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Status unknownNCT04618627Updated Nov 6, 2020

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

An observational study in Lung Ultrasound, sponsored by Assiut University. Status unknown. Open to participants aged 1 Hour to 1 Month. Per ClinicalTrials.gov, last updated 2020-11-06.

Sponsored by Assiut University · Observational

The sponsor has not verified this record recently (last verified Nov 2020), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
100
Ages
1 Hour to 1 Month
Sex
All
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Study summary

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.

Read the 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.

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Conditions studied

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In context

Respiratory Distress Syndrome

1,597 studies on the registry are indexed under Respiratory Distress Syndrome; 312 are open to participants now.

This study's planned enrollment of 100 is close to the median of 100 across 540 observational studies indexed under Respiratory Distress Syndrome.

Browse Respiratory Distress Syndrome studies →

Lead sponsor

Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
1 Hour to 1 Month
Sexes eligible
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

Inclusion criteria

    • Gestational age \< 28 weeks.

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

Exclusion criteria

Exclusion Criteria:

    • Gestational age ≤ 28 weeks.

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

Observational model
Other
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No

Interventions

  • Otherlung ultrasound

    Role of lung ultrasonography in prediction of the seveity and the need for surfactant administration in neonates with respiratory distress syndrome.

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What researchers measure

Primary outcomes

  1. 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

    Time frame: baseline

Secondary outcomes

  1. 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.

    Time frame: baseline

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Study locations

No study locations are listed for this record.

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References and documents

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. PubMed 20732945 ↗
  • 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. doi: 10.1177/000992289703600506. PubMed 9152555 ↗
  • 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. PubMed 18196931 ↗
  • Copetti R, Cattarossi L. The 'double lung point': an ultrasound sign diagnostic of transient tachypnea of the newborn. Neonatology. 2007;91(3):203-9. doi: 10.1159/000097454. Epub 2006 Dec 6. PubMed 17377407 ↗
  • 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. PubMed 25220126 ↗
  • 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:bcr2014206803. doi: 10.1136/bcr-2014-206803. PubMed 25512394 ↗
  • 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. PubMed 22392031 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 6, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04618627
Lead sponsor
Assiut University
Responsible party
Mohammed Elyan Ahmed (doctor, Assiut University) — Principal investigator
First posted
Nov 6, 2020
Start date
Nov 20, 2020 (estimated)
Primary completion
Nov 20, 2021 (estimated)
Completion
Dec 20, 2021 (estimated)
Last update
Nov 6, 2020

Study contacts

mohammed elyan, md
Contact
mohammedelyan645@gmail.com
01063540529
fatma ali, professor
study director · assiut university children hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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