N/A
N=11
Premie Pouch to Manage Deformational Plagiocephaly in Very Low Birth Weight Infants
Plagiocephaly
Bottom Line
View on ClinicalTrials.gov: NCT03184441 ↗Enrolled (actual)
11
Serious AEs
0.0%
Results posted
Aug 2018
Primary outcome: Primary: Safety of Use of the Premie Pouch in VLBW Infants — 0 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Premie Pouch (Device)
- Age
- Pediatric
- Sex
- All
- Sponsor
- Boston Children's Hospital
- Primary completion
- Aug 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety of Use of the Premie Pouch in VLBW Infants |
— | — |
| SECONDARY Feasibility of Use of the Premie Pouch in VLBW Infants |
20.1 | — |
| SECONDARY Number of Participants With Normal Cranial Index |
5 | — |
| SECONDARY Number of Participants With Normal Cranial Symmetry |
10 | — |
| SECONDARY Premie Pouch Ease of Use |
18 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Infants weighing /= 22 weeks gestation.
- Infants 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.
- 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.
Data sourced from ClinicalTrials.gov (NCT03184441). 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.