Effects of Positive Expiratory Pressure on Airways in Infants with Pneumonia

Effects of Airway Positive Expiratory Pressure (PEP) on Respiratory Distress and Respiratory Rate in Hospitalized Infants with Pneumonia: protocol for a randomized, blind, controlled clinical trial

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

REBEC

Registry ID

RBR-5bdqznf

Enrollment

Registered

2025-12-23

Start date

2026-04-01

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pneumonia, Infant Respiratory Tract Diseases

Interventions

This is a randomized, controlled, multicenter clinical trial with two parallel, double-blind arms. Experimental group: ten infants with pneumonia hospitalized in pediatric wards and their parents or l

Eligibility

Age

29 Days to 2 Years

Inclusion criteria

Inclusion criteria: Infants aged between 29 days and 2 years; hospitalized in pediatric wards with a clinical diagnosis of pneumonia; parents or legal guardians accompanying the infants during hospitalization aged 18 years or older

Exclusion criteria

Exclusion criteria: Infants with chronic respiratory conditions; congenital heart disease; malformations of the thoracic cage and or upper airways; associated acute respiratory diseases such as acute viral bronchiolitis, tuberculosis or pertussis; neurological disorders; hemodynamic instability; need for invasive or noninvasive mechanical ventilation at the time of data collection

Design outcomes

Primary

Measure	Time frame
To assess respiratory distress using the Wood-Downes-Ferres Scale, which considers specific clinical signs to generate the final score. The assessed parameters include wheezing, use of accessory muscles, airflow, cyanosis, respiratory rate, and heart rate. Each parameter may receive a score ranging from 0 to 3, except for cyanosis and heart rate, which are scored as 0 or 1 according to their presence at the time of assessment. The final classification is obtained by summing all scores, with a possible range from 0 to 14 points, and is classified as follows: 0–3, mild; 4–7, moderate; and 8–14, severe. Data collected before and after the intervention;To evaluate respiratory rate by visually counting respiratory movements over one minute	—

Measure

Time frame

To assess respiratory distress using the Wood-Downes-Ferres Scale, which considers specific clinical signs to generate the final score. The assessed parameters include wheezing, use of accessory muscles, airflow, cyanosis, respiratory rate, and heart rate. Each parameter may receive a score ranging from 0 to 3, except for cyanosis and heart rate, which are scored as 0 or 1 according to their presence at the time of assessment. The final classification is obtained by summing all scores, with a possible range from 0 to 14 points, and is classified as follows: 0–3, mild; 4–7, moderate; and 8–14, severe. Data collected before and after the intervention;To evaluate respiratory rate by visually counting respiratory movements over one minute

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Secondary

Measure	Time frame
To assess the amount of aspirated secretion after the intervention using a precision scale;To assess heart rate using a pulse oximeter;To assess peripheral oxygen saturation using a pulse oximeter;To assess pulmonary auscultation using a stethoscope positioned on the participant’s chest;To assess potential adverse events identified during the intervention;To assess the level of acceptance of the intervention by infants using the Face, Legs, Activity, Cry, and Consolability scale. This scale comprises five behavioral dimensions, each scored from 0 to 2, resulting in a total score ranging from 0 to 10. Scores will be interpreted as follows: a score of 0 indicates a relaxed or comfortable infant; scores from 1 to 3 suggest mild discomfort; scores from 4 to 6 correspond to moderate pain; and scores from 7 to 10 indicate severe discomfort and/or severe pain;To assess parents’ or legal guardians’ perspectives regarding the intervention performed in infants through a semi-structured interview. Responses will be fully recorded and used to construct a qualitative database	—

Measure

Time frame

To assess the amount of aspirated secretion after the intervention using a precision scale;To assess heart rate using a pulse oximeter;To assess peripheral oxygen saturation using a pulse oximeter;To assess pulmonary auscultation using a stethoscope positioned on the participant’s chest;To assess potential adverse events identified during the intervention;To assess the level of acceptance of the intervention by infants using the Face, Legs, Activity, Cry, and Consolability scale. This scale comprises five behavioral dimensions, each scored from 0 to 2, resulting in a total score ranging from 0 to 10. Scores will be interpreted as follows: a score of 0 indicates a relaxed or comfortable infant; scores from 1 to 3 suggest mild discomfort; scores from 4 to 6 correspond to moderate pain; and scores from 7 to 10 indicate severe discomfort and/or severe pain;To assess parents’ or legal guardians’ perspectives regarding the intervention performed in infants through a semi-structured interview. Responses will be fully recorded and used to construct a qualitative database

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Countries

Contacts

Public ContactKarolinne Monteiro

Faculdade de Ciências da Saúde do Trairi - Universidade Federal do Rio Grande do Norte

smkarolinne@gmail.com+55(84)3342-2287

Outcome results

None listed

Source: REBEC (via WHO ICTRP) · Data processed: Aug 10, 2026