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NCT Number: NCT07186790

Non-invasive Ventilation

Risk factors for non invasive ventilation failure in preterms that lead them to use invasive ventilation

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Key information

Age range

1 day–28 day

Sex eligibility

All sexes

Study type

Observational

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

-

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.

Exclusion criteria

-

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.

Treatment and study plan

Primary outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Sara Mohamed Hadia, Principal investigator

CONTACT

[email protected]

+201030372978

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study 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

Acronym: CPAP

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Sep 22, 2025
Registry last updated
Sep 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.