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N/A N=32 Prevention

Treatment of Cranial Molding Deformities in Preterm Infants

Preterm Infants · Dolichocephaly · Positional Scaphocephaly

Bottom Line

View on ClinicalTrials.gov: NCT02366936 ↗
Enrolled (actual)
32
Serious AEs
0.0%
Results posted
Apr 2017
Primary outcome: Primary: Cranial Index (CI) — 79 cranial index

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Tortle Midliner (Device)
Age
Pediatric · 0+ yrs
Sex
All
Sponsor
Duke University
Primary completion
Jun 2016

Outcome Measures

OutcomeResultp-value
PRIMARY
Cranial Index (CI)		 79 —
PRIMARY
Number of Infants That Developed Dolichocephaly by the End of the Study		 3 —

Summary

The purpose of this study is to determine the effectiveness of the Tortle Midliner positioning system in prevention and/or treatment of dolichocephaly, which can develop in preterm infants during the hospital stay. Specific Aim: Determine if the use of the Tortle Midliner is a more effective prevention and treatment strategy for dolichocephaly than current standard of care intervention in the Duke Intensive Care Nursery (ICN).

Eligibility Criteria

Inclusion Criteria

  • Birth weight of <1500 g
  • Gestational age of ≤ 30 weeks
  • <2 weeks chronological age
  • ≤30 weeks gestation at time of parent consent
  • Receiving continuous positive airway pressure (CPAP), nasal cannula or room air
  • Signed the informed consent from the legal caregiver

Exclusion Criteria

  • Determined to be too medically unstable by their attending physician
  • Diagnosed with a genetic/chromosomal abnormality, congenital neuromuscular disorder, craniofacial abnormalities, congenital hydrocephalus, post-hemorrhagic hydrocephalus, or other diagnoses determined by the PI that impacts generalizability of results
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02366936). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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