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

Sponsor
Ankara City Hospital Bilkent (Other)
Overall Status
Recruiting
CT.gov ID
NCT05260424
Collaborator
(none)
400
1
26
15.4

Study Details

Study Description

Brief 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. 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.

Condition or Disease Intervention/Treatment Phase
  • Other: non-invasive ventilation

Study Design

Study Type:
Observational
Anticipated Enrollment :
400 participants
Observational Model:
Case-Crossover
Time Perspective:
Prospective
Official Title:
Predictors for Nasal Intermittent Positive Pressure Ventilation Failure for Premature Infants With Respiratory Distress Syndrome
Actual Study Start Date :
Dec 1, 2020
Anticipated Primary Completion Date :
Feb 1, 2023
Anticipated Study Completion Date :
Feb 1, 2023

Arms and Interventions

Arm Intervention/Treatment
non-invasive ventilation failure

babies who will be intubated in the first 72 hours

Other: non-invasive ventilation
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

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

Outcome Measures

Primary Outcome Measures

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

  1. To describe the incidence and early precursors of non-invasive ventilation failure. [2 year]

    Invasive, non-invasive ventilation and supplemental oxygen day time

  2. Looking for early predictors, [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 [2 year]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ankara City Hospital Bilkent Ankara Turkey 06000

Sponsors and Collaborators

  • Ankara City Hospital Bilkent

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Ankara City Hospital Bilkent
ClinicalTrials.gov Identifier:
NCT05260424
Other Study ID Numbers:
  • E1-20-1250
First Posted:
Mar 2, 2022
Last Update Posted:
Mar 2, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 2, 2022