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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Newborn Morbidity; Newborn Asphyxia; Delivery Preterm
• Intervention / Treatment: Other: Simulator based training to manage asphyxia and essential newborn care using neonatalie

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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Khem N Pokhrel, PhD; Phone Number: 9851113827; Email: pratikjee@gmail.com
• Study Contact Backup: Name: Amrendra Ray, MPH

Study Locations

• Nepal
  • Lalitpur, Nepal
    • Recruiting
    • Development and Research Service International Nepal
    • Contact: Amrendra Ray, MPH
    • Contact: Khem Narayan Pokhrel, PhD; Phone Number: 9851113827; Email: pratikjee@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Newborn care service providers with simulation-based training and newborns; 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	Other: Simulator based training to manage asphyxia and essential newborn care using neonatalie; 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.
No Intervention: Controlled health facilities with newborn care service providers with no training and newborns; The newborn care providers from control health facilities will not receive any additional training. They provide usual services.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Skill performance of the newborn care provider	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.	six months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neonatal health outcomes	Neonatal health outcomes is measured as neonates who received services for asphyxia management and other essential newborn care	six months

Collaborators and Investigators

• Sponsor: Integrated Development Foundation Nepal
• Collaborators: Women and Children Welfare Society Nepal
• Investigators: Study Chair: Santosh Adhikari, MD, Kanti Children's Hospital, Kathmandu

Study record dates

Study Major Dates

• Study Start (Estimated): February 18, 2024
• Primary Completion (Estimated): February 28, 2025
• Study Completion (Estimated): April 30, 2025

Study Registration Dates

• First Submitted: December 29, 2023
• First Submitted That Met QC Criteria: January 9, 2024
• First Posted (Actual): January 19, 2024

Study Record Updates

• Last Update Posted (Estimated): February 9, 2024
• Last Update Submitted That Met QC Criteria: February 7, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Nepal; Cluster Randomized Controlled Trial; Skilled birth attendant; Management of newborn asphyxia; Neonatalie
• Additional Relevant MeSH Terms: Pathologic Processes; Wounds and Injuries; Infant, Newborn, Diseases; Death; Asphyxia; Asphyxia Neonatorum
• Other Study ID Numbers: NP593-2023; 2023-0091 (Laerdal Foundation)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No