Skip to content

Assesment of hypothermia complication in two methods , head cooling and total body cooling in neonatal with birth asphyxia

Assesment of hypothermia compllication , in Two methods , head cooling and total body cooling in neonatal with birth asphyxia

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT201204055168N2
Enrollment
60
Registered
2012-07-03
Start date
2011-09-23
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

neonates with moderate to severe birth asphyxia. Diseases of the nervous system

Interventions

Intervention 1: 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
Treatment - Devices
Treatment - Drugs
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 a
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 (recta

Sponsors

Research of Nursing and Midwifery faculty, Tabriz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion 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,

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
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.;Bradycardia. Timepoint: Every 4 hours for 84 hours. Method of measurement: Using the monitor device.;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.;Hypotension. Timepoint: Every 4 hours for 84 hours. Method of measurement: Using the Monitor.;Thrombocytopenia. Timepoint: Every 24 hours for 84 hours. Method of measurement: CBC test.;Necrotic skin damage. Timepoint: Every 4 hours for 84 hours. Method of measurement: Clinical observation of ecchymosis, bruises, wounds deep and necrotic skin.;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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMaliheh Assadollahi

Tabriz University of Medical Sciences

assadollahim@tbzmed.ac.ir+98 41 1479 9713

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026