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

P

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)

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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