A few studies have been done about preventive drugs for apnea of preterm infants so we decided to investigate the prophylactic effects of aminophylline on the apnea incidence in higher risk neonate (preterm neonate with a weight below 1200 grams). In our study the prophylactic effect of aminophylline on the apnea incidence will be investigated in two groups of aminophylline given (group A) and control (group C).In the aminophylline given group (A), after considering the inclusion and exclusion criteria, 5 mg/kg aminophylline as loading dose was begun then each 8 hours, 1/5 mg/kg as maintenance dose was used until first 10 days of life. In control group, no aminophylline was used in first 10 days of life.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013052610026N1
Registration date:2013-08-15, 1392/05/24
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-08-15, 1392/05/24
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 Sciences, Isfahan, Iran
Expected recruitment start date
2012-03-19, 1390/12/29
Expected recruitment end date
2013-06-24, 1392/04/03
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Prophylactic aminophylline for prevention of apnea in preterm neonate with weight less than 1200 gr.
Public title
Prophylactic aminophylline for prevention of apnea in preterm neonate with weight less than 1200 gr.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria are infants born premature and at birth weight equal and lower than 1200 grams and spontaneous breathing at age 24 hours.
Infants who have major congenital anomalies; asphyxia; occurrence of apnea and need to mechanical ventilation in first 24 hours of birth; congenital cyanotic heart disease and sepsis in the first seven days of birth will excluded.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
52
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
This study is a randomized clinical trial (RCT). Infants admitted to the neonatal intensive care unit (NICU) at Alzahra and Shahid Beheshti hospitals in Isfahan-Iran, will included in this study. The prophylactic effect of aminophylline on the apnea incidence will be investigated in two groups of aminophylline given (group A) and control (group C).
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences,Hezarjerib Av,Isfahan, Iran
City
Isfahan
Postal code
Approval date
2011-08-20, 1390/05/29
Ethics committee reference number
391323
Health conditions studied
1
Description of health condition studied
Apnea
ICD-10 code
P28.3
ICD-10 code description
Primary sleep apnoea of newborn
Primary outcomes
1
Description
Cyanosis
Timepoint
10 days
Method of measurement
nursing documentation and monitor download
2
Description
Bradycardy
Timepoint
10 days
Method of measurement
nursing documentation and monitor download
3
Description
Apnea
Timepoint
10 days
Method of measurement
nursing documentation and monitor download
Secondary outcomes
1
Description
CPAP
Timepoint
10 days
Method of measurement
daily recorded sheets
2
Description
Hospital stay
Timepoint
10 days
Method of measurement
daily recorded sheets
3
Description
Death
Timepoint
During Hospital stay
Method of measurement
daily recorded sheets
4
Description
Mechanical ventilation
Timepoint
10 days
Method of measurement
daily recorded sheets
5
Description
Oxygen dependency time
Timepoint
During Oxygen dependency time
Method of measurement
daily recorded sheets
6
Description
Side effects
Timepoint
10 days
Method of measurement
daily recorded sheets
Intervention groups
1
Description
In the aminophylline given group (A), after considering the inclusion and exclusion criteria for the premature neonate with a weight equal and lower than 1200 gr. who is breathing spontaneously at age 24 hours, 5 mg/kg aminophylline as loading dose will be begun (parenteral) then each 8 hours, 1/5 mg/kg as maintenance dose will be used until first 10 days of life.
Category
Prevention
2
Description
In control group (C), after considering the inclusion and exclusion criteria for the premature neonate with a weight equal and lower than 1200 gr. who is breathing spontaneously at age 24 hours, no aminophylline was used in first 10 days of life.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Neonatal intensive care unit (NICU) at Alzahra and Shahid Beheshti hospitals in Isfahan-Iran
Full name of responsible person
Dr. Amir Mohammad Armanian
Street address
Number 133, shahid ansari Alley, Saeb Street, Isfahan, Iran
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr. Ebrahim Esfandiari
Street address
Faculty of Medicine, Isfahan University of Medical Sciences, Hezar-Jerib St., Isfahan, Iran
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan 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
Isfahan University of Medical Sciences
Full name of responsible person
Dr. Raha Afghari
Position
Resident of pediatrics
Other areas of specialty/work
Street address
Department of Pediatrics, Isfahan University of Medical Sciences, Isfahan, Iran
City
Isfahan
Postal code
81638-93113
Phone
+98 31 1630 7533
Fax
Email
golgoonehafghari@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Child Growth and Development Research Center, Isfahan University of Medical Sciences
Full name of responsible person
Amir Mohammad Armanian
Position
Neonatologist
Other areas of specialty/work
Street address
Number 133, shahid ansari Alley, Saeb Street, Isfahan, Iran
City
Isfahan
Postal code
Phone
+98 31 1235 5059
Fax
Email
armanian@med.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr. Amir Mohammad Armanian
Position
Assistant professor of neonatology
Other areas of specialty/work
Street address
Number 133, shahid ansari Alley, Saeb Street, Isfahan, Iran
City
Isfahan
Postal code
Phone
Fax
Email
armanian@med.mui.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)