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PlagiocephalyNCT02283229

Newborn Head Molding and Later Asymmetries

A study testing Newborns with preventive caring advices and Newborns with normal caring advices in people with Plagiocephaly, run by University of Oulu at 1 site in Finland.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial 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). Read more about this study

Who is it for?
Ages 1 day to 6 daysHealthy volunteers can take part
Conditions the study is for
Plagiocephaly
What is being tested?
Newborns with preventive caring advices and Newborns with normal caring advices
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
135 participants
Where
1 siteFinland
Study dates
Feb 2012to Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 day to 6 days
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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)

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Finland1 site

  • Oulu University Hospital

    Oulu, 90220

Other trials in Finland

About this study

Official title: 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.

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.

Conditions
Plagiocephaly
Being tested
Newborns with preventive caring advices, Newborns with normal caring advices
Keywords
Plagiocephaly, torticollis, occlusal defect
Medical subject headings
Plagiocephaly, Torticollis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Newborns with preventive caring advicesBehavioural

    Advices to prevent head molding

  • Newborns with normal caring advicesOther

    Normal handling

Study groups in NCT02283229
Study groupRoleWhat they receive
ActiveActive comparatorNewborns with preventive caring advices
Receives: Behavioral: Newborns with preventive caring advices
SurveillancePlacebo comparatorNewborns with normal caring advices
Receives: Other: Newborns with normal caring advices

What is being measured

The primary outcome is the main question the study is designed to answer.

  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%)

    Measured: 3 months

Secondary outcomes (7)

  1. Severity of plagiocephaly

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

    Measured: 3 months

  2. Change in plagiocephaly

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

    Measured: From 3 to 6 months

  3. Occlusal defects

    The number of children in groups with occlusal defects

    Measured: 6 years

  4. Change in occlusal defects

    The number of children with occlusal defects

    Measured: from 6 years to 10 years

  5. Change in facial symmetry

    The number of children with facial asymmetry

    Measured: from 6 years to 10 years

  6. Change in occlusal defects

    The number of children with occlusal defects

    Measured: from 10 years to 15 years

  7. Change in facial symmetry

    The number of children with facial asymmetry

    Measured: from 10 years to 15 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Nov 2014 (estimated)
  2. Study startFeb 2012
  3. Primary completionDec 2027 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
135 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02283229
Sponsor's protocol ID
EETTMK:27/2011
Status last verified
Nov 2023
First submitted
28 Oct 2014
Last updated
28 Nov 2023
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

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

Questions about this trial

What is this clinical trial studying?

A study testing Newborns with preventive caring advices and Newborns with normal caring advices in people with Plagiocephaly, run by University of Oulu at 1 site in Finland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 28 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Presence of Plagiocephaly (The number of children in groups with plagiocephaly (CI, OCLR =/> 104% ) (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02283229, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2023.

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