Diagnosis of Transient Tachypnea of Newborn
Thoracic Fluid Content Using Electrical Cardiometry Versus Lung Ultrasound in the Diagnosis of Transient Tachypnea of Newborn
1 other identifier
observational
50
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jan 2022
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2022
CompletedFirst Submitted
Initial submission to the registry
September 9, 2022
CompletedFirst Posted
Study publicly available on registry
September 14, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2023
CompletedSeptember 16, 2022
September 1, 2022
10 months
September 9, 2022
September 14, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
change of thoracic fluid content
measured by electrical cardiometry ( ICON®; Osypka Medical, Berlin, Germany)
at enrollment and after 72 hours of birth
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
Eligibility Criteria
50 neonates diagnosed with Transient Tachypnea of Newborn admitted at Neonatal Intensive Care Unit, Tanta University Hospitals
You may qualify if:
- fifty newborns with gestational age ≥ 34 weeks (calculated from the first day of last menstrual period and using New Ballard score) diagnosed with TTN
You may not qualify if:
- Gestational age less than 34 weeks.
- Major congenital abnormalities.
- Congenital heart diseases.
- Neonatal sepsis.
- Neonatal pneumonia.
- Other causes of respiratory distress (RD)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tanta Universitylead
Study Sites (1)
Tanta University, faculty of medicine
Tanta, 31527, Egypt
Related 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.
PMID: 29936563BACKGROUNDPaviotti 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.
PMID: 28749485BACKGROUNDIbrahim 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.
PMID: 30040751BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
ashraf abuhamama
Tanta university faculty of medicine
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- clinical professor
Study Record Dates
First Submitted
September 9, 2022
First Posted
September 14, 2022
Study Start
January 1, 2022
Primary Completion
November 1, 2022
Study Completion
January 1, 2023
Last Updated
September 16, 2022
Record last verified: 2022-09
Data Sharing
- IPD Sharing
- Will not share