A cranial molding helmet is used to help align skull bones while the cranium is growing; indications include plagiocephaly or following certain cranial surgery.

The helmet is a medical orthotic brace, custom-made based on the child’s unique head shape and measurement. These helmets are standard treatment, not investigational. 

Cranial molding helmets are different from a cranial protective helmet which is used for skull protection, such as safety equipment for athletics or for certain neurological conditions.

The helmet exterior is fabricated of rigid plastic, and the interior is soft adjustable interface material which the orthotist adjusts as the child grows. We use Orthomerica Starband helmets.

Helmets rely on brain growth to help reshape the cranial bones. Brain growth is greatest between birth and age 12 months; during this time, skull bones are more malleable.

An infant’s brain grows fastest up to age 7 months, and a little slower to age 12 months. Helmets are not generally recommended after age 12 months because brain growth has slowed.

Cranial helmets are designed to fit close at prominent areas, and looser at flattened areas, to help improve bone alignment.

Certain medical conditions that affect brain growth must be considered before starting helmet therapy, such as craniosynostosis or hydrocephalus.

If plagiocephaly is resistant to a 2-3 month trial of conservative treatment  AAP states a cranial molding orthotic may be used between ages 4-12 months.

Earlier is best, as helmets rely on brain growth to help shape the skull; brain growth starts to slow at age 7.2 months, and again at age 12 months. AAP does not recommend helmets after age 12 months. 

The FDA regulates all cranial devices, and cranial molding orthotics are approved between ages 3-18 months.

A pediatric neurosurgeon may prescribe a post-operative helmet following cranial surgery; these are selected based on the type of surgery and age of the child.

We use hand measurements, photographs, and the Orthomerica Starscanner for cranial measurements.

The Starscanner (Orthomerica Starscanner Laser Data Acquisition System) is a non-invasive, non-radiation diagnostic tool, using low-power eye-safe laser to provide 3-D digital cranial measurements; electronic data is encrypted.

The FDA regulates the Starscanner device; all clinics must comply with the US Code of Federal Regulations and have annual recertification. STARscanner information and additional information is at the Orthomerica website:  https://www.starbandkids.com/

Helmet therapy relies on brain and cranial growth and may not provide the head shape that Parents/Guardians anticipate. We will discuss treatment goals before starting.

Medical conditions that can interfere with brain growth must be ruled out, such as craniosynostosis and hydrocephalus; this must be done by the PCP or Specialist, we cannot do this. 

The helmet wear schedule is rigorous, Parents/Guardians and other caregivers (family, friends, daycare personnel) must be willing to comply with the treatment regimen, otherwise we should not begin helmet therapy.

If helmet therapy is chosen, the treatment schedule should be followed as recommended. Early discontinuation of treatment may result in incomplete correction of the head shape.

Please notify us ahead of time if an appointment must be rescheduled. Throughout this process, we ask Parents/Guardians to call us with any questions or concerns.

The PCP (or Specialist) and Parents/Guardians decide whether to proceed with helmet therapy. The PCP or Specialist will sign a prescription, which is submitted to the insurance provider for authorization.

The insurance approval process takes time, as long as 4 weeks. FDA requires helmets to be applied within 14 days of a scan, so after a helmet is authorized by the insurance provider, an appointment will be set up for another scan.

Presbyterian NM requires a Pediatric Neurosurgeon to rule out craniosynostosis before helmet therapy; in our region, these specialists are located in El Paso and Albuquerque (see Plagiocephaly Resources).

Helmet Transfer Pattern Guide

Parents/Guardians will select the helmet color and pattern (also called transfers) at https://www.orthomerica.com/transfers/ 

Helmets are available solid colors and patterns. Solid colors are usually always available; if a pattern is chosen, a second option should be selected in case the first choice is not available.

Starting treatment

The treatment time-frame is usually 4-6 months, although certain cases may require less or more time depending on the age of your child and their individual needs. Treatment with post-operative helmets following cranial surgery is determined by the neurosurgeon. 

Clinic visit schedule:

• initial appointment and cranial scan (1 hr)
• initial helmet fitting (45 min)
• follow-up every 4 wks with scan (30-45 min)
• final visit with comparison scan (30-45 min)

Initial helmet wear schedule

• Day 1: Three times during the day (alternate 1 hr on, 1 hr off) but not during naps or at night. 
• Day 2: Three times during the day (alternate 2 hrs on, 2 hrs off) but not during naps or at night. 
• Day 3: Two times during the day (alternate 4 hrs on, 4 hrs off) but not during naps or at night. 
• Day 4: Two times during the day (alternate 8 hrs on, 8 hrs off) including during naps and at night. First night to sleep in helmet.
• Day 5: Full time wear (23 hrs/day) except for 1 hr, usually during bath time; you may split this hour up, for example 30 mins AM and PM. You will continue this schedule until the end of the treatment period.

Check the scalp each time you remove the helmet (see Skin Care).

Ongoing Wear Schedule

• The helmet should be worn for 23 hrs/day.
• Remove the helmet if your child has a fever.
• The helmet may be removed during some activities such as physical therapy, or swimming.
• If your child has not been able to wear the helmet for 48 hrs, restart the wear schedule and increase wear slowly over a few days.

Please call our office if you adjust the wear schedule; we will need to return to full time wear as soon as possible.

Ending treatment

It is best to taper off helmet wear at the end of treatment. Allow time for your child to adapt to receiving sensory information without a helmet. For example, since their head has been protected from impacts, they must learn to avoid hitting their head.

Scalp Check

• Check the entire scalp several times each day.
• In good light, move hair aside to check for red spots, rash, dry flaky skin, or blisters. 
• Clean scalp at each bath and allow to dry thoroughly.
• Check the helmet interior for discoloration or odor; clean helmet interior and allow to dry thoroughly (see Helmet Care below). 

Skin irritation

• Red spots: “normal” red spots should disappear within an hour after removing the helmet. Red spots can lead to skin breakdown and should be cleaned and monitored frequently during the day.
• Perspiration: your child may perspire more while adjusting to the helmet during the first several days; this is normal, keep your child cool and dress in cool clothing. 
  Remove the helmet for a few minutes throughout the day, dry the head and helmet with a towel and reapply helmet. Time out of the helmet no more than 10 minutes total for the day.
  For moisture or perspiration, a thin cotton interface may be placed between the helmet and scalp to absorb sweat (100% cotton sheeting, not bulky material or terrycloth); cotton interfaces can be washed daily and reused. The orthotist may drill air holes in the back of the helmet.

Other causes of skin irritation or skin reaction:

• bacterial infection, or a fungal (yeast) infection, can be picked up anywhere that children play; a bacterial infection is treated very differently from a fungal infection, or an infection may be a combination of bacterial and fungal. Contact your child’s PCP to make the correct diagnosis; bacterial infections may be treated with a topical antibiotic, fungal infections may be treated with an antifungal medication; using some medications under an occluded helmet may effectively increase the dose concentration.
• sensitivity to powders, lotions, or wipes that contain perfumes or other ingredients.
• allergic reaction to the cleaning agent used to clean the helmet interior, such as alcohol.
• allergic reaction to medications, food, pets, molds, or seasonal allergies.
• sensitivity to new environments (day care, church, homes).

Swimming

• Remove the helmet for swimming, keep the helmet dry, do not immerse in water.
• After swimming, shampoo child’s skin and hair to remove chlorine, sunscreen, etc.
• Reapply the helmet after the hair is completely dry.

If you notice a red spot that does not go away, or skin breakdown, call us to describe the problem, or take a picture and email it to us.

We may ask you to remove the helmet until you can come to the office, where we can relieve the area that is in contact with the skin. We may adjust the wear schedule to allow the skin to heal.

For a problem that does not resolve, or for any medical treatment, contact your child’s PCP. 

• Only the orthotist can modify the interior and exterior of the helmet.
• You may decorate the exterior of your helmet, however do not apply decorative stickers that the child can peel off and which are a choking hazard.
• The helmet has a chafe strap and a stop-gap foam insert. Call us if these parts are loose, as this can be a choking hazard.

• Do not immerse the helmet in water.
• Normal helmet wear and tear includes discoloration and odor.
• Clean the helmet interior frequently, such as during diaper changes and bath time.
• Keep towels handy to frequently dry baby’s head and the helmet interior.
• Be prepared to clean the helmet when you’re traveling or running errands. Keep a small bottle of rubbing alcohol (or vinegar and water) and washcloth in your car or diaper bag.
• Keep the helmet away from family pets which have been known to chew the plastic and foam liner. This does happen!

• Use 91% isopropyl alcohol in a spray bottle and apply generously to the STARband. If your child is allergic to rubbing alcohol you may use vinegar and water.
• Do not use other cleaning products (such as baby wipes or antiseptic wipes) as these may cause deterioration of the helmet foam, and worse, may be harmful to the baby’s skin, cause an allergic reaction or skin breakdown.

• After spraying with alcohol, scrub the helmet liner with a white paper towel or soft toothbrush, a clean washcloth or cotton gauze.
• Wipe again with damp towel to remove residue of cleaner. After cleaning, allow the helmet to dry completely.
• Use a fan or dry in the sun if needed as residual moisture can cause skin problems.  

• Make sure baby’s head and the inside of the STARband are dry before donning the helmet.
• Do not use a hair dryer to dry the helmet as it can melt the plastic foam.
• Drying in the sun may help alleviate odor.

U.S. Food and Drug Administration. Code of Federal Regulations (CFR). Neurological devices. Sec. 882.5970 Cranial orthosis. July 20, 2022.

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