Newborn Head Molding and Later Asymmetries

NCT02283229 | Enrolling By Invitation DMC

• 1 other identifier: EETTMK:27/2011
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 1

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.

Conditions

Plagiocephaly

Keywords

Plagiocephaly; torticollis; occlusal defect

Outcome Measures

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%)

  3 months

Secondary Outcomes (7)

• Severity of plagiocephaly

  3 months

• Change in plagiocephaly

  From 3 to 6 months

• Occlusal defects

  6 years

• Change in occlusal defects

  from 6 years to 10 years

• Change in facial symmetry

  from 6 years to 10 years

Other Outcomes (2)

• Development (Development quotients by Griffiths scales in groups)

  3 months

• Change in Development (Development quotients by Griffiths scales in groups)

  From 3 months to 6 months

Study Arms (2)

Active

ACTIVE COMPARATOR

Newborns with preventive caring advices

Behavioral: Newborns with preventive caring advices

Surveillance

PLACEBO COMPARATOR

Newborns with normal caring advices

Other: Newborns with normal caring advices

Interventions

Newborns with preventive caring advices BEHAVIORAL

Advices to prevent head molding

Active

Newborns with normal caring advices OTHER

Normal handling

Surveillance

Eligibility Criteria

• Age: 1 Day - 6 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• University of Oulu: lead

Study Sites (1)

Oulu University Hospital

Oulu, 90220, Finland

Location

Related Publications (6)

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

MeSH Terms

Conditions

Plagiocephaly; Torticollis

Condition Hierarchy (Ancestors)

Craniofacial Abnormalities; Musculoskeletal Abnormalities; Musculoskeletal Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dystonia; Dyskinesias; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Pertti Pirttiniemi, Professor

  University of Oulu

  STUDY CHAIR

• Marita Valkama, Ph.D., M.D.

  University of Oulu, Oulu University Hospital

  PRINCIPAL INVESTIGATOR

• Virpi Harila, Ph.D.

  University of Oulu

  STUDY DIRECTOR

• Henri Aarnivala, M.D.

  University of Oulu

  PRINCIPAL INVESTIGATOR

• Tuomo Heikkinen, Dos

  University of Oulu

  PRINCIPAL INVESTIGATOR

• Ville Vuollo, Ph.M.

  University of Oulu

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, M.D. Adjunct Professor, pediatrician and neonatologist

Study Record Dates

• First Submitted: October 28, 2014
• First Posted: November 5, 2014
• Study Start: February 1, 2012
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: November 28, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)