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Evaluation of efficacy of inhaled Amikacin in prevention of Ventilator Associated Pneumonia in children aged one month to 18 years

Evaluation of efficacy of inhaled Amikacin in prevention of Ventilator Associated Pneumonia in children aged one month to 18 years: An open Labelled Randomised Controlled Trial - Nil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/02/080372
Enrollment
348
Registered
2025-02-12
Start date
Unknown
Completion date
Unknown
Last updated
2025-03-03

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

Conditions

Health Condition 1: J958- Other intraoperative and postprocedural complications and disorders of respiratory system, not elsewhere classified

Interventions

Intervention1: Inhaled amikacin alonf with standard care: Inhaled amikacin 20 mg/kg/day once a day for 5 days along with standard care for prevention of Ventilator associated Pneumonia Control Interve
therefore, regular oral rinsing or cleaning with chlorhexidine mouthwash (0.12%) for decontamination, reduction of plaque formation thus preventing gingivitis and use of toothbrush and oral swabs to r
suction the hypopharynx before endotracheal suctioning and repositioning
change the circuits when visible, soiled, or malfunctioning
and always use a humidifier or heat moisture exchanger. 5)Shorten the duration of ventilation:Spontaneous breathing trails and sedation window with neuromuscular blockade holidays.

Sponsors

All India Institute of Medical sciences, Rishikesh
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Mechanically ventilated children between the ages of one month - 18 years of age admitted to PICU, Department of Paediatrics, AIIMS Rishikesh

Exclusion criteria

Exclusion criteria: 1. Already on invasive mechanical ventilation for more than 24 hours 2. Children who received invasive mechanical ventilation within the previous seven days 3. Severe acute kidney injury without renal replacement therapy, chronic kidney disease 4.Children scheduled for extubation within the next 24 hours

Design outcomes

Secondary

MeasureTime frame
Duration of mechanical ventilation, PICU stay, and antibiotic therapy in days Proportion of children getting successful extubation All-cause mortality at discharge or day 28 (whichever is earlier) Occurrence of adverse events (bronchospasm, acute kidney injury, and amikacin-resistant VAPTimepoint: Discharge or day 28 of hospital stay—

Primary

MeasureTime frame
Incidence of VAP after the five-day course of inhaled AmikacinTimepoint: 7 days—

Countries

India

Contacts

Public ContactLokesh Tiwari

AIIMS Rishikesh

lokeshdoc@yahoo.com9631638095

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026