Clinical Trials Logo
  1. Home
  2. Respiratory Failure
  3. NCT01941524
  4. Details
NCT01941524 Clinical Trial

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

Respiratory Failure Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01941524
Other study ID # 502-14-02215338-09873
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date March 3, 2013
Est. completion date June 20, 2015

Study information
Verified date March 2020
Source Poznan University of Medical Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 22
Est. completion date June 20, 2015
Est. primary completion date June 20, 2015
Accepts healthy volunteers No
Gender All
Age group N/A to 2 Days
Eligibility Inclusion Criteria:

- 26-30 gestational age

- surfactant instillation

Exclusion Criteria:

- congenital heart disease

- congenital central nervous disorder

- congenital genetic disorders

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Poractant alfa instillation
aEEG and NIRS monitoring during poractant alfa instilation
• Beractant instillation
aEEG and NRs monitoring during beractant instillation

Locations
Country Name City State
Poland Department of Neonatology Poznan Great Poland

Sponsors (1)
Lead Sponsor Collaborator
Poznan University of Medical Sciences

Country where clinical trial is conducted

Poland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Cerebral oxygenation Cerebral tissue oxygenation measured with near-infrared spectroscopy 4 hours after surfactant instillation
Primary Brain bioelectrical activity Brain bioelectrical activity measured with amplitude-integrated electroencephalography (aEEG) 4 hours after surfactant instillation
See also
  Status Clinical Trial Phase
Completed NCT03909854 - Pragmatic Investigation of Volume Targeted Ventilation-1 N/A
Recruiting NCT03662438 - HOPE (Home-based Oxygen [Portable] and Exercise) for Patients on Long Term Oxygen Therapy (LTOT) N/A
Recruiting NCT05308719 - Nasal Oxygen Therapy After Cardiac Surgery N/A
Recruiting NCT05535543 - Change in the Phase III Slope of the Volumetric Capnography by Prone Positioning in Acute Respiratory Distress Syndrome
Completed NCT04030208 - Evaluating Safety and Efficacy of Umbulizer in Patients Requiring Intermittent Positive Pressure Ventilation N/A
Recruiting NCT04668313 - COVID-19 Advanced Respiratory Physiology (CARP) Study
Recruiting NCT04542096 - Real Time Evaluation of Dynamic Changes of the Lungs During Respiratory Support of VLBW Neonates Using EIT
Recruiting NCT05883137 - High-flow Nasal Oxygenation for Apnoeic Oxygenation During Intubation of the Critically Ill
Completed NCT04505592 - Tenecteplase in Patients With COVID-19 Phase 2
Completed NCT03943914 - Early Non-invasive Ventilation and High-flow Nasal Oxygen Therapy for Preventing Delayed Respiratory Failure in Hypoxemic Blunt Chest Trauma Patients. N/A
Active, not recruiting NCT03472768 - The Impact of Age-dependent Haptoglobin Deficiency on Plasma Free Hemoglobin Levels During Extracorporeal Membrane Oxygenation Support
Not yet recruiting NCT04538469 - Absent Visitors: The Wider Implications of COVID-19 on Non-COVID Cardiothoracic ICU Patients, Relatives and Staff
Not yet recruiting NCT02542423 - Endocan Predictive Value in Postcardiac Surgery Acute Respiratory Failure. N/A
Completed NCT02265198 - Relationship of Pulmonary Contusion to Pulmonary Inflammation and Incidence of Acute Respiratory Distress Syndrome N/A
Completed NCT01885442 - TryCYCLE: A Pilot Study of Early In-bed Leg Cycle Ergometry in Mechanically Ventilated Patients N/A
Completed NCT02105298 - Effect of Volume and Type of Fluid on Postoperative Incidence of Respiratory Complications and Outcome (CRC-Study) N/A
Completed NCT02814994 - Respiratory System Compliance Guided VT in Moderate to Severe ARDS Patients N/A
Completed NCT01659268 - Performance of Baccalaureate Nursing Students in Insertion of Laryngeal Mask: a Trial in Mannequins N/A
Terminated NCT01333059 - Cycling of Sedative Infusions in Critically Ill Pediatric Patients N/A
Completed NCT01249794 - Non Invasive Ventilation After Cardiac Surgery N/A