Introduction: the effect of early administration of phenobarbital on the outcome Hpyvksyk ischemic encephalopathy, single-center, phase three trials, single- center, phase 3 trial 2) Participant: Inclusion criteria: age of 38 and 42 weeks; Five-minute Apgar score less than 3 at birth or delay in breathing for more than 5 minutes after birth; lethargy; seizures; abnormal neonatal reflexes; hypotonia in the early stages of birth
Exclusion criteria: two twins; Congenital malformations; Chromosomal abnormalities; Congenital infection or Koryoamnyotit; ); Encephalopathy 3) Intervention: Patients were divided into two groups of 15 people, in addition to routine therapy for patients with hypoxemic encephalopathy at birth, after the initial blood sample was taken from the patients were treated with 20 mg/kg intravenous phenobarbital within 6 hours of birth and second group not receive additional doses of phenobarbital5) Comparison: Two weeks 6) Outcome: reduction of Nitric oxide level
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014090919101N1
Registration date:2014-09-17, 1393/06/26
Registration timing:prospective
Last update:
Update count:0
Registration date
2014-09-17, 1393/06/26
Registrant information
Name
Gholamreza Panahandeh
Name of organization / entity
Shahrekord University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 38 1222 0016
Email address
panahandeh@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahrekord University of Medical Sciences
Expected recruitment start date
2014-09-23, 1393/07/01
Expected recruitment end date
2015-03-21, 1394/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of phenobarbital on the outcome of early ischemic encephalopathy Hypoxemic
Public title
The effect of phenobarbital on the outcome of early ischemic encephalopathy Hypoxemic
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age of 38 and 42 weeks; Five-minute Apgar score less than 3 at birth or delay in breathing for more than 5 minutes after birth; lethargy; seizures; abnormal neonatal reflexes; hypotonia in the early stages of birth
Exclusion criteria: two twins; Congenital malformations; Chromosomal abnormalities; Congenital infection or Koryoamnyotit; ); Encephalopathy
Age
From 1 day old to 1 day old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
N/A
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
Ethics Committee of Shahrekord University of Medical Sciences
Street address
Shahrekord,Rahmatieh, Shahrekord University of Medical Sciences
City
Shahrekord
Postal code
Approval date
2014-08-03, 1393/05/12
Ethics committee reference number
5-8-92
Health conditions studied
1
Description of health condition studied
Hypoxic ischaemic encephalopathy of newborn
ICD-10 code
P91.6
ICD-10 code description
Hypoxic ischaemic encephalopathy of newborn, unspecified
Primary outcomes
1
Description
reduction of Nitric oxide level
Timepoint
A week later
Method of measurement
sampling
Secondary outcomes
empty
Intervention groups
1
Description
The first group receive 20 mg/kg intravenous phenobarbital within 6 hours of birth
Category
Treatment - Drugs
2
Description
The second group not receive additional doses of phenobarbital
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahrekord Hajar Hospital
Full name of responsible person
Panahandeh Gholamreza
Street address
Shahrekord University Of Medical Sciences
City
Shahrekord
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Shahrekord University of Medical Scie
Full name of responsible person
Vice chancellor for research of Shahrekord University of Medical Scie
Street address
Shahrekord, Shahrekord University of Medical Sciences
City
Shahrekord
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 Shahrekord University of Medical Scie
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
Shahrekord University of Medical Sciences
Full name of responsible person
Panahandeh Gholamreza
Position
Pediatric Endocrinologist, Assistant Professor
Other areas of specialty/work
Street address
Shahrekord University of Medical Sciences
City
Shahrekord
Postal code
Phone
+98 38 1333 0065
Fax
Email
gholamrezapanahandeh@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahrekord University of Medical
Full name of responsible person
Panahandeh Gholamreza
Position
Pediatric Endocrinologist, Assistant Professor Sciences
Other areas of specialty/work
Street address
Shahrekord , Shahrekord University of Medical Sciences
City
Shahrekord
Postal code
Phone
+98 38 1222 0016
Fax
Email
gholamrezapanahandeh@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahrekord University of Medical Sciences
Full name of responsible person
Gholamreza Panahande
Position
Pediatric Endocrinologist, Assistant Professor
Other areas of specialty/work
Street address
Shahrekord, Shahrekord University of Medical Sciences
City
Shahrekord
Postal code
Phone
+98 38 1222 0016
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)