Neurocognitive function among HIV-infected children hospitalized with severe pneumonia Nervous System Diseases
Conditions
Interventions
This study is a prospective longitudinal observational study nested under the EMPIRICAL study (a randomized open-label clinical trial) compared to a longitudinal cohort of HIV-negative children with s
Sponsors
Makerere University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Cohort of HIV positive children with severe pneumonia: 1. Aged between 28 and 365 days 2. Participating in the EMPIRICAL trial 3. Current hospitalization due to pneumonia with criteria for parenteral antibiotics (=1 World Health Organization criteria) 4. Pneumonia, defined as chest indrawing or fast breathing for age (for infants aged 28 to 60 days, =60 breaths per minute; for infants aged 61 to 365 days, =50 breaths per minute) 5. HIV-confirmed infection (with at least one molecular method: DNA PCR or RNA PCR/viral load) 6. Informed consent obtained from caregivers Cohort of HIV negative children with severe pneumonia: 1. Aged between 28 and 365 days 2. Current hospitalization due to pneumonia with criteria for parenteral antibiotics (=1 World Health Organization criteria) 3. Pneumonia, defined as chest indrawing or fast breathing for age (for infants aged 28 to 60 days, =60 breaths per minute; for infants aged 61 to 365 days, =50 breaths per minute) 4. Informed consent obtained from caregivers Cohort of HIV positive children without pneumonia: 1. Aged between 28 and 365 days 2. HIV-confirmed infection (with at least one molecular method: DNA PCR or RNA PCR/viral load) 3. Informed consent obtained from caregivers
Exclusion criteria
Exclusion criteria: 1. Clinical TB (pulmonary or extrapulmonary) diagnosis. Defined as the necessity of TB treatment prescribed by a physician, known bacteriologically confirmed TB case (at least one biological specimen positive by culture or Xpert MTB/RIF) at the moment of randomization, previously treated for TB or currently on treatment for TB, or documented evidence of close TB exposure. 2. Pure wheezers. Defined as a clear clinical improvement after a bronchodilator test. 3. Active malignancies, systemic immunosuppressive medications, or evidence of condition other than HIV and pneumonia 4. Weighing <2.5 kg 5. Hemoglobin less than <6 g/dl in the screening blood test or in a test done in the last 48 h 6. Neutropenia <500 /mm³ in the screening blood test or in a test done in the last 48 h
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Development measured in participants the intervention group (empirical treatment for CMV, TB, or both) and SoC alone using mean scaled scores on the Bayley scale of infant development at discharge, 1 year post-randomization, and at 2 years of age | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Development measured in participants the intervention group (empirical treatment for CMV, TB, or both), SoC alone, and a matched cohort of HIV-positive infants without pneumonia using mean scaled scores on the Bayley scale of infant development at discharge, 1-year post-randomization, and at 2 years of age 2. Development measured in participants the intervention group (empirical treatment for CMV, TB, or both), SoC alone, and a cohort of HIV negative infants with severe pneumonia using mean scaled scores on the Bayley scale of infant development at discharge, 1 year post-randomization, and at 2 years of age | — |
Countries
Uganda
Contacts
Public ContactDamalie Nalwanga
Outcome results
None listed