Trial in Childhood Pneumonia With Malnutrition

Summary

The impetus for this study came from the findings of the investigators' recently published study entitled "Day-care management of severe and very severe pneumonia, without associated co-morbidities such as severe malnutrition, in an urban health clinic in Dhaka, Bangladesh". If day-care management is found to have comparable efficacy to that of hospital management of severe and very severe pneumonia in children then they could be managed at outpatient, day-care set ups reducing hospitalization and thus freeing beds for management of other children who need hospital care. Such management could also be implemented in rural areas of Bangladesh and potentially to other developing countries. Additionally, availability of the treatment facility in community set-ups will be cost and time saving for the population. But, as patients with severe malnutrition were excluded from the pilot study for ethical reasons, the peer reviewers of the manuscript felt that the study findings cannot be applied to the treatment of severe and very severe pneumonia in general. Similarly, management of severely malnourished children with associated complications relies on hospital-based treatment. In another study, a day-care clinic approach by providing antibiotics, micronutrients, diet and supportive care to severely malnourished children showed that they could be successfully managed at existing day-care clinics using a protocolized approach. Therefore, after the successful conduction and publication of these two study results in international journals with severe and very severe pneumonia as well as severe malnutrition at the day-care clinic, it is mandatory to perform the final study where the investigators will include severe malnutrition as well as associated co-morbidities to be applied to the treatment of severe and severe pneumonia in children in general to make the treatment approach more widely applicable.

Conditions

• Malnutrition
• Pneumonia

Interventions

OTHER

Day-care clinic

Inj. Ceftriaxone and other micronutrients will be given to children at the day-care clinic from 8:00 a.m. to 5:00 p.m. daily.

OTHER

Hospital Management

Inj. Ceftriaxone and other micronutrients will be given to children at the hospital from admission till discharge.

Sponsors & Collaborators

• University of Basel

  collaborator OTHER

• Institute of Child health & Shishu Sasthya Foundation Hospital (ICHSH), Bangladesh

  collaborator UNKNOWN

• Radda MCH-FP Centre, Bangladesh

  collaborator OTHER

• International Centre for Diarrhoeal Disease Research, Bangladesh

  lead OTHER

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

2008-11-30

Primary Completion

2013-06-30

Completion

2013-06-30

Countries

• Bangladesh

Study Locations