The aim of study is determination hypothermia side effect in two cooling methods: head cooling and total body cooling in neonates suffering from asphyxia.The study population of this study includes infants born with moderate or severe asphyxia And they are born in last 6 hours.Participated Infants are divided in2 groups. first group cooled with head cooling method during 1 hour until reached Core body temperature to(34-35),and the second group cooled with total bady cooling during 1 hour until reached Core body temperature to(32.5-33.5),and 72 hours kept at this temperature and then heated up gradually during 8-12hours. During 84 hours, every 4 hours, Bradycardia, apnea, cyanosis and seizuresis s, hypotension, thrombocytopenia, pulmonary hemorrhage, necrotic tissue damage,are measured and documented.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201204055168N2
Registration date:2012-07-03, 1391/04/13
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-07-03, 1391/04/13
Registrant information
Name
Maliheh Assadollahi
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1479 6770
Email address
assadollahim@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy for Research ,Tabriz University of Medical Sciences -College of Nursing and Midwifery, Tabriz University
Expected recruitment start date
2011-09-23, 1390/07/01
Expected recruitment end date
2012-01-21, 1390/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assesment of hypothermia compllication , in Two methods , head cooling and total body cooling in neonatal with birth asphyxia
Public title
Assesment of hypothermia complication in two methods , head cooling and total body cooling in neonatal with birth asphyxia
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria
1. Infants with gestational age 35 weeks or more,
2. Six – hour infant or less than that
3. Infants weight more than 1800g
4. Apgar score 6 or less within 10 minutes from birth
5. Cord of pH 7 or less alkali deficiency 12 or less
6. Hypoxia ischemic encephalopathy moderate or severs
7. Infants with normal respiratory condition and infants under ventilation
Exclusion criteria:
1. Infants with bradycardia less than 70,
2. Infants with hypotension any response to medication,
3. Infants with severe pulmonaryhemorage,
4. Coagulation disorders,
5. Resistance hypoxia,
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tabriz University of Medical Sciences
Street address
- Tabriz University of Medical Sciences - Research
City
Tabriz
Postal code
51745-347
Approval date
2012-03-12, 1390/12/22
Ethics committee reference number
918
Health conditions studied
1
Description of health condition studied
neonates with moderate to severe birth asphyxia
ICD-10 code
G90-G99
ICD-10 code description
Diseases of the nervous system
Primary outcomes
1
Description
Apnea
Timepoint
Every 4 hours for 84 hours
Method of measurement
Color Cyanosis, bradycardia, and arterial oxygen saturation less than 70% when using pulse oximetry or monitor device
2
Description
Bradycardia
Timepoint
Every 4 hours for 84 hours
Method of measurement
Using the monitor device
3
Description
convulsion
Timepoint
Every 4 hours for 84 hours
Method of measurement
Using clinical symptoms and the presence of waves with short wave length and high frequency in the EEG
4
Description
Hypotension
Timepoint
Every 4 hours for 84 hours
Method of measurement
Using the Monitor
5
Description
Thrombocytopenia
Timepoint
Every 24 hours for 84 hours
Method of measurement
CBC test
6
Description
Necrotic skin damage
Timepoint
Every 4 hours for 84 hours
Method of measurement
Clinical observation of ecchymosis, bruises, wounds deep and necrotic skin
7
Description
Pulmonary hemorrhage
Timepoint
Every 4 hours for 84 hours
Method of measurement
Using clinical signs and symptoms of pulmonary hemorrhage on chest radiograph confirmed by physician
Secondary outcomes
empty
Intervention groups
1
Description
Thirty neonatal with moderate and severe asphyxia cooled with head cooling method to achieve the target temperature (rectal 34-33) for 1 hour,and held for 72 hours at this temperature, The neonatal are heated gradually during the 8-12 time to reach the normal temperature (36.5).
Category
Treatment - Devices
2
Description
In the second group thirty neonatal with moderate and severe asphyxia cooled with total bady cooling method,using Turn off Varmr and cold water bag (15-10)° C,to achieve the target temperature (rectal 32.5-33.5) for 1 hour,and held for 72 hours at this temperature, Then neonatal are heated gradually during the 8-12 time to reach the normal temperature (36.5).