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 range

23 Weeks – 30 Weeks

Sex

ALL

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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