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NCT Number: NCT05652738

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

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).

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Key information

Conditions

Hypoxic Encephalopathy Asphyxia Neonatorum Birth Asphyxia Body Temperature Changes Brain Diseases Central Nervous System Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Hypothermia Hypothermia, Newborn Hypoxia Hypoxia, Brain Infant, Newborn, Diseases Neonatal Encephalopathy Nervous System Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Respiratory

Age range

1 hour–6 hour

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Marwa Mohamed Farag

Alexandria, 0356, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Passive cooling application

Device

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

cooling using Blanket roll III

Device

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

Primary outcomes

  1. Myocardial function through using tissue Doppler (TD).

    Time frame: first 4 days of life

    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.

  2. Left ventricular function through using conventional echocardiography.

    Time frame: first 4 days of life

    Ejection fraction in percent .

Secondary outcomes

  1. Right ventricular function using conventional echocardiography

    Time frame: first 4 days of life

    TAPSE (tricuspid annular plane systolic excursion) in mm .

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study title

The Impact of Passive Cooling Versus Blanket-Roll III on The Myocardial Function of Asphyxiated Neonates: A Randomized Clinical Trial

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Dec 15, 2022
Registry last updated
May 16, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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