Universal Versus Conditional Three-day Follow-up Visit for Children With Unclassified Fever

Summary

Fevers in childhood are common and usually self-resolve. In sub-Saharan Africa, when a febrile child presents to a community health worker (CHW), the child is assessed for malaria, pneumonia, and diarrhea, and other danger signs, according to WHO guidelines for integrated Community Case Management (iCCM) of childhood illnesses. In the cases where 1) there are no danger signs present, and 2) malaria, pneumonia, and diarrhea have been ruled out, the World Health Organization (WHO) recommends that all children be reassessed in 3 days. It is hypothesized that health outcomes for these cases will be equivalent if the CHW advises to come back in 3 days only if symptoms have not resolved. In order to assess this hypothesis, a two-arm cluster-randomized, community-based non-inferiority trial in Southern Nations, Nationalities and People's Regional State (SNNPR) in Southwest Ethiopia will be conducted to assess the non-inferiority of CHW-advised systematic follow-up on day 3 compared to conditional follow-up for non-severe febrile illness in children age 2 to 59 months, in which no cause of fever can be identified and where danger signs are absent.

Conditions

• Fever

Interventions

BEHAVIORAL

Systematic follow-up

Febrile children without a diagnosable illness and without danger signs do not need to return to the HEW unless they are still sick, as over 90% of fevers resolve by themselves. HEW advice and procedures * Children with unclassified fever should come back for re-assessment after 2 days only if the child still has fever or is sick * Children who are getting worse should come back immediately or at any time for a re-assessment * All children who come back for re-assessment, regardless of when they come back, should have a full assessment of their condition again. * HEW should fill out a loose child assessment form * If child still has fever and a negative rapid diagnostic test for malaria (mRDT), the HEW should refer the child to the nearest health centre.

BEHAVIORAL

Conditional follow-up

Health extension workers will be trained to counsel caregivers of children with unclassified fever that they should have a conditional follow-up visit, i.e. only to come back for re-assessment after 2 days if the child still has fever or is sick. This is in line with national IMNCI guidelines.

Sponsors & Collaborators

• Karolinska Institutet

  collaborator OTHER

• Centers for Disease Control and Prevention

  collaborator FED

• Malaria Consortium

  lead OTHER

Principal Investigators

• Karin Kallander, MSc, PhD · Malaria Consortium

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

2 Months

Max Age

59 Months

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-12-01

Primary Completion

2016-11-30

Completion

2017-05-01

Countries

• Ethiopia

Study Locations