Investigating The Effect Of Melatonin On Infantile Colic
Design
A clinical trial; without a control group; a sample size of 69 infants using the formula; phase 2
Settings and conduct
In this study, which was conducted on 69 infants with infant colic, the infants were treated with melatonin at a minimum dose of 1 mg for one week, and after the end of the treatment period and one week after that, according to the Wessle criteria, duration of crying and restlessness were evaluated. This study was conducted in medical centers of Yazd
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Mature infants; Birth weight should be between 2,500 grams and 4,000 grams; Breastfeed; Growth and weight growth charts and head circumference relative to age should be normal; Be diagnosed with Wessel criteria by a pediatrician;
Exclusion criteria:
The presence of other diseases in the digestive system; Use of medication that affects the treatment.
Intervention groups
For sampling, after ruling out other causes and diagnosing infantile colic by a pediatrician and obtaining informed consent from the parents, the infant entered the study and the duration of infantile colic attacks was recorded. The infant was prescribed melatonin tablets with a minimum dose of 1 mg/dl at 6 pm every day for one week.
Main outcome variables
Duration of colic;
Severity of symptoms;
Number of colic attacks per week;
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20080930001285N2
Registration date:2023-07-04, 1402/04/13
Registration timing:retrospective
Last update:2023-07-04, 1402/04/13
Update count:0
Registration date
2023-07-04, 1402/04/13
Registrant information
Name
mehrdad shakiba
Name of organization / entity
shahid sadoghi hospital
Country
Iran (Islamic Republic of)
Phone
+98 913 151 8475
Email address
shakiba@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-21, 1397/02/01
Expected recruitment end date
2019-01-21, 1397/11/01
Actual recruitment start date
2018-04-21, 1397/02/01
Actual recruitment end date
2019-03-19, 1397/12/28
Trial completion date
2019-03-19, 1397/12/28
Scientific title
Investigating The Effect Of Melatonin On Infantile Colic
Public title
Investigating The Effect Of Melatonin On Infantile Colic
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
It was diagnosed with Wessel Criteria.
Exclusion criteria:
The presence of other diseases of the digestive system
Use of medication that affects the treatment
Age
From 7 days old to 6 months old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
70
Actual sample size reached:
69
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Sadoughi University of Medical Sciences
Street address
Central Administration, Bahonar Sq., Yazd, I.R Iran
City
Yazd
Province
Yazd
Postal code
8916978477
Approval date
2018-03-12, 1396/12/21
Ethics committee reference number
IR.SSU.MEDICINE.REC.1397.058
Health conditions studied
1
Description of health condition studied
Infantile colic
ICD-10 code
R10.4
ICD-10 code description
Infantile colic
Primary outcomes
1
Description
Having infantile colic based on Wessle criteria
Timepoint
At the beginning of the intervention and 7 and 14 days later
Method of measurement
Calling the infants's parents and checking for symptoms of infantile colic and recording information
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: For sampling, after ruling out other causes and diagnosing infantile colic by a pediatrician and obtaining informed consent from the parents, the infant entered the study, and the duration of infantile colic attacks (infant crying) was recorded, and for the infant, melatonin tablets with a dose of 1 mg/dl (minimum dose) was prescribed at 6 pm every day for one week. After one week, the infant's parents were contacted by phone and the infant was evaluated for the presence of symptoms of infantile colic and the changes after taking the drug, and the group that recovered completely was evaluated again for the symptoms of infantile colic one week after the end of the treatment period.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Medical centers of Yazd city
Full name of responsible person
Mehrdad Shakiba
Street address
Shahid Sadoughi Hospital, Ebne Sina Blvd, Shahid Ghandi Blvd,