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

May 12, 2023 updated by: Marwa Mohamed Farag, Alexandria University

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Alexandria, Egypt, 0356
        • Marwa Mohamed Farag

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 hour to 6 hours (Child)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group I: (passive cooling group)
Device: Passive cooling application
Passive cooling application for asphyxiated neonates and their effect on myocardial function and hemodynamics
Placebo Comparator: Group II: (Blanket roll III cooling group)
Device: cooling using Blanket roll III
standard care using Blanket roll III in asphyxiated neonates and their effect on myocardial function and hemodynamics

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
first 4 days of life
Left ventricular function through using conventional echocardiography.
Time Frame: first 4 days of life
Ejection fraction in percent .
first 4 days of life

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Right ventricular function using conventional echocardiography
Time Frame: first 4 days of life
TAPSE (tricuspid annular plane systolic excursion) in mm .
first 4 days of life

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alexandria University

Investigators

  • Principal Investigator: Reham M Wagdy, PhD, Faculty of Medicine, Alexandria University, Egypt
  • Principal Investigator: Hossam M Kamel, MBChB, Faculty of Medicine, Alexandria University, Egypt
  • Principal Investigator: Rasha M Adel Nasra, Alexandria University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 20, 2022

Primary Completion (Actual)

April 20, 2023

Study Completion (Actual)

May 1, 2023

Study Registration Dates

First Submitted

November 25, 2022

First Submitted That Met QC Criteria

December 14, 2022

First Posted (Actual)

December 15, 2022

Study Record Updates

Last Update Posted (Actual)

May 16, 2023

Last Update Submitted That Met QC Criteria

May 12, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0107176

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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