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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03655457
Enrollment
64
Registered
2018-08-31
Start date
2018-03-21
Completion date
2019-02-28
Last updated
2018-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Ultrasound Scores

Keywords

Lung, RDS, Surfaktant

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

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.

Interventions

DEVICEgroup 1 Poractant alfa

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.

DEVICEgroup 2 beractant

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.

Sponsors

Zekai Tahir Burak Women's Health Research and Education Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
1 Hours to 6 Hours
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

* major congenital anomalies.

Design outcomes

Primary

MeasureTime frameDescription
Lung usg scoresfirst daysEvaluation 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

Countries

Turkey (Türkiye)

Contacts

Primary ContactDavut Bozkaya, MD
drbozkaya@gmail.com+905053197531
Backup ContactEvrim Alyamaç Dizdar, MD
drevrimdizdar@gmail.com+905063668840

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026