Newborn Head Molding and Later Asymmetries
Primary Purpose
Plagiocephaly
Status
Enrolling by invitation
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Newborns with preventive caring advices
Newborns with normal caring advices
Sponsored by
About this trial
This is an interventional prevention trial for Plagiocephaly focused on measuring Plagiocephaly, torticollis, occlusal defect
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
Sites / Locations
- Oulu University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Active
Surveillance
Arm Description
Newborns with preventive caring advices
Newborns with normal caring advices
Outcomes
Primary Outcome Measures
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%)
Secondary Outcome Measures
Severity of plagiocephaly
The number of children in groups with plagiocephaly as mild; aOCLR 104-107%; moderate 107-111%; severe =/>111 %
Change in plagiocephaly
The number of children in groups with plagiocephaly as mild; aOCLR 104-107%; moderate 107-111%; severe =/>111 %
Occlusal defects
The number of children in groups with occlusal defects
Change in occlusal defects
The number of children with occlusal defects
Change in facial symmetry
The number of children with facial asymmetry
Change in occlusal defects
The number of children with occlusal defects
Change in facial symmetry
The number of children with facial asymmetry
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02283229
Brief Title
Newborn Head Molding and Later Asymmetries
Official Title
Newborn Head Molding and Later Asymmetries in Follow up (3D Head Shape Modelling)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
February 2012 (Actual)
Primary Completion Date
December 2027 (Anticipated)
Study Completion Date
December 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Oulu
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plagiocephaly
Keywords
Plagiocephaly, torticollis, occlusal defect
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
135 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Active
Arm Type
Active Comparator
Arm Description
Newborns with preventive caring advices
Arm Title
Surveillance
Arm Type
Placebo Comparator
Arm Description
Newborns with normal caring advices
Intervention Type
Behavioral
Intervention Name(s)
Newborns with preventive caring advices
Intervention Description
Advices to prevent head molding
Intervention Type
Other
Intervention Name(s)
Newborns with normal caring advices
Intervention Description
Normal handling
Primary Outcome Measure Information:
Title
Presence of Plagiocephaly (The number of children in groups with plagiocephaly (CI, OCLR =/> 104% )
Description
The number of children in groups with plagiocephaly (CI, OCLR =/> 104%)
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Severity of plagiocephaly
Description
The number of children in groups with plagiocephaly as mild; aOCLR 104-107%; moderate 107-111%; severe =/>111 %
Time Frame
3 months
Title
Change in plagiocephaly
Description
The number of children in groups with plagiocephaly as mild; aOCLR 104-107%; moderate 107-111%; severe =/>111 %
Time Frame
From 3 to 6 months
Title
Occlusal defects
Description
The number of children in groups with occlusal defects
Time Frame
6 years
Title
Change in occlusal defects
Description
The number of children with occlusal defects
Time Frame
from 6 years to 10 years
Title
Change in facial symmetry
Description
The number of children with facial asymmetry
Time Frame
from 6 years to 10 years
Title
Change in occlusal defects
Description
The number of children with occlusal defects
Time Frame
from 10 years to 15 years
Title
Change in facial symmetry
Description
The number of children with facial asymmetry
Time Frame
from 10 years to 15 years
Other Pre-specified Outcome Measures:
Title
Development (Development quotients by Griffiths scales in groups)
Description
Difference in Development quotients by Griffiths scales in groups
Time Frame
3 months
Title
Change in Development (Development quotients by Griffiths scales in groups)
Description
Difference in Development quotients by Griffiths scales in groups
Time Frame
From 3 months to 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
6 Days
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pertti Pirttiniemi, Professor
Organizational Affiliation
University of Oulu
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Marita Valkama, Ph.D., M.D.
Organizational Affiliation
University of Oulu, Oulu University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Virpi Harila, Ph.D.
Organizational Affiliation
University of Oulu
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Henri Aarnivala, M.D.
Organizational Affiliation
University of Oulu
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tuomo Heikkinen, Dos
Organizational Affiliation
University of Oulu
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ville Vuollo, Ph.M.
Organizational Affiliation
University of Oulu
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oulu University Hospital
City
Oulu
ZIP/Postal Code
90220
Country
Finland
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
24951081
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.
Results Reference
result
PubMed Identifier
25823758
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.
Results Reference
result
PubMed Identifier
27383684
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.
Results Reference
result
PubMed Identifier
27624627
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.
Results Reference
result
PubMed Identifier
31892114
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.
Results Reference
result
PubMed Identifier
31614700
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.
Results Reference
result
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Newborn Head Molding and Later Asymmetries
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