Brain Oxygenation and Function of Preterm Newborns During Administration of Two Different Surfactant Preparations

Poznan University of Medical Sciences (PUMS)

Status and phase: Completed; Phase 4

Conditions: Respiratory Failure; Respiratory Distress Syndrome, Newborn

Treatments: Drug: Beractant instillation; Drug: Poractant alfa instillation

Study type: Interventional

Funder types: Other

Identifiers

NCT01941524

502-14-02215338-09873

Details and patient eligibility

About

The purpose of the study is to determine whether there are differences in bioelectrical function (measured by amplitude integrated electroencephalography) and brain oxygenation (measured by near infrared spectroscopy) while and after instillation of two different surfactant preparations.

Full description

Patients randomized to one of the treatment groups: 1) SRT with porcine preparation - poractant alfa; 2) SRT with bovine preparation - beractant. Continuous monitoring and simultaneous recordeding of 1) saturation (SpO2) and heart rate (HR) measured with pulse oximetry, cerebral tissue oxygenation measured with near-infrared spectroscopy, amplitude-integrated electroencephalography.

Enrollment: 22 patients

Sex: All

Ages: 15 minutes to 2 days old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 26-30 gestational age
• surfactant instillation

Exclusion criteria

• congenital heart disease
• congenital central nervous disorder
• congenital genetic disorders

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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22 participants in 2 patient groups

Poractant goup

Active Comparator group

Description:

Newborns, who will be monitored by amplitude integrated electroencephalography (aEEG) and near infrared spectroscopy (NIRS) during poractant instillation.

Treatment:

Drug: Poractant alfa instillation

Beractant group

Active Comparator group

Description:

Newborns who will be monitored by aEEG and NIRS during beractant instillation

Treatment:

Drug: Beractant instillation