Newborn Head Molding and Later Asymmetries

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое Newborns with preventive caring advices
  Advices to prevent head molding
• Другое Newborns with normal caring advices
  Normal handling

Первичные конечные точки

• Presence of Plagiocephaly (The number of children in groups with plagiocephaly (CI, OCLR =/> 104% ) [Срок оценки: 3 months]

Вторичные конечные точки (7)

• Severity of plagiocephaly [Срок оценки: 3 months]
• Change in plagiocephaly [Срок оценки: From 3 to 6 months]
• Occlusal defects [Срок оценки: 6 years]
• Change in occlusal defects [Срок оценки: from 6 years to 10 years]
• Change in facial symmetry [Срок оценки: from 6 years to 10 years]
• Change in occlusal defects [Срок оценки: from 10 years to 15 years]
• Change in facial symmetry [Срок оценки: from 10 years to 15 years]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• Congenital anomalies,
• Very early discharge,
• Parental refusal

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

Финляндия · 1 центр

• Oulu University Hospital — Oulu

Публикации

• 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. PMID 24951081
• 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. PMID 25823758
• 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. PMID 27383684
• 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. PMID 27624627
• 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. PMID 31892114
• 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. PMID 31614700

Идентификаторы

NCT: NCT02283229 · EETTMK:27/2011

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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