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

Neonatal Encephalopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05652738
• Other study ID #: 0107176
• Status: Completed
• Phase: N/A
• Start date: January 20, 2022
• Est. completion date: May 1, 2023

Study information

• Verified date: May 2023
• Source: Alexandria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: May 1, 2023
• Est. primary completion date: April 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Hour to 6 Hours

Eligibility

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.

Related Conditions & MeSH terms

• Asphyxia
• Asphyxia Neonatorum
• Birth Asphyxia
• Brain Diseases
• Hypothermia
• Hypothermia, Newborn
• Hypoxia, Brain
• Hypoxic Encephalopathy
• Neonatal Encephalopathy

Intervention

Device:
• Passive cooling application
Passive cooling application for asphyxiated neonates and their effect on myocardial function and hemodynamics
• cooling using Blanket roll III
standard care using Blanket roll III in asphyxiated neonates and their effect on myocardial function and hemodynamics

Locations

Country	Name	City	State
Egypt	Marwa Mohamed Farag	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Alexandria University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Left ventricular function through using conventional echocardiography.	Ejection fraction in percent .	first 4 days of life
Secondary	Right ventricular function using conventional echocardiography	TAPSE (tricuspid annular plane systolic excursion) in mm .	first 4 days of life