NCT05538780

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

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

January 1, 2022

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 14, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
Last Updated

September 16, 2022

Status Verified

September 1, 2022

Enrollment Period

10 months

First QC Date

September 9, 2022

Last Update Submit

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

Age0 Days - 3 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

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

Study Sites (1)

Tanta University, faculty of medicine

Tanta, 31527, Egypt

RECRUITING

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: 29936563BACKGROUND
  • 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.

    PMID: 28749485BACKGROUND
  • 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.

    PMID: 30040751BACKGROUND

MeSH Terms

Conditions

Transient Tachypnea of the Newborn

Condition Hierarchy (Ancestors)

Respiratory Distress Syndrome, NewbornRespiratory Distress SyndromeLung DiseasesRespiratory Tract DiseasesRespiration DisordersTachypneaInfant, Premature, DiseasesInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • ashraf abuhamama

    Tanta university faculty of medicine

    STUDY DIRECTOR

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

Locations