A pilot study of hypertonic saline in children with chest infections and disabilities

Phase 4

Recruiting

• Conditions: Acute lower respiratory tract infections; Severe neurological impairment; Cerebral palsy; Respiratory - Other respiratory disorders / diseases; Neurological - Other neurological disorders; Infection - Other infectious diseases

• Registration Number: ACTRN12615000766516
• Lead Sponsor: Paediatric Intensive Care Unit, Royal Children's Hospital Melbourne

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-07-23
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Participants must meet the following criteria:
Be aged between 2 and 18 years of age.
Have a diagnosis of CP GMFCS level IV or V or other neurological impairment with equivalent functional impairment including children with; developmental delay, chromosomal abnormalities, neurodegenerative and metabolic conditions.
Have a clinical diagnosis of LRTI caused by either aspiration pneumonia, bacterial pneumonia, or viral infection.
Must require at least one of oxygen therapy, high flow nasal prongs (HFNP), biphasic positive airway pressure (BIPAP), continuous positive airway pressure (CPAP), or mechanical ventilation.

Exclusion Criteria

Acute wheeze associated with severe bronchospasm.
Known intolerance of hypertonic saline within the last 12 months.
Neuromuscular conditions.
Active pulmonary haemorrhage.
Low platelets (less than 20).
Undrained pneumothorax.
High cardiovascular instability.
Requiring extracorporeal membrane oxygenation or high frequency oscillation ventilation.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Peripheral oxygen saturation/fraction of inspired oxygen ratio (SF ratio). SpO2 will be measured using infant SpO2 sensor (Nellcor, CovidienTM) (3 to 20 kg) or paediatric SpO2 sensor (Nellcor, CovidienTM) (10 to 50 kg) placed on the hand or foot. The sensor will be applied so that the light emitter and photo-detector are placed opposite each other (Philips, 2010). Nursing staff and physiotherapist will ensure the probe provides a consistent SpO2 trace through assessment of the signal quality indicator and pleth waveform (Philips, 2010). Fraction of inspired oxygen will be measured via the ventilator circuitry or oxygen blender for high flow circuitry as appropriate. [Baseline, post nebulization, post completion of chest physiotherapy, and 5, 10, 15, 20, 25, 30 minutes post completion of chest physiotherapy. ]