Diaphragm UltrasoundNCT07148102
Diaphragmatic Ultrasound and Thoracic Fluid Content for Prediction of Non-Invasive Ventilation Failure in Neonates
An observational study of Diaphragm Ultrasound and Electrical Cardiometry, run by Lamiaa Khaled Zidan at 1 site in Egypt.
Trial summary
This research assessed diaphragmatic ultrasound and thoracic fluid content (TFC) as potential early predictive tools for detecting NIV failure in preterm neonates. Read more about this study
- Who is it for?
- Ages 30 to 30 minutes
- Conditions the study is for
- Diaphragm Ultrasound, Electrical Cardiometry, Non Invasive Ventilation (NIV)
- What is being tested?
- Diaphragmatic US and EC
- Type of treatment
- Medical device
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2020to 1 May 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 30 to 30 minutes
- All sexes
- No healthy volunteers
- Child
Study population: Preterm neonates (28-34 weeks GA) with RDS and requiring NIV
Who may be able to join
- Preterm neonates of both sexes, with gestational ages ranging from 28 to 34 weeks, diagnosed with RDS and requiring non-invasive ventilation within 30 minutes of birth
Who cannot join
- Exclusion criteria included intubation in the delivery room, complex congenital heart disease, major congenital anomalies in the lungs or airways, and other causes of respiratory distress unrelated to RDS.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Medicine, Tanta University
Tanta, Tanta, Q2x2+cp Tanta 2, Egypt, 31527
About this study
This research assessed diaphragmatic ultrasound and thoracic fluid content (TFC) as potential early predictive tools for detecting NIV failure in preterm neonates.
Read the detailed description
Non-invasive ventilatory support (NIV) is considered a gold standard care for preterm infants with respiratory distress syndrome (RDS); however, NIV failure remains a frequent challenge that is often associated with many adverse outcomes
- Conditions
- Diaphragm Ultrasound, Electrical Cardiometry, Non Invasive Ventilation (NIV), RDS of Prematurity
- Being tested
- Diaphragmatic US, EC
- Keywords
- EC, NIV, RDS, TFC, DTF, DE
- Medical subject headings
- Respiratory Distress Syndrome In Premature Infants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diaphragmatic USDevice
Diaphragmatic thickening fraction (DTF) and diaphragmatic excursion (DE) were measured by ultrasound within the first three hours of life and repeated either 24 hours later in successful cases or immediately before intubation in cases who had NIV failure.
ECDevice
TFC was assessed using electrical cardiometry (EC). Measurements were obtained within the first three hours of life and repeated either 24 hours later in successful cases or immediately before intubation in cases who had NIV failure.
| Study group | Role | What they receive |
|---|---|---|
| CPAP | 30 infants supported by nasal CPAP Receives: Device: Diaphragmatic US; Device: EC | |
| NIPPV | 30 infants supported by non-invasive positive pressure ventilation Receives: Device: Diaphragmatic US; Device: EC | |
| NHFOV | 30 infants supported with nasal high-frequency oscillatory ventilation Receives: Device: Diaphragmatic US; Device: EC |
What is being measured
The primary outcome is the main question the study is designed to answer.
The predictive value
The predictive value of DTF, DE, and TFC for NIV failure in preterm neonates with RDS.
Measured: Two years
Secondary outcomes (1)
Success Rate
Comparing success rates among CPAP, NIPPV, and NHFOV groups,
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2025
- Study start1 May 2020
- Primary completion1 May 2023
- Study completion1 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diaphragm UltrasoundStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lamiaa Khaled Zidan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lamiaa Khaled Zidan, Tanta University
- Investigators
- Heba Saied Elmahdy, Professor, Study director, Faculty of Medicine, Tanta University, Tanta, Q2x2+cp Tanta 2, Egypt, 31527
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07148102
- Sponsor's protocol ID
- DTF, DE, TFC with NIV failure
- Status last verified
- Aug 2025
- First submitted
- 22 Aug 2025
- Last updated
- 29 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Elgendy EM, Elmahdy HS, Nassar MAE, Zidan LK, Eltomey MA, Elsharkawy HM. Diaphragmatic ultrasound and thoracic fluid content for prediction of non-invasive ventilation failure in neonates: a randomized controlled trial. Eur J Pediatr. 2025 Dec 9;185(1):3. doi: 10.1007/s00431-025-06605-8.
PubMed 41364345
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diaphragmatic Ultrasound and Thoracic Fluid Content for Prediction of Non-Invasive Ventilation Failure in Neonates
- ClinicalTrials.gov ID
- NCT07148102
- Acronym / sponsor ID
- DTF, DE, TFC with NIV failure
- Conditions
- Diaphragm Ultrasound, Electrical Cardiometry, Non Invasive Ventilation (NIV), RDS of Prematurity
- Keywords
- EC, NIV, RDS, TFC, DTF, DE
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Lamiaa Khaled ZidanUniversity, hospital or other
- Study start
- 1 May 2020 (actual)
- Primary completion
- 1 May 2023 (actual)
- Study completion
- 1 May 2023 (actual)
- First posted
- 29 Aug 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.
This research assessed diaphragmatic ultrasound and thoracic fluid content (TFC) as potential early predictive tools for detecting NIV failure in preterm neonates.
Detailed description
Non-invasive ventilatory support (NIV) is considered a gold standard care for preterm infants with respiratory distress syndrome (RDS); however, NIV failure remains a frequent challenge that is often associated with many adverse outcomes
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CPAP | – | Device: Diaphragmatic US, Device: EC30 infants supported by nasal CPAP |
| NIPPV | – | Device: Diaphragmatic US, Device: EC30 infants supported by non-invasive positive pressure ventilation |
| NHFOV | – | Device: Diaphragmatic US, Device: EC30 infants supported with nasal high-frequency oscillatory ventilation |
Who may qualify
- Ages
- 30 to 30 minutes
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Preterm neonates (28-34 weeks GA) with RDS and requiring NIV
Key inclusion criteria (1 listed)
- Preterm neonates of both sexes, with gestational ages ranging from 28 to 34 weeks, diagnosed with RDS and requiring non-invasive ventilation within 30 minutes of birth
Key exclusion criteria (1 listed)
- Exclusion criteria included intubation in the delivery room, complex congenital heart disease, major congenital anomalies in the lungs or airways, and other causes of respiratory distress unrelated to RDS.
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 |
|---|---|---|
| Diaphragmatic USDiaphragmatic thickening fraction (DTF) and diaphragmatic excursion (DE) were measured by ultrasound within the first three hours of life and repeated either 24 hours later in successful cases or immediately before intubation in cases who had NIV failure. | Device | CPAP, NHFOV, NIPPV |
| ECTFC was assessed using electrical cardiometry (EC). Measurements were obtained within the first three hours of life and repeated either 24 hours later in successful cases or immediately before intubation in cases who had NIV failure. | Device | CPAP, NHFOV, NIPPV |
Primary outcome
The predictive value
Time frame: Two years
The predictive value of DTF, DE, and TFC for NIV failure in preterm neonates with RDS.
1 secondary outcome
Success Rate
Time frame: Two years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2025.
- Derived from this study: PubMed 41364345Elgendy EM, Elmahdy HS, Nassar MAE, Zidan LK, Eltomey MA, Elsharkawy HM. Diaphragmatic ultrasound and thoracic fluid content for prediction of non-invasive ventilation failure in neonates: a randomized controlled trial. Eur J Pediatr. 2025 Dec 9;185(1):3. doi: 10.1007/s00431-025-06605-8.
- Individual participant dataSharing planned: Undecided
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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.
Heba Saied Elmahdy, Professor study director
Faculty of Medicine, Tanta University, Tanta, Q2x2+cp Tanta 2, Egypt, 31527
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diaphragm Ultrasound and Electrical Cardiometry, run by Lamiaa Khaled Zidan 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 1 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: finished, as of the sponsor's last update on 29 Aug 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 predictive value (time frame: Two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07148102, which also lists 1 linked publication.
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 29 Aug 2025.