Clin2
NCT07201324Possibly a fitNot yet recruiting

Helmet therapy for babies with head shape issues

Plagiocephaly, NonsynostoticBrachycephaly

Part of Bones, joints & muscles, Genetic & congenital clinical trials.

This study tests if wearing a special helmet can improve neck movement and temperature regulation in babies with moderate to severe flat head or other positional head deformities.

Summary written for real people, not researchers, by Clin2.

Phase
N/A
Enrollment
270 people
Ages
4 months to 1 year
Study type
Observational

Who can take part

  • Your baby has a severe or very severe positional head deformity (like flat head).
  • Treatment must start when your baby is between 4 and 12 months old.
  • Your baby will need to wear the helmet for at least 12 weeks.
  • Your baby does not have craniosynostosis (early skull fusion), hydrocephalus (fluid on the brain), or torticollis (tight neck muscle).
  • Your baby does not have a metabolic disorder.
  • You must be able to have your baby wear the helmet for 23 hours each day.

View the official record on ClinicalTrials.gov

Quick eligibility check

Answer a few plain-language questions, based on this study's own requirements, to get a preliminary sense of fit.

Similar studies

Other trials that look related to this one.

NCT05917678Recruiting
Compare head-shape treatments for infants with flat spots

This study looks at whether repositioning and a custom head-shaping helmet help improve head shape in babies who have cranial deformation. You may be asked to follow standard care and have your baby monitored for changes over time.

Dallas, Texas
NCT05848895Recruiting
Osteopathy treatment for infants with positional head shape

This study tests an osteopathic manual therapy plan (hands-on treatment) for babies with positional plagiocephaly, aiming to improve head shape and comfort. It also asks families to attend multiple treatment and measurement visits so researchers can track change over time.

San Diego, California
NCT06762691Not yet recruiting
Cranial helmet registry for babies

This registry tracks the outcomes of babies who use a cranial remolding orthosis (helmet). It helps doctors learn more about how these helmets work and how to improve care.

Madison Heights, Michigan
NCT06956768Not yet recruiting
Helmet therapy for flat head in infants

This study tracks how head shape changes in infants with positional plagiocephaly (flat head) while they wear a molding helmet and after treatment ends.

NCT07356401Recruiting
Cranial helmet treatment: parent expectations and satisfaction

This study looks at how well cranial helmets work for babies with flat head syndrome and how parents feel about the treatment and results.

Ankara, Keçiören
NCT07758426Not yet recruiting
Tummy time and positioning for premature babies with head shape changes

This study tests whether tummy time and special positioning can help improve head shape in premature babies with flat spots. It is done in the hospital while your baby is still receiving care.

Porto Alegre, Rio Grande do Sul

Hear when a new Brachycephaly trial opens

We’ll email you when one opens — at most once a week, no account needed, unsubscribe anytime.