Earliest Lung Ultrasound Time for Predicting the Need of Surfactant

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.

Study Overview

• Status: Completed
• Conditions: Respiratory Distress Syndrome
• Intervention / Treatment: Diagnostic test: lung ultrasound

• Study Type: Observational
• Enrollment (Actual): 71

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 minutes to 6 hours (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

extreme preterm babies with a gestational age 32 weeks or less were admitted to NICU. Only babies who were treated with CPAP because of clinical signs of respiratory distress were enrolled the study.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
lung ultrasound at 30 minutes	lung ultrasound findings	30 minutes
lung ultrasound at 1 hour	lung ultrasound findings	1 hour
lung ultrasound at 2 hour	lung ultrasound findings	2 hour
lung ultrasound at 4 hour	lung ultrasound findings	4 hour
lung ultrasound at 6 hour	lung ultrasound findings	6 hour

Collaborators and Investigators

• Sponsor: Gozdem Kayki

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): December 31, 2019
• Study Completion (Actual): December 31, 2019

Study Registration Dates

• First Submitted: September 3, 2020
• First Submitted That Met QC Criteria: September 3, 2020
• First Posted (Actual): September 10, 2020

Study Record Updates

• Last Update Posted (Actual): September 11, 2020
• Last Update Submitted That Met QC Criteria: September 9, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Infant, Newborn, Diseases; Infant, Premature, Diseases; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn
• Other Study ID Numbers: go 20 334

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No