跳至主要内容
临床试验/NCT05111899
NCT05111899进行中(未招募)不适用

Leading Advancements in the Uptake of Newborn Community Health (LAUNCH)

University of Washington2 个研究点 分布在 1 个国家目标入组 316 人开始时间: 2022年7月11日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
316
试验地点
2
主要终点
Mid-upper arm circumference

研究概览

简要总结

The primary objective of the study is to determine the impact of a behavior change intervention that partners Orthodox priests with members of the Health Development Army (HDA) and train them to conduct newborn health outreach to increase rates of early initiation of and exclusive breastfeeding through 6 months and vaccination coverage at six months.

Secondary objectives include:

  • Determine the impact of the intervention on infant growth at six months, observed and self-reported changes in nutrition and feeding practices of mother and infants, and early identification of newborn illness.
  • Design a culturally relevant, scalable intervention for community-based newborn and infant health in Gondar in partnership with local partners, the Federal Ministry of Health, and the Gondar Regional Health Bureau.

详细描述

The study will test a model the leverages existing community networks to improve the health of newborns in Gondar, Ethiopia. The intervention will be implemented at the community level by pairs of trained Ethiopian Orthodox priests and members of the Heath Development Army (HDA). A list of priests serving at the EOC churches in the intervention arm will be obtained through the woreda diocese and their respective churches. All the priests will be contacted through the church leadership and asked to participate in the study intervention. The intervention will be implemented in collaboration with HDA members recruited by HEWs under the health centers in the catchment areas of the intervention churches.

An initial 5 day training will be given to priests and HDA members. The training will focus on newborn health topics including early initiation of and exclusive breastfeeding, maternal nutrition, immunization, childhood illnesses, child health care services, etc. At the end of the training action plans will be prepared by the training organizers, priests, and HDA. Priest will be asked to integrate health messages and education into their routine family visits around the birth of a child in structured intervals as culturally appropriate.

The trained priests and HDA members will be dispatched to their respective communities to begin the intervention. Their primary activities will be identification of near-term pregnant and newly delivered women, providing health education to their families, follow-up visits to enable newborn-mother pairs to access child health care services, and to provide health education at religious and community gatherings. Specifically, pre-planned visits of parishioners' families will be done by the respective priests and the partnering HDA members during the last month of pregnancy, immediately after the delivery of the baby and around the time of baptism for the newborn. These visits will be used to educate pregnant and postpartum women and their families on newborn health topics including initiation of breastfeeding, duration of breastfeeding/ exclusive breastfeeding, vaccination, cord care, and utilization of available newborn health care services. These community based activities will be monitored through regular follow-up visits by the UoG study team and discussions with priests and HDA members.

Newborn-mother pairs will be recruited within the first 10 days after delivery as reported to the study team by Health Extension Workers (HEWs) engaged in the study. Recruitment will start one month following the start of the intervention and all reported newborn-mother pairs who meet the screening criteria will be included in the study until the calculated sample sizes are reached. HEW's routine registers of new deliveries will be used to trace, recruit and screen study participants. Newborn-mother pairs who fulfill an initial screening criteria will be reported to the study team at the University of Gondar (UoG) who will travel to the study site regularly for recruitment of study participants and data collection. Newborn-mother pairs will be reported to the UoG study team both through phone calls made by HEWs and in-person at the time of regular onsite visits by the team.

Newborn-mother pairs will be recruited within the first 10 days after delivery as reported to the study team by Health Extension Workers (HEWs) engaged in the study. Recruitment will start one month following the start of the intervention and all reported newborn-mother pairs who meet the screening criteria will be included in the study until the calculated sample sizes are reached. HEW's routine registers of new deliveries will be used to trace, recruit and screen study participants. Newborn-mother pairs who fulfill an initial screening criteria will be reported to the study team at the University of Gondar (UoG) who will travel to the study site regularly for recruitment of study participants and data collection. Newborn-mother pairs will be reported to the UoG study team both through phone calls made by HEWs and in-person at the time of regular onsite visits by the team.

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
14 Years 至 49 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • Newborn-mother pairs visited by the study staff (Enrolled women and newborns)
  • The following inclusion criteria will be used during recruitment:
  • Newborns should be those delivered at least one month after the start of the intervention period
  • Newborn-mother pairs should be EOC parishioners
  • Newborn's family should have a soul father (a spiritual advisor assigned to the family in the Ethiopian Orthodox tradition)
  • Mother must have lived in the study area for at least 6 months
  • Mothers must give written informed consent for themselves and their newborn
  • Formative focus group discussion and key informant interview participants (FGD and KII participants)
  • The following inclusion criteria will be used during recruitment:
  • Mothers of newborns <6 months old
  • Fathers of newborn children <6 months
  • Ethiopian Orthodox priests from the North Gondar region
  • Healthcare workers from government Health Centers (unit of primary care)
  • All participants must have established residency in the region for >6 months
  • All participant must give verbal informed consent

排除标准

  • Newborn-mother pairs visited by the study staff (Enrolled women and newborns)
  • The following exclusion criteria will be used during recruitment:
  • Newborns with gross developmental abnormalities that would make anthropometric measurements and interpretations difficult
  • Newborns identified by the study team as in distress and in need of immediate, emergency care during the enrollment visit
  • Newborn whose mother is not a member of an EOC parish
  • Newborns whose mothers have died by the time of recruitment
  • Newborn whose family plans to re-locate away from the study site in less than 6 months
  • Newborns who were part of a multiple birth but are not the first born should be excluded
  • Formative focus group discussion and key informant interview participants (FGD and KII participants)
  • The following exclusion criteria will be used during recruitment:
  • Newly established residence in the Woreda (<6 months)

研究组 & 干预措施

Intervention

Experimental

干预措施: Newborn Health Education (Behavioral)

Control

No Intervention

结局指标

主要结局

Mid-upper arm circumference

时间窗: Up to six months

Anthropometric Measurement using MUAC tapes

Proportion of mothers exclusive breastfeeding

时间窗: Up to six months

Self-reported breastfeeding behavior

次要结局

  • Immunization status(Up to six months)
  • Frequency of acute illness(Up to six months)
  • Frequency of hospitalization status(Up to six months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Brandon Guthrie

Associate Professor, School of Public Health: Global Health

University of Washington

研究点 (2)

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