Non Invasive Ventilation Failure in PretermsCPAPNCT07186790
Non-invasive Ventilation
An observational study of Non Invasive Ventilation Failure in Preterms, run by Assiut University.
Trial summary
Risk factors for non invasive ventilation failure in preterms that lead them to use invasive ventilation Read more about this study
- Who is it for?
- Ages 1 day to 28 days
- Conditions the study is for
- Non Invasive Ventilation Failure in Preterms
- How many people
- 160 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2025to 1 Oct 2025
- Phase
- Observational
- 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
Study population: The study population will consist of preterms aged <32 weeks and what is the risk factors for failure of non invasive ventilation that lead them to use invasive ventilation
Who may be able to join
- -
- The study will include neonates who meet all of the following criteria:
- Preterms born at a gestational age of less than 32 weeks.
- Birth weight less than 1,500 grams (very low birth weight).
- Received initial non-invasive ventilation (e.g., CPAP or HFNC) within the first hours of life.
- Admitted to participating NICUs during the study period.
- Complete medical records available for review and analysis.
Who cannot join
- -
- Preterms will be excluded from the study if they meet any of the following conditions:
- Received immediate invasive mechanical ventilation at birth without a trial of non-invasive ventilation.
- Presence of major congenital anomalies (e.g., congenital diaphragmatic hernia, significant cardiac malformations).
- Diagnosed with chromosomal abnormalities or genetic syndromes.
- Incomplete or missing medical records that prevent accurate data extraction.
- Preterms transferred from another hospital after initiation of respiratory support.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Risk Factors for Initial Non Invasive Ventilation Failure in Preterms With Gestational Age <32 Weeks in Neonatal Intensive Care Units of Assiut University Children Hospital ,One Year Study
Risk factors for non invasive ventilation failure in preterms that lead them to use invasive ventilation
Read the detailed description
Non-invasive ventilation (NIV) is widely utilized in the initial respiratory management of very low birth weight (VLBW) preterms , particularly those born at a gestational age of less than 32 weeks, to avoid complications associated with invasive mechanical ventilation. Despite advances in neonatal respiratory care, the risk of initial NIV failure remains a significant clinical concern due to its association with increased morbidity and the subsequent need for intubation and invasive support. Early identification of neonates at high risk for NIV failure is crucial for timely intervention and optimization of respiratory strategies to improve outcomes (Wu et al., 2024).
Previous multicenter and prospective studies have highlighted various clinical and physiological parameters contributing to the failure of NIV in preterms. These include lower gestational age, severe respiratory distress syndrome (RDS), higher oxygen requirements, and hemodynamic instability in the immediate postnatal period (Boix et al., 2023). The complexity of respiratory adaptation in this population necessitates robust risk stratification tools and predictive models to support clinical decision-making in the neonatal intensive care unit (NICU) (Fernandez-Gonzalez et al., 2022).
Recent research efforts, including the establishment of predictive models, have focused on incorporating variables such as Apgar scores, initial FiO₂, surfactant administration, and radiographic findings to identify preterms most likely to fail NIV. Understanding these risk factors is essential not only for improving survival but also for reducing the incidence of bronchopulmonary dysplasia (BPD) and other long-term pulmonary complications (Shen et al., 2024).
Furthermore, expert consensus guidelines from neonatology societies advocate for early use of continuous positive airway pressure (CPAP) and targeted surfactant therapy to mitigate the progression of RDS and enhance NIV success. However, despite adherence to best practices, a considerable proportion of VLBW preterms still experience respiratory deterioration necessitating escalation to invasive ventilation (Akin et al., 2025).
Emerging data also point to institution-specific practices, such as type of NIV modality used (e.g., nasal intermittent positive pressure ventilation vs. high-frequency oscillatory NIV) (Wang et al., 2025).
Given the significant clinical implications, understanding and applying these risk factors can help neonatal teams anticipate NIV failure early, apply targeted respiratory strategies, and improve short- and long-term outcomes in preterms (Afzal et al., 2024; de Souza Júnior et al., 2023; Yazici et al., 2025).
What is being measured
The primary outcome is the main question the study is designed to answer.
Risk factors for initial non invasive ventilation failure in preterms with gestational age <32 weeks in neonatal intensive care units of assiut university children hospital,one year study
Risk factors for initial non invasive ventilation failure in preterms with gestational age <32 weeks in neonatal intensive care units of assiut university children hospital,one year study
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2025
- Study start1 Oct 2025 (estimated)
- Primary completion1 Oct 2025 (estimated)
- Study completion1 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Non Invasive Ventilation Failure in PretermsStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara mohamed hadia mohamed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07186790
- Sponsor's protocol ID
- Non invasive ventilation
- Acronym
- CPAP
- Status last verified
- Sep 2025
- First submitted
- 16 Sep 2025
- Last updated
- 22 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Bastos de Souza Junior NW, Rosa TR, Cerantola JCK, Ferrari LSL, Probst VS, Felcar JM. Predictive factors for extubation success in very low and extremely low birth weight preterm infants. Can J Respir Ther. 2023 Sep 15;59:204-213. doi: 10.29390/001c.87789. eCollection 2023.
PubMed 37781349Fernandez-Gonzalez SM, Sucasas Alonso A, Ogando Martinez A, Avila-Alvarez A. Incidence, Predictors and Outcomes of Noninvasive Ventilation Failure in Very Preterm Infants. Children (Basel). 2022 Mar 17;9(3):426. doi: 10.3390/children9030426.
PubMed 35327798Yazici A, Buyuktiryaki M, Sari FN, Alyamac Dizdar E. Risk factors for noninvasive ventilation failure in preterm infants at less than 30 weeks of gestation with respiratory distress syndrome. J Trop Pediatr. 2024 Dec 5;71(1):fmae051. doi: 10.1093/tropej/fmae051.
PubMed 39840596Wang W, Tan R, Dong W. Non-invasive intermittent positive pressure ventilation vs non-invasive high-frequency oscillatory ventilation as post-extubation support in extremely birth weight infants: a retrospective study. Eur J Pediatr. 2025 Apr 21;184(5):303. doi: 10.1007/s00431-025-06117-5.
PubMed 40257605Shen F, Yu MY, Rong H, Guo Y, Zou YS, Cheng R, Yang Y. Establishment and Validation of a Risk Prediction Model for Non-Invasive Ventilation Failure After Birth in Premature Infants with Gestational Age < 32 Weeks. Lung. 2024 Oct;202(5):543-552. doi: 10.1007/s00408-024-00727-w. Epub 2024 Jul 3.
PubMed 38958717Akin MS, Sari FN, Cetinkaya AK, Acikgoz IC, Dizdar EA. The Predictors and Outcomes of Early Noninvasive Positive Pressure Ventilation Failure in Very Preterm Infants: A Prospective Study. Am J Perinatol. 2026 Mar;43(4):437-444. doi: 10.1055/a-2624-5642. Epub 2025 Jun 16.
PubMed 40523391
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors for Initial Non Invasive Ventilation Failure in Preterms With Gestational Age <32 Weeks in Neonatal Intensive Care Units of Assiut University Children Hospital ,One Year Study
- ClinicalTrials.gov ID
- NCT07186790
- Acronym / sponsor ID
- CPAP / Non invasive ventilation
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 22 Sep 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.
Risk factors for non invasive ventilation failure in preterms that lead them to use invasive ventilation
Detailed description
Non-invasive ventilation (NIV) is widely utilized in the initial respiratory management of very low birth weight (VLBW) preterms , particularly those born at a gestational age of less than 32 weeks, to avoid complications associated with invasive mechanical ventilation. Despite advances in neonatal respiratory care, the risk of initial NIV failure remains a significant clinical concern due to its association with increased morbidity and the subsequent need for intubation and invasive support. Early identification of neonates at high risk for NIV failure is crucial for timely intervention and optimization of respiratory strategies to improve outcomes (Wu et al., 2024).
Previous multicenter and prospective studies have highlighted various clinical and physiological parameters contributing to the failure of NIV in preterms. These include lower gestational age, severe respiratory distress syndrome (RDS), higher oxygen requirements, and hemodynamic instability in the immediate postnatal period (Boix et al., 2023). The complexity of respiratory adaptation in this population necessitates robust risk stratification tools and predictive models to support clinical decision-making in the neonatal intensive care unit (NICU) (Fernandez-Gonzalez et al., 2022).
Recent research efforts, including the establishment of predictive models, have focused on incorporating variables such as Apgar scores, initial FiO₂, surfactant administration, and radiographic findings to identify preterms most likely to fail NIV. Understanding these risk factors is essential not only for improving survival but also for reducing the incidence of bronchopulmonary dysplasia (BPD) and other long-term pulmonary complications (Shen et al., 2024).
Furthermore, expert consensus guidelines from neonatology societies advocate for early use of continuous positive airway pressure (CPAP) and targeted surfactant therapy to mitigate the progression of RDS and enhance NIV success. However, despite adherence to best practices, a considerable proportion of VLBW preterms still experience respiratory deterioration necessitating escalation to invasive ventilation (Akin et al., 2025).
Emerging data also point to institution-specific practices, such as type of NIV modality used (e.g., nasal intermittent positive pressure ventilation vs. high-frequency oscillatory NIV) (Wang et al., 2025).
Given the significant clinical implications, understanding and applying these risk factors can help neonatal teams anticipate NIV failure early, apply targeted respiratory strategies, and improve short- and long-term outcomes in preterms (Afzal et al., 2024; de Souza Júnior et al., 2023; Yazici et al., 2025).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 day to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- The study population will consist of preterms aged <32 weeks and what is the risk factors for failure of non invasive ventilation that lead them to use invasive ventilation
Key inclusion criteria (7 listed)
- -
- Preterms born at a gestational age of less than 32 weeks.
- Birth weight less than 1,500 grams (very low birth weight).
- Received initial non-invasive ventilation (e.g., CPAP or HFNC) within the first hours of life.
- Admitted to participating NICUs during the study period.
Key exclusion criteria (7 listed)
- -
- Received immediate invasive mechanical ventilation at birth without a trial of non-invasive ventilation.
- Presence of major congenital anomalies (e.g., congenital diaphragmatic hernia, significant cardiac malformations).
- Diagnosed with chromosomal abnormalities or genetic syndromes.
- Incomplete or missing medical records that prevent accurate data extraction.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Risk factors for initial non invasive ventilation failure in preterms with gestational age <32 weeks in neonatal intensive care units of assiut university children hospital,one year study
Time frame: One year
Risk factors for initial non invasive ventilation failure in preterms with gestational age <32 weeks in neonatal intensive care units of assiut university children hospital,one year study
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 22 Sep 2025.
- Results publication: PubMed 37781349Bastos de Souza Junior NW, Rosa TR, Cerantola JCK, Ferrari LSL, Probst VS, Felcar JM. Predictive factors for extubation success in very low and extremely low birth weight preterm infants. Can J Respir Ther. 2023 Sep 15;59:204-213. doi: 10.29390/001c.87789. eCollection 2023.
- Results publication: PubMed 35327798Fernandez-Gonzalez SM, Sucasas Alonso A, Ogando Martinez A, Avila-Alvarez A. Incidence, Predictors and Outcomes of Noninvasive Ventilation Failure in Very Preterm Infants. Children (Basel). 2022 Mar 17;9(3):426. doi: 10.3390/children9030426.
- Results publication: PubMed 39840596Yazici A, Buyuktiryaki M, Sari FN, Alyamac Dizdar E. Risk factors for noninvasive ventilation failure in preterm infants at less than 30 weeks of gestation with respiratory distress syndrome. J Trop Pediatr. 2024 Dec 5;71(1):fmae051. doi: 10.1093/tropej/fmae051.
- Results publication: PubMed 40257605Wang W, Tan R, Dong W. Non-invasive intermittent positive pressure ventilation vs non-invasive high-frequency oscillatory ventilation as post-extubation support in extremely birth weight infants: a retrospective study. Eur J Pediatr. 2025 Apr 21;184(5):303. doi: 10.1007/s00431-025-06117-5.
- Results publication: PubMed 38958717Shen F, Yu MY, Rong H, Guo Y, Zou YS, Cheng R, Yang Y. Establishment and Validation of a Risk Prediction Model for Non-Invasive Ventilation Failure After Birth in Premature Infants with Gestational Age < 32 Weeks. Lung. 2024 Oct;202(5):543-552. doi: 10.1007/s00408-024-00727-w. Epub 2024 Jul 3.
- Results publication: PubMed 40523391Akin MS, Sari FN, Cetinkaya AK, Acikgoz IC, Dizdar EA. The Predictors and Outcomes of Early Noninvasive Positive Pressure Ventilation Failure in Very Preterm Infants: A Prospective Study. Am J Perinatol. 2026 Mar;43(4):437-444. doi: 10.1055/a-2624-5642. Epub 2025 Jun 16.
- Individual participant dataSharing planned: Undecided
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Non Invasive Ventilation Failure in Preterms, run by Assiut University.
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 7 inclusion and 7 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: opening soon, as of the sponsor's last update on 22 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Sara Mohamed Hadia, Principal investigator (+201030372978, Sara.17289857@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Risk factors for initial non invasive ventilation failure in preterms with gestational age <32 weeks in neonatal intensive care units of assiut university children hospital,one year study (time frame: One year). 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 NCT07186790, which also lists 6 linked publications.
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 22 Sep 2025.