Protocol summary

Summary
The purpose of this study was to evaluate the effectiveness of oral erythromycin(low dose) on feeding tolerance in admitted premature neonates at kermanshah-imam Reza hospital NICU.The inclusion criteria were : preterm babies with gestational age between 28-34 w and birth weight between 1000-1800gr 2)postnatal age less than 3 days of life Exclusion criteria were: 1) birth asphexia 2) electrolyte imbalance3) the presence of major congenital abnormalities; 4) necrotizing enterocolitis 5)formula feeding 6)cyanotic congenital heart disease 7)usage of prokinetic agents ( such as metoclopramide) 8)mechanical ventilation 9) history of surgery . preterm newborns with postnatal age less than 3 days were included. The sample size included 70 preterm neonates.newborns were randomized (using parallel blocks of 10 according to apredetermined list of random number) to receive one of the following 2groups: case group(n=35) received oral erythromycin(2.5 mg/kg/q6h for ten 10 days) and control group( no intervention)(n=35) .The neonate in both groups received breast milk. And feeding started within the first three days of life. The primary outcome measure was the duration required by the infant to achieve full enteral feeds(150ml/kg/day for at least 24h .The Secondary outcome measures were duration of hospital admission and vomiting.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201110104961N5
Registration date: 2012-09-15, 1391/06/25
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2012-09-15, 1391/06/25
Registrant information
Name
Homa Babaei
Name of organization / entity
Kermanshah University of Medical Secinces
Country
Iran (Islamic Republic of)
Phone
00988314276303 داخلی 2292
Email address
homa_babaei@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kermanshah University of Medical Sciences‎
Expected recruitment start date
2011-08-06, 1390/05/15
Expected recruitment end date
2012-08-05, 1391/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Survey the effect of oral erythromycin(low dose) on feeding tolerance in admitted premature neonates at imam Reza hospital NICU
Public title
Survey the effect of oral erythromycin(low dose) on feeding tolerance in admitted premature neonates at imam Reza hospital NICU
Purpose
Prevention
Inclusion/Exclusion criteria
The inclusion criteria were : preterm babies with gestational age between 28-34 w and birth weight between 1000-1800gr 2)postnatal age less than 3 days of life Exclusion criteria were: 1) birth asphexia 2) electrolyte imbalance3) the presence of major congenital abnormalities; 4) necrotizing enterocolitis 5)formula feeding 6)cyanotic congenital heart disease 7)usage of prokinetic agents ( such as metoclopramide) 8)mechanical ventilation 9) history of surgery
Age
To 3 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Kermanshah University of Medical Sciences‎
Street address
cliical research developemental center,Kermanshah university of medical sciences, Kermanshah,Iran
City
kermanshah
Postal code
6714415333
Approval date
2011-07-24, 1390/05/02
Ethics committee reference number
7872/آ/707/7/پ

Health conditions studied

1

Description of health condition studied
feeding tolernce
ICD-10 code
p92
ICD-10 code description
Feeding problems of newborn

Primary outcomes

1

Description
feeding tolerance
Timepoint
q3h
Method of measurement
inspection

Secondary outcomes

1

Description
duration of admission
Timepoint
daily
Method of measurement
medical record

Intervention groups

1

Description
The intervention group received oral erythromycin(2.5 mg/kg/q6h) plus breast milk
Category
Treatment - Drugs

2

Description
control group( no intervention ) only received breast milk
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Reza Hospital, Kermanshah University of Medical Sciences
Full name of responsible person
Street address
City
kermanshah

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr farid Najafi
Street address
Deputy of Research, Kermanshah University of Medical ‎Sciences
City
kermnshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Homa Babaei, MD
Position
neonatologist
Other areas of specialty/work
Street address
Department of Pediatrics,Kermanshah University of Medical Sciences
City
kermanshah
Postal code
Phone
+98 83 1427 6303
Fax
Email
homa_babei@kums.ac.ir homa_babaei@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
homa babaei
Position
neontologist
Other areas of specialty/work
Street address
Department of pediatrics ,Kermanshah University of Medical Sciences
City
kermnshah
Postal code
6714415333
Phone
+98 83 1427 6303
Fax
Email
homa_babaei@kums.ac.ir homa_babaei@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
homa babaei
Position
neoaatologist
Other areas of specialty/work
Street address
Department of Pediatrics, Kermanshah University of Medical Sciences
City
kermanshah
Postal code
6714415333
Phone
+98 83 1427 6303
Fax
Email
homa_bbaei@kums.ac.ir homa_babei@yahoo.com
Web page address
www.kums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
Loading...