Born Too Soon in a Resource-limited Setting on the Thailand-Myanmar Border: Can we Improve Care in a Special Care Baby Unit?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- The neonatal mortality rate of preterm neonates (< 37+ weeks of gestation) expressed in number of newborns dying at less than 28 days of age per 1000 livebirths.
研究概览
简要总结
Since 2008, preterm neonates are taking care of in a Special Baby Care Unit (SCBU). Those born less than 34 weeks of gestation are followed-up monthly for one year for monitoring their hematocrit level, growth and development.
Medical chart reviews are useful to evaluate the burden of diseases, characterize care treatment patterns and clinical outcomes by patients' subgroups; ultimately it can help identifying gaps in care pathways thus improving quality of care and ultimately reducing mortality. Medical records of all preterm neonates hospitalized in the SCBU including those followed up during their first year of life are computerized.
The investigators propose to review the clinical charts of the preterm neonates in regards to four main points of care a) feeding, b) infections including early onset of neonatal sepsis, necrotizing enterocolitis and umbilical cord infection, c) body temperature control and d) respiratory distress.
This medical charts review will be complemented by i) focus group discussions (FGD) with the medical staff working in the SCBU on the benefits and difficulties in using the existing guidelines for preterm care and by ii) interviews with mothers who delivered a preterm neonate on their experience in caring for their child and the challenges they faced.
While performing the retrospective part of the project and after discussing the preliminary findings from the medical staff perception of the existing guidelines, the investigators will evaluate the feasibility to implement some additional recommendations to improve preterm birth outcomes based on recent literature and new protocols for resource-limited settings.
详细描述
This study aims to describe the neonatal clinical outcome of preterm neonates (< 37+0 weeks of gestation) in terms of mortality and prematurity-related morbidity and the growth and neurodevelopment of preterm neonates (< 34+0 weeks of gestation) in the first year of life in order to optimize service delivery for preterm neonates in a resource-constraint setting. The study will consist of 3 parts as follows:
Part A: A retrospective chart review of preterm neonates born in one of the birthing SMRU unit between January 2008 and December 2017 and for whom a medical chart is available. In addition we propose to analyze the growth trajectory, the prevalence of anemia (Hct < 33%) and the level of neurodevelopment achieved in the first year of life reported in the clinical charts of preterm neonates born < 34+0 weeks of gestation.
Part B: Focus Group Discussion (FGD) of the medical staff working in the SCBU firstly on the benefits and difficulties in using existing guidelines for preterm care and secondly on the feasibility and acceptability of the revised guidelines 3-6 months after their implementation.
Part C: Interviews of mothers who delivered preterm neonates (< 37+0 weeks of gestation) to understand the challenges they faced while caring for their child.
This study was funded by Shoklo Malaria Research Unit Core funding (Wellcome Trust). Grant reference number is 220211.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Part A: Neonatal medical record for preterm neonates (< 37+0 weeks of gestation) in one of the SMRU clinics between January 2008 and December 2017
- •Part B: Male or female medical staff (Medics, midwives & nurses) aged 18 years and above, who have been working for SMRU since the introduction of the Special Care Baby Unit (2008-2011) or after its establishment (2012-2017) and have actively cared for preterm newborns. Medical staff (Medics, midwives & nurses) who have provided written informed consent and willing to participate to a Focus Group Discussion
- •Part C: Mothers, aged 18 years and above, who have had a preterm newborn (< 37+0 weeks of gestation) admitted in SMRU clinics.
- •Multigravida or primigravid, presently in the SCBU or already discharged home who willing to discuss the broad topics include caring for the preterm newborn at home. Any mothers will be approached so that responses might provide a comprehensive overview of mothers concerns.
- •Mothers who have provided written informed consent and willing to participate to an interview
排除标准
- •Parts A: Neonatal medical record of neonates < 37+0 weeks of gestation receiving palliative care only.
- •Neonatal medical record of neonates < 37+0 weeks of gestation born and hospitalized in tertiary hospital.
- •Neonatal medical record of neonates < 37+0 weeks of gestation born at home and not hospitalized in SMRU clinics during the neonatal period.
- •Neonatal medical record of neonates < 37+0 weeks of gestation born in SMRU clinics but transferred in tertiary hospital for further neonatal care.
- •Neonatal medical record of neonates born term (37+0 weeks or more)
- •Part B: Medical staff who has never been directly involved in caring for preterm neonates.
- •Part C: Mothers aged less than 18 years old
结局指标
主要结局
The neonatal mortality rate of preterm neonates (< 37+ weeks of gestation) expressed in number of newborns dying at less than 28 days of age per 1000 livebirths.
时间窗: 1 year
The time lapse between birth and full enteral feeding expressed as mean (SD) days to reach full enteral feeding.
时间窗: 1 year
The neonatal prematurity-related morbidity rates.
时间窗: 1 year
(i.e. necrotizing enterocolitis; sepsis; hypothermia; apnoea of prematurity; respiratory distress syndrome; gastric reflux) expressed as the number of specific-morbidity per number of preterm newborn aged less than 28 days and presented as percentage.
次要结局
- The proportion of anaemia (haematocrit < 33%) during the first year of life of neonates born < 34+0 weeks of gestation.(1 year)
- The growth trajectory changes during the first year of life of neonates born < 34+0 weeks of gestation expressed as mean (SD) monthly weight/height gain and mean z-scores at end of follow-up.(1 year)
- Medical staff and mothers' perception of the difficulties and challenges of caring for preterm neonates analysed by themes and performed using NVivo solfware package.(1 year)
- The mean (SD) neurodevelopment score at 6 and 12 month of life of neonates born < 34+0 weeks of gestation.(1 year)