Passive Cooling Versus Blanket-Roll III on The Myocardial Function of Asphyxiated Neonates

Alexandria University100 enrolled

Overview

Studying the effect of passive versus Blanket roll III modality of therapeutic hypothermia (TH)on myocardial function of asphyxiated neonates through using tissue Doppler (TD).

A clinical trial study of 100 Gestational-age-matched asphyxiated cooled neonates will divided into two groups, 50 in each group for comparison the myocardial function using passive cooling and BLANKET ROLL III as modality of TH.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

SINGLE

Enrollment

100

Conditions

Hypoxic Encephalopathy Birth Asphyxia Neonatal Encephalopathy Hypothermia, Newborn

Interventions

Passive cooling applicationDEVICE

Passive cooling application for asphyxiated neonates and their effect on myocardial function and hemodynamics

cooling using Blanket roll IIIDEVICE

standard care using Blanket roll III in asphyxiated neonates and their effect on myocardial function and hemodynamics

Eligibility

Sex: ALLMin age: 1 HourMax age: 6 Hours

Medical Language ↔ Plain English

Inclusion Criteria: * Evidence of perinatal/intrapartum hypoxia, as indicated by at least one of: * Apgar score of less than or equal to 5 at 10 minutes * Needing mechanical ventilation or ongoing resuscitation at 10 minutes * PH in cord blood gas is less than 7.00 or a base excess worse than or equal to minus 12 mmol /L on cord/arterial/venous/capillary blood gas obtained within 60 minutes of birth. * Evidence of moderate or severe encephalopathy. * Greater than or equal to 35 weeks gestational age. * Birth weight greater than or equal to 1800 g. * Able to begin cooling before 6 hours of birth. Exclusion Criteria: * Congenital cyanotic heart disease. * Multiple congenital anomalies. * Birth asphyxia's babies after start of cooling with cardiovascular instability.

Locations (1)

Marwa Mohamed Farag

Alexandria, Egypt

Outcomes

Primary Outcomes

Myocardial function through using tissue Doppler (TD).

neonatal echocardiography using a (Vivid IQ) with a (3-8 MHz) with software for Tissue Doppler imaging (TDI) , myocardial performance index and measuring velocities of different waveforms, cm/sec.

Time frame: first 4 days of life

Left ventricular function through using conventional echocardiography.

Ejection fraction in percent .

Time frame: first 4 days of life

Secondary Outcomes

Right ventricular function using conventional echocardiography

TAPSE (tricuspid annular plane systolic excursion) in mm .

Time frame: first 4 days of life

Data from ClinicalTrials.gov

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