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General information
IRCT20120614010026N9
IRCT20120614010026N10
IRCT20120614010026N9IRCT20120614010026N10
2018-01-14, 1396/10/24
2018-01-14, 1396/10/24
2018-01-14 05:0708:5908
Protocol summary
Study aim
Determining the effect of intermediate dose of oral Erythromycin on treating feeding intolerance in preterm neonates
Design
In this research 84 preterm neonates with inclusion criteria admitted in Alzahra and Beheshti hospitals are selected. Neonates were randomly divided in to two groups based on numbering syringes of Erythromycin and placebo. neonates are receiving 20 cc/kg/ day feeding and if they tolerate it, 20 cc/kg/day feeding is added every day to receive to 150 cc/ kg/ day. neonates are randomly divided in to two groups. The first group is receiving 20 mg/kg/day erythromycin for 8 days every 6 hours and control group is receiving distilled water, respectively. The principal investigator, blinded to the syringes’ content, was responsible for patient selection and allocated the infants to the interventions in sequence of being entered into the study and based on the table of random numbers
Settings and conduct
Alzahra and Shahid beheshti hospitals
Participants/Inclusion and exclusion criteria
Preterm infants weighing less than 1800 g who have had frequent milk intolerance without any signs of infection or serious anomalies
Intervention groups
neonates are receiving 20 cc/kg/ day feeding and if they tolerate it, 20 cc/kg/day feeding is added every day to receive to 150 cc/ kg/ day. neonates are randomly divided in to two groups. The first group is receiving 20 mg/kg/day erythromycin for 8 days every 6 hours and control group is receiving distilled water, respectively
Main outcome variables
time duration to receive to 75. 110, 150 cc/kg/ day feeding volume
General information
Reason for update
Acronym
erythromycin
IRCT registration information
IRCT registration number:IRCT20120614010026N10
Registration date:2018-01-14, 1396/10/24
Registration timing:retrospective
Last update:2018-01-14, 1396/10/24
Update count:1
Registration date
2018-01-14, 1396/10/24
Registrant information
Name
Amir mohammad Armanian
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1235 5059
Email address
armanian@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan university of medical science
Expected recruitment start date
2016-03-20, 1395/01/01
Expected recruitment end date
2017-09-21, 1396/06/30
Actual recruitment start date
2016-03-20, 1395/01/01
Actual recruitment end date
2017-09-21, 1396/06/30
Trial completion date
empty
Scientific title
Evaluating the effect of intermediate dose of oral Erythromycin on feeding intolerance in premature infants
Public title
The effect of Erythromycin on feeding intolerance in premature infants
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
premature infants
weight lower than 1800 grams
feeding volume less than 75 cc/kg/ day in the 14th day after birth
frequent lavage (i.e. => 2 times lavage; >50% of milk volume)
parents willingness
Exclusion criteria:
presence of sepsis
gastrointestinal anomalies
cyanotic heart disease
history of operation on gastrointestinal system in the first 14 days after birth
consumption of medication effective in erythromycin metabolism in the same time
incidence of arrhythmia or prolonged QT interval
parents unwillingness
Age
From 14 days old to 1 month old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
84
Actual sample size reached:
84
Randomization (investigator's opinion)
Randomized
Randomization description
Table of random numbers
Blinding (investigator's opinion)
Double blinded
Blinding description
The syringes of Erythromycin and distilled water are similar in appearance, color and cover. A trained nurse who is not participated in this study, numbered syringes and give them to this study colleague. The colleague divided these syringes among neonates without knowing a bout content of syringe
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Isfahan university of medical science
Street address
isfahan, hezar jarib street, isfahan university of medical sciene
City
isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2016-09-22, 1395/07/01
Ethics committee reference number
IR.MUI.REC.1395.3.994
Health conditions studied
1
Description of health condition studied
feeding intolerance
ICD-10 code
p92.3
ICD-10 code description
Underfeeding of newborn
Primary outcomes
1
Description
time duration to reach to 75, 110 and 150 cc/kg/ day feeding volume
Timepoint
daily, during intervention
Method of measurement
observation
Secondary outcomes
1
Description
time duration of oxygen dependency
Timepoint
during intervention
Method of measurement
observation
2
Description
time duration of hospitalization
Timepoint
during intervention
Method of measurement
observation
3
Description
sepsis incidence
Timepoint
during intervention
Method of measurement
physical examination
4
Description
necrotizing enterocolitis incidence
Timepoint
during intervention
Method of measurement
physical examination
Intervention groups
1
Description
in intervention group: erythromycin syrup, 20 mg/kg/ day, every 6 hours. for 8 days
in control group: distilled water, 20 cc/kg/day, every 6 hours, for 8 days
Category
Treatment - Drugs
2
Description
Control group: distilled water equal volume of erythromycin for 8 days
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Beheshti hospital
Full name of responsible person
dr amirmohammad armanian
Street address
isfahan, motahari street, in front of aseman hotel
City
isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3236 7001
Email
armanian@med.mui.ac.ir
2
Recruitment center
Name of recruitment center
alzahra hospital
Full name of responsible person
dr amirmohammad armanian
Street address
isfahan, shohadaye sofe street
City
isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3236 7001
Email
armanian@med.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mehdi Nematbakhsh
Street address
isfahan, hezar jarib street, isfahan university of medical science
City
isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
armanian@med.mui.ac.ir
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
Amir-mohammad Armanian
Position
Neonatalogist/ Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Alzahra Hospital, Shohadaye Sofe Street, Isfahan City, Iran Country
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3621 0008
Fax
Email
armanian@med.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Amir-mohammad Armanian
Position
Neonatalogist, Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Alzahra Hospital, Shohadaye Sofe Street, Isfahan City, Iran Country
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3621 0008
Fax
Email
armanian@med.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Amir-mohammad Armanian
Position
Neonatalogist/ Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Alzahra Hospital, Shohadaye Sofe Street, Isfahan City, Iran Country
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3621 0008
Fax
Email
armanian@med.mui.ac.ir
Web page address
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
There is no more information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Not applicable
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