Clinical Trials Directory

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UnknownNCT03655457

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

Evaluation of the Efficacy of Different Surfactant Preparations in Preterm Infants by Lung Ultrasound

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
64 (estimated)
Sponsor
Zekai Tahir Burak Women's Health Research and Education Hospital · Academic / Other
Sex
All
Age
1 Hour – 6 Hours
Healthy volunteers
Not accepted

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

Detailed description

Outcomes: Improvement of Lung usg scores after surfactanct and the difference between groups at different time points (2nd and 6hr). Secondary outcome: The correlation between lung usg scores and clinical scores (silverman scores), FiO2 and PCO2 levels, failure of weaning to noninvasive ventilation after surfactant 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.

Conditions

Interventions

TypeNameDescription
DEVICEgroup 1 Poractant alfaComparison 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.
DEVICEgroup 2 beractantlComparison 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.

Timeline

Start date
2018-03-21
Primary completion
2019-01-30
Completion
2019-02-28
First posted
2018-08-31
Last updated
2018-12-11

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT03655457. Inclusion in this directory is not an endorsement.