Randomized Controlled Trial (RCT) in Children With Severe Pneumonia

NCT00455468 | Completed DMC

• 1 other identifier: 2005-037
• Study Type: interventional
• Target: 368
• Locations: 1 country
• Sites: 1

Brief Summary

Pneumonia is the leading cause of childhood morbidity and death in many developing countries including Bangladesh, causing about 2 million deaths worldwide each year. Pneumonia is an infection of the lungs, most commonly caused by viruses or bacteria like Streptococcus pneumoniae and Haemophilus influenzae. Depending on the clinical presentation, pneumonia can be classified as very severe, severe or non-severe, with specific treatment for each of them except for antibiotic therapy. Severe and very severe pneumonia require hospitalization for additional supportive treatment such as suction, oxygen therapy and administration of bronchodilator. In Bangladesh, the number of hospital beds is inadequate for admission of all pneumonia cases that require hospitalization; however, it is also important to provide institutional care to those children who cannot be hospitalized due to bed constraints. Provision of appropriate antibiotics and supportive cares during the period of stay at established day-care centres could be an effective alternative. The impetus for this study came from the findings of our recently completed study titled "Daycare-based management of severe pneumonia in under-5 children when hospitalization is not possible due to the lack of beds". This study successfully managed children (n=251), but it was not a randomized trial and thus direct comparison of the efficacy of management of severe pneumonia at the day-care centre, essential for building confidence for implementing this management policy, is not possible. We, the researchers at the International Centre for Diarrhoeal Disease Research, Bangladesh, could not plan a randomized, controlled trial (RCT) because of ethical reasons. Now that we have data suggesting effectiveness as well as safety of the day-care based treatment for management of children with severe pneumonia, a RCT should be possible. Two hundred fifty-one children with severe pneumonia were enrolled at the Radda Clinic from June 2003 to May 2005. The mean age was 7±7 (2-55) months, 86% infants, 63% boys and 91% breast-fed. History of cough was present in 99% cases, fever in 89% and rapid breathing in 67% cases. Forty-four percent of children were febrile (≥38°C), 93% children had vesicular breath sound and 99% bilateral rales. Fifty-seven percent of children were hypoxic with mean oxygen saturation of (93±4)%, which was corrected by oxygen therapy (98±3)%. Eighty percent of children had severe pneumonia and 20% had very severe pneumonia. The mean duration of clinic stay was (7±2) days. Two hundred thirty-four (93%) children completed the study successfully, 11 (4.4%) referred to hospitals (only one participant had to visit hospital at night due to deterioration of his condition, 9 were referred to hospital at the time of clinic closure i.e., at 5 pm and one participant was referred to hospital during the morning hours) and 6 (2.4%) left against medical advice (LAMA). There was no death during the period of clinic stay but only four (1.6%) deaths occurred during the 3 months follow-up. The study indicated that treatment of severe pneumonia in children at the day-care centre is effective and safe and thus it is comparable to the hospital care. If the day-care based management is found to have comparable efficacy to that of hospitalized management of 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 hospitalized care. Additionally, availability of the treatment facility in community set-ups will be cost and time saving for the population. Children of either sex, aged 2-59 months, attending the Radda Clinic and Institute of Child Health and Shishu Hospital (ICHSH) with severe pneumonia will be randomized to receive either the day-care management at the clinic or hospitalized management at the ICHSH. Children randomized to receive day-care treatment will stay at the clinic from 8 am-5 pm and will receive antibiotics and other supportive cares. At 5 pm, they would be send to respective homes with advice to bring back their children to the clinic next morning, and advised to provide other supports at home. The same management would be continued till improvement and discharged and followed up every 2 weeks for 3 months. Children randomized to receive hospitalized management would be admitted at ICHSH and receive standard treatment like antibiotics and other supportive cares. The same treatment would be continued for 24 hours/day (rather than 9 hours/day at the day-care clinic) till improvement and discharged and followed-up at the ICHSH every 2 weeks for 3 months. About 3000 children with pneumonia visit Radda Clinic each year and about 200 of them will have severe pneumonia requiring hospitalization. Thus, we hope to enroll 368 (184 in each site) children with severe pneumonia during a 2-year study period.

Conditions

Severe Pneumonia

Keywords

Severe pneumonia; children; day care management; hospitalized management; Randomized controlled trial; Under five children

Interventions

Day-care treatment vs. hospital care PROCEDURE

Eligibility Criteria

• Age: 2 Months - 59 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age: 2 to 59 months
• Sex: Both boys and girls
• Severe pneumonia according to WHO criteria (Severe pneumonia is defined as cough or difficult breathing with lower chest wall in drawing with or without fast breathing which is defined as the respiratory rate ≥ 50 breaths per minute for children aged 2-11 months and ≥ 40 breaths per minute for children aged 12-59 months)
• Attend the Radda Clinic and ICHSH between 8:00 am to 4:00 pm (Sunday through Saturday)
• Written informed consent by respective parents/guardians

You may not qualify if:

• Very severe and non-severe pneumonia
• Nosocomial pneumonia
• History of taking antibiotics for pneumonia within 48 hour prior to enrollment
• Chronic illnesses like tuberculosis, cystic fibrosis
• Congenital deformities/anomalies e.g. Down's Syndrome, congenital heart disease
• Immunodeficiency
• Trauma/burn
• Bronchiolitis
• Bronchial asthma
• Lives far away from the Radda Clinic and ICHSH (outside 5 km radius from the respective study site)

Sponsors & Collaborators

• International Centre for Diarrhoeal Disease Research, Bangladesh: lead

Study Sites (1)

ICDDR,B

Dhaka, 1212, Bangladesh

Location

Related Publications (2)

• Ashraf H, Alam NH, Chisti MJ, Salam MA, Ahmed T, Gyr N. Observational follow-up study following two cohorts of children with severe pneumonia after discharge from day care clinic/hospital in Dhaka, Bangladesh. BMJ Open. 2012 Jul 27;2(4):e000961. doi: 10.1136/bmjopen-2012-000961. Print 2012.

  PMID: 22842561 DERIVED

• Ashraf H, Mahmud R, Alam NH, Jahan SA, Kamal SM, Haque F, Salam MA, Gyr N. Randomized controlled trial of day care versus hospital care of severe pneumonia in Bangladesh. Pediatrics. 2010 Oct;126(4):e807-15. doi: 10.1542/peds.2009-3631. Epub 2010 Sep 20.

  PMID: 20855397 DERIVED

MeSH Terms

Conditions

Pneumonia

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Hasan Ashraf, MD

  ICDDR,B: Centre for Health and Population Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 1, 2007
• First Posted: April 3, 2007
• Study Start: December 1, 2005
• Primary Completion: December 1, 2007
• Study Completion: April 1, 2009
• Last Updated: July 12, 2011

Record last verified: 2007-03

Locations

BA (1)