CompletedNot Applicable

Treatment of Cranial Molding Deformities in Preterm Infants

United States32 participantsStarted 2015-06

Plain-language 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).

Who can participate

Age range23 Weeks – 30 Weeks

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Cranial Index (CI)

Timeframe: 34 weeks gestational age

Number of Infants That Developed Dolichocephaly by the End of the Study

Timeframe: 34 weeks gestational age

Trial details

NCT IDNCT02366936

SponsorDuke University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-06

Results submitted2017-03-07

View on ClinicalTrials.gov More Preterm Infants trials