Study Including Neonates Who Underwent Flexible Fiberoptic Bronchoscopy in Last 10 Years at Sohag University HospitalsNCT07211971
the Value of Flexible Bronchoscopy in the Neonatal Intensive Care Unit at Sohag University Hospitals
A study testing retrospective study including neonates who underwent flexible fiberoptic bronchoscopy over a period of 10 years from January 2015 to January 2025. in people with Study Including Neonates Who Underwent Flexible Fiberoptic Bronchoscopy in Last 10 Years at Sohag University Hospitals, run by Sohag University at 1 site in Egypt.
Trial summary
The aim of this study to describe the utility of flexible fiberoptic bronchoscopy for the diagnosis and management of different respiratory diseases in the neonatal ICU. Read more about this study
- Who is it for?
- Ages 1 day to 28 days
- Conditions the study is for
- Study Including Neonates Who Underwent Flexible Fiberoptic Bronchoscopy in Last 10 Years at Sohag University Hospitals
- What is being tested?
- retrospective study including neonates who underwent flexible fiberoptic bronchoscopy over a period of 10 years from January 2015 to January 2025.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Sep 2025to 10 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 28 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- neonates aged from 1 day to 28 days with recurrent dyspnea, stridor, recurrent chocking or suspicious respiratory tract anomaly; with recurrent pulmonary infection or atelectasis in the same lung lobe; with suspicious tracheal stenosis in radiological image [X-ray or computed tomography (CT) scan]; inability to be extubated without clear reason; or confirmed congenital esophageal atresia to clarify the presence and position of esophagobronchial fistula before surgery.
Who cannot join
- neonates with neurological , cardiac problem ,age above 28 days
- -
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study to describe the utility of flexible fiberoptic bronchoscopy for the diagnosis and management of different respiratory diseases in the neonatal ICU.
Read the detailed description
Study including neonates who underwent flexible fiberoptic bronchoscopy over a period of 10 years from January 2015 to January 2025. The study population comprised neonates admitted to the NICU in Sohag University Hospitals between January 2015 and january 2025.
- The inclusion criteria were neonates aged from 1 day to 28 days with recurrent dyspnea, stridor, recurrent chocking or suspicious respiratory tract anomaly; with recurrent pulmonary infection or atelectasis in the same lung lobe; with suspicious tracheal stenosis in radiological image [X-ray or computed tomography (CT) scan]; inability to be extubated without clear reason; or confirmed congenital esophageal atresia to clarify the presence and position of esophagobronchial fistula before surgery.
- Exclusion criteria : neonates with neurological , cardiac problem ,age above 28 days Clinical data such as age, sex; weight at bronchoscopy; mechanical ventilation during hospitalization.
- Clinical indications and results of bronchoscopy were also retrospectively collected.
- Medical and surgical intervention needed for management after diagnosis by FB.
- Being tested
- retrospective study including neonates who underwent flexible fiberoptic bronchoscopy over a period of 10 years from January 2015 to January 2025.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
retrospective study including neonates who underwent flexible fiberoptic bronchoscopy over a period of 10 years from January 2015 to January 2025.Diagnostic test
retrospective study including neonates who underwent flexible fiberoptic bronchoscopy over a period of 10 years from January 2015 to January 2025.
| Study group | Role | What they receive |
|---|---|---|
| neonates who underwent flexible fiberoptic bronchoscopy | Other | Not described Receives: Diagnostic Test: retrospective study including neonates who underwent flexible fiberoptic bronchoscopy over a period of 10 years from January 2015 to January 2025. |
What is being measured
The primary outcome is the main question the study is designed to answer.
the number of patients underwent flexible bronchoscopy in NICU at sohag university hospitals
this study conducted to detrmine the number of patient underwent flexible bronchoscopy and importance of flexible bronchoscopy to reach final diagnosis and help in management of different respiratory diseases in NICU at sohag university hospitals by using the documented data including (number of patients, result of bronchoscopy of each patient as diagnosis and treatment)
Measured: immediatly after bronchoscopy
diagnosis of each neonate which reached by the broncscopy
this study conducted to detrmine the number of patient underwent flexible bronchoscopy and importance of flexible bronchoscopy to reach final diagnosis and help in management of different respiratory diseases in NICU at sohag university hospitals by using the documented data including (number of patients, result of bronchoscopy of each patient as diagnosis and treatment)
Measured: immediatly after bronchoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2025
- Study start10 Sep 2025
- Primary completion10 Sep 2026 (estimated)
- Study completion10 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Study Including Neonates Who Underwent Flexible Fiberoptic Bronchoscopy in Last 10 Years at Sohag University HospitalsStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hager Khaled Abdelmonem, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07211971
- Sponsor's protocol ID
- Soh-Med-25-9-10MS
- Status last verified
- Sep 2025
- First submitted
- 23 Sep 2025
- Last updated
- 8 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- the Value of Flexible Bronchoscopy in the Neonatal Intensive Care Unit at Sohag University Hospitals
- ClinicalTrials.gov ID
- NCT07211971
- Acronym / sponsor ID
- Soh-Med-25-9-10MS
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 10 Sep 2025 (actual)
- Primary completion
- 10 Sep 2026 (estimated)
- Study completion
- 10 Sep 2026 (estimated)
- First posted
- 8 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study to describe the utility of flexible fiberoptic bronchoscopy for the diagnosis and management of different respiratory diseases in the neonatal ICU.
Detailed description
Study including neonates who underwent flexible fiberoptic bronchoscopy over a period of 10 years from January 2015 to January 2025. The study population comprised neonates admitted to the NICU in Sohag University Hospitals between January 2015 and january 2025.
- The inclusion criteria were neonates aged from 1 day to 28 days with recurrent dyspnea, stridor, recurrent chocking or suspicious respiratory tract anomaly; with recurrent pulmonary infection or atelectasis in the same lung lobe; with suspicious tracheal stenosis in radiological image [X-ray or computed tomography (CT) scan]; inability to be extubated without clear reason; or confirmed congenital esophageal atresia to clarify the presence and position of esophagobronchial fistula before surgery.
- Exclusion criteria : neonates with neurological , cardiac problem ,age above 28 days Clinical data such as age, sex; weight at bronchoscopy; mechanical ventilation during hospitalization.
- Clinical indications and results of bronchoscopy were also retrospectively collected.
- Medical and surgical intervention needed for management after diagnosis by FB.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| neonates who underwent flexible fiberoptic bronchoscopy | Other | Diagnostic Test: retrospective study including neonates who underwent flexible fiberoptic bronchoscopy over a period of 10 years from January 2015 to January 2025. |
Who may qualify
- Ages
- 1 day to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- neonates aged from 1 day to 28 days with recurrent dyspnea, stridor, recurrent chocking or suspicious respiratory tract anomaly; with recurrent pulmonary infection or atelectasis in the same lung lobe; with suspicious tracheal stenosis in radiological image [X-ray or computed tomography (CT) scan]; inability to be extubated without clear reason; or confirmed congenital esophageal atresia to clarify the presence and position of esophagobronchial fistula before surgery.
Key exclusion criteria (2 listed)
- neonates with neurological , cardiac problem ,age above 28 days
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| retrospective study including neonates who underwent flexible fiberoptic bronchoscopy over a period of 10 years from January 2015 to January 2025.retrospective study including neonates who underwent flexible fiberoptic bronchoscopy over a period of 10 years from January 2015 to January 2025. | Diagnostic test | neonates who underwent flexible fiberoptic bronchoscopy |
Primary outcome
the number of patients underwent flexible bronchoscopy in NICU at sohag university hospitals
Time frame: immediatly after bronchoscopy
this study conducted to detrmine the number of patient underwent flexible bronchoscopy and importance of flexible bronchoscopy to reach final diagnosis and help in management of different respiratory diseases in NICU at sohag university hospitals by using the documented data including (number of patients, result of bronchoscopy of each patient as diagnosis and treatment)
diagnosis of each neonate which reached by the broncscopy
Time frame: immediatly after bronchoscopy
this study conducted to detrmine the number of patient underwent flexible bronchoscopy and importance of flexible bronchoscopy to reach final diagnosis and help in management of different respiratory diseases in NICU at sohag university hospitals by using the documented data including (number of patients, result of bronchoscopy of each patient as diagnosis and treatment)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2025.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing retrospective study including neonates who underwent flexible fiberoptic bronchoscopy over a period of 10 years from January 2015 to January 2025. in people with Study Including Neonates Who Underwent Flexible Fiberoptic Bronchoscopy in Last 10 Years at Sohag University Hospitals, run by Sohag University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the number of patients underwent flexible bronchoscopy in NICU at sohag university hospitals (time frame: immediatly after bronchoscopy). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2025.