Myocardial Function of Asphyxiated Neonates Under Different Modalities of Therapeutic Hypothermia

Sponsor

Alexandria University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05652738

Collaborator

(none)

100

Enrollment

Location

Arms

15.9

Anticipated Duration (Months)

6.3

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Hypoxic Encephalopathy Birth Asphyxia Neonatal Encephalopathy Hypothermia, Newborn	Device: Passive cooling application Device: cooling using Blanket roll III	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Diagnostic

Official Title:

Evaluation of Myocardial Function of Asphyxiated Neonates Under Different Modalities of Therapeutic Hypothermia

Actual Study Start Date :

Jan 20, 2022

Anticipated Primary Completion Date :

Jan 20, 2023

Anticipated Study Completion Date :

May 20, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Myocardial function through using tissue Doppler (TD). [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.
Left ventricular function through using conventional echocardiography. [first 4 days of life]
Ejection fraction in percent .

Secondary Outcome Measures

Right ventricular function using conventional echocardiography [first 4 days of life]
TAPSE (tricuspid annular plane systolic excursion) in mm .

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Hour to 6 Hours

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Marwa Mohamed Farag	Alexandria		Egypt	0356

Sponsors and Collaborators

Alexandria University

Investigators

Principal Investigator: Rasha Mohammed Adel Nasra, PhD, Faculty of medicine, Alexandria University, Egypt
Principal Investigator: Hossam Mostafa Kamel, MBChB, Faculty of medicine, Alexandria University, Egypt