Skip to content

Non-invasive Ventilation

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07186790
Acronym
CPAP
Enrollment
160
Registered
2025-09-22
Start date
2025-10-01
Completion date
2025-10-01
Last updated
2025-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non Invasive Ventilation Failure in Preterms

Brief summary

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).

Interventions

None listed

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Days to 28 Days
Healthy volunteers
No

Inclusion criteria

\- The study will include neonates who meet all of the following criteria: 1. Preterms born at a gestational age of less than 32 weeks. 2. Birth weight less than 1,500 grams (very low birth weight). 3. Received initial non-invasive ventilation (e.g., CPAP or HFNC) within the first hours of life. 4. Admitted to participating NICUs during the study period. 5. Complete medical records available for review and analysis.

Exclusion criteria

\- Preterms will be excluded from the study if they meet any of the following conditions: 1. Received immediate invasive mechanical ventilation at birth without a trial of non-invasive ventilation. 2. Presence of major congenital anomalies (e.g., congenital diaphragmatic hernia, significant cardiac malformations). 3. Diagnosed with chromosomal abnormalities or genetic syndromes. 4. Incomplete or missing medical records that prevent accurate data extraction. 5. Preterms transferred from another hospital after initiation of respiratory support.

Design outcomes

Primary

MeasureTime frameDescription
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 studyOne yearRisk 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

Contacts

Primary ContactSara Mohamed Hadia, Principal investigator
Sara.17289857@med.aun.edu.eg+201030372978

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026