This study is conducted to compare the effect of aminophylin and caffeine on osteopenia of prematurity in preterm newborns. In a randomized controlled clinical trial, 120 preterm newborn infant with gestation age less than 32 week randomly allocate to aminophylin or caffeine group. Exclusion criteria include gestation age more than 32 weeks; neonatal neuromuscular disorder, cholestasis, treatment with phenobarbital or corticosteroid, and birth asphyxia. Aminophylin group receive loading dose of 5mg/kg and then 1-2 mg/kg every 8 hour. Caffeine group will receive 20mg/kg loading dose and then 5-10mg/kg daily. All neonates will receive these drugs till corrected gestation age 34 weeks or becoming apnea free for one week. Neonates will follow for 6 weeks or 45 days after birth to determine calcium, phosphorous and alkalin phosphatase levels and wrist radiography for detection serologic and radiographic evidences of osteopenia of prematurity as our primary outcome. The secondary outcome is broncho-pulmonary dysplasia based on oxygen dependency at 28 days or 36 weeks corrected gestation age.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201312163915N10
Registration date:2014-01-20, 1392/10/30
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-01-20, 1392/10/30
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
Vice Chancellor for Research, Tabriz University of Medical Sciences
Expected recruitment start date
2013-12-22, 1392/10/01
Expected recruitment end date
2014-12-22, 1393/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of aminophylin and caffeine on osteopenia of prematurity in preterm newborns
Public title
Comparing the effect of aminophylin and caffeine on osteopenia of prematurity in preterm newborns
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: gestation age less than 32 weeks;aminophylin or caffeine recieption;osteopenia of prematurity survey on 45 days.
Exclusion criteria: gestation age over 32 weeks; neonatal neuromuscular disorder; cholestasis; phenobarbital or corticosteroid therapy; birth asphyxia (apgar score less than 4 at 5 minute).
Age
To 1 year old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
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
Ethic Committee of Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences; Golgasht street
City
Tabriz
Postal code
Approval date
2013-12-02, 1392/09/11
Ethics committee reference number
92140
Health conditions studied
1
Description of health condition studied
osteopenia of prematurity
ICD-10 code
E83.9
ICD-10 code description
Disorder of mineral metabolism, unspecified
Primary outcomes
1
Description
Osteopenia of prematurity
Timepoint
4 to 6 weeks after bith
Method of measurement
caLcium, phosphorus and alkalin phospatase measurment
Secondary outcomes
1
Description
Bronchopulmonary dysplasia
Timepoint
28 days after birth and 36 weeks corrected gestation age
Method of measurement
The received FiO2
Intervention groups
1
Description
Administration of intravenous caffein with loading dose of 20 mg/kg and then 5-10 mg/kg from second day of birth till 34 week postmenstrual age to control group
Category
Treatment - Drugs
2
Description
Administration of intravenous aminophylin with loading dose of 3-5 mg/kg and then 1-2 mg/kg from second day of birth till 34 week post menstrual age to intervention group
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
NICU of Alzahra Hospital
Full name of responsible person
Street address
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Tabriz University of Medical Sciences
Full name of responsible person
Dr Rashidi
Street address
Golgasht Street;Tabriz University of Medical Sciences
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research, 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
Academic member
Other areas of specialty/work
Street address
NICU;Alzahra Hospital; South Artesh Street
City
Tabriz
Postal code
Phone
+98 41 1553 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
Academic member
Other areas of specialty/work
Street address
NICU, Alzahra Hospital; South Artesh Street
City
Tabriz
Postal code
Phone
+98 41 1553 9161
Fax
Email
gharehbaghimm@yahoo.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)