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Enrolling by invitationNCT02283229Updated Nov 28, 2023

Newborn Head Molding and Later Asymmetries

An interventional study of Newborns with preventive caring advices and Newborns with normal caring advices in Plagiocephaly, sponsored by University of Oulu. Enrolling by invitation at 1 site in Finland. Open to participants aged 1 Day to 6 Days, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-11-28.

Sponsored by University of Oulu · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 2 years 8 months after the study started (first participant enrolled Feb 2012, registered Oct 2014).
Phase
Not applicable
Study type
Interventional
Enrollment
135
Allocation
Randomized
Ages
1 Day to 6 Days
Sex
All
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Study 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.

Read the 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.

02

Conditions studied

  • Plagiocephaly

Keywords

  • Plagiocephaly
  • torticollis
  • occlusal defect
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In context

Plagiocephaly

16 studies on the registry are indexed under Plagiocephaly; 4 are open to participants now.

Browse Plagiocephaly studies →

Lead sponsor

University of Oulu is the lead sponsor of 141 studies on the registry; 22 are open to participants now.

Browse University of Oulu studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Day to 6 Days
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Congenital anomalies,
  • Very early discharge,
  • Parental refusal
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
135 participants (estimated)

Study arms

  • Active comparator
    Active

    Newborns with preventive caring advices

    Behavioral: Newborns with preventive caring advices

  • Placebo comparator
    Surveillance

    Newborns with normal caring advices

    Other: Newborns with normal caring advices

Interventions

  • BehavioralNewborns with preventive caring advices

    Advices to prevent head molding

  • OtherNewborns with normal caring advices

    Normal handling

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What researchers measure

Primary outcomes

  1. 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%)

    Time frame: 3 months

Secondary outcomes

  1. Severity of plagiocephaly

    The number of children in groups with plagiocephaly as mild; aOCLR 104-107%; moderate 107-111%; severe =/\>111 %

    Time frame: 3 months

  2. Change in plagiocephaly

    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

  3. Occlusal defects

    The number of children in groups with occlusal defects

    Time frame: 6 years

  4. Change in occlusal defects

    The number of children with occlusal defects

    Time frame: from 6 years to 10 years

  5. Change in facial symmetry

    The number of children with facial asymmetry

    Time frame: from 6 years to 10 years

  6. Change in occlusal defects

    The number of children with occlusal defects

    Time frame: from 10 years to 15 years

  7. Change in facial symmetry

    The number of children with facial asymmetry

    Time frame: from 10 years to 15 years

Other outcomes

  1. Development (Development quotients by Griffiths scales in groups)

    Difference in Development quotients by Griffiths scales in groups

    Time frame: 3 months

  2. Change in Development (Development quotients by Griffiths scales in groups)

    Difference in Development quotients by Griffiths scales in groups

    Time frame: From 3 months to 6 months

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Study locations

1 site
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References and documents

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. PubMed 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. PubMed 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. PubMed 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. PubMed 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. PubMed 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. PubMed 31614700 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Feb 2012 (actual). Primary completion is estimated for Dec 2027, 190 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 28, 2014
First posted
Nov 5, 2014
StartActual
Feb 2012
Primary completionEst.
Dec 2027
CompletionEst.
Dec 2027
Last update
Nov 28, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 28, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02283229
Lead sponsor
University of Oulu
Responsible party
Marita Valkama (PhD, M.D. Adjunct Professor, pediatrician and neonatologist, University of Oulu) — Principal investigator
First posted
Nov 5, 2014
Start date
Feb 2012
Primary completion
Dec 2027 (estimated)
Completion
Dec 2027 (estimated)
Last update
Nov 28, 2023

Study contacts

Pertti Pirttiniemi, Professor
study chair · University of Oulu
Marita Valkama, Ph.D., M.D.
principal investigator · University of Oulu, Oulu University Hospital
Virpi Harila, Ph.D.
study director · University of Oulu
Henri Aarnivala, M.D.
principal investigator · University of Oulu
Tuomo Heikkinen, Dos
principal investigator · University of Oulu
Ville Vuollo, Ph.M.
principal investigator · University of Oulu

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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