Effect of prophylactic azithromycin on chest infections in children with neurological and neuromuscular impairment
Randomised, triple blinded, placebo trial comparing 26 weeks of azithromycin to placebo in children with neurological/neuromuscular impairment to reduce the the risk of lower respiratory tract infection
Menzies School of Health Research
94 participants
Dec 15, 2021
Interventional
Conditions
Summary
Neurological Impairment (NI) in children is often caused by conditions such as cerebral palsy and other neuromuscular conditions. Many children with NI are prone to chest infections which can lead to long stays in hospital, additional impairment and even premature death. Despite the suffering caused to children and their families by these infections and the high cost to health services, there is very little information on how best to prevent them. Some doctors prescribe long-term antibiotics but we don't really know whether this treatment makes any difference to the numbers of chest infections children suffer from, or whether these antibiotics can cause long term harm. The trial (PARROT-Junior) is a sub-study of a parent study (PARROT). In PARROT-Junior, we will recruit children aged 0.3-3 years, with NI who are at risk of chest infections, along with their parents/primary care giver to take part. Children included in the trial will be given either azithromycin or a placebo for 6 months to evaluate whether regular azithromycin reduces the frequency of chest infections. For the analysis, results from PARROT-Junior will be combined with data from the children recruited from Brisbane/Darwin in the parent study (PARROT). Our target sample size thus includes the subset of Brisbane/Darwin-enrolled children from PARROT.
Eligibility
Plain Language Summary
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Interventions
Azithromycin The dosing regimen is based on body weight (10mg/kg rounded) and will be administered as an oral suspension 3 times weekly (Mon/Wed/Fri) for 26 weeks. Adherence to the trial medications will be monitored using a treatment diary and withdrawals from study treatment will also be monitored.
Locations(2)
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ACTRN12621001486819