Evaluation of effect of vitamin E in prevention of intraventricular hemorrhage in preterm neonates with gestational age below 30 weeks in alzahra hospital
This randomized clinical trial was conducted to evaluate effect of vitamin E in prevention of intraventricular hemorrhage in preterm newborn with gestational age less than 30 week born in Alzahra Hospital affiliated to Isfahan University of Medical Sciences since fall 2014 to spring 2016. written informed consent was taken from the child's parents. The infants were randomly allocated to either the case or the control group by a simple randomization method using a table of random numbers. The inclusion criteria were prematurity with gestational age equal or less than 30 weeks, no need for mechanical ventilation, normal blood pressure, 5-minute Apgar scores of ≥7, no presence of sepsis, abdominal distension, bile secretion and IVH. The neonates who needed sodium bicarbonate or resuscitation or mechanical ventilation in the first three days after birth were excluded from study. Besides that, abdominal distension and bile secretion during the study were considered other exclusion criteria. Seventy six neonates with 30-week gestational age or less were enrolled in this study. The neonates were randomly divided in two groups matched for age and gender. Immediately after birth, all neonates underwent brain sonography to determine if they had IVH. For the cases group (consist of 38 newborn) 10 units of vitamin E (1 cc of vitamin E per a drop) and in the control group (consist of 38 newborn) 1 cc distilled water was administered orally through orogastric tube for three days. In the fourth and seventh days after birth, brain sonography was conducted to evaluate IVH in the neonates. The presence of sepsis, incidence of necrotizing enterocolitis (NEC) and hypotension, drug reaction and mortality was recorded.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015042521910N2
Registration date:2017-01-26, 1395/11/07
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-01-26, 1395/11/07
Registrant information
Name
Behzad Barekatain
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3261 6670
Email address
b_barekatain@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Isfahan University of Medical Sciences
Expected recruitment start date
2014-09-21, 1393/06/30
Expected recruitment end date
2016-04-20, 1395/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of effect of vitamin E in prevention of intraventricular hemorrhage in preterm neonates with gestational age below 30 weeks in alzahra hospital
Public title
effect of vitamin E in intraventricular hemorrhage in preterm neonates
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: preterm infants with gestational age less than 30weeks; lack of congenital malformations or CNS disease at birth; the infant's mother take one course of steroid prior to delivery; absent of maternal chorioamnionitis; lack of use of mechanical ventilation; oxygen saturation greater than 90%; normal blood pressure; APGAR score greater than 7 at 5 minute; lack or sepsis; lack of IVH at the beginning of study; lack of abdominal distention at the beginning of study.
Exclusion criteria: need for administration of sodium bicarbonate during first 3 days of birth; need of resuscitation during first 3 days of birth; abdominal distention during vit E administration; need for mechanical ventilation.
Age
To 1 month old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciense
Street address
Hezarjerib boulevard, Isfahan University of Medical Sciense
City
Isfahan
Postal code
Approval date
2015-10-31, 1394/08/09
Ethics committee reference number
IR.MUI.REC.1394.3.569
Health conditions studied
1
Description of health condition studied
Intraventricular hemorrahge
ICD-10 code
P52.9
ICD-10 code description
Intracranial (nontraumatic) haemorrhage of fetus and newborn, unspecified
Primary outcomes
1
Description
Intra Ventricular Hemorrahge
Timepoint
4th and 7th days
Method of measurement
Brain Sonography
Secondary outcomes
1
Description
Sepsis
Timepoint
During Study
Method of measurement
Clinical Sign and Blood Culture
2
Description
Necrotizing Enterocolitis
Timepoint
During Study
Method of measurement
Clinical Sign and Abdominal Graphy
3
Description
Death
Timepoint
During Study
Method of measurement
Observation
Intervention groups
1
Description
In Intervention group we prescribed 10 unit of Vit E ( equall to 1 cc) orally via orogastric tube once in day for 3 days
Category
Prevention
2
Description
In control group we prescribed 1 cc of distilled water orally via orogastric tube once in day for 3 days
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Behzad Barekatain
Street address
Isfahan, Sofeh street
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Isfahan University of Medical Sciense
Full name of responsible person
Mehdi Nematbakhsh
Street address
Hezarjerib boulevard, Isfahan University of Medical Sciense
City
Isfahan
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 of Isfahan University of Medical Sciense