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A clinical trial to study hemodynamics in cooled and non cooled neonates with Birth asphyxia

â??HEMODYNAMICS IN COOLED NEONATES WITH HYPOXIC ISCHEMIC ENCEPHALOPATHY IN A TERTIARY CARE CENTER- A RANDOMIZED CONTROL TRIAL

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/01/007735
Enrollment
32
Registered
2017-01-23
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: null- NEONATES WITH HYPOXIC ISCHEMIC ENCEPHALOPATHY Health Condition 2: I998- Other disorder of circulatory system Health Condition 3: I998- Other disorder of circulatory system

Interventions

Intervention1: Functional Echocardiography,Cooling: Baseline Echo (Zero hour echo) done in all eligible neonate (Term infants enrolled in Randomized control trial of hypothermia for encephalopathy in

Sponsors

Department of Neonatology Institute of child health and hospital for children
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Age 1.8kg, Gestation >36 weeks based on available information regarding last menstrual period or ultrasound) AND 2.Need for continued resuscitation at 5 minutes of age and/or 5 minute Apgar score (for babies born at home) AND 3. Evidence of moderate or severe encephalopathy at structured clinical examination

Exclusion criteria

Exclusion criteria: 1.Congenital heart disease (VSD/ASD/PDA) 2.SEVERE PPHN on Admission

Design outcomes

Primary

MeasureTime frame
Trend of Fractional Shortening among cooled and non-cooled neonates with moderate to severe hypoxic ischemic encephalopathy upto 96 hrs from the time of admission in NICUTimepoint: At 1 hour after admission in NICU, and then every 8 ± 2 hours till 96hrs of age—

Secondary

MeasureTime frame
1.Trend of Ejection fraction 2.Trend of Mean velocity of circumferential fiber shortening 3.Trend of Cardiac output 4.Trend of SVC flow 5.Trend of IVC collapsibility index 6.Correlation of Heart rate with Fractional shortening 7.Correlation of Mean blood Pressure with Fractional shortening 8.Correlation of LACTATE levels with Fractional shortening 9.Correlation of Cardio-Troponin I levels with Fractional shortening 10.Incidence of hypotension (MBP40mmhg) Timepoint: At 1 hour after admission in NICU, and then every 8 ± 2 hours till 96hrs of age—

Countries

India

Contacts

Public ContactDrCNKamalarathnam

MADRAS MEDICAL COLLEGE

drkamal.rathnam@gmail.com9790789376

Outcome results

None listed

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