Methodology:
This prospective observational study was carried out in the Department
of Pediatric Oncology, of a Regional Cancer Centre, in India from
1st April 2018 to 31st March 2019
after obtaining institutional review board and Ethical Committee
approval. All consecutive ALL children ≤14 years at diagnosis and
receiving maintenance chemotherapy during the study period were included
after obtaining written informed consent. Children with pre-existing
primary or acquired immunodeficiency were excluded. Data regarding
diagnosis, treatment, and infections requiring admission and inpatient
care (severe infection) during maintenance phase were recorded. Total
duration of maintenance chemotherapy was divided into four phases – 0
to 6 months, 7 to 12 months, 13 to 18 months and 19 to 24 months and
period of maintenance at the time of recruitment was recorded. Serum
immunoglobulin levels were measured by turbidimetric method using
Vitros® kit (Ortho diagnostics) at recruitment and
compared to age-matched reference ranges. All recruited children were
followed up for development any severe infection for a period of 6
months from the date of recruitment, or till completion of maintenance
treatment, or occurrence of any event or death due to any cause.