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OpenTrials
Completed

NCT Number: NCT05260424

Predictors for Nasal Intermittent Positive Pressure Ventilation Failure for Premature Infants With Respiratory Distress Syndrome

Non-invasive respiratory support methods have been widely used in premature babies with respiratory distress syndrome (RDS) which has changed the basic management of premature babies in the early period. According to the 2019 European Guidelines on RDS management, early nasal CPAP is recommended as first-line therapy in infants <30 weeks of age who are at risk of RDS who do not require mechanical ventilation (MV). However, some of the premature babies have faced non-invasive ventilation failure. Remarkably, infants who experience non-invasive ventilation failure are at increased risk of death, pneumothorax, intraventricular hemorrhage, and bronchopulmonary dysplasia (BPD), among other morbidities. In non-invasive ventilation failure, although demographic factors such as small gestational age, low birth weight, and male gender play a role, it has been suggested that surfactant deficiency may also play an important role. The most frequently reported risk factor in predicting non-invasive failure in studies is the fraction of inspiring oxygen during the first hours of life. In addition, positive end-expiratory airway pressure (PEEP) required for patient stabilization was found to be a potential predictor. However, there are still limited data to predict non-invasive ventilation failure. "Which newborns are at high risk for non-invasive ventilation failure?" and "When should the surfactant be applied?". The study is a single-center, prospective study to evaluate prognostic factors, and most importantly to define the FiO2 threshold, which is an indicator of possible non-invasive ventilation failure in infants supported with nasal intermittent positive pressure ventilation.

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Key information

Who can participate

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

Inclusion criteria

  • <32 weeks preterm babies
  • Those who have received nasal intermittent positive pressure ventilation

Exclusion criteria

  • Babies born> 32 weeks
  • Babies with congenital anomalies
  • Babies who have intubated in the delivery room
  • Babies whose parents refuse to participitate

Treatment and study plan

Non-invasive ventilation

Other

Babies who will have or won't have non-invasive ventilation failure in the first 72 hoursof life, will be compared.

Primary outcomes

  1. Risk of intubation in the first 72 hours in premature babies

    Time frame: 2 year

    To determine the risk of intubation in the first 72 hours of life in premature babies less than 32 weeks of gestation who have supported with nasal intermittent positive pressure ventilation

Secondary outcomes

  1. To describe the incidence and early precursors of non-invasive ventilation failure.

    Time frame: 2 year

    Invasive, non-invasive ventilation and supplemental oxygen day time

  2. Looking for early predictors,

    Time frame: 2 year

    Looking for early predictors, including combinations of breathed oxygen fraction (FiO2) and non-invasive ventilation level in early life

  3. morbidity and mortality

    Time frame: 2 year

    To investigate the negative consequences of non-invasive ventilation failure.

Sponsors and collaborators

Lead sponsor

Ankara City Hospital Bilkent

Other

Registry information

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Mar 2, 2022
Registry last updated
Nov 18, 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.

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