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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05652738

Enrollment

100

Registered

2022-12-15

Start date

2022-01-20

Completion date

2023-05-01

Last updated

2023-05-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

therapeutic hypothermia, asphyxiated neonates, tissue Doppler

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.

Interventions

DEVICEPassive cooling application

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

DEVICEcooling using Blanket roll III

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

1 Hours to 6 Hours

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.

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026