Neonatal Sepsis, Evaluation, Bangladesh

NCT01333982 | Completed DMC

• 1 other identifier: PR-09056
• Study Type: interventional
• Target: 20,000
• Locations: 1 country
• Sites: 1

Brief Summary

More than half of under-five deaths in Bangladesh occur in the first month of life (neonatal period), and a substantial proportion of these deaths are due to infections (sepsis). According to the recently formulated Bangladesh National Neonatal Health Strategy (NNHS), the Government of Bangladesh is committed to improve access to quality management of neonatal infections. The strategy emphasizes that health service providers at all levels acquire the skills for managing sepsis. Responding to the recommendations in the National Neonatal Health Strategy, this operations research seeks to evaluate alternative approaches for the management of neonatal sepsis in the community. The evaluation will focus on assessing intervention coverage, provider quality of care, and referral and referral compliance, and will undertake cost-benefit analysis of community-based neonatal sepsis management. The programme and evaluation will be within the existing health service delivery system in Bangladesh and is thus designed to inform the effective scaling up of neonatal sepsis management and contribute to the implementation of the NNHS. The interventions to be evaluated will be nested in the Maternal, Neonatal and Child Survival (MNCS) programme being implemented by the Government of Bangladesh, in partnership with and supported by UNICEF, and several national NGOs. This operations research is being implemented by the Government of Bangladesh in collaboration with UNICEF, SNL - Save the Children (USA), Bangladesh Perinatal Society, and ICDDR,B. It will take place in four MNCS programme upazilas, where 10 unions will be randomly selected for intervention and 10 unions will be comparison. The intervention consists of training of community health workers, village doctors and health facility workers on managing neonatal sepsis in addition to essential newborn care training. In the comparison areas the health workers will only receive essential newborn care training. The intervention and evaluation will continue for at least 18 months, with rolling surveys and two special surveys at 6 and 12 months into the project. The rolling surveys will look at intervention coverage, care-seeking, and referral and referral compliance, while the two special surveys will assess provider performance, referral compliance, and quality of care. In addition, the investigators will document implementation processes to understand what worked and what did not and why.

Conditions

Sepsis

Keywords

Neonatal Sepsis; Evaluation; Bangladesh; Drying; Wrapping; Bathing

Outcome Measures

Primary Outcomes (1)

• Appropriate management of all cases of neonatal sepsis in the community by community level health care provider

  Neonatal Sepsis cases, if referred, received pre-referral antibiotic and complied with referred places, or if managed on site, managed by community level health care providers trained on neonatal sepsis management and received appropriate antibiotics and minimum course of antibiotics

  18 months

Secondary Outcomes (3)

• Newborns will be dried and wrapped immediately after birth

  18 months

• Newborns receiving breast feeding within one hour after birth

  18 months

• Newborns first bathed at least three days after birth

  18 months

Study Arms (2)

Referral compliance

EXPERIMENTAL

Health workers will receive a basic maternal, newborn and child health training under the MNCS programme. Newborn sepsis management training will be organised for the study. The Bangladesh Perinatal Society (BPS) will take the lead in developing and implementing the training programme with support from Saving Newborn Lives (SNL) and other partners.Referral slips will be used in the intervention unions for all the sick newborns identified so that they seek care on a timely fashion.

Other: Amoxycillin, Gentamicin

Neonatal sepsis

EXPERIMENTAL

Existing health delivery systems in the community level in managing neonatal sepsis.

Other: Counselling

Interventions

Amoxycillin, Gentamicin OTHER

If referral fails, community management of neonatal sepsis according to clinical algorithm.

Referral compliance

Counselling OTHER

counselling of management of neonatal sepsis in the community according to clinical algorithm.

Neonatal sepsis

Eligibility Criteria

• Age: Up to 2 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• development of danger signs of neonatal sepsis during neonatal period

You may not qualify if:

• developing signs not in neonatal period

Sponsors & Collaborators

• International Centre for Diarrhoeal Disease Research, Bangladesh: lead
• Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh: collaborator
• Johns Hopkins Bloomberg School of Public Health: collaborator

Study Sites (1)

Sunamganj, Bandarban, Sherpur

Bāndarban, Bangladesh

Location

MeSH Terms

Conditions

Sepsis; Neonatal Sepsis

Interventions

Amoxicillin; Gentamicins; Counseling

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Shams El Arifeen, MBBS, DrPh

  International Centre for Diarrhoeal Disease Research, Bangladesh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2010
• First Posted: April 12, 2011
• Study Start: April 1, 2010
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: October 30, 2014

Record last verified: 2011-04

Locations

BA (1)