Apnea is a common commorbity in preterm infants who admitted in NICU That causes increased hospital stay and treatment expenditure. In addition preterm infants are at high risk of carnitine deficiency with manifistations of apnea, hypotonia and poor growth. so we decided to study the effect of oral carnitine supplement in apnea of preterm infants in the NICU of sums related hospitals. This study is a comparative, randomized, prospective clinical trials in 112 preterm infants including of birth weight≤1500 gr or gestational age ≤32 weeks. That divided to two grops, one is control with peacebo and another is study group with oral carnitine supplement (100mg/kg/day).That begun in 2nd or 3rd day of life and continues for 2 weeks. During this period, we monitor the preterm infants for developing apnea, and bradycardia. Then after evaluated the result . any infants with sever congenital anomalies, genetic and chromosomal abnormalities, inborn error of metabolism, severe IVH, sever liver disease, sepsis are excluded from the study.
General information
Acronym
The effect of oral carnitine supplement in apnea of prematurity
IRCT registration information
IRCT registration number:IRCT2013052010441N2
Registration date:2013-06-28, 1392/04/07
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-06-28, 1392/04/07
Registrant information
Name
Narjes Pishva
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1612 5481
Email address
pishvan@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz neonatal research center
Expected recruitment start date
2012-08-10, 1391/05/20
Expected recruitment end date
2013-07-11, 1392/04/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of oral carnitine supplement in apnea of prematurity in the NICU of sums related hospitals
Public title
The effect of oral carnitine supplement in apnea of prematurity in the NICU of sums related hospitals
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criterion: all newborn infants who have a gestational age of ≤32 week or have birth weight of≤1500 gr.
Exclusion criteria: any neonate with sever congenital anomalies; genetic and chromosomal abnormalities; inborn error of metabolism; severe IVH; sever liver disease and sepsis.
Age
From 2 years old to 15 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
112
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shiraz University of Medical Sciences Ethics Committee
Street address
Shiraz University of Medical Sciences, Zand street
City
Shiraz
Postal code
0711
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
CT- 92-6497
Health conditions studied
1
Description of health condition studied
Apnea in preterm infants
ICD-10 code
P28.4
ICD-10 code description
Other apnoea of newborn
Primary outcomes
1
Description
Apnea in preterm infants
Timepoint
2 days to 2 weeks
Method of measurement
monitoring
Secondary outcomes
1
Description
Episodes of apnea and growth indices in the infants
Timepoint
2 days to 2 weeks
Method of measurement
Monitoring
Intervention groups
1
Description
intervention:Neonates were randomly assigned to receive oral carnnitine (100mg/kg/day) divided in q12hr,that were initiated within 72 hours of birth and recording episods of apnea and bradycardia and side effects of carnitine in q8hr
Category
Treatment - Drugs
2
Description
in control group: receive oral placebo ( with the same amount in volume) initiated within 72 hours of birth and recording of apnea episods q8hr . finally interpreting the result
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shiraz University of Medical Science related hospital
Full name of responsible person
Dr. Pishva
Street address
Fars, Shiraz, Zand street Nemazee Hospital
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Gholam reza Hatam
Street address
7th floor dean of research Fars, Shiraz, Zand street building of university of medical science
City
shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Bolod Soleimani
Position
MD,Neonatal fellowship
Other areas of specialty/work
Street address
Nemazee hospital, zand street, shiraz
City
Shiraz
Postal code
7193711354
Phone
+98 71 1612 5481
Fax
+98 71 1647 4298
Email
soleimani_b@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Narjes pishva/ Dr.Fariba Hemmati
Position
MD, Neonatal super specialist
Other areas of specialty/work
Street address
Nemazee hospital zand street, shiraz
City
shiraz
Postal code
71937-11354
Phone
+98 71 1612 5481
Fax
+98 71 1647 4298
Email
pishvan@sums.ac.ir, hemmatif@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Marzieh Dasht Peyma
Position
Researcher of neonatal research center
Other areas of specialty/work
Street address
Neonatal research cente, Nemazee hospital, zand street
City
Shiraz
Postal code
71937-11354
Phone
+98 71 1612 5481
Fax
Email
marziehdashtpeyma@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)