Tramsen, L., Salzmann-Manrique, E., Bochennek, K., Klingebiel, T., Reinhardt, D., Creutzig, U., . . . Lehrnbecher, T. (2016). Lack of effectiveness of neutropenic diet and social restrictions as anti-infective measures in children with acute myeloid leukemia: An analysis of the AML-BFM 2004 trial. Journal of Clinical Oncology, 34, 2776–2783. 

To evaluate the impact of dietary and social restrictions on infections among children participating in a clinical trial

Data on infectious complications were abstracted from medical records at the institutions where the patients were treated. At the same time, an international survey was conducted regarding practices in restricting social contacts, pets at home, and food diets. Analysis was conducted by linking institutional survey results with associated patient infection–related outcome data.

• N = 339   
• AGE RANGE = 0–18 years, 30% were between 1–18 years
• MALES: 50%, FEMALES: 50%
• CURRENT TREATMENT: Chemotherapy
• KEY DISEASE CHARACTERISTICS: All had acute myeloid leukemia (AML)
• OTHER KEY SAMPLE CHARACTERISTICS: 59% were deemed high risk for neutropenia

• SITE: Multi-site   
• SETTING TYPE: Multiple settings    
• LOCATION: International

• PHASE OF CARE: Multiple phases of care
• APPLICATIONS: Pediatrics

• Cohort comparison, retrospective

Infection was defined as clinical signs and symptoms associated with the institution of antibiotics, an isolated pathogen, or an identified infection site though a physical exam or imaging study.

A wide variety of restrictions existed. Over 90% were restricted from attending kindergarten or school, and more than 80% were restricted from eating raw seafood or meat. Higher restriction of social contacts was associated with an increased incidence of bactermia (incidence rate ratio [IRR] = 1.21, p = 0.003). Higher restriction of pets at home was associated with a decreased incidence of pneumonia (IRR = 0.86, p = 0.05). No relationship was observed between food restriction and infections. When adjusted for age, risk stratification, and antibiotic prophylaxis, none of the restrictions used were associated with infections. Patients who were overweight (p = 0.002) or underweight (p = 0.028) had higher risks of infection.

The restriction of social contact, pets at home, and the use of dietary restrictions were not significantly associated with the decreased incidence of infections.

• Risk of bias (no control group)
• Risk of bias (no blinding)
• Risk of bias (no random assignment)
• Key sample group differences that could influence results

The findings suggest that strict neutropenic diets; restrictions of social contact, such as school attendance; and restriction of pets at home do not reduce infections in pediatric patients with neutropenia. These policies need to be questioned and evaluated further for their effects on overall clinical and quality-of-life outcomes.