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Completed

NCT Number: NCT06213207

Cluster Randomized Controlled Trial Applying Helping Baby Breathe in Nepal

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other

The intervention, HBB training package will be used which was applied to train the hospitals staff in Nepal (Chaulagain et al., 2021) and Laerdal Global Health (Laerdal Global Health, 2021) to enhance the competencies on the resuscitation to newborn using NeoNatalie. Health workers will receive 5 days simulation training by expert pediatrician and pediatric nurse who have prior working experience in Neonatal Intensive Care Unit (NICU) or Special Neonatal Care Unit. After the training, mentoring and coaching will be provided experienced newborn coach/trainer on a monthly basis for six months.

Primary outcomes

  1. Skill performance of the newborn care provider

    Time frame: six months

    The skill performance of the newborn care providers covering all nine components of essential newborn care. Their skills related to resuscitation procedures will be measured using skill inventory.

Sponsors and collaborators

Lead sponsor

Integrated Development Foundation Nepal

Other

Collaborators

  • Women and Children Welfare Society Nepal

Registry information

Official study 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

Acronym: SaLiN

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 19, 2024
Registry last updated
Apr 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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