabol
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Deputy of Zabol University of Medical Sciences
Full name of responsible person
Dr Iraj Shahramian
Street address
Pediatric Ward, Amir-Al-Momenin Hospital-Zabol
City
Zabol
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Deputy of Zabol University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Zabol University of Medical Sciences
Full name of responsible person
Ali Bazi
Position
MSc
Other areas of specialty/work
Street address
Rajaee Street, Deputy of Education, First floor, Deputy of Research, Zabol
City
Zabol
Postal code
9861615881
Phone
+98 543220770
Fax
Email
m.baziali@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zabol University of Medical Sciences
Full name of responsible person
Ali Bazi
Position
MSc
Other areas of specialty/work
Street address
Rajaee Street, Deputy of Education, First floor, Deputy of Research, Zabol
City
Zabol
Postal code
Phone
+98 543220770
Fax
Email
m.baziali@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Zabol University of Medical Sciences
Full name of responsible person
Ali Bazi
Position
MSc
Other areas of specialty/work
Street address
Rajaee Street, Deputy of Education, First floor, Deputy of Research, Zabol
City
Zabol
Postal code
9861615881
Phone
+98 543220770
Fax
Email
m.baziali@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)