Premature neonates often are at risk of developing carnitine deficiency because of immaturity of the biosynthetic pathway, lack of sufficient predelivery transplacental transport, and lack of sufficient exogenous supplementation. Systemic carnitine deficiency may present with apnea, hypotonia, and poor growth. The aim of this study was to determine the effect of oral carnitine supplementation on hypoglycemia, sepsis and apnea of very low birth weight neonates. Sixty preterm neonates who were <1500 g were enrolled in this prospective, double-blind study within first 72 hours of life. Hypoglycemia, sepsis and episodes of apnea are the primary outcome measures. Neonates were allocated to intervention and control groups( 30 in each group). Intervention group received 20mg/kg/day carinitine by N/G tube until 11th day of birth. Episodes of apnea were measured by pulse oxymetery, hypoglycemia by glucometer and sepsis by result of blood culture.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138707281162N6
Registration date:2008-10-29, 1387/08/08
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2008-10-29, 1387/08/08
Registrant information
Name
Ashraf Mohammadzadeh
Name of organization / entity
Neonatal Research Center of Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 1852 1121
Email address
mohamadzadeha@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences
Expected recruitment start date
2007-03-05, 1385/12/14
Expected recruitment end date
2008-11-06, 1387/08/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of oral supplement of carnitine on hypoglycemia, sepsis and apnea of very low birth weight neonates
Public title
Effect of oral supplement of carnitine on hypoglycemia, sepsis and apnea of very low birth weight neonates
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion/Exclusion:
Neonates with appropriate for gestational age, birth weight < 1500g, in 3 days of life, without cardiovascular disease, congenital anomaly and respiratory or metabolic diseases.
Exclusion: History of diabetes, hypertension, preeclampsia or long fever in mother. Mechanical ventilation, severe hypotension, shock, metabolic disease during the intervention for neonates.
Age
To 3 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
vice chanceler of mums
Street address
ghoreshi bulding-daneshgah street-mashhad-Iran
City
mashhad
Postal code
91379-13131
Approval date
2007-03-05, 1385/12/14
Ethics committee reference number
22798/824
Health conditions studied
1
Description of health condition studied
Carnitine supplementation in very low birth weight neonates
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Septicemia
Timepoint
Daily
Method of measurement
Positive blood culture
2
Description
Hypoglycemia (serum glucose less than 40 mg/dl)
Timepoint
daily
Method of measurement
glucometer
3
Description
Apnea
Timepoint
Daily
Method of measurement
Number of apnea episodes (by pulsoximetry)
Secondary outcomes
1
Description
Duration of admission in hospital
Timepoint
dailly
Method of measurement
Number of hospitalization days
Intervention groups
1
Description
carnitine supplemention (20mg/kg/day) up to 11th day of birth
Category
empty
Recruitment centers
1
Recruitment center
Name of recruitment center
NICU Emaereza hospital-Neonatal Research Centerdr.
Full name of responsible person
Ashraf Mohammadzadeh
Street address
Neonatal Research Center- NICU- Emamreza hospital-mashhad-Iran
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Street address
City
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?