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

NCT05260424 | Completed

• 1 other identifier: E1-20-1250
• Study Type: observational
• Target: 397
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Distress Syndrome, Newborn; Premature

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

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

  2 year

• Looking for early predictors,

  2 year

• morbidity and mortality

  2 year

Study Arms (2)

non-invasive ventilation failure

babies who will be intubated in the first 72 hours

Other: non-invasive ventilation

non-invasive ventilation success

babies who will not intubated in the first 72 hours

Other: non-invasive ventilation

Interventions

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.

non-invasive ventilation failure; non-invasive ventilation success

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Preterm babies \< 32 weeks gestational age who have received nasal intermittent positive pressure ventilation.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara City Hospital Bilkent

Ankara, 06000, Turkey (Türkiye)

Location

Related 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.

  PMID: 23595061 BACKGROUND

• 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.

  PMID: 31112987 BACKGROUND

• 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.

  PMID: 24039148 BACKGROUND

MeSH Terms

Conditions

Respiratory Distress Syndrome, Newborn; Premature Birth

Interventions

Noninvasive Ventilation

Condition Hierarchy (Ancestors)

Respiratory Distress Syndrome; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2021
• First Posted: March 2, 2022
• Study Start: December 1, 2020
• Primary Completion: February 1, 2024
• Study Completion: February 1, 2024
• Last Updated: November 18, 2025

Record last verified: 2024-05

Locations

TU (1)