Premie Pouch to Manage Deformational Plagiocephaly in Very Low Birth Weight Infants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 6
- 主要终点
- Safety of Use of the Premie Pouch in VLBW Infants
研究概览
简要总结
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.
详细描述
Prematurely born infants are prone to developing Deformational Plagiocephaly (DP), a flattened head shape from repeatedly being positioned in the same direction while on a flat or solid surface. Left untreated approximately 30-40% of infants retain this abnormal head shape at 3-4 years of age. According to reports DP has the potential to affect the infant's social and neurobehavioral development.
Recent research on the PlagioCradle™ device demonstrates prevention and correction of DP in hospitalized infants. However, extremely premature infants, weighing < 1 kilogram cannot use the device known as the PlagioCradle™. This device only accommodates infants weighing > 1 kilogram. When infants eventually reach 1 kilogram, healthcare providers have trouble fitting them to the smallest version of the PlagioCradle™ device and must place the infant in a layer meant for a larger infant. Use of the larger layer often requires that infants' lay in a side-lying position until their head shapes begin to improve. It is more desirable that infants be placed in the appropriate layer so that they may be positioned supine, prone, side-lying left and right, to ensure optimal development. This pilot project proposes to develop and test a new device to manage (defined as resolving, prohibiting, inhibiting or preventing) the development of DP in prematurely born infants weighing < 1 kilogram.
NICU (Neonatal Intensive Care Unit) nurses have used waterbed therapy, air-filled mattresses, foam mattresses and repositioning procedures in an attempt to manage the development of DP, but these methods have had limited success. The reason these devices are not successful is because they do not provide structure or support for the soft cranium that has un-fused sutures and that have not become fixed or solidified. As a result, the soft, malleable cranium then takes the shape of the bedding or device it is placed upon, which is usually flat (including the aforementioned positioning devices).
The PlagioCradle™ (previously known as the cranial cup) is an orthotic device developed by Gary Rogers M.D., J.D., M.B.A., M.P.H., a craniofacial surgeon formerly of Boston Children's Hospital and James Miller C.P.O. a licensed orthotist. The PlagioCradle™ is an anatomically correcting, repeatedly adjustable, concave-shaped resting surface for an infant's head and body that effectively eliminates uneven pressure on the infant's occiput while maintaining correct body alignment. In addition, the posterior neck area of the infant is supported by a fixed bridge section, which also serves to off-load or reduce contact pressure between the rest surface and the occiput, especially as the cavity of the device deepens. The PlagioCradle™ has been found to be an effective tool in preventing or correcting DP in preterm and term infants. The PlagioCradle™ accommodates infants weighing 1 Kg or larger.
The Premie Pouch is meant to serve as precursor to the PlagioCradle™ by managing the development of DP starting immediately following birth. Like the PlagioCradle™, the concave-shaped foam insert will provide a resting surface for the infant's head and body that eliminate uneven pressure on the infant's occiput while maintaining correct body alignment. Also, the posterior neck area of the infant will be supported by a fixed bridge section of the foam insert. However the Premie Pouch is designed specifically for the VLBW infant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- — 至 40 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Premie Pouch
All participants will receive the experimental treatment with the Premie Pouch device.
干预措施: Premie Pouch (Device)
结局指标
主要结局
Safety of Use of the Premie Pouch in VLBW Infants
时间窗: From date of enrollment to date of study completion (range 19-47 days)
Frequency of participants with adverse events reported using the Premie Pouch Adverse Event Data Collection Tool.
次要结局
- Number of Participants With Normal Cranial Symmetry(Cranial symmetry at study completion)
- Premie Pouch Ease of Use(From date of enrollment to date of study completion (range 19-47 days))
- Feasibility of Use of the Premie Pouch in VLBW Infants(Number of hours per each 24 hour period on the device)
- Number of Participants With Normal Cranial Index(Cranial index at study completion)
研究者
Michele DeGrazia
Director of Nursing Research, Neonatal Intensive Care Unit
Boston Children's Hospital