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

NCT01941524 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2020-03-05

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Poractant alfa instillation

aEEG and NIRS monitoring during poractant alfa instilation

DRUG

Beractant instillation

aEEG and NRs monitoring during beractant instillation

Sponsors & Collaborators

  • Poznan University of Medical Sciences

    lead OTHER

Principal Investigators

  • Tomasz Szczapa, M.D. · Poznan University of Medical Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
15 Minutes
Max Age
2 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-03-03
Primary Completion
2015-06-20
Completion
2015-06-20

Countries

  • Poland

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01941524 on ClinicalTrials.gov