Evaluation of the Efficacy of Surfaktant in Preterm Infants by Lung Ultrasound

NCT03655457 | Unknown

• 1 other identifier: 22032018
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

To compare the lung ultrasound scores after two different natural surfactant administration as a parameter reflecting lung inflation. Poractant alfa decreases lung ultrasound scores as efficient as beractant treatment

Conditions

Lung Ultrasound Scores

Keywords

Lung; RDS; Surfaktant

Outcome Measures

Primary Outcomes (1)

• Lung usg scores

  Evaluation of Lung Usg Scores in infants treated with surfactant in the first six hours (Brat lung usg scores). Each item scored 0-3. (0 indicates A-pattern (defined by the presence of the only A-lines); 1, B-pattern (defined as the presence of ≥3 well-spaced B-lines); 2, severe B-pattern (defined as the presence of crowded and coalescent B-lines with or without consolidations limited to the subpleural space); and 3, extended consolidations.) \- Higher values represent a worse outcome

  first days

Study Arms (2)

group 1 Poractant alfa

EXPERIMENTAL

Poractant alfa generic name: curosurf 120 and 240 mg flk dosage: 200 mg/ kg intratracheal application frequency and duration: in the first two hours

Device: group 1 Poractant alfa

group 2 beractant

ACTIVE COMPARATOR

beractant generic name: survanta 8 cc flk dosage: 4 cc/ kg intratracheal application frequency and duration: in the first two hours

Device: group 2 beractant

Interventions

group 1 Poractant alfa DEVICE

Comparison of lung usg scores in infants treated with Poractant alfa and Beractant: 0 indicates A-pattern (defined by the presence of the only A-lines); 1, B-pattern (defined as the presence of ≥3 well-spaced B-lines); 2, severe B-pattern (defined as the presence of crowded and coalescent B-lines with or without consolidations limited to the subpleural space); and 3, extended consolidations.

group 1 Poractant alfa

group 2 beractant DEVICE

lComparison of lung usg scores in infants treated with Poractant alfa and Beractant: 0 indicates A-pattern (defined by the presence of the only A-lines); 1, B-pattern (defined as the presence of ≥3 well-spaced B-lines); 2, severe B-pattern (defined as the presence of crowded and coalescent B-lines with or without consolidations limited to the subpleural space); and 3, extended consolidations.

group 2 beractant

Eligibility Criteria

• Age: 1 Hour - 6 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Preterm infants of 32 gestational weeks and below, who admit to the NICU with signs of respiratory distress, treated with non invasive or mechanical ventilation and require surfactant treatment in 6 hours of life will be enrolled.

You may not qualify if:

• major congenital anomalies.

Sponsors & Collaborators

• Zekai Tahir Burak Women's Health Research and Education Hospital: lead

Study Sites (1)

Zekai Tahir Burak Matarnity Teaching

Ankara, 06230, Turkey (Türkiye)

RECRUITING

Study Officials

• Evrim Alyamaç Dizdar, MD

  zekai tahir burak matarnity teaching hospital

  STUDY DIRECTOR

Central Study Contacts

Davut Bozkaya, MD

CONTACT

+905053197531; drbozkaya@gmail.com

Evrim Alyamaç Dizdar, MD

CONTACT

+905063668840; drevrimdizdar@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2018
• First Posted: August 31, 2018
• Study Start: March 21, 2018
• Primary Completion: January 30, 2019
• Study Completion: February 28, 2019
• Last Updated: December 11, 2018

Record last verified: 2018-03

Locations

TU (1)