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

Assessment of the Cerebral Tissue Oxygenation and the Bioelectrical Brain Activity of Preterm Newborns During Administration of Two Different Surfactant

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01941524

Enrollment

Registered

2013-09-13

Start date

2013-03-03

Completion date

2015-06-20

Last updated

2020-03-05

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

Conditions

Respiratory Distress Syndrome, Newborn, Respiratory Failure

Keywords

Brain oxygenation, NIRS, aEEG, surfactant

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.

Interventions

DRUGPoractant alfa instillation

aEEG and NIRS monitoring during poractant alfa instilation

DRUGBeractant instillation

aEEG and NRs monitoring during beractant instillation

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

15 Minutes to 2 Days

Healthy volunteers

Inclusion criteria

* 26-30 gestational age * surfactant instillation

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
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)

Countries

Poland

Outcome results

None listed

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