NCT04618627

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2020

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 1, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 6, 2020

Completed
14 days until next milestone

Study Start

First participant enrolled

November 20, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2021

Completed
Last Updated

November 6, 2020

Status Verified

November 1, 2020

Enrollment Period

1 year

First QC Date

November 1, 2020

Last Update Submit

November 1, 2020

Conditions

Lung Ultrasound

Outcome Measures

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

    baseline

Secondary Outcomes (1)

  • Compare point-of-care lung ultrasound with chest x ray in the rate of detection of RDS in neonates.

    baseline

Interventions

lung ultrasoundOTHER

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

Eligibility Criteria

Age1 Hour - 1 Month
Sexall
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Gestational age \< 28 weeks. * Birth weight \<1000 grams. * Newborns diagnosed only with RDS clinically and by chest X-Ray findings

You may qualify if:

  • Gestational age \< 28 weeks.
  • Birth weight \<1000 grams.
  • Newborns diagnosed only with RDS clinically and by chest X-Ray findings

You may not qualify if:

  • Gestational age ≤ 28 weeks.
  • Birth weight ≤ 1000 grams.
  • Newborns with congenital anomalies.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (7)

  • 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.

    PMID: 20732945BACKGROUND

  • 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.

    PMID: 9152555BACKGROUND

  • 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.

    PMID: 18196931BACKGROUND

  • 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.

    PMID: 17377407BACKGROUND

  • 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.

    PMID: 25220126BACKGROUND

  • 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.

    PMID: 25512394BACKGROUND

  • 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.

    PMID: 22392031BACKGROUND

Study Officials

  • fatma ali, professor

    assiut university children hospital

    STUDY DIRECTOR

Central Study Contacts

mohammed elyan, md

CONTACT

01063540529mohammedelyan645@gmail.com

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
doctor

Study Record Dates

First Submitted

November 1, 2020

First Posted

November 6, 2020

Study Start

November 20, 2020

Primary Completion

November 20, 2021

Study Completion

December 20, 2021

Last Updated

November 6, 2020

Record last verified: 2020-11