Evaluation of theraputic effects of induced local hypothermia in neonates with hypoxic - ischemic encephalopathy addmited to Fatemieh and Besat hospitals - Hamedan
Introduction and background: Hypoxic-ischemic encephalopathy is one of the most important causes of permanent damage to brain tissue that redound to mortality and/or late sequelae such as cerebral palsy or delayed neural development. 15-20 percent of Hypoxic-ischemic encephalopathy (HIE) cases die during neonatal period and 25-30 percent of those who survive suffer from neural development problems such as cerebral palsy and mental retardation. Hypothermia or lowering temperature of brain or total body is a new and promising treatment. Objective: Present study was done to assess therapeutic effects of induced local hypothermia in hypoxic-ischemic encephalopathy (HIE) among neonates admitted to Fatemieh and Beasat hospitals of Hamedan. Design: Randomised (random blocks)- with a control group and two centre. Setting and conduct: A) Participants: neonates with at least one of following criteria that were in stage II of intensity of HIE: 1-Apgar score 5 or less at fifth minutes after birth 2- Fetal heart rate less than 60 beat per minutes 3-Prolonged metabolic acidosis 4-Need for positive pressure ventilation more than 1 min or delayed crying more than 5 min from birth 5- Occurrence of acute perinatal events Exclusion criteria: 1- Gestational age 35 weeks or less 2- Congenital anomalies Sample size: 36 neonates 18 in control group and 18 in case group Interventions: In the control group: Standard therapy such as O2 therapy and anticonvulsant as needed. In the intervention group: in addition to Standard therapy, induced head hypothermia by putting ice bag into oxyhood of neonates. Time of intervention: from admission in NICU to the end of sixth hour of life. Main outcome measures: evaluation of effect of hypothermia on: 1- mortality rate 2- incidence of convulsion in both groups 3- days of hospitalization 4- time of initiation of enteral feeding in both groups
General information
Acronym
not have
IRCT registration information
IRCT registration number:IRCT201011065110N1
Registration date:2010-12-11, 1389/09/20
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-12-11, 1389/09/20
Registrant information
Name
Behnaz Basiri
Name of organization / entity
Hamedan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1821 3770
Email address
b.basiri@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Hamedan University of Medical Science
Expected recruitment start date
2008-06-29, 1387/04/09
Expected recruitment end date
2009-12-30, 1388/10/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of theraputic effects of induced local hypothermia in neonates with hypoxic - ischemic encephalopathy addmited to Fatemieh and Besat hospitals - Hamedan
Public title
Effect of hypothermia on hypoxic-ischemic encephalopathy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: at least one of diagnostic criteria of HIE include:
1-APGAR score <5 at 5 minutes
2-Fetal heart rate <60 bpm
3-Prolonged metabolic acidosis(>1 hour)
4-Need of positive pressure ventilation>1 min or delay in crying >10 min of birth
5-Occurance of acute perinatal events
Exclusion criteria:
1- Gestational age <35 weeks
2- Congenital anomalies
Age
To 6 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
36
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
Ethic committee of Hamedan University of Medical Science
Street address
Daneshgah boulevard- Faculty of medicine
City
Hamedan
Postal code
65157518
Approval date
2008-02-09, 1386/11/20
Ethics committee reference number
145839/9/35/16/پ
Health conditions studied
1
Description of health condition studied
Hypoxic - ischemic encephalopathy
ICD-10 code
p91.6
ICD-10 code description
Hypoxic ischemic encephalopathy of newborn
Primary outcomes
1
Description
Mortality
Timepoint
Total number of death at discharge time
Method of measurement
Physical examination
2
Description
Convulsion
Timepoint
Total number of convulsion at disharge time
Method of measurement
Physical examination
Secondary outcomes
1
Description
Time of initiation of enteral feeding
Timepoint
From biginning of intervention to discharge
Method of measurement
Days reported in patient sheet
2
Description
Duration of Hospital stay
Timepoint
Biginning of intervention to discharge
Method of measurement
Days reported in patient sheets
Intervention groups
1
Description
In intervention groop, Induction of local hypothermia with putting ice bags in the oxyhood of patients
Category
Treatment - Other
2
Description
In control groop: rootne measures include O2 therapy , anticonvulsants .
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
NICU Fatemieh Hospital - Hamedan
Full name of responsible person
Behnaz Basiri
Street address
Fatemieh Hospital - Pasdaran Street
City
Hamedan
2
Recruitment center
Name of recruitment center
NICU- Besat Hospital
Full name of responsible person
Behnaz Basiri
Street address
Besat Hospital- Motahati Boulevard
City
Hamedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Science
Full name of responsible person
Ms. Ahmadkhani
Street address
Vice chancellor for research, Hamedan University of Medical Science- Daneshgah Boulevard
City
Hamedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan University of Medical Science
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
Hamedan University of Medical Science
Full name of responsible person
Behnaz Basiri
Position
Neonatologist- Assistant Professor
Other areas of specialty/work
Street address
NICU- Fatemieh Hospital- Pasdaran street
City
Hamedan
Postal code
6517789975
Phone
+98 81 1827 8080
Fax
+98 81 1838 2929
Email
b.basiri@umsha.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Science
Full name of responsible person
Behnaz Basiri
Position
Neonatologist - Assistant Professor
Other areas of specialty/work
Street address
NICU - Fatemieh Hospital- Pasdaran street
City
Hamedan
Postal code
6517789975
Phone
+98 81 1827 8080
Fax
+98 81 1838 2929
Email
b.basiri@umsha.ac.ir; behnazbasiri@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Science
Full name of responsible person
Behnaz Basiri
Position
Neonatologist - Assistant Professor
Other areas of specialty/work
Street address
NICU- Fatemieh Hospital- Pasdaran Street
City
Hamedan
Postal code
6517789975
Phone
+98 81 1827 8080
Fax
+98 81 1838 2929
Email
b.basiri@umsha.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)