Diagnosis of Transient Tachypnea of Newborn

Transient Tachypnea of the Newborn Clinical Trial

Official title:

Thoracic Fluid Content Using Electrical Cardiometry Versus Lung Ultrasound in the Diagnosis of Transient Tachypnea of Newborn

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05538780
• Other study ID #: 34987/10/21
• Status: Recruiting
• Start date: January 1, 2022
• Est. completion date: January 1, 2023

Study information

• Verified date: September 2022
• Source: Tanta University
• Contact: ashraf abuhamama, PhD
• Phone: 0020403322645
• Email: ashraf.abohamama[@]med.tanta.edu.eg
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Transient tachypnea of the newborn (TTN) is the most common cause of respiratory distress in fullterm newborn. TTN is a diagnosis of exclusion, It is primarily diagnosed based on medical history and typical clinical presentation. Lung ultrasonography is an accurate, non invasive and reliable tool for diagnosing TTN. Cardiometry is presently the only tool to evaluate thoracic fluid content continuously and noninvasively at the bedside.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: January 1, 2023
• Est. primary completion date: November 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Days to 3 Days

Eligibility

Inclusion Criteria:

• fifty newborns with gestational age = 34 weeks (calculated from the first day of last menstrual period and using New Ballard score) diagnosed with TTN

Exclusion Criteria:

1. Gestational age less than 34 weeks.

2. Major congenital abnormalities.

3. Congenital heart diseases.

4. Neonatal sepsis.

5. Neonatal pneumonia.

6. Other causes of respiratory distress (RD)

Related Conditions & MeSH terms

• Tachypnea
• Transient Tachypnea of the Newborn

Locations

Country	Name	City	State
Egypt	Tanta University, faculty of medicine	Tanta

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

References & Publications (3)

Hammad Y, Hasanin A, Elsakka A, Refaie A, Abdelfattah D, Rahman SA, Zayed M, Hassabelnaby Y, Mukhtar A, Omran A. Thoracic fluid content: a novel parameter for detection of pulmonary edema in parturients with preeclampsia. J Clin Monit Comput. 2019 Jun;33(3):413-418. doi: 10.1007/s10877-018-0176-6. Epub 2018 Jun 23. — View Citation

Ibrahim M, Omran A, AbdAllah NB, Ibrahim M, El-Sharkawy S. Lung ultrasound in early diagnosis of neonatal transient tachypnea and its differentiation from other causes of neonatal respiratory distress. J Neonatal Perinatal Med. 2018;11(3):281-287. doi: 10.3233/NPM-181796. — View Citation

Paviotti G, De Cunto A, Moressa V, Bettiol C, Demarini S. Thoracic fluid content by electric bioimpedance correlates with respiratory distress in newborns. J Perinatol. 2017 Sep;37(9):1024-1027. doi: 10.1038/jp.2017.100. Epub 2017 Jul 27. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change of thoracic fluid content	measured by electrical cardiometry ( ICON®; Osypka Medical, Berlin, Germany)	at enrollment and after 72 hours of birth
Primary	change of ultrasound data: double-lung point, interstitial lung syndrome, and fuzziness of the pleural lines (A-lines) and pleural effusion.	using Siemens Acuson X300 ultrasound machine ( Siemens Health Care GmbH, Erlangen, Germany )	at enrollment and after 72 hours of birth