In a randomized controlled clinical trial we assess the efficacy of two doses of vitamin A (high and low doses) in prevention of bronchopulmonary dysplasia in preterm infants.One hundred preterm infants with gestation age less than 32 weeks and birth weight less than 1500 grams randomly allocate in two groups based on random number list. Fifty neonates in first group receive 1500 unit intramuscular vitamin A 3 times/ week till forth week of life and 50 neonates in second group receive 5000 unit vitamin A intra muscularly 3 times/ week till 4 weeks of life. All care and drug interventions are same in both groups and nurses and physicians are blind about patient groups.The primary outcome is need for oxygen at 28 days of birth. oxygen dependency is determined by pulse oxymetry and o2 saturation less than 90%. All neonates reassess at 36 weeks corrected gestation age for the severity of bronchopulmonary dysplasia.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201505253915N17
Registration date:2015-10-31, 1394/08/09
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-10-31, 1394/08/09
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
Expected recruitment start date
2015-05-22, 1394/03/01
Expected recruitment end date
2016-05-21, 1395/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparing the efficacy of high and low doses of vitamin A in prevention of bronchopulmonary dysplasia in preterm infants
Public title
comparing the efficacy of two doses of vitamin A in preterm infants
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: prematurity less than 32 weeks; birth weght less than 1500 grams
Exclusion criteria: major congenital anomalies; birth asphyxia
death before 1 week of life; cyanotic congenital heart disease; intraventricular hemorrhage grade III or more
Age
To 28 days old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
100
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
Ethic Committee of Tabriz University of Medical Sciences
Street address
Golgasht street
City
Tabriz
Postal code
Approval date
2015-05-11, 1394/02/21
Ethics committee reference number
tbzmed.rec.1394.101
Health conditions studied
1
Description of health condition studied
bronchopulmonary dysplasia
ICD-10 code
P27.1
ICD-10 code description
Bronchopulmonary dysplasia originating in the perinatal period
Primary outcomes
1
Description
Bronchopulmonary dysplasia
Timepoint
28 days of life
Method of measurement
need for supplemental oxygen and FiO2
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: intramuscular vitamin A 1500 IU three times/ week from first week of life till 4 weeks.
Category
Treatment - Drugs
2
Description
Intervention group 2: intramuscular vitamin A 5000 IU three times/ week from first week of life till 4 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
NICU; Al Zahra Hospital
Full name of responsible person
Dr Manizheh Mostafa Gharehbaghi
Street address
South Artesh Street
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Vice Chancellor for Tabriz University of Medical Sciences
Full name of responsible person
Dr Farhoodi
Street address
Golgasht street
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Vice Chancellor for 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
Position
professor
Other areas of specialty/work
Street address
Alzahra Hospital; South Artesh street
City
Tabriz
Postal code
Phone
+98 41 3553 9161
Fax
Email
gharehbaghimm@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
Dr Manizheh Mostafa Gharehbaghi
Position
Professor
Other areas of specialty/work
Street address
Al Zahra Hospital; South Artesh street
City
Tabriz
Postal code
Phone
+98 41 3553 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
Dr Manizheh Mostafa Gharehbaghi
Position
Professor
Other areas of specialty/work
Street address
Al Zahra Hospital; South Artesh Street
City
Tabriz
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)