RecruitingPhase 3ACTRN12615000563561

Bell's Palsy in Children: A Multi-centre, double-blind, Randomised, Placebo-controlled Trial to Determine Whether Prednisolone Improves Recovery at 1 Month.

A multi-centre randomised controlled trial of children aged between 6 months and 18 years presenting to emergency departments with symptoms of Bell's palsy, to determine whether treatment with oral prednisolone versus a placebo, increases the proportion of children who have complete recovery at 1 month, where complete recovery is defined as grade 1 on the House Brackmann scale.


Sponsor

Franz Babl

Enrollment

540 participants

Start Date

Oct 13, 2015

Study Type

Interventional

Conditions

Summary

Children diagnosed with Bell's palsy have a sudden weakness of facial muscles on one side of their face. Bell's palsy usually improves in children in about four to six weeks without treatment. However, in some children it may be a year before the facial weakness has completely resoved and in a small number of cases, the facial muscle weakness is permanent. Recent research in adults with Bell's palsy has shown that a short course of treamtent with steroids (prednisolone) led to improved recovery time. Prednisolone is believed to reduce the irritation to the facial nerve. There are no similar studies in children and, because children's bodies respond different to adults', it is not known whether a short course of prednisolone will help children to recover more quickly. Currently, some doctors treat with prednisolone and others do not resulting in confusion and variability in medical care. The study aims to answer the following question: In children presenting to Emergency Departments with recent onset of Bell's palsy, does treatment with prednisolone result in a higher proportion of children with recovery at 1 month compared with placebo. Up to 13 hospitals in Australia and New Zealand will participate in enrolling 540 children/young people, aged 6 months to 18 years, who present to ED's within 72 hours of symptom onset.


Eligibility

Sex: Both males and femalesMin Age: 6 MonthssMax Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study is testing whether a short course of the steroid prednisolone helps children recover faster from Bell's palsy — a sudden weakness or paralysis of one side of the face. Research in adults suggests steroids help, but this has never been properly tested in children. Up to 540 children aged 6 months to 18 years will be enrolled across hospitals in Australia and New Zealand. You may be eligible if: - Your child is between 6 months and 18 years of age and weighs at least 5 kg - Your child has been diagnosed with Bell's palsy by a doctor - Symptoms started within the past 72 hours You may NOT be eligible if: - Your child has had Bell's palsy before or was already in this study - Your child has a condition that makes steroid use unsafe (e.g., diabetes, active TB, active chickenpox, peptic ulcer, or allergy to prednisolone) - Your child is currently on steroids or used them within the past two weeks - Your child has had a cancer diagnosis or may have leukaemia - Your child is pregnant or breastfeeding - Your child has had a live vaccine in the past month - The facial weakness only affects the lower half of the face (suggesting a different cause) - Your child has had a recent ear infection or signs of herpes infection - Your family cannot attend a follow-up in one month Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Intervention: Prednisolone. Prednisolone is a corticosteroid that has strong evidence for effectiveness in reducing the length of facial palsy symptoms in adults suffering from Bell's palsy. Partici

Intervention: Prednisolone. Prednisolone is a corticosteroid that has strong evidence for effectiveness in reducing the length of facial palsy symptoms in adults suffering from Bell's palsy. Participants assigned to the intervention will receive 1mg/kg/day of prednisolone (dosing is based on weight categories) up to a maximum of 50mg/day for 10 days. The prednisolone will be administered as an oral solution as a once daily dose. Strategies used to monitor adherence will be a survey relating to compliance at the end of the 10 day course of treatment, in addition to the return of the bottles.


Locations(9)

The Royal Childrens Hospital - Parkville

NSW,QLD,SA,WA,VIC, Australia

Monash Medical Centre - Clayton campus - Clayton

NSW,QLD,SA,WA,VIC, Australia

The Children's Hospital at Westmead - Westmead

NSW,QLD,SA,WA,VIC, Australia

Womens and Childrens Hospital - North Adelaide

NSW,QLD,SA,WA,VIC, Australia

Gold Coast Hospital - Southport

NSW,QLD,SA,WA,VIC, Australia

Logan Hospital - Meadowbrook

NSW,QLD,SA,WA,VIC, Australia

Queensland Children's Hospital - South Brisbane

NSW,QLD,SA,WA,VIC, Australia

Perth Children's Hospital - Nedlands

NSW,QLD,SA,WA,VIC, Australia

Auckland, New Zealand

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ACTRN12615000563561


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