Impact Study of Community Based Treatment of Neonatal Infection by Health Extension Workers on Neonatal Mortality

Save the Children

Status: Completed

Conditions: Neonatal Infections

Treatments: Other: Community Based

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00743691

SNL 50124

Details and patient eligibility

About

The purpose of the study is to determine whether community based management of infections with antibiotics administered by health extension workers reduce all cause mortality in neonates after the first day of life compared to current MOH IMNCI model of referral to hospital

Full description

Although 44% of neonatal deaths in Ethiopia are due to infection, access to treatment for neonatal infections is very low for most families. Even though the newly adapted Integrated Management of Newborn and Childhood Illness (IMNCI) package includes assessment of newborns, if a baby has any danger signs that may be suggestive of infection and is taken to health posts, the baby is to be referred to hospital for treatment. Given that only about 5% of neonatal deaths occur in hospitals and the distance to hospital is often far and the costs prohibitive, very few babies are likely to receive essential lifesaving antibiotics. Evidence from India, Bangladesh, and Nepal demonstrates that community health workers can effectively manage neonatal infections at home. However it is not known whether and community-based management of neonatal infections is effective, feasible and acceptable in the Ethiopian context. Local evidence regarding lives saved and cost is required in order to inform health policy and programming regarding community-based treatment of neonatal infections.

Enrollment: 19,476 patients

Sex: All

Ages: 1 minute to 4 weeks old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants who give consent to be treated at Health Post by Health extension worker

Exclusion criteria

• If Newborn is Critically sick

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

---

19,476 participants in 2 patient groups

Arm1

No Intervention group

Description:

Make a diagnosis of Neonatal infections and refer patients according to IMNCI guideline

2

Active Comparator group

Description:

Health extension Workers will Make a diagnosis of Neonatal infections and treat with antibiotics when referal is not possible

Treatment:

Other: Community Based