Respiratory Distress Syndrome Clinical Trial
Official title:
Earliest Lung Ultrasound Time for Predicting the Need of Surfactant
NCT number | NCT04544514 |
Other study ID # | go 20 334 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | January 1, 2017 |
Est. completion date | December 31, 2019 |
Verified date | September 2020 |
Source | Hacettepe University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
Lung ultrasonography (LUS) is fast and easy technique. it also has high reliability, so it
has started to be used more in evaluating respiratory distress in the neonatal period. The
most important feature of LUS is being radiation-free. Three LUS findings that show
respiratory distress syndrome were described. They were white lung appearance, lack of
preserved areas and loss of pleural integrity. The sensitivity of these findings was found to
be 98-100% and the specificity 92-100%. A few studies have shown that surfactant need can be
determined by LUS.
It was observed that lung findings were more severe in LUS performed in the early period
because of non-completed fetal lung fluid clearence, but the findings could be improved
during follow-up. Therefore, it is not known when the earliest time of LUS shows the actual
clinical condition and course of the patient.
This study was planned to find the most reliable and earliest US time. Evaluation with LUS
was done at 30 minutes and repeated at 1, 2, 4 and 6 hours of life. The LUS findings would be
compared with x-ray findings and the correlation of surfactant need with LUS findings would
also be investigated.
Status | Completed |
Enrollment | 71 |
Est. completion date | December 31, 2019 |
Est. primary completion date | December 31, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 6 Hours |
Eligibility |
Inclusion Criteria: - preterm babies with a gestational age 32 weeks or less - babies treated with CPAP Exclusion Criteria: - If a baby was intubated in delivery room because of the responsiveness to face-mask ventilation, he/she was excluded. - congenital heart diseases - complex congenital malformations - chromosomal abnormalities. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Gozdem Kayki |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | lung ultrasound at 30 minutes | lung ultrasound findings | 30 minutes | |
Primary | lung ultrasound at 1 hour | lung ultrasound findings | 1 hour | |
Primary | lung ultrasound at 2 hour | lung ultrasound findings | 2 hour | |
Primary | lung ultrasound at 4 hour | lung ultrasound findings | 4 hour | |
Primary | lung ultrasound at 6 hour | lung ultrasound findings | 6 hour |
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