Clinical trial NCT06213207: Cluster Randomized Controlled Trial Applying Helping Baby Breathe in Nepal
Official title: Saving Lives of Newborn (SaLiN): A Cluster Randomized Controlled Trial Applying Helping Baby Breathe to Manage Birth Asphyxia in Sarlahi District of Madhesh Province, Nepal
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Newborn Morbidity
Newborn Asphyxia
Delivery Preterm
Keywords: Skilled birth attendant
Management of newborn asphyxia
Neonatalie
Cluster Randomized Controlled Trial
Nepal
Lead sponsor: Integrated Development Foundation Nepal
Sponsor class: OTHER
Collaborators: name: Women and Children Welfare Society Nepal
First posted: 2024-01-19
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The intervention is targeted to provide simulator based training to newborn care service providers. The training is comprised of essential newborn care practices and the providers will be followed up and provided mentoring and coaching for the period of six months.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The cluster randomized controlled trial will be conducted in the selected health facilities/birthing centers of Sarlahi district in Nepal. Further from the selected health facilities. The investigators will assess the newborn in terms of their health outcomes. Characteristics related to the performance of skilled birth attendants will be measured prior to the intervention. After six months of the intervention, endline assessment will be conducted. The intervention unit are the health facilities which provide the services as birthing centers. The effectiveness of the intervention will be examined using generalized estimating equation against baseline vs. endline on skills performance of the health workers and newborn health outcomes. The study will be implied in the similar settings to improve the skill performance and newborn health outcomes in order to reduce neonatal mortality.

Detailed description: In Nepal, health facilities need to be strengthened and the staff should be tailored training at health facilities who are designated as birthing center. Although, the health facility readiness survey has shown that health facilities had availability of bag and mask (neonatal) neonatal resuscitation equipment in delivery room (Kc et al., 2020). However, health workers were found to have lack of adequate knowledge on basic emergency and neonatal care (BEmONC) signal function including poor knowledge and skill on newborn resuscitation. resulting in poor child health outcomes during facility-births and had poor knowledge and skill on newborn resuscitation (Lama et al., 2020). Newborn resuscitation simulation training was effective in improving clinical performance of health service providers and perinatal outcomes (Vadla, Moshiro, et al., 2022). NeoNatalie™ is a low-cost, highly portable, and realistic manikin that helps health workers learn and practice standard newborn care and resuscitation measures to better handle birth asphyxia(Laerdal helping save lives, 2022). Use of NeoNatalie, a newborn simulator for neonatal resuscitation training has improved performance of midwives and their motivation(Vadla, Mdoe, et al., 2022). There has been intervention that provided training on helping baby breathe (HBB) in large hospitals in Nepal. However, the use of simulator and training to the midwives at birthing center has not been evaluated for the effectiveness of simulator in increasing their performance and newborn health outcomes. Therefore, this study aimed to improve the performance of skilled-birth attendant in providing resuscitation to the newborn with birth asphyxia by applying simulator-based training.

Eligibility criteria: Inclusion Criteria

Health service providers those are directly involved in providing newborn care services

Have received Community-based Integrated Management of Neonatal and Childhood Illness (CB-IMNCI) training Have worked in the study facilities at least one year

Exclusion Criteria:

Health workers, Those lack experience at least six months of working in birthing centers Those who does not qualify as skilled birth attendant (non-SBA) Those who received training already

Primary outcomes:
measure: Skill performance of the newborn care provider
timeFrame: six months
Secondary outcomes:
Other outcomes:
Locations:
city: Lalitpur
country: Nepal
facility: Development and Research Service International Nepal
Study officials:
affiliation: Kanti Children's Hospital, Kathmandu
name: Santosh Adhikari, MD
role: STUDY_CHAIR
References: