Role of Lung Ultrasonography in Prediction of the Seveity and the Need for Surfactant Administration in Neonates With Respiratory Distress Syndrome

We aim to identify the diagnostic role of a lung ultrasonography (LUS) score to predict the severity and the need for surfactant therapy in newborns with respiratory distress syndrome (RDS), and to compare it with a chest X-ray score.

Study Overview

• Status: Unknown
• Conditions: Lung Ultrasound
• Intervention / Treatment: Other: lung ultrasound

Detailed Description

Respiratory distress syndrome (RDS) is a common problem in preterm infants. This condition is caused by deficiency of pulmonary surfactant in an immature lung and is related to morbidity and mortality in preterm infants. The incidence of RDS increases with the decreasing of gestational age (GA). The National Institute of Child Health and Human Development Neonatal Research Network reports a 93 percent incidence of RDS in a cohort of extremely preterm infants (GA 28 weeks or below)1. Although the risk is lower, RDS occurs even in a significant number of late preterm infants2. Diagnosis of RDS is based on clinical manifestations, arterial blood gas and chest X-ray findings. Chest X-ray is considered a first-line imaging test for diagnosis of RDS2. Chest X-ray findings, however, are not related to the respiratory prognosis3 .

Recently, lung ultrasonography (LUS) has been used in critically ill patient and it has become an important tool for neonatologists4. Specific LUS patterns have been described for typical neonatal respiratory conditions such as RDS5, transient tachypnea of the newborn (TTN)6, meconium aspiration syndrome (MAS)7, and pneumothorax8,9.As reported in The Consensus Conference on lung ultrasound, both LUS and chest X-ray are accurate in the diagnosis of RDS and TTN in neonates10.

Surfactant replacement therapy is crucial in the management of RDS. Recent guidelines recommend to treat affected babies with early nasal continuous positive airway pressure (nCPAP) and early selective surfactant administration10. The European Association of Perinatal Medicine and the American Academy of Pediatrics advise surfactant administration when oxygen requirement increases despite early nCPAP treatment11,12. Some studies have recently highlighted the usefulness of LUS in predicting neonatal intensive care unit admission or the need for mechanical ventilation13,14 or nCPAP failure15. Many scores based on LUS findings have proved their reliability in adult critical care16,17. In the neonatal field few studies presented chest X-ray derived scores18 or directly compared LUS with chest ray. There are no data, to our knowledge, that compare the accuracy of LUS with chest X-ray in predicting the need for surfactant administration in infants with RDS18-20.

Basically, each lung was divided into 3 areas (upper anterior, lower anterior, and lateral) and examined using a linear microprobe through both transverse and longitudinal scans. For each lung area, a 0- to 3-point score was given (total score ranging from 0-18). The LUS score encompassed signs typical of TTN and RDS21-22 . and described the total spectrum of possible conditions (a normal aerated lung, an interstitial pattern, an alveolar pattern, and consolidation). In details, the LUS score was assigned as follows: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. A-lines represent reflection of pleura due to ultrasound diffusing through an airfilled lung; B-lines are due to fluid filling the interstitium (and the alveolar space if they become confluent)23,24.

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 hour to 1 month (Child)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Gestational age < 28 weeks.

• Birth weight <1000 grams.
• Newborns diagnosed only with RDS clinically and by chest X-Ray findings

Description

Inclusion Criteria:

• • Gestational age < 28 weeks.

  • Birth weight <1000 grams.
  • Newborns diagnosed only with RDS clinically and by chest X-Ray findings

Exclusion Criteria:

• • Gestational age ≤ 28 weeks.

  • Birth weight ≤ 1000 grams.
  • Newborns with congenital anomalies.

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity and specificity lung ultrasound examination in identifying the severity and need for surfactant administration in neonates with RDS	Sensitivity and specificity lung ultrasound examination in identifying the severity and need for surfactant administration in neonates with RDS	baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compare point-of-care lung ultrasound with chest x ray in the rate of detection of RDS in neonates.	Compare point-of-care lung ultrasound with chest x ray in the rate of detection of RDS in neonates.	baseline

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Study Director: fatma ali, professor, Assiut university children hospital

Publications and helpful links

General Publications

• Stoll BJ, Hansen NI, Bell EF, Shankaran S, Laptook AR, Walsh MC, Hale EC, Newman NS, Schibler K, Carlo WA, Kennedy KA, Poindexter BB, Finer NN, Ehrenkranz RA, Duara S, Sanchez PJ, O'Shea TM, Goldberg RN, Van Meurs KP, Faix RG, Phelps DL, Frantz ID 3rd, Watterberg KL, Saha S, Das A, Higgins RD; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Neonatal outcomes of extremely preterm infants from the NICHD Neonatal Research Network. Pediatrics. 2010 Sep;126(3):443-56. doi: 10.1542/peds.2009-2959. Epub 2010 Aug 23.
• Volpicelli G, Elbarbary M, Blaivas M, Lichtenstein DA, Mathis G, Kirkpatrick AW, Melniker L, Gargani L, Noble VE, Via G, Dean A, Tsung JW, Soldati G, Copetti R, Bouhemad B, Reissig A, Agricola E, Rouby JJ, Arbelot C, Liteplo A, Sargsyan A, Silva F, Hoppmann R, Breitkreutz R, Seibel A, Neri L, Storti E, Petrovic T; International Liaison Committee on Lung Ultrasound (ILC-LUS) for International Consensus Conference on Lung Ultrasound (ICC-LUS). International evidence-based recommendations for point-of-care lung ultrasound. Intensive Care Med. 2012 Apr;38(4):577-91. doi: 10.1007/s00134-012-2513-4. Epub 2012 Mar 6.
• Kurl S, Heinonen KM, Kiekara O. The first chest radiograph in neonates exhibiting respiratory distress at birth. Clin Pediatr (Phila). 1997 May;36(5):285-9.
• Copetti R, Cattarossi L, Macagno F, Violino M, Furlan R. Lung ultrasound in respiratory distress syndrome: a useful tool for early diagnosis. Neonatology. 2008;94(1):52-9. doi: 10.1159/000113059. Epub 2008 Jan 15.
• Copetti R, Cattarossi L. The 'double lung point': an ultrasound sign diagnostic of transient tachypnea of the newborn. Neonatology. 2007;91(3):203-9. Epub 2006 Dec 6.
• Piastra M, Yousef N, Brat R, Manzoni P, Mokhtari M, De Luca D. Lung ultrasound findings in meconium aspiration syndrome. Early Hum Dev. 2014 Sep;90 Suppl 2:S41-3. doi: 10.1016/S0378-3782(14)50011-4.
• Migliaro F, Sodano A, Capasso L, Raimondi F. Lung ultrasound-guided emergency pneumothorax needle aspiration in a very preterm infant. BMJ Case Rep. 2014 Dec 14;2014. pii: bcr2014206803. doi: 10.1136/bcr-2014-206803.

Study record dates

Study Major Dates

• Study Start (Anticipated): November 20, 2020
• Primary Completion (Anticipated): November 20, 2021
• Study Completion (Anticipated): December 20, 2021

Study Registration Dates

• First Submitted: November 1, 2020
• First Submitted That Met QC Criteria: November 1, 2020
• First Posted (Actual): November 6, 2020

Study Record Updates

• Last Update Posted (Actual): November 6, 2020
• Last Update Submitted That Met QC Criteria: November 1, 2020
• Last Verified: November 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: RLUSIRDS

Drug and device information, study documents

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