Premie Pouch to Manage Deformational Plagiocephaly in Very Low Birth Weight Infants (NCT03184441) | Clinical Trial Compass
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 range40 Days
SexALL
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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.
✕. Infants with a craniofacial anomaly, craniosynostosis, cervical anomaly, or critical airway.
✕. Infants with Cutis Aplasia or significant skin breakdown to the scalp, because the experimental device may worsen a preexisting condition.
What they're measuring
1
Safety of Use of the Premie Pouch in VLBW Infants
Timeframe: From date of enrollment to date of study completion (range 19-47 days)
✕. Infants that are to be transferred to a non-participating hospital within 14 days of enrollment as this timeframe may not allow adequate evaluation of the Premie Pouch.