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A multi-centre, randomised, controlled trial of bronchoalveolar lavage (BAL) directed therapy in young children with cystic fibrosis (CF).

A multi-centre, randomised, controlled trial of bronchoalveolar lavage (BAL) directed therapy to improve clinical outcomes in young children with cystic fibrosis.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12605000665639
Acronym
ACF BAL Study
Enrollment
165
Registered
2005-10-19
Start date
1999-11-18
Completion date
Unknown
Last updated
2020-01-13

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

Conditions

None listed

Brief summary

1. This study will examine the use and safety of FB and BAL to identify lower respiratory tract infection (especially PA) in infants and young children with CF and direct therapy in an attempt to eradicate proven early lung infection. 2. The role of infection and inflammation in the development of CF lung disease will be examined in a large cohort of CF infants recruited prospectively and followed longitudinally.

Interventions

This study is designed to examine: 1.The clinical value, safety and cost effectiveness of flexible bronchoscopy (FB) and bronchoalveolar lavage (BAL) to identify lower respiratory tract infection (especially Pseudomonas aeruginosa (Pa)) in infants and young children with cystic fibrosis (CF) and to direct therapy in an attempt to eradicate proven early lung infection and delay progressive lung disease. 2. The role of and relationship between lower respiratory infection and inflammation in the de

This study is designed to examine: 1.The clinical value, safety and cost effectiveness of flexible bronchoscopy (FB) and bronchoalveolar lavage (BAL) to identify lower respiratory tract infection (especially Pseudomonas aeruginosa (Pa)) in infants and young children with cystic fibrosis (CF) and to direct therapy in an attempt to eradicate proven early lung infection and delay progressive lung disease. 2. The role of and relationship between lower respiratory infection and inflammation in the development and pathophysiology of lung disease in a large cohort of CF infants recruited prospectively and followed longitudinally.

Sponsors

NHMRC
Lead SponsorGovernment body

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
0 to 6 Months
Healthy volunteers
No

Inclusion criteria

All infants diagnosed with cystic fibrosis through the neonatal screening program in Queensland, New South Wales, South Australia, Victoria, Auckland and North Auckland Infants diagnosed with meconium ileus may be enrolled when diagnosis of cystic fibrosis is confirmed. A diagnosis of cystic fibrosis must be confirmed with a positive sweat chloride (Gibson Cooke with a chloride > 60mmol/l).Informed consent from parents or guardians.

Exclusion criteria

Informed consent cannot be obtained. Infant is severely ill at the time of diagnosis and requires ventilatory support. Family are planning to move overseas in the next few years.

Outcome results

None listed

Source: ANZCTR · Data processed: Mar 28, 2026