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Investigators from the California Department of Public Health (CDPH), Richmond, CA, and the University of California, Berkeley, CA, conducted a retrospective study to assess the efficacy of Human Botulism Immune Globulin (BIG-IV) in treating infant botulism. CDPH developed BIG-IV, which was licensed in 2003, and CDPH is the sole source of BIG-IV in the United States. For the study, the investigators reviewed the medical records of all patients with laboratory-confirmed infant botulism in the United States treated with BIG-IV from 2003 to 2015. The primary outcomes were length of stay (LOS) and hospital charges. Outcomes in children treated with BIG-IV were compared to those of patients receiving placebo in the BIG-IV Pivotal Trial, conducted from 1992 to 1997 (see related article AAP Grand Rounds, 2016;15[4]:42).1 The main comparison was between children treated with BIG-IV within the first 7 days of hospitalization (when BIG-IV treatment is known to be efficacious)1 compared to the placebo group. Subgroup analyses were conducted for children treated on hospital days (HD) 0–3, 4–7, and >7. T-tests were used to assess differences between treated and placebo groups; hospital charges were adjusted to 2013 US dollars.
A total of 1,192 children with infant botulism received BIG-IV, including 1,133 (95%) who were treated within 7 days of hospitalization; there were 63 children in the placebo group. Among those receiving BIG-IV on HD 0–7, mean LOS was 2.2 + 0.04 weeks versus 5.7 + 0.6 weeks for the placebo group (P<.001). Mean hospital charges were $118,600 + $3,500 and $207,500 + $25,600 for those receiving BIG-IV or placebo, respectively (P=.002). Overall, treatment with BIG-IV within 7 days of hospitalization reduced mean LOS by 3.6 weeks and lowered mean hospital costs by $88,900. For children treated with BIG-IV on HD 0–3 (n=941), mean LOS was 2.0 weeks and mean charges were $109,100 (P<.001 for each, compared to the placebo group). Children receiving BIG-IV on HD 4–7 (n=192) had a mean LOS of 3.1 weeks (P<.001, compared to the placebo group), and mean hospital charges of $165,600 (P=.14). LOS and hospital charges for children receiving BIG-IV >7 days after hospitalization (n=59 with data available) did not have a shorter LOS or reduced costs compared to those receiving placebo.
The authors conclude that the use of BIG-IV has significantly reduced LOS and hospital charges in patients with infant botulism, particularly when it was administered soon after hospital admission.
Commentary
Dr Brady has disclosed no financial relationship relevant to this commentary. This commentary does not contain a discussion of an unapproved/investigative use of a commercial product/device.
Infant botulism results when swallowed spores of Clostridium botulinum germinate and produce botulinum neurotoxin in the large intestine. This toxin is absorbed into the circulation and travels to the neuromuscular junction, where it blocks the release of acetylcholine.2 In the past, infant botulism was attributed to honey ingestion, which is now discouraged.3 A source of exposure may not be apparent from the initial history.4 Infants with botulism present with constipation, feeding difficulties, hypotonia, and a weak cry.5 Hypoventilation and, occasionally, respiratory arrest may ensue. The neurologic manifestations are acute, bilateral, symmetrical, and descending. Fever is absent, the infant remains responsive, and the heart rate is normal; these features aid in distinguishing botulism from sepsis. Definitive diagnosis requires detection of the toxin in the infant’s stool, which is only available in specialized laboratories.6 Therefore, the physical examination is key to making a presumptive diagnosis. The investigators in the current study again demonstrate that early recognition and prompt treatment with BIG-IV reduces LOS in infants with botulism.
In an accompanying report, the authors examine the “clinical mimics” of infant botulism.7 Among those receiving BIG-IV, 76 infants did not have laboratory-confirmed botulism. An alternative diagnosis was established for 44 (57.9%). Spinal muscular atrophy (SMA) type I was the most common single diagnosis. Infants with SMA type I often presented with a history of several weeks of progressive weakness, as compared to the more acute presentation of botulism. Additional alternate diagnoses included Guillain-Barre syndrome, metabolic disorders, transverse myelitis, and encephalitis.
Bottom Line
Infant botulism should be suspected in infants who present with constipation, weakness, and bilateral cranial neuropathies. Early BIG-IV shortens LOS. Therefore, initiation of treatment with BIG-IV should be based on clinical rather than laboratory diagnosis.
EDITORS’ NOTE
The effectiveness of BIG-IV does not preclude the need for meticulous respiratory and nutritional support of affected infants. If sepsis is suspected, aminoglycosides should be avoided, as they potentiate the neuromuscular blockade by botulinum toxins.
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