CompletedNot Applicable

Premie Pouch to Manage Deformational Plagiocephaly in Very Low Birth Weight Infants

United States11 participantsStarted 2016-06

Plain-language summary

This pilot project proposes to develop and test a new device to manage (defined as resolving, prohibiting, inhibiting or preventing) the development of Deformational Plagiocephaly (DP) in prematurely born infants weighing \< 1 kilogram.

Who can participate

Age range

40 Days

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

. Infants weighing \</= 900 grams. (Selecting a weight below the 1 Kg cut off for using the device will allow the infant an opportunity to use the device before outgrowing it.)
. Infants born at \>/= 22 weeks gestation.
. Infants \</= 40 days of age at enrollment.
. Infants that receive medical clearance from their healthcare team.
. Infants that have an estimated minimum hospital length of stay = / \> 14 days from the time of enrollment.
. Every effort will be made to include infants from non-English speaking families as long as using all available resources; the parents can successfully communicate with the research team. The research team will utilize interpreter services and other resources (immediate family members and supports) to facilitate this process when applicable.

Exclusion criteria

. Infants that require only prone positioning to maintain airway patency (such as those with Pierre Robin Syndrome/Sequence) will not be eligible to participate; this is because infants must be able to lie supine for at least part of the day.
. Infants requiring medical devices such as a continuous ventricular drain, subgaleal shunt, or intravenous catheters (unless placement of the IV is temporary) as they prevent proper positioning using the Premie Pouch.

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

Safety of Use of the Premie Pouch in VLBW Infants

Timeframe: From date of enrollment to date of study completion (range 19-47 days)

Trial details

NCT IDNCT03184441

SponsorBoston Children's Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-08

Results submitted2018-01-23

View on ClinicalTrials.gov More Plagiocephaly trials