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临床试验/NCT03450668
NCT03450668已完成不适用

Comparison of the mOm Incubator With a Standard Incubator for the Maintenance of Thermal Stability in Preterm Infants With User Feedback

mOm incubators1 个研究点 分布在 1 个国家目标入组 74 人开始时间: 2021年10月27日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
74
试验地点
1
主要终点
thermo-regulation

研究概览

简要总结

The mOm Incubator is a collapsible infant incubator designed to provide a level of thermoregulation that meets the standards set for conventional incubators whilst being low cost and space-saving. Babies recruited will be clinically stable, at least 30 weeks gestational age and require at least 48 hours incubator care. A standard or test incubator will be used for the first 24 hours chosen randomly, then the baby will be moved to the over arm for a further 24 hours.

详细描述

Investigators will recruit babies who are in the Neonatal Unit at St. Peter's Hospital. Babies will be clinically stable from a cardio-respiratory point of view. They will also be requiring incubator care (so they will weigh less than approximately 1400g) but not requiring additional humidification. This effectively excludes babies born less than 30 weeks gestation who are routinely humidified for the first week (if 28-30 weeks gestation) or two weeks (if less than 28 weeks gestation). Some term babies may also be eligible for the study if they are being nursed in an incubator for clinical reasons.

Identification and recruitment of babies will be carried out by the attending Consultant Neonatologist and the research team.

For twins, consecutive enrolment will be possible if only one mOm incubator is available.

There will be two arms to the protocol. The first arm will consist of standard incubator care, where the care of the baby is unchanged, but non-invasive, more frequent (hourly) temperature and other physiological measures of stability than would normally be collected in routine care (nominally every three hours) will be collected. The second arm will be the baby receiving normal care in the mOm incubator, with another set of hourly detailed, non-invasive, observations. The planned care and monitoring of the baby will be otherwise unchanged. No additional blood tests or any other invasive testing or monitoring are required. The clinical team will have full control and responsibility for the baby's care and can terminate the study for the baby at any time for any reason.

In addition, investigators will collect the views of staff on the baby's comfort, visibility, care, usability and acceptability during each arm of the study.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Supportive Care
盲法
Triple (Participant, Care Provider, Investigator)

盲法说明

Choice of incubator used is randomized and blinded until the subject has been recruited and incubator arm assigned. After which it will be known to all concerned.

入排标准

年龄范围
1 Minute 至 6 Months(Child)
性别
All
接受健康志愿者
是

入选标准

  • •At least 30 weeks gestational age and less than or equal to 6kg
  • •In need of at least 48 hours incubation in a stable temperature environment
  • •Must be clinically stable
  • •Parental/legal guardian written informed consent has been given

排除标准

  • •Does not require humidity regulation
  • •Parent/legal guardian must not be from a vulnerable group

研究组 & 干预措施

standard incubator

Active Comparator

routinely used standard incubator already used in the neonatal unit

干预措施: mOm incubator (Device)

standard incubator

Active Comparator

routinely used standard incubator already used in the neonatal unit

干预措施: standard incubator (Device)

mOm incubator

Experimental

new test incubator

干预措施: mOm incubator (Device)

mOm incubator

Experimental

new test incubator

干预措施: standard incubator (Device)

结局指标

主要结局

thermo-regulation

时间窗: 24 hours

ability of incubator to maintain stable temperature of baby

次要结局

  • Usability(24 hours)

研究者

发起方
mOm incubators
申办方类型
Other
责任方
Sponsor

研究点 (1)

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