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Selective Insufflation and Ventilatory Transfer in neonatal lung expansion

Selective Insufflation and Ventilatory Transfer in neonatal lung expansion: an interventional, randomized, controlled study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-58tvk8s
Enrollment
70
Registered
2023-07-03
Start date
2023-06-01
Completion date
Unknown
Last updated
2026-03-02

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

Conditions

Newborn

Interventions

This is an interventional, controlled, randomized, two-arm study. Newborns with hypoventilated or atelectatic pulmonary areas identified by chest ultrasound to be performed daily will be allocated int
s thorax (hypoventilated area), the stimulus is gentle during inspiration and accompanies expiration, without restricting movement). Handling will be performed only once for each newborn, with total h

Sponsors

Complexo Hospital de Clínicas da Universidade Federal do Paraná
Lead Sponsor
Complexo Hospital de Clínicas da Universidade Federal do Paraná
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: Newborns admitted to the neonatal intensive care unit of the Complexo Hospital de Clínicas de Curitiba - Paraná; with areas of hypoventilation or pulmonary atelectasis; whose guardians consent to the participation and sign the Informed Consent Form and/or Informed Consent Form

Exclusion criteria

Exclusion criteria: Atelectasis of the left hemithorax caused by malposition of the endotracheal cannula; chest malformation; presence of a chest drain; active pulmonary hemorrhage; severe pulmonary hypertension; hemodynamic instability when using vasoactive drugs

Design outcomes

Primary

MeasureTime frame
It is expected to achieve pulmonary expansion after the respiratory physiotherapy care with the management to which the newborn will be randomized. This will be verified by chest ultrasound, and the measures to be taken are: image size, location of the hypoventilated area, excursion and bilateral diaphragmatic thickness

Secondary

MeasureTime frame
To evaluate changes in vital parameters comparing before and after the performance of respiratory physiotherapy, the heart rate will be stipulated by means of oximetry monitors, having as reference of normality values between 120 - 160 beats per minute. The respiratory rate will be counted from the observation of the newborn's thorax with the aid of a chronometer, normality between 40 - 60 incursions per minute. The peripheral oxygen saturation will be read by the monitors, using a sensor suitable for reading, considered normality between 90 - 95%. Pain will be assessed by means of the Neonatal Infant Pain Scale, the scale ranges from 0 to 7 points, composed of five behavioral indicators: facial expression, crying, arms, legs and state of consciousness; and one physiological: breathing. The presence of pain is considered from 3 points on. Respiratory distress will be assessed using the Silverman-Andersen Bulletin, which is an instrument used in neonatology to classify and monitor the severity of respiratory distress. To calculate the final score five items are evaluated: chest and abdominal movements, inward costal retraction, xiphoid retraction, nose wing beats, and expiratory moaning. The score is made from the sum of the values assigned to each parameter assessed, a score above four indicates moderate-to-severe respiratory difficulty, above eight represents severe respiratory failure. It is an easy-to-apply, low-cost, and non-invasive method;Increase in the amplitude of diaphragmatic excursion after respiratory physiotherapy with the manual costal stabilization maneuver and the lower abdominal support maneuver with ileocostal support.  This will be verified by diaphragmatic ultrasound examination, with diaphragmatic excursion and thickness being measured

Countries

Brazil

Contacts

Public ContactEvellin Gomes

Complexo Hospital de Clínicas

evellinfisio@hotmail.com+55(41)3360-1041

Outcome results

None listed

Source: REBEC (via WHO ICTRP) · Data processed: Mar 14, 2026