Neck Support Pillow Infant Head Positioner

Product Information

Some babiesare born with a different type of torticollis, which isn't painful. What Are the Signs & Symptoms of Torticollis? For the most part, a baby with torticollis will eat, sleep and play like any other baby, except when it comes to activities that involve turning. You may see: Improve awareness and understanding among your colleagues and care communities regarding a safe sleep environment for infants, and etiologies and associated management options for flat head syndrome. For an infant between four and 12 months old especially, additional items like a pillow on their bed can increase the risk of death. To sleep, place your baby on a firm mattress without pillows.

Discourage the use of infant head shaping pillows. Review this safety communication with your colleagues, care teams, parents, and caregivers who recommend, use, or may use infant head shaping pillows. The FDA is informing parents, caregivers, and health care providers of the risks associated with use of infant head shaping pillows. The FDA is working with stakeholders to increase awareness of the issue. Siblings help when they play with the baby on the floor, encouraging the baby to follow them with his head in the restricted direction. The most common feature is that the baby prefers to rotate their head to one side and not the other. Breast feeding mothers may notice that their baby prefers to feed from one side. Babies that have difficulty turning their head to the left generally find it more difficult to feed from their mother’s right breast. If your child develops acquired torticollis, the typical course of treatment is to apply heat and use massage and stretching to ease the pain. Botox injections are also an option for older children with severe torticollis. Your pediatrician can refer you to a neurologist or orthopedist for more treatment.Have some tummy time. Allow your baby to spend some time lying on their stomach while awake. Sing or talk to your baby, or hold up fun toys to catch their attention and encourage head movement. Your baby works hard to turn toward you, struggles to turn their head all the way, and becomes upset because the movement is hard. Use your baby’s appetite as an incentive. Offer the bottle or your breast in a way that gets them to turn away from the favored side.

Get them to play with their hands and feet . Babies like to bring their hands together and their feet up to their hands. When your baby does this, it builds up muscles they will need to crawl. This tightens and shortens one of the “strap muscles” that turn the head. These sternocleidomastoid muscles (SCMs) run from the collarbone to behind the ear. Infant head shaping pillows are not FDA-approved. The safety and effectiveness of these products have not been established for the prevention or treatment of flat head syndrome (also known as positional plagiocephaly or deformational plagiocephaly), or the more serious condition where the developing infant’s skull bones join together too early (known as craniosynostosis). Recommendations for Parents and CaregiversIf a parent or caregiver reports a problem with an infant head shaping pillow, advise them to discontinue its use and report it to the FDA and the manufacturer. Prompt reporting of problems can help the FDA identify and better understand the risks associated with medical devices. If your doctor used forceps or a vacuum device during delivery, those also might have put pressure on your baby’s SCM. Symptoms If you notice signs that look like your baby might have torticollis, set up an exam with your doctor. If you experience adverse events associated with using an infant head shaping pillow, we encourage you to file a voluntary report through MedWatch, the FDA Safety Information and Adverse Event Reporting program. Health care personnel employed by facilities that are subject to FDA's user facility reporting requirements should follow the reporting procedures established by their facilities.

Recently, the FDA became aware of companies marketing infant head shaping pillows with claims for the prevention and treatment of flat head syndrome without FDA clearance or approval. The FDA has communicated our concerns about these promotional materials to these companies and will continue to monitor promotional materials and claims for these medical devices. If your baby has the condition at birth, it’s called congenital muscular torticollis. That’s the most common type. If your infant has an unusual head shape, talk to your infant’s health care provider about management options. Know that the use of infant head shaping pillows may delay the necessary evaluation and management of harmless conditions, such as flat head syndrome, or more serious conditions, such as craniosynostosis. Appropriate tummy time is also important. Several times a day, when babies are awake, put them on their bellies for 20 minutes, Dr. Burke advises. This encourages them to turn their heads from side to side, push up on their arms and increase their muscle tone.

FDA Actions

If your doctor determines your baby has torticollis, it’s important to start treatment right away to prevent permanent asymmetry, a flat spot on your baby’s head and restricted head movement. Treatment options may include: Physical therapy The FDA will keep the public informed if significant new information becomes available. Reporting Problems to the FDA If you act early, you can help prevent any long-term problems for your baby. Without treatment, your baby might get complications, including: The sternocleidomastoid muscle, connecting from the collar bone to the skull, plays a vital role in head movement. When this muscle is tight, babies may display a head tilt and difficulty turning to one side. Signs of torticollis can include a consistently tilted head or a preference for looking in one direction. Observing these signs in your baby's behavior or in photos can prompt further evaluation.

Although babies can be completely safe and comfortable in their cribs without any extra items, many companies promote pillows for young babies and newborns. They're often said to help prevent "flat head" syndrome in babies and are used in cots and cribs. However, the American Academy of Pediatrics recommends waiting to let your baby use a pillow until they are two years old. Is It Safe to Let Your Baby Sleep with a Pillow? Repositioning devices and pillows marketed for use in cribs or bassinets require constant supervision and are generally not recommended. These devices have limited effectiveness and may pose safety risks. Consult with a healthcare professional, such as a pediatrician or pediatric physical therapist, for guidance specific to your baby's condition. If you notice that your child may have signs of torticollis or flat head syndrome please make sure that it is seen by a competent pediatric orthopedist. Only one cranial center offer a free evaluation, which is the Cranial Therapy Center in Lakewood, NJ. Be aware that infant head shaping pillows are not safe or effective for preventing or treating flat head syndrome or other medical conditions.Do not use infant head shaping pillows due to the risk of sudden unexpected infant death (SUID), inclusive of sudden infant death syndrome (SIDS), and suffocation and death. If kids still don’t respond to treatment, pediatricians refer them to the eye doctor for a visual exam. Some babies may tilt their heads to see better because their eyes are crossed, a condition called strabismus . Older kids may be at risk of crib accidents. Your older kid may use a pillow as a step to climb up the crib. They can suddenly fall and sustain a serious injury. What to Do if You're Worried About Flat Head Syndrome