Earliest Lung Ultrasound Time for Predicting the Need of Surfactant

NCT04544514 | Completed

• 1 other identifier: go 20 334
• Study Type: observational
• Target: 71
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Respiratory Distress Syndrome

Outcome Measures

Primary Outcomes (5)

• 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

Interventions

lung ultrasound DIAGNOSTIC_TEST

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

Eligibility Criteria

• Age: 30 Minutes - 6 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• preterm babies with a gestational age 32 weeks or less
• babies treated with CPAP

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gozdem Kayki: lead

Related Publications (1)

• 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.

  PMID: 33758395 DERIVED

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Investigator

Study Record Dates

• First Submitted: September 3, 2020
• First Posted: September 10, 2020
• Study Start: January 1, 2017
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: September 11, 2020

Record last verified: 2020-09