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

NCT05652738 | Completed

• 1 other identifier: 0107176
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Hypoxic Encephalopathy; Birth Asphyxia; Neonatal Encephalopathy; Hypothermia, Newborn

Keywords

therapeutic hypothermia; asphyxiated neonates; tissue Doppler

Outcome Measures

Primary Outcomes (2)

• 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.

  first 4 days of life

• Left ventricular function through using conventional echocardiography.

  Ejection fraction in percent .

  first 4 days of life

Secondary Outcomes (1)

• Right ventricular function using conventional echocardiography

  first 4 days of life

Study Arms (2)

Group I: (passive cooling group)

ACTIVE COMPARATOR

Device: Passive cooling application

Group II: (Blanket roll III cooling group)

PLACEBO COMPARATOR

Device: cooling using Blanket roll III

Interventions

Passive cooling application DEVICE

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

Group I: (passive cooling group)

cooling using Blanket roll III DEVICE

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

Group II: (Blanket roll III cooling group)

Eligibility Criteria

• Age: 1 Hour - 6 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Congenital cyanotic heart disease.
• Multiple congenital anomalies.
• Birth asphyxia's babies after start of cooling with cardiovascular instability.

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Marwa Mohamed Farag

Alexandria, 0356, Egypt

Location

MeSH Terms

Conditions

Hypoxia, Brain; Asphyxia Neonatorum; Hypothermia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypoxia; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Body Temperature Changes

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary Investigator and Lecturer in Pediatrics, Faculty of Medicine

Study Record Dates

• First Submitted: November 25, 2022
• First Posted: December 15, 2022
• Study Start: January 20, 2022
• Primary Completion: April 20, 2023
• Study Completion: May 1, 2023
• Last Updated: May 16, 2023

Record last verified: 2023-05

Locations

EG (1)