We will conduct a study in preterm newborn infants admitted in NICU to determine efficacy of Azithromycin in prevention of BPD. Premature newborn infant born in Al-Zahra hospital in Tabriz will be randomly assigned into the two following groups. The intervention group will receive oral Azithromycin 10mg/kg from 7th day for one week and then 5 mg/kg for another week and the control group do not receive any intervention. All newborn infants will be treated according to hospital guidelines for respiratory distress syndrome. The patients will be followed for 3 months and Fio2, O2 saturation (spo2), duration of oxygen therapy and hospitalization will be determined and compared between groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138902223915N1
Registration date:2011-01-03, 1389/10/13
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-01-03, 1389/10/13
Registrant information
Name
Manizheh Mostafa Gharehbaghi
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1526 2253
Email address
peirovifara@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Vice Chancellor of Tabriz University of Medical Sciences(Pediatric Health Research Center)
Expected recruitment start date
2010-05-22, 1389/03/01
Expected recruitment end date
2011-05-22, 1390/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of Azithromycin in prevention of bronchopulmonary dysplasia in premature newborn infants
Public title
Azithromycin and prevention of bronchopulmonary dysplasia
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: birth weight less than 1500g, feeding starting before 7 days, parental consent for study
Exclusion criteria: major congenital anomalies, congenital heart disease, chromosomal defects, death before 7th day of birth, sign of necrotising enterocolitis before 7th day of birth, severe intraventricular hemorrhage (grade 3 or 4)
Age
From 7 years old to 120 years old
Gender
Both
Phase
0
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tabriz University of Medical Sciences
Street address
Vice Chancellor of Research, Third floor, Building No.2, Tabriz University of Medical Sciences, Golgasht street
City
Tabriz
Postal code
Approval date
2010-07-26, 1389/05/04
Ethics committee reference number
4931/4/5
Health conditions studied
1
Description of health condition studied
bronchopulmonary dysplasia, need for oxygen beyond 28 days of birth
ICD-10 code
P27.1
ICD-10 code description
bronchopulmonary dysplasia originating in perinatal period
Primary outcomes
1
Description
duration of need for oxygen
Timepoint
daily
Method of measurement
days count before O2 discontinue
2
Description
needed FIO2
Timepoint
daily
Method of measurement
oxymeter and blender
3
Description
spo2
Timepoint
daily
Method of measurement
pulseoxymetry
Secondary outcomes
1
Description
duration of hospitalization
Timepoint
days of hospital stay
Method of measurement
time between admission and discharge
Intervention groups
1
Description
Azithromycin, orally, from 7th day of birth for one week with a single dose of 10 mg/kg/daily and then 5 mg/kg/daily for subsequent week
Category
Treatment - Drugs
2
Description
Control group: no intervention
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
NICU. Al Zahra Hospital
Full name of responsible person
Dr Gharehbaghi
Street address
South Artesh Street
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Pediatric Health Research Center, Tabriz University of Medical Sciences,
Full name of responsible person
Dr Mohamad Barzegar
Street address
Pediatric Health Research Center, Children Hospital, Sheshgelan Street
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Pediatric Health Research Center, Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Dr Manizheh Mostafa Gharehbaghi/ Dr Majid Mahaleii
Position
Associate Professor/ Fellowship of Neonatology
Other areas of specialty/work
Street address
Al Zahra Hospital .South Artesh Street
City
Tabriz
Postal code
Phone
+98 41 1553 9161
Fax
Email
gharehbaghimm@yahoo.com/mahalei@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Manizheh Mostafa Gharehbaghi
Position
Associate Professor of Pediatrics and neonatology
Other areas of specialty/work
Street address
alZahra Hospital. South Artesh
City
Tabriz
Postal code
Phone
+98 41 1553 9161
Fax
Email
gharehbaghimm@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Manizheh Mostafa Gharehbaghi
Position
Associate Professor of Pediatrics
Other areas of specialty/work
Street address
al Zahra Hospital. South Artesh Street
City
Tabriz
Postal code
Phone
Fax
Email
gharehbaghimm@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)