Predictors for Nasal Intermittent Positive Pressure Ventilation Failure for Premature Infants With Respiratory Distress Syndrome
November 17, 2025 updated by: Ankara City Hospital Bilkent
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
397
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Ankara, Turkey (Türkiye), 06000
- Ankara City Hospital Bilkent
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
N/A
Sampling Method
Probability Sample
Study Population
Preterm babies < 32 weeks gestational age who have received nasal intermittent positive pressure ventilation.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
non-invasive ventilation failure
babies who will be intubated in the first 72 hours
|
Babies who will have or won't have non-invasive ventilation failure in the first 72 hoursof life, will be compared.
|
|
non-invasive ventilation success
babies who will not intubated in the first 72 hours
|
Babies who will have or won't have non-invasive ventilation failure in the first 72 hoursof life, will be compared.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
2 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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 year
|
|
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
|
2 year
|
|
morbidity and mortality
Time Frame: 2 year
|
To investigate the negative consequences of non-invasive ventilation failure.
|
2 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Dargaville PA, Aiyappan A, De Paoli AG, Dalton RG, Kuschel CA, Kamlin CO, Orsini F, Carlin JB, Davis PG. Continuous positive airway pressure failure in preterm infants: incidence, predictors and consequences. Neonatology. 2013;104(1):8-14. doi: 10.1159/000346460. Epub 2013 Apr 4.
- Gulczynska E, Szczapa T, Hozejowski R, Borszewska-Kornacka MK, Rutkowska M. Fraction of Inspired Oxygen as a Predictor of CPAP Failure in Preterm Infants with Respiratory Distress Syndrome: A Prospective Multicenter Study. Neonatology. 2019;116(2):171-178. doi: 10.1159/000499674. Epub 2019 May 21.
- Shi Y, Tang S, Zhao J, Shen J. A prospective, randomized, controlled study of NIPPV versus nCPAP in preterm and term infants with respiratory distress syndrome. Pediatr Pulmonol. 2014 Jul;49(7):673-8. doi: 10.1002/ppul.22883. Epub 2013 Sep 4.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2020
Primary Completion (Actual)
February 1, 2024
Study Completion (Actual)
February 1, 2024
Study Registration Dates
First Submitted
October 20, 2021
First Submitted That Met QC Criteria
February 18, 2022
First Posted (Actual)
March 2, 2022
Study Record Updates
Last Update Posted (Estimated)
November 18, 2025
Last Update Submitted That Met QC Criteria
November 17, 2025
Last Verified
May 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Obstetric Labor, Premature
- Obstetric Labor Complications
- Pregnancy Complications
- Respiratory Tract Diseases
- Lung Diseases
- Respiration Disorders
- Infant, Premature, Diseases
- Infant, Newborn, Diseases
- Respiratory Distress Syndrome
- Congenital, Hereditary, and Neonatal Diseases and Abnormalities
- Premature Birth
- Respiratory Distress Syndrome, Newborn
- Therapeutics
- Airway Management
- Respiratory Therapy
- Respiration, Artificial
- Noninvasive Ventilation
Other Study ID Numbers
- E1-20-1250
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.