Earliest Lung Ultrasound Time for Predicting the Need of Surfactant

NCT ID: NCT04544514

Last Updated: 2020-09-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

71 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-01-01

Study Completion Date

2019-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Respiratory Distress Syndrome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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lung ultrasound

LUS was performed within first 20 to 30 minutes and repeated at 1, 2, 4 and 6 hours.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

30 Minutes

Maximum Eligible Age

6 Hours

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gozdem Kayki

OTHER

Sponsor Role lead

Responsible Party

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Gozdem Kayki

Investigator

Responsibility Role SPONSOR_INVESTIGATOR

References

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Kayki G, Yigit S, Tandircioglu UA, Celik HT, Yurdakok M. Lung ultrasound (LUS) and surfactant treatment: looking for the best predictive moment. J Perinatol. 2021 Jul;41(7):1669-1674. doi: 10.1038/s41372-021-01039-0. Epub 2021 Mar 23.

Reference Type DERIVED
PMID: 33758395 (View on PubMed)

Other Identifiers

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go 20 334

Identifier Type: -

Identifier Source: org_study_id

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