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

Alexandria University

Status: Completed

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

Treatments: Device: cooling using Blanket roll III; Device: Passive cooling application

Study type: Interventional

Funder types: Other

Identifiers

NCT05652738

0107176

Details and patient eligibility

About

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).

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 1 to 6 hours old

Volunteers: No 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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups, including a placebo group

Group I: (passive cooling group)

Active Comparator group

Treatment:

Device: Passive cooling application

Group II: (Blanket roll III cooling group)

Placebo Comparator group

Treatment:

Device: cooling using Blanket roll III