Effects and safety of hypertonic saline combined with airway clearance in non-hospitalized children with recurrent wheezing.

Background: The International Study of Wheezing in Infants defines recurrent wheezing as the presence of three or more medically documented episodes of wheezing within one year. To date, there is no evidence on the use of hypertonic saline (HS) combined with airway clearance techniques (ACT) for children with recurrent wheezing treated in an outpatient setting. Therefore, this is the first study to explore the use of such interventions in infants with recurrent wheezing. Objectives: To evaluate the effects and safety of a three-month protocol including HS and ACT for non-hospitalized infants with recurrent wheezing. Methods: Randomized, double-blind, controlled trial, including outpatient infants with recurrent wheezing. Children were randomized to either 3% HS or 0.9% saline groups and were treated with bronchodilator and nebulized with the respective solutions before ACT. The primary outcome was the Wang score. Secondary outcomes included the number of hospitalizations and respiratory crisis, need for rescue medication, and school absences. All variables were measured during the three previous months from inclusion and during intervention period. The study protocol was registered at ClinicalTrials.gov (NCT04331496) on March, 31, 2020. Results: Forty children were included. Regarding immediate effects, significant differences (p<0.001) were found for time, but not for group or interaction (group × time), in all outcome variables (increase in SpO2, decrease in heart and respiratory rate, wheezing episodes, retraction, and Wang score). Comparing the previous three months with the study period, there were significant differences in both groups for the severity of crisis (p<0.001) and medication steps (p=0.002). Conclusion: A three-month protocol including HS and ACT for outpatient infants with recurrent wheezing was safe and reduced morbidity. No differences were found between the use of HS and 0.9% saline.

Immediate Effects and Safety of High-Frequency Chest Wall Compression Compared to Airway Clearance Techniques in Non-Hospitalized Infants With Acute Viral Bronchiolitis.

BACKGROUND: No studies have investigated the use and safety of high-frequency chest wall compression (HFCWC) for non-hospitalized infants with acute viral bronchiolitis (AVB). The aim of the present study was to evaluate the immediate effects and safety of HFCWC as compared to airway clearance techniques in children with AVB. METHODS: In this randomized clinical trial in non-hospitalized infants (0-12 months old) with mild to moderate AVB, children were randomized into 2 groups: airway clearance techniques (20 min of prolonged slow expiration and provoked cough) or HFCWC (15 min). A single session was performed and children were evaluated at baseline and at 10 min and 20 min after treatments. Outcomes measures were the Wang severity score, [Formula: see text], sputum wet-weight, and the presence of adverse events. RESULTS: A total of 91 infant subjects, mean age 7.9 ± 2.6 months, were included. Significant (P = .004) between-group differences were found in the Wang score, which was 0.28 points lower in the airway clearance techniques group. There was a greater increase of infants classified as normal and a greater decrease of those classified as mild according to the Wang score when airway clearance techniques were used compared to the use of HFCWC (P = .009). The sputum wet-weight was lower in subjects treated with the airway clearance techniques (P < .001). Although [Formula: see text]improved in both groups, no differences were found between them. There was also no difference for adverse events, and the majority of children did not present any adverse events after 20 min. CONCLUSIONS: The use of HFCWC induced similar clinical effects as airway clearance techniques and was safe for non-hospitalized infants with AVB. Both techniques reduced respiratory symptoms and acutely improved [Formula: see text]. (ClinicalTrials.gov: NCT03835936.).

Safety of airway clearance combined with bronchodilator and hypertonic saline in non-hospitalized infants with acute bronchiolitis.

BACKGROUND: Acute viral bronchiolitis (AVB) is associated with significant morbidity and no study has addressed the safety of airway clearance techniques (ACT) for non-hospitalized infants. This study aimed to evaluate the safety of the use of ACT combined with bronchodilator and hypertonic saline in non-hospitalized children with the first episode of AVB. METHODS: A quasi-experimental study of infants aged 2-12 months, with a clinical diagnosis of AVB (mild to moderate), was performed. The Wang score, breathing frequency, oxygen saturation (SpO2), heart rate (HR), and the presence of adverse events were evaluated before, 10 and 20 min after the application of a protocol including ACT (nasal irrigation, prolonged slow expiration, and provoked cough), bronchodilator and hypertonic saline inhalation. A total of 265 infants, mean age 6.86±3.01 months, were included. RESULTS: A reduction (p<0.001) in the Wang score and in the breathing frequency as well as an increase in SpO2 were found. There was also a transient HR increment at 10 min followed by a reduction at 20 min (p<0.05). The proportion of patients presenting with chest retraction and wheezing decreased (p<0.001) after treatment. Most of the children (88.3%) did not experience adverse events. A post-treatment increment (p<0.001) of patients classified as having normal values, as well as a decrease in those with mild and moderate AVB, was found for the Wang score levels. CONCLUSION: The use of ACT combined with bronchodilator and hypertonic saline was safe, immediately after treatment, for non-hospitalized children with mild to moderate AVB. No clinically important deterioration or adverse events were identified in the follow-up period.