Infant, Premature Respiratory Tract Diseases
Conditions
Interventions
This is a randomized, controlled, two-arm parallel, single-blind clinical trial. Preterm newborns admitted to the neonatal intensive care unit of the Ana Bezerra University Hospital will be enrolled a
Sponsors
Faculdade de Ciências da Saúde do Trairi - Universidade Federal do Rio Grande do Norte
Hospital? Universitário Ana Bezerra
Eligibility
Age
96 Hours to 37 Weeks
Inclusion criteria
Inclusion criteria: Preterm newborns of both sexes; with gestational age of less than 37 weeks; chronological age greater than 96 hours of life; receiving non-invasive ventilation (NIV), including Continuous Positive Airway Pressure (CPAP) or Bilevel Positive Airway Pressure (Bilevel); and with Silverman-Andersen Score (SAS) greater than 0
Exclusion criteria
Exclusion criteria: Newborns presenting hemodynamic instability (persistent alterations in heart rate or blood pressure above or below expected values or predefined alarm limits, and difficult-to-control arrhythmias); use of invasive mechanical ventilation (IMV); a clinical diagnosis of pneumothorax, pleural effusion, atelectasis, anemia, or structural and/or functional abnormalities of the chest wall, diaphragm, or upper airways; cardiovascular malformations; and diagnosed genetic syndromes
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess respiratory distress using the Silverman-Andersen Score (SAS), a scale that quantifies the degree of respiratory distress in newborns based on five parameters: upper and lower intercostal retractions, xiphoid retraction, nasal flaring, and expiratory grunting. Each item is scored from 0 to 2, yielding a total score ranging from 0 (no respiratory distress) to 10 (maximum respiratory distress). Data will be collected before the intervention, immediately after the intervention, and at follow-up (30 minutes post-intervention);To assess peripheral oxygen saturation using pulse oximetry, measured with a multiparametric monitor (Dixtal® DX2021) available at the newborn’s bedside. Data will be collected before the intervention, immediately after the intervention, and at follow-up (30 minutes post-intervention) | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess heart rate using pulse oximetry, measured with a multiparametric monitor (Dixtal® DX2021) available at the newborn’s bedside. Data will be collected before the intervention, immediately after the intervention, and at follow-up (30 minutes post-intervention);To assess respiratory rate by visually counting respiratory movements for 1 minute, concurrently with respiratory auscultation using a stethoscope (Littmann® Classic III). Data will be collected before the intervention, immediately after the intervention, and at follow-up (30 minutes post-intervention);To assess pain using the Neonatal Infant Pain Scale (NIPS - Brazil). This scale evaluates five behavioral indicators (facial expression, crying, arm position, leg position, and state of arousal) and one physiological indicator (breathing pattern). Each item is scored as 0 or 1, except for crying, which is scored on a 0-2 scale. The total score ranges from 0 to 7, with scores greater than 3 indicating the presence of pain. Data will be collected before the intervention, immediately after the intervention, and at follow-up (30 minutes post-intervention);To assess neonatal behavior, considering aspects of the sleep-wake cycle. Based on this observation, the newborn will be classified as sleeping/drowsy, awake/alert, or irritable/crying. Data will be collected before the intervention, immediately after the intervention, and at follow-up (30 minutes post-intervention);To assess diaphragmatic excursion using ultrasonography with a SonoSite M-Turbo® device (Bothell, WA, USA). A convex transducer will be positioned medially and directed cranially, maintaining the ultrasound beam perpendicular to the posterior third of the right hemidiaphragm in the subcostal region. B-mode will be used to obtain optimal visualization of the diaphragm, with the liver serving as an acoustic window on the right side to select the scanning line. M-mode will then be used to measure the craniocaudal amplitude of diaphragmatic excursion | — |
Countries
BR
Contacts
Public ContactKarolinne Monteiro
Faculdade de Ciências da Saúde do Trairi - Universidade Federal do Rio Grande do Norte
Outcome results
None listed