Cluster Randomized Controlled Trial Applying Helping Baby Breathe in Nepal (SaLiN)

Integrated Development Foundation Nepal

Status: Enrolling

Conditions: Newborn Asphyxia; Delivery Preterm; Newborn Morbidity

Treatments: Other: Simulator based training to manage asphyxia and essential newborn care using neonatalie

Study type: Interventional

Funder types: Other

Identifiers

NCT06213207

NP593-2023

2023-0091

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 20 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Newborn care service providers with simulation-based training and newborns

Experimental group

Description:

Newborn care providers will be the subject for receiving intervention. The will receive 5 days training on managing essential newborn care and birth asphyxia using neonatalie. The service providers will be provided monthly mentoring and coaching. The newborn who receive the services

Treatment:

Other: Simulator based training to manage asphyxia and essential newborn care using neonatalie

Controlled health facilities with newborn care service providers with no training and newborns

No Intervention group

Description:

The newborn care providers from control health facilities will not receive any additional training. They provide usual services.