Determining the effect of Gabapentin on the effective number of breast milk consumption and the volume of formula consumption in infants 3 to 6 months
Design
Clinical trial with control group, of parallel groups, randomized double-blind phase 3 on 64 patients
Settings and conduct
64 infants aged 3 to 6 months with refusal feeding disorder and normal examinations referred to pediatric gastrointestinal clinics in Isfahan who according to the standard reflux questionnaire, do not have reflux based on random permutation blocks in volume 4, classified on Gender is equally divided into case and control groups. Assignors to groups and mothers will be unaware of the allocation process and sequence. The case group is given gabapentin at a dose of 5 mg per kg body weight every 8 hours, and if it is not too drowsy at the end of the first week, the dose is increased to 10 mg per kg body weight. Before the start of the drug and at the end of the second week and the first month, the number of effective feeding times of breastfeeding and the volume of formula consumed by the infant (in cc) are recorded.
Participants/Inclusion and exclusion criteria
Including criteria:
Age 3 to 6 months
The score of the reflux questionary 16 or lower
Absence of an acute or chronic disease
Excluding criteria:
The score of the reflux questionary greater than 16
Presence of an acute or chronic disease
Starting of complementary foods
Intervention groups
Infants 3 to 6 months of age with refusal feeding disorder are given gabapentin in the case group and placebo in the control group.
Main outcome variables
infant feeding, use of anti-reflux drugs, change different formulas , cost of treatment
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190410043224N4
Registration date:2021-02-20, 1399/12/02
Registration timing:registered_while_recruiting
Last update:2021-02-20, 1399/12/02
Update count:0
Registration date
2021-02-20, 1399/12/02
Registrant information
Name
Peiman Nasri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3261 6331
Email address
peiman.nasri@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-02-19, 1399/12/01
Expected recruitment end date
2021-05-22, 1400/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of Gabapentin with placebo in feeding improvement in feeding refusal infants age 3 to 6 months
Public title
"Effect of Gabapentin in treatment of feeding refusal disorder"
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 3 to 6 months
The score of reflux questionary 16 or lower
Lack of an acute or chronic disease
Exclusion criteria:
The score of the reflux questionary greater than 16
Presence of an acute or chronic disease
Starting of complementary foods
Age
From 3 months old to 6 months old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are divided into 2 equal case and control groups on sex by permutation blocks randomization in volume 4, using the R softwsre.
Blinding (investigator's opinion)
Double blinded
Blinding description
Individuals assigning infants to groups, as well as mothers will be unaware of the allocation process and sequence.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Imam khomeini Ave
City
Isfahan
Province
Isfehan
Postal code
8195163381
Approval date
2021-02-04, 1399/11/16
Ethics committee reference number
IR.MUI.MED.REC.1399.970
Health conditions studied
1
Description of health condition studied
lnfants feeding refusal disorder
ICD-10 code
R63.3
ICD-10 code description
Feeding difficulties
Primary outcomes
1
Description
Number of effective breastfeeding
Timepoint
At the beginning of the study and at the end of the second week and the first month
Method of measurement
The number of feedings from the mother's breast that lasts at least 10 minutes or the mother feels empty breasts and the volume of formula to cc
2
Description
volume of formula consumed
Timepoint
Before the intervention, the end of the second week and the end of the first month
Method of measurement
Frequency of breastfeeding that lasts at least 10 minutes or the mother feels empty breasts-volume of formula consumed in mililiter
Secondary outcomes
1
Description
restlessness
Timepoint
The end of the first months
Method of measurement
Asking from mother
Intervention groups
1
Description
Intervention group:Intervention group: The intervention group includes 32 infants aged 3 to 6 months who have feeding refusal and have no reflux or other acute or chronic disease. How to choose them is random and with the help of software and mothers and prescribing doctors do not know whether the drug or placebo is given to the infants.They are given gabapentin syrup, which contains 60 mg of the drug per cc, and is made by a pharmacologist, a faculty member of Isfahan University of Medical Sciences, who is a partner in the project, at a dose of 5 mg per kilogram of body weight every 8 hours. And if infant do not get too sleepy at the end of the first week the dose is rised to 10 mg per kilogram of body weight. The amount of milk consumed is recorded before the start of the drug and at the end of the second week and the first month.
Category
Treatment - Drugs
2
Description
Control group: Control group: In the control group, the same number of intervention groups of patients are randomly selected with the help of software and they are given a placebo with the same dose of the main drug. And monitoring them is like an intervention group. Mothers and prescribing physicians are not aware that the drug or placebo is given to the child. Medication is one of the basic ingredients of the main medicine and does not contain only gabapentin.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hossein Hospital Gastroenterology Clinic
Full name of responsible person
Dr peiman nasri
Street address
Imam khomeini Ave
City
Isfahan
Province
Isfehan
Postal code
8195163381
Phone
+98 31 3386 6266
Email
peiman.nasri@med.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ahmad heydari
Street address
Imam khomeini Ave
City
Isfahan
Province
Isfehan
Postal code
8195163381
Phone
+98 31 3386 6266
Email
heydari.pedres@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Ahmad Heydari
Position
pediatrician Gastroentrology fellow
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Imam khomeini Ave
City
Isfahan
Province
Isfehan
Postal code
8195163381
Phone
+98 31 3386 6266
Email
heydari.pedres@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ahmad Heydari
Position
Pediatrician Gastroentrology fellow
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Imam khomeini Ave
City
Isfahan
Province
Isfehan
Postal code
8195163381
Phone
+98 31 3386 6266
Email
heydari.pedres@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ahmad Heydari
Position
Pediatrician Gastroentrology fellow
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Imam khomeini Ave
City
Isfahan
Province
Isfehan
Postal code
8195163381
Phone
+98 31 3386 6266
Email
heydari.pedres@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available