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

Phase 4

Completed

• Conditions: Respiratory Failure; Respiratory Distress Syndrome, Newborn
• Interventions: Drug: Poractant alfa instillation; Drug: Beractant instillation

• Registration Number: NCT01941524
• Lead Sponsor: Poznan University of Medical Sciences

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2013-03-03
• Study First Submitted: 2013-06-19
• Study First Submitted QC: 2013-09-09
• Study First Posted: 2013-09-13
• Primary Completion: 2015-06-20
• Study Completion: 2015-06-20
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-02
• Last Update Posted: 2020-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

• 26-30 gestational age
• surfactant instillation

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Poractant goup	Poractant alfa instillation	Newborns, who will be monitored by amplitude integrated electroencephalography (aEEG) and near infrared spectroscopy (NIRS) during poractant instillation.
Beractant group	Beractant instillation	Newborns who will be monitored by aEEG and NIRS during beractant instillation

Primary Outcome Measures

Name	Time	Method
Cerebral oxygenation	4 hours after surfactant instillation	Cerebral tissue oxygenation measured with near-infrared spectroscopy
Brain bioelectrical activity	4 hours after surfactant instillation	Brain bioelectrical activity measured with amplitude-integrated electroencephalography (aEEG)

Trial Locations

Locations (1)

Department of Neonatology; 🇵🇱 Poznan, Great Poland, Poland