Newborn Head Molding and Later Asymmetries

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Plagiocephaly
• Intervention / Treatment: Behavioral: Newborns with preventive caring advices; Other: Newborns with normal caring advices

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.

• Study Type: Interventional
• Enrollment (Estimated): 135
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Finland
  • Oulu, Finland, 90220
    • Oulu University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 6 days (Child)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Active; Newborns with preventive caring advices	Behavioral: Newborns with preventive caring advices; Advices to prevent head molding
Placebo Comparator: Surveillance; Newborns with normal caring advices	Other: Newborns with normal caring advices; Normal handling

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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 %	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

Other Outcome Measures

Outcome Measure	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)	Difference in Development quotients by Griffiths scales in groups	From 3 months to 6 months

Collaborators and Investigators

• Sponsor: University of Oulu
• Investigators: Study Chair: Pertti Pirttiniemi, Professor, University of Oulu; Principal Investigator: Marita Valkama, Ph.D., M.D., University of Oulu, Oulu University Hospital; Study Director: Virpi Harila, Ph.D., University of Oulu; Principal Investigator: Henri Aarnivala, M.D., University of Oulu; Principal Investigator: Tuomo Heikkinen, Dos, University of Oulu; Principal Investigator: Ville Vuollo, Ph.M., University of Oulu

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2012
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: October 28, 2014
• First Submitted That Met QC Criteria: November 2, 2014
• First Posted (Estimated): November 5, 2014

Study Record Updates

• Last Update Posted (Actual): November 28, 2023
• Last Update Submitted That Met QC Criteria: November 27, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: torticollis; Plagiocephaly; occlusal defect
• Additional Relevant MeSH Terms: Congenital Abnormalities; Musculoskeletal Diseases; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Plagiocephaly
• Other Study ID Numbers: EETTMK:27/2011

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO