Newborn Head Molding and Later Asymmetries

Plagiocephaly Clinical Trial

Official title:

Newborn Head Molding and Later Asymmetries in Follow up (3D Head Shape Modelling)

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02283229
• Other study ID #: EETTMK:27/2011
• Status: Enrolling by invitation
• Phase: N/A
• Start date: February 2012
• Est. completion date: December 2027

Study information

• Verified date: November 2023
• Source: University of Oulu
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Prospective randomized clinical interventional trial after birth in maternity ward, and follow up to 8-9 years of age.

Hypothesis: Preventive handling and caring advices to parents of newborns decrease craniofacial asymmetries (deformational plagiocephaly and torticollis). The minimum sample size of the study was calculated at 86 (43 in each arm) using a 5% significance level, a power of 80% and a fall in the prevalence of DP from 31% to 8%. Craniofacial asymmetries and appearances of occlusal defects are followed up to 9 years. 50 preterm infants can participate without intervention.

Description:

The amount of craniofacial abnormal molding after birth in newborns and the frequency of plagiocephaly in infancy or later consequences of those in childhood are not known in finnish population. Head malposition and deformational plagiocephaly, however, have been linked to delayed development in early life and even much later to orthognathic problems demanding surgery in adulthood.

In this study parents with healthy newborns are randomized to have normal discharge home or discharged with extra advice information for caregivers; to charge both sided feeding and handling habits; to change regularly sleeping and lying positions; to have early tummy times.

Anthropometric measurements of the infants; tilting degrees of the head and rotations of the neck (range of movement =ROM) are taken at discharge home and at the age of 3 and 6 months, and 1, 3, 5-6 and 8-9 years. Two-dimensional digital photographs (upto the age of 6 months) and three-dimensional imaging (from the age of 3 months) are taken to measurements of the head shape (Cephalic index=CI and (approximate) Oblique Cranial Length Ratio= (a)OCLR measured using a semiautomated, computer-based method). The development quotient by Griffiths scales are assessed at the age of 3 and 6 months. Dental occlusal defect evaluation are started at the age of 3 ys.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 135
• Est. completion date: December 2027
• Est. primary completion date: December 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Day to 6 Days

Eligibility

Inclusion Criteria:

• 1-6 days after birth;

• Healthy newborns in maternal ward, and living in near by Oulu region.

• Preterms at the age of 34-44 gestation weeks in near by Oulu region (non randomized)

Exclusion Criteria:

• Congenital anomalies,

• Very early discharge,

• Parental refusal

Related Conditions & MeSH terms

• Plagiocephaly

Intervention

Behavioral:
• Newborns with preventive caring advices
Advices to prevent head molding

Other:
• Newborns with normal caring advices
Normal handling

Locations

Country	Name	City	State
Finland	Oulu University Hospital	Oulu

Sponsors (1)

Lead Sponsor	Collaborator
University of Oulu

Country where clinical trial is conducted

Finland, 

References & Publications (6)

Aarnivala H, Vuollo V, Harila V, Heikkinen T, Pirttiniemi P, Holmstrom L, Valkama AM. The course of positional cranial deformation from 3 to 12 months of age and associated risk factors: a follow-up with 3D imaging. Eur J Pediatr. 2016 Dec;175(12):1893-19 — View Citation

Aarnivala H, Vuollo V, Harila V, Heikkinen T, Pirttiniemi P, Valkama AM. Preventing deformational plagiocephaly through parent guidance: a randomized, controlled trial. Eur J Pediatr. 2015 Sep;174(9):1197-208. doi: 10.1007/s00431-015-2520-x. Epub 2015 Apr — View Citation

Aarnivala HE, Valkama AM, Pirttiniemi PM. Cranial shape, size and cervical motion in normal newborns. Early Hum Dev. 2014 Aug;90(8):425-30. doi: 10.1016/j.earlhumdev.2014.05.007. Epub 2014 Jun 13. — View Citation

Launonen AM, Aarnivala H, Kyteas P, Vuollo V, Heikkinen T, Kau CH, Pirttiniemi P, Harila V, Valkama AM. A 3D Follow-Up Study of Cranial Asymmetry from Early Infancy to Toddler Age after Preterm versus Term Birth. J Clin Med. 2019 Oct 11;8(10):1665. doi: 1 — View Citation

Launonen AM, Vuollo V, Aarnivala H, Heikkinen T, Pirttiniemi P, Valkama AM, Harila V. Craniofacial Asymmetry from One to Three Years of Age: A Prospective Cohort Study with 3D Imaging. J Clin Med. 2019 Dec 27;9(1):70. doi: 10.3390/jcm9010070. — View Citation

Vuollo V, Holmstrom L, Aarnivala H, Harila V, Heikkinen T, Pirttiniemi P, Valkama AM. Analyzing infant head flatness and asymmetry using kernel density estimation of directional surface data from a craniofacial 3D model. Stat Med. 2016 Nov 20;35(26):4891- — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Development (Development quotients by Griffiths scales in groups)	Difference in Development quotients by Griffiths scales in groups	3 months
Other	Change in Development (Development quotients by Griffiths scales in groups)	Difference in Development quotients by Griffiths scales in groups	From 3 months to 6 months
Primary	Presence of Plagiocephaly (The number of children in groups with plagiocephaly (CI, OCLR =/> 104% )	The number of children in groups with plagiocephaly (CI, OCLR =/> 104%)	3 months
Secondary	Severity of plagiocephaly	The number of children in groups with plagiocephaly as mild; aOCLR 104-107%; moderate 107-111%; severe =/>111 %	3 months
Secondary	Change in plagiocephaly	The number of children in groups with plagiocephaly as mild; aOCLR 104-107%; moderate 107-111%; severe =/>111 %	From 3 to 6 months
Secondary	Occlusal defects	The number of children in groups with occlusal defects	6 years
Secondary	Change in occlusal defects	The number of children with occlusal defects	from 6 years to 10 years
Secondary	Change in facial symmetry	The number of children with facial asymmetry	from 6 years to 10 years
Secondary	Change in occlusal defects	The number of children with occlusal defects	from 10 years to 15 years
Secondary	Change in facial symmetry	The number of children with facial asymmetry	from 10 years to 15 years