All studies
RecruitingNot ApplicableInterventional

A study to find out whether gradually stopping brace treatment or stopping it all at once is better for babies with hip dysplasia

This study, called WINDY, is for babies under 6 months old who have a common hip problem called developmental dysplasia of the hip (DDH). This is when a baby’s hip joint hasn’t developed properly. They are already being successfully treated with a soft brace called a Pavlik harness. Currently, doctors don't all agree on how to stop using the brace – some remove it straight away, others gradually reduce its use. This study aims to compare these two ways of stopping the brace to see which is best. It will also check if a bigger study like this would be possible. Your baby's care will be closely monitored, and your input will help improve how future babies with hip problems are treated.

At a glance

Status
Recruiting
Phase
Not Applicable
Sponsor
University of Liverpool
Enrolment target
60
Start
01 Nov 2025
Estimated completion
01 Sep 2026

What is this study about?

This study is about a condition called Developmental Dysplasia of the Hip, or DDH. This is a common condition where a baby's hip joint doesn't grow correctly, which can sometimes lead to it slipping out of place. It affects about 1 in every 100 babies. Often, the first treatment is a soft brace called a Pavlik harness, which helps the hip develop properly.

Once the Pavlik harness has successfully helped the hip, doctors then need to decide how to stop using it. Some doctors take the brace off all at once, while others suggest gradually wearing it less and less over a few weeks. At the moment, we don't know which method is better and if one leads to fewer problems later on. This study wants to find out if it's possible to run a larger study comparing these two ways of stopping the brace, so we can give clearer advice to parents and doctors in the future.

By taking part, you would be helping researchers understand the best way to manage this important part of your baby’s care. Both methods of stopping the brace are already used safely in NHS hospitals, so your baby would receive standard care, but we would be carefully watching to see what happens. This research could make a real difference to many babies and families in the future.

Key takeaways

  • Compares two ways of stopping Pavlik harness treatment.
  • For babies under 6 months old with improved hip development.
  • Aims to see if a larger study is possible.
  • Involves questionnaires about your baby and family.
  • Both treatment options are already used by the NHS.
  • Could help improve future care for babies with hip problems.

Who may be eligible?

This study is looking for babies who are under 6 months old. They must already be wearing a special soft brace called a Pavlik harness for a hip problem and have shown good improvement with it. This means their hip ultrasound scan looks much better.

Your baby won't be able to join the study if they have certain nerve and muscle problems, or if you, as their parent or guardian, find it difficult to fill in forms or follow the study's plan. You also need to be able to understand and agree to take part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Is my baby under 6 months old?
  2. Has my baby been successfully treated with a Pavlik harness?
  3. Does my baby's hip ultrasound show good improvement?
  4. Am I able to fill out questionnaires and follow the study instructions?
  5. Does my baby NOT have any known nerve or muscle conditions?
Answer every question to see your result.

What does participation involve?

If you decide to take part, your baby will be assigned by chance to one of two groups. One group will stop wearing the brace suddenly, and the other group will continue to wear it only at night for four extra weeks.

You, as the parent, will be asked to fill out some short questionnaires about how your baby and family are doing. You'll do this at the very beginning, and then again after 2, 4, and 6 weeks. You can complete these questionnaires online or over the phone, whichever is easier for you. The study will also look at information from your baby's hospital records, such as follow-up appointments, hip scans, and if they needed any further treatment. The study expects to run from September 2024 to December 2026.

Potential risks and benefits

There's no guarantee that your baby will directly benefit from taking part in this study. However, the information we gather could help improve how babies with hip problems are treated in the future. The risks are very low because both ways of stopping the brace are already standard care in NHS hospitals. Occasionally, putting on and taking off the brace can cause minor skin irritation or discomfort, but these are known issues with standard brace treatment. You will also need to spend some time completing questionnaires. You are free to withdraw your baby from the study at any time without it affecting their medical care.

Locations (4)

  • Alderhey Childrens Hospital
    City only
    Liverpool, England
  • University Hospital of Wales
    Approximate
    Cardiff, Wales
  • University Hospital Southampton NHS Foundation Trust
    City only
    Southampton, England
  • Oxford University Hospitals
    City only
    Oxford, England

Common questions

What is DDH?

DDH stands for Developmental Dysplasia of the Hip. It's a condition where a baby's hip joint doesn't form correctly, which can lead to it being unstable or dislocated.

What is a Pavlik harness?

It's a soft brace that helps keep a baby's hips in the correct position so they can develop properly.

Is my baby guaranteed to get better if we join?

There's no guarantee of direct benefit for your baby, but your participation will help us learn how to better treat future babies with hip problems.

How much time will this take?

You'll need to complete four short questionnaires over six weeks. These can be done online or by phone.

Who is paying for this study?

The study is funded by the National Institute for Health and Care Research (NIHR), a government body that funds health research.

How to find out more

Joanna Craven

Always speak to your GP or specialist before deciding to take part in a study.

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