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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active | Active Comparator | Newborns with preventive caring advices |
|
| Surveillance | Placebo Comparator | Newborns with normal caring advices |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Newborns with preventive caring advices | Behavioral | Advices to prevent head molding |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Severity of plagiocephaly | The number of children in groups with plagiocephaly as mild; aOCLR 104-107%; moderate 107-111%; severe =/>111 % | 3 months |
| Change in plagiocephaly | The number of children in groups with plagiocephaly as mild; aOCLR 104-107%; moderate 107-111%; severe =/>111 % |
| Measure | Description | Time Frame |
|---|---|---|
| Development (Development quotients by Griffiths scales in groups) | Difference in Development quotients by Griffiths scales in groups | 3 months |
| Change in Development (Development quotients by Griffiths scales in groups) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pertti Pirttiniemi, Professor | University of Oulu | Study Chair |
| Marita Valkama, Ph.D., M.D. | University of Oulu, Oulu University Hospital | Principal Investigator |
| Virpi Harila, Ph.D. | University of Oulu | Study Director |
| Henri Aarnivala, M.D. | University of Oulu | Principal Investigator |
| Tuomo Heikkinen, Dos | University of Oulu | Principal Investigator |
| Ville Vuollo, Ph.M. | University of Oulu | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oulu University Hospital | Oulu | 90220 | Finland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24951081 | Result | 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. | |
| 25823758 | Result | 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. |
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| ID | Term |
|---|---|
| D059041 | Plagiocephaly |
| D014103 | Torticollis |
| ID | Term |
|---|---|
| D019465 | Craniofacial Abnormalities |
| D009139 | Musculoskeletal Abnormalities |
| D009140 | Musculoskeletal Diseases |
| D000013 | Congenital Abnormalities |
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| Newborns with normal caring advices |
| Other |
Normal handling |
|
| From 3 to 6 months |
| Occlusal defects | The number of children in groups with occlusal defects | 6 years |
| Change in occlusal defects | The number of children with occlusal defects | from 6 years to 10 years |
| Change in facial symmetry | The number of children with facial asymmetry | from 6 years to 10 years |
| Change in occlusal defects | The number of children with occlusal defects | from 10 years to 15 years |
| Change in facial symmetry | The number of children with facial asymmetry | from 10 years to 15 years |
Difference in Development quotients by Griffiths scales in groups
| From 3 months to 6 months |
| 27383684 | Result | 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. |
| 27624627 | Result | 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. |
| 31892114 | Result | 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. |
| 31614700 | Result | 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. |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D004421 | Dystonia |
| D020820 | Dyskinesias |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |