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

Respiratory Distress Syndrome, Newborn Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05260424
• Other study ID #: E1-20-1250
• Status: Completed
• Start date: December 1, 2020
• Est. completion date: February 1, 2024

Study information

• Verified date: May 2024
• Source: Ankara City Hospital Bilkent
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 393
• Est. completion date: February 1, 2024
• Est. primary completion date: February 1, 2024
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Premature
• Premature Birth
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn
• Syndrome

Intervention

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.

Locations

Country	Name	City	State
Turkey	Ankara City Hospital Bilkent	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Ankara City Hospital Bilkent

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	2 year
Secondary	To describe the incidence and early precursors of non-invasive ventilation failure.	Invasive, non-invasive ventilation and supplemental oxygen day time	2 year
Secondary	Looking for early predictors,	Looking for early predictors, including combinations of breathed oxygen fraction (FiO2) and non-invasive ventilation level in early life	2 year
Secondary	morbidity and mortality	To investigate the negative consequences of non-invasive ventilation failure.	2 year