Respiratory Distress Syndrome, Newborn Premature Birth
Conditions
Interventions
This is a 5-arm, open-label, randomized controlled trial stratified by gestational age (greater than 28 weeks and less than 32 weeks, and greater than 32 weeks and less than 37 weeks). After respirato
Group 2 (G2) – RAM® Cannula - 72 participants
Group 3 (G3) – Dräger Babyflow® Nasal Mask - 72 participants
Group 4 (G4) – Conventional binasal prongs (Ventcare®)- 72 participants
Group 5 (G5) – Flexible anatomical binasal prongs Fanem® - 72 participants, totaling 360 participants. Randomization will be performed using sequentially numbered, sealed, opaque envelopes containing
Sponsors
Fundação Hospitalar de Feira de Santana
Faculdade de Medicina da Universidade de São Paulo - FMUSP
Eligibility
Age
28 Weeks to 36 Weeks
Inclusion criteria
Inclusion criteria: Preterm newborns, that is, those born before completing 37 weeks of gestational age; with a gestational age greater than 28 weeks; of both sexes; admitted to the neonatal intensive care unit; with mild to moderate respiratory distress identified by the Silverman Andersen bulletin; authorized by the guardian to participate in the research by signing the free and informed consent form
Exclusion criteria
Exclusion criteria: Patients with multiple congenital malformations; intolerant to non-invasive ventilation interfaces; patients whose legal guardians do not sign the Informed Consent Form
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Differences in safety and efficacy are expected to be found between the various interfaces used for non-invasive ventilation, verified through comparative analysis of clinical data (success rate of non-invasive ventilation, need for intubation and occurrence of adverse events), based on the finding of variations equal to or greater than 10% between groups of patients | — |
Secondary
| Measure | Time frame |
|---|---|
| It is expected to reduce the incidence of failure in non-invasive ventilation, verified through the need for orotracheal intubation or change in ventilatory strategy, based on the finding of a minimum reduction of 10% in the failure rate among the non-invasive ventilation groups studied;It is expected to reduce the occurrence of nasal and facial injuries in patients undergoing non-invasive ventilation, verified through serial clinical inspection and standardized photographic records, based on the finding of a minimum reduction of 15% in the incidence of injuries classified as stages I and II compared to the control group;It is expected to reduce the use of analgesia and sedation in the unit, verified through the analysis of medical prescription and medication administration records, based on the finding of a minimum reduction of 15% in the frequency of doses administered per patient/day during the period of non-invasive ventilation, compared to the control group;It is expected to reduce the length of hospital stay and the length of stay in the intensive care unit, verified through the analysis of institutional records of hospital discharge and bed transfers, based on the finding of a minimum reduction of 20% in the average number of days of hospitalization among the groups studied | — |
Countries
BR
Contacts
Public ContactAndré Neves
Fundação Hospitalar de Feira de Santana
Outcome results
None listed