Newborn Infection Control and Care Initiative for Health Facilities to Accelerate Reduction of Newborn Mortality
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,938
- 试验地点
- 1
- 主要终点
- Time between onset of suspected danger signs and referral to appropriate facility
研究概览
简要总结
Newborn mortality continues to be unacceptably high in Cambodia, despite reductions in maternal and under five year old mortality. Evidence exists that a large proportion of newborn mortality globally and in Cambodia is attributable to infections and sepsis. The study proposes a package intervention to address infection control in the perinatal period in facilities and to improve the timeliness of referral of newborns with suspected infections to appropriate health facilities for treatment through upgrading of hygiene practices in facilities and linking of community based volunteers with health facilities and families in the community setting.
By delivering a coordinated intervention that combines improved education for health center midwives, village health care workers, and mothers of newborns, along with improved care coordination with increase in number of interactions (points of contact) between mothers and health care personnel, the investigators will see improved knowledge of newborn danger signs among mothers and health care workers, more rapid case detection of significant newborn illnesses, and more rapid and appropriate referral of ill newborns.
The investigators also hypothesize that the common causes of newborn sepsis in Cambodia are different from those reported in Western cultures, and that Staphylococcus aureus will be a common pathogen as described in neighboring Laos. The investigators will evaluate the causes of newborn sepsis in the subset of infants referred to Takeo Provincial Hospital.
详细描述
The study will incorporate mixed methods: formative (qualitative) research, and a stepped wedge cluster randomized intervention trial and process evaluation. It is anticipated that the results of this study will provide data for policy level actions on newborn survival in Cambodia and in other settings with similar health outcomes. The study may contribute to the potential scale up of a linked model of community-facility care for newborns.
Globally, infection causes approximately 35% of all newborn mortality [1]. Verbal autopsy data collected in Svay Rieng province in 2009 show that bacterial sepsis is the likely cause in 40% of newborn deaths, by far the largest category (exceeding the next highest cause by 17%) [2].
The NICCI intervention addresses a number of barriers identified by the Royal Government of Cambodia and USAID to improving neonatal survival, including the capacity and performance of health providers to deliver newborn care through strengthened training; upgrading hygiene through enhanced infection control in facilities; and increasing community engagement in the demand for and delivery of health services for newborns through improving referral processes and addressing barriers to timely care seeking. The proposed study will address the crucial gap in post-natal care by linking the community (via Village Health Support Groups) with Health Center staff to follow mothers and newborns during the first week of life
Quality Assurance: Investigators will include provision for the management of all data collection and will include appropriate procedures in a Standard Operating Practices document. Training of data collectors at the start of the study will ensure quality and consistency and supervisory monitoring of data collection will occur monthly.
Data Checks and Data Source Verification: Data will be collected, checked, and entered into a data management system at the National Institute of Public Health. All participants will be identified by a unique identifier which will be the link for all databases. All study data will be collected by project staff so outcomes do not depend on subject compliance other than refusal to answer project surveys (although study participants always have a right to decline to answer a survey based on informed consent principles). Data collected in the community will be transferred to central databases at NIPH and entered into a database using REDcap or a comparable program that is compatible with data management capacity at NIPH. The investigators will use special screens with filters for invalid entries and identification of missing values for data entry verification. Analysis will be conducted in SPSS and/or SAS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Health Centers: historically, a health center which providing services for more than 20 births per month
- •Individuals: women in the last trimester of pregnancy with any ethnicity, age is equal or older than 18 years, and pregnancy results in a live birth.
排除标准
- •Birth of baby with known congenital malformation
- •Inability to obtain informed consent or adhere to protocol
结局指标
主要结局
Time between onset of suspected danger signs and referral to appropriate facility
时间窗: 2 years
% of VHSG who know 6 danger signs
时间窗: 2 years
Improved hygiene behavior by family
时间窗: 2 years
It is a composite score of: 1) % of mothers/caretakers interviewed said they wash hand after going to toilet; 2) % of mothers/caretakers interviewed said that they wash hand before touching newborn; 3) % of mothers/caretakers interviewed said that they wash hand before eating; and 4) % of mothers/caretakers interviewed said that they wash hand after cleaning baby's bottom.
Improved infection control behavior among HC staff
时间窗: 2 years
A composite score from: % of HC staff reported that they washed hands: 1) before patient contact (when they examine mother and newborn); 2) Before and after aseptic procedure; 3) After expose to blood/body fluids; 4) after patient contact (after removing gloves); and 5) after touching patient surroundings
% of families who seek care from an appropriate facility
时间窗: 2 years
% of mothers who know at last 3 danger signs
时间窗: 2 years
次要结局
- % of mothers who received messages on care seeking from VHSG(2 years)
- % of mothers who received messages on hygiene from HC staff(2 years)
- % of newborns visited at least once by VHSG on or before day 7 of life(2 years)
- % of HC staff who know 6 danger signs(2 years)
- % of HC staff who recall hygiene messages(2 years)
- % of newborns visited at least twice by VHSG on or before day 7 of life(2 years)
- % of VHSG who can deliver hygiene messages(2 years)
- % of mothers who received messages on hygiene from VHSG(2 years)
研究者
Var Chivorn
Principle Investigator
National Institute of Public Health, Cambodia