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Research Spotlight: Complications in Cranial Remolding Helmet Treatment

Updated: Nov 16, 2021

Before starting treatment the most common question we are asked is "Will this helmet hurt my baby or lead to any negative side effects?"
What we have found in today's article is that most complications that arise in helmet therapy can be avoided with clear education prior to treatment (Wilbrand et al., 2011).

First of All Who's Saying This?

This is a review of Complications in Helmet Therapy by Wilbrand et al. (2011), an article published in the Journal of Cranio-Maxillo-Facial Surgery.

What Does This Article Say?

It was found that helmet therapy results in minimal complications, most of which can be avoided with family education. This retrospective observational study looked at 410 patients with “moderate” or “severe” non-synostotic cranial deformity. Both Brachycephaly and Plagiocephaly were included in this

study. The authors identified six specific categories of complications:

1. Pressure sores

2. Local ethanol erythema (superficial redness due to ethanol use in the helmet)

3. Skin infection

4. Bacterial abscess

5. Deficient fitting

6. Failure to achieve success

The study revealed that 25.4% of patients experienced one of the above complications and that this was not dependent on severity of diagnosis. Complications were identified as rare for patients with both moderate and severe cranial deformities. In addition, all skin irritations resolved spontaneously or following initial adjustment.

How Did Researchers Prove It?

Authors reviewed records of patients that fit the moderate or severe category of deformity. This category was determined with a classification system utilizing cranial vault asymmetry index and cephalic index. Any patients that were evaluated in the clinic and did not meet the criteria for helmet treatment were excluded from the study. Data from a two-year period was collected and over 400 infants met the inclusion criteria for the study.

These records were then analyzed for adverse events and

descriptive statistics were performed.


This study was conducted all within one clinic and therefore researcher bias may be present in interpretation of results.

What Does This Mean for My Baby?

This means that the helmet is a safe and effective treatment for plagiocephaly. This research shows that further education can prevent any secondary complications from occurring. Speak up and talk to your practitioner if you have concerns or questions regarding treatment.

Results of this study further emphasize the importance of caregiver education and we have worked hard to make the treatment process clear and understandable for our families. However, this is all a brand-new experience for you and your baby and it is important for you to feel comfortable every step of the way.

We are frequently adjusting our materials based on the feedback of our families. We take patient safety and parent concerns seriously. This article stated that numerous follow up appointments significantly reduce the occurrence of complications (Wilbrand et al., 2011). This is one of the many reasons we always begin treatment with a one week follow up appointment in order to prevent future irritation.

What Does This Mean for Me As A Caregiver?

If you are concerned let us know as soon as you can and then we can fix the problem quickly! We have found that the following tips lead to a care free and worry-free treatment process for our families:

1. Clean your helmet once a day with unscented baby shampoo. Avoid harsh chemicals that can build up inside the helmet lining.

2. Do not adjust the strap past the line that was drawn by your practitioner during the delivery appointment.

3. If you see redness that persists throughout the first week, make sure to share this with your practitioner at your first follow up appointment.

4. Continue with your everyday routine. If the helmet is making a part of your routine more difficult, let us know and we can help!

What Does This Mean for the Medical Community?

This article serves as an educational tool for the medical community that demonstrates helmets are a SAFE, and often, NECESSARY therapeutic device! Further education materials for caregivers are essential to successful treatment without secondary complications.

So What's Next Researchers?! Check out our Helmet Research Center


Wilbrand, J.-F., Wilbrand, M., Malik, C. Y., Howaldt, H.-P., Streckbein, P., Schaaf, H., & Kerkmann, H. (2012). Complications in helmet therapy. Journal of Cranio-Maxillofacial Surgery, 40(4), 341–346.



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