Clinical trial NCT02283229: Newborn Head Molding and Later Asymmetries
Official title: Newborn Head Molding and Later Asymmetries in Follow up (3D Head Shape Modelling)
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Plagiocephaly
Keywords: Plagiocephaly
torticollis
occlusal defect
Lead sponsor: University of Oulu
Sponsor class: OTHER
First posted: 2014-11-05
Enrollment: 135
Sex: ALL
Minimum age (years): 1
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Presence of Plagiocephaly (The number of children in groups with plagiocephaly (CI, OCLR =/> 104% )
timeFrame: 3 months
Secondary outcomes:
measure: Severity of plagiocephaly
timeFrame: 3 months
measure: Change in plagiocephaly
timeFrame: From 3 to 6 months
measure: Occlusal defects
timeFrame: 6 years
measure: Change in occlusal defects
timeFrame: from 6 years to 10 years
measure: Change in facial symmetry
timeFrame: from 6 years to 10 years
measure: Change in occlusal defects
timeFrame: from 10 years to 15 years
measure: Change in facial symmetry
timeFrame: from 10 years to 15 years
Other outcomes:
measure: Development (Development quotients by Griffiths scales in groups)
timeFrame: 3 months
measure: Change in Development (Development quotients by Griffiths scales in groups)
timeFrame: From 3 months to 6 months
Locations:
city: Oulu
country: Finland
facility: Oulu University Hospital
Study officials:
affiliation: University of Oulu
name: Pertti Pirttiniemi, Professor
role: STUDY_CHAIR
affiliation: University of Oulu, Oulu University Hospital
name: Marita Valkama, Ph.D., M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Oulu
name: Virpi Harila, Ph.D.
role: STUDY_DIRECTOR
affiliation: University of Oulu
name: Henri Aarnivala, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Oulu
name: Tuomo Heikkinen, Dos
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Oulu
name: Ville Vuollo, Ph.M.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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 1.
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):4891-4904. doi: 10.1002/sim.7032. Epub 2016 Jul 6.
citation: 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):1893-1903. doi: 10.1007/s00431-016-2773-z. Epub 2016 Sep 13.
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.
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: 10.3390/jcm8101665.