Respiratory Distress Syndrome, NewbornNCT05260424
Predictors for Nasal Intermittent Positive Pressure Ventilation Failure for Premature Infants With Respiratory Distress Syndrome
An observational study of Respiratory Distress Syndrome, Newborn and Premature, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Respiratory Distress Syndrome, Newborn, Premature
- What is being tested?
- non-invasive ventilation
- How many people
- 397 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2020to 1 Feb 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- Child, Adult, Older adult
Study population: Preterm babies < 32 weeks gestational age who have received nasal intermittent positive pressure ventilation.
Who may be able to join
- <32 weeks preterm babies
- Those who have received nasal intermittent positive pressure ventilation
Who cannot join
- Babies born> 32 weeks
- Babies with congenital anomalies
- Babies who have intubated in the delivery room
- Babies whose parents refuse to participitate
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Respiratory Distress Syndrome, Newborn, Premature
- Being tested
- non-invasive ventilation
- Medical subject headings
- Respiratory Distress Syndrome, Newborn, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non-invasive ventilationOther
Babies who will have or won't have non-invasive ventilation failure in the first 72 hoursof life, will be compared.
| Study group | Role | What they receive |
|---|---|---|
| non-invasive ventilation failure | babies who will be intubated in the first 72 hours Receives: Other: non-invasive ventilation | |
| non-invasive ventilation success | babies who will not intubated in the first 72 hours Receives: Other: non-invasive ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Risk of intubation in the first 72 hours in premature babies
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
Measured: 2 year
Secondary outcomes (3)
To describe the incidence and early precursors of non-invasive ventilation failure.
Invasive, non-invasive ventilation and supplemental oxygen day time
Measured: 2 year
Looking for early predictors,
Looking for early predictors, including combinations of breathed oxygen fraction (FiO2) and non-invasive ventilation level in early life
Measured: 2 year
morbidity and mortality
To investigate the negative consequences of non-invasive ventilation failure.
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2022
- Study start1 Dec 2020
- Primary completion1 Feb 2024
- Study completion1 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Respiratory Distress Syndrome, NewbornStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe 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
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 397 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05260424
- Sponsor's protocol ID
- E1-20-1250
- Status last verified
- May 2024
- First submitted
- 20 Oct 2021
- Last updated
- 18 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 23595061Gulczynska 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.
PubMed 31112987Shi 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.
PubMed 24039148
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors for Nasal Intermittent Positive Pressure Ventilation Failure for Premature Infants With Respiratory Distress Syndrome
- ClinicalTrials.gov ID
- NCT05260424
- Acronym / sponsor ID
- E1-20-1250
- Conditions
- Respiratory Distress Syndrome, Newborn, Premature
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 397 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 1 Feb 2024 (actual)
- Study completion
- 1 Feb 2024 (actual)
- First posted
- 2 Mar 2022 (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.
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 design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| non-invasive ventilation failure | – | Other: non-invasive ventilationbabies who will be intubated in the first 72 hours |
| non-invasive ventilation success | – | Other: non-invasive ventilationbabies who will not intubated in the first 72 hours |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Preterm babies < 32 weeks gestational age who have received nasal intermittent positive pressure ventilation.
Key inclusion criteria (2 listed)
- <32 weeks preterm babies
- Those who have received nasal intermittent positive pressure ventilation
Key exclusion criteria (4 listed)
- Babies born> 32 weeks
- Babies with congenital anomalies
- Babies who have intubated in the delivery room
- Babies whose parents refuse to participitate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| non-invasive ventilationBabies who will have or won't have non-invasive ventilation failure in the first 72 hoursof life, will be compared. | Other | non-invasive ventilation failure, non-invasive ventilation success |
Primary outcome
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
3 secondary outcomes
To describe the incidence and early precursors of non-invasive ventilation failure.
Time frame: 2 year
Looking for early predictors,
Time frame: 2 year
morbidity and mortality
Time frame: 2 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2025.
- Background: PubMed 23595061Dargaville 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.
- Background: PubMed 31112987Gulczynska 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.
- Background: PubMed 24039148Shi 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.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Distress Syndrome, Newborn and Premature, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
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 2 inclusion and 4 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: finished, as of the sponsor's last update on 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Risk of intubation in the first 72 hours in premature babies (time frame: 2 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 NCT05260424, which also lists 3 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 18 Nov 2025.