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临床试验/NCT05609305
NCT05609305进行中(未招募)不适用

FAcilitating Safe Transition to Home for Preterm Infants: an Observational Study

University of Nottingham1 个研究点 分布在 1 个国家目标入组 155 人开始时间: 2022年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
155
试验地点
1
主要终点
Final barrier to discharge home

研究概览

简要总结

Finding out what the common discharge barriers are in neonatal units will help design and develop services to facilitate safe, early discharge in preterm babies. This study will have 2 components. Retrospectively the study team will study the electronic medical records of preterm infants admitted to 20 neonatal units throughout the UK to identify the PMA at which each of the barriers to discharge are reached and identify the final discharge barrier. In a smaller-scale prospective study, the study team will investigate what is the final discharge barrier for infants admitted for neonatal care in the Royal Derby Hospital. The study team will follow up with the family, 2 weeks after discharge home, to find out if the infant has remained well and not required readmission to the hospital (information which will not be available in the electronic patient records analysed retrospectively). This will help determine whether the discharge was appropriate and safe.

详细描述

Infants born before 37 completed weeks of gestation are expected to need additional care and are routinely admitted to neonatal units in the UK. Neonatal care in the National Health Service (NHS) is designated as intensive or high dependency care when infants need intensive support such as with breathing (e.g., mechanical ventilation), nutrition (e.g., parenteral nutrition) and/or other medical needs (e.g., cardiovascular support with inotropes). With increasing maturity, preterm infants stop needing these and spend some time with less additional support such as for feeding and keeping warm while they grow and mature sufficiently to go home safely. This period is designated as "special care."

Depending on how premature babies are and other medical needs, preterm infants spend a varying length of time in the hospital with most going home between 37 and 40 weeks post-menstrual age (PMA)1. PMA is the time elapsed between the first day of the mother's last menstrual period (as a marker of the day when the pregnancy started) and the current age. Length of hospital stay (number of days from birth to discharge home) and PMA at discharge are inversely correlated with gestational age at birth i.e., the more premature the infant, the longer they stay in hospital and the more likely they are to be at a higher PMA when going home. Data from the National Neonatal Research Database (NNRD), which collects information from all NHS neonatal units in the UK, showed that, between 2011 and 2014, infants born at 24 weeks' GA spent an average of 123 days in the hospital (going home at the average PMA of 41.6 weeks) which reduced to an average of 34 days (and PMA 35.9 weeks) for those born at 31 weeks' GA. With more recent data (2010-2020), we found that infants born at 22-26 weeks' GA have a length of the hospital (median (IQR)) of 88 (69-110) days while those born at 27-31 weeks' stay for 44 (33-57) days. The more immature group (22-26 weeks' GA) were 38 (36-41) weeks' PMA at discharge while 27-31 weeks' infants were 36 (35-37) PMA at discharge (Szatkowski et al., unpublished). These data show that preterm infants need a considerable period to get ready to be discharged home.

Although neonatal care is lifesaving and its availability has, undoubtedly, improved the survival and well-being of premature infants; staying in the neonatal unit longer than necessary can be detrimental to the preterm infant and family. The environment of neonatal units with bright lights, noise, and lack of one-to-one developmental care can have adverse effects on the infant's development. Prolonged hospitalisation also means prolonged separation from the family and continued stress for parents. In parent and public consultation during the set-up of the FEED1 trial, a large, ongoing randomised controlled trial in the UK, it was found that parents overwhelmingly supported the need to find ways to reduce the length of hospital stay. The parents said that reducing the time spent in the hospital "by even a few days" would improve their well-being significantly.

Prolonged hospitalisation also means an increased cost of care. A reduction in length of stay can save money for the NHS. The 2020/21 tariff for NHS care specifies the cost of care for infants in neonatal units. The cost of one day of "special care" is £709.16 (https://www.england.nhs.uk/costing-in-the-nhs/national-cost-collection/). From 2012-2020, there were, on average, approximately 39,000 infants born each year before 37 weeks' GA cared for in neonatal units in the UK6. If, with a better understanding of discharge barriers and optimal discharge planning, length of stay could be reduced by 2 days per infant, the NHS would save approximately £56 million per year.

Earlier discharge is safe and improves parental well-being and quality of life at home and can save millions of pounds in cost of care. However, before a preterm infant can go home, it must be ensured that infants are ready to be discharged safely.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

入排标准

年龄范围
26 Weeks 至 37 Weeks(Child)
性别
All
接受健康志愿者

入选标准

  • Born at <37 weeks' gestational age (GA)
  • Admitted to neonatal care for >48 hours
  • Discharged home alive
  • For prospective component:
  • *Parent or legal guardian available who can give informed consent

排除标准

  • Infants with major congenital anomalies or genetic syndromes
  • Infants who die before discharge home
  • Infants who are transferred for continuing care outside of neonatal service before discharge home

结局指标

主要结局

Final barrier to discharge home

时间窗: 01/01/2012 to 31/12/22

defined as the last to be achieved Able to maintain thermoregulation without additional support Breathing spontaneously without any caffeine (without supplemental oxygen or in supplemental oxygen (\<1L/min) with plan for home oxygen therapy) without any episodes of apnoea for at least 5 days Achieved safe oral feeding (adequate oral feeds or are ready for discharge on home NG-feeding regimen) defined as the last of the following four to be achieved, Able to maintain thermoregulation without additional support Breathing spontaneously without any caffeine (without supplemental oxygen or in supplemental oxygen (\<1L/min) with plan for home oxygen therapy) without any episodes of apnoea for at least 5 days Achieved safe oral feeding (adequate oral feeds or are ready for discharge on home NG-feeding regimen) Achieved a weight of at least 1700 grams

次要结局

  • age(01/01/2012 to 31/12/22)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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