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

Not Applicable

Completed

• Conditions: Hypoxic Encephalopathy; Birth Asphyxia; Neonatal Encephalopathy; Hypothermia, Newborn
• Interventions: Device: cooling using Blanket roll III; Device: Passive cooling application

• Registration Number: NCT05652738
• Lead Sponsor: Alexandria University

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).

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 Timeline

• Study Start: 2022-01-20
• Study First Submitted: 2022-11-25
• Study First Submitted QC: 2022-12-14
• Study First Posted: 2022-12-15
• Primary Completion: 2023-04-20
• Status Verified: 2023-05
• Study Completion: 2023-05-01
• Last Update Submitted: 2023-05-12
• Last Update Posted: 2023-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group II: (Blanket roll III cooling group)	cooling using Blanket roll III	-
Group I: (passive cooling group)	Passive cooling application	-

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (1)

Marwa Mohamed Farag; 🇪🇬 Alexandria, Egypt