Necrotizing enterocolitis (NEC) has been recognized for well over 5 decades yet remains the most common life-threatening surgical emergency in the newborn. The incidence of NEC has decreased steadily in preterm and very-low-birthweight infants over several decades and is typically uncommon in term newborns and infants with a birthweight greater than 2,500 g. Evidence accumulating during the past decade, however, suggests that practitioners should consider NEC in this broader subset of term infants with chromosomal and congenital anomalies complicated by heart or gastrointestinal defects when signs and symptoms of feeding intolerance, abdominal illness, or sepsis are present. The short- and long-term consequences of NEC are devastating in all infants, and although early disease recognition and treatment are essential, promoting human milk feeding as a primary modality in prevention is critical. This article highlights our current understanding of the pathophysiology, the clinical presentation, the risk factors for NEC in term infants compared with premature infants, and the treatment of NEC and discusses strategies in the prevention of NEC. Finally, we review the long-term consequences of NEC and the importance of primary care practitioners in the long-term care of infants after hospitalization for NEC.
Objective
To evaluate safety and explore efficacy of recombinant human lactoferrin (talactoferrin, TLf) to reduce infection.
Study design
We conducted a randomized, double blind, placebo-controlled trial in 6 0 infants with birth weights of 750 to 1500 grams. Each infant received enteral TLf or placebo on day 1 through 28 days of life; TLf dose was 150 mg/kg/12 hour. Primary outcomes were bacteremia, pneumonia, urinary tract infection, meningitis and necrotizing enterocolitis. Secondary outcomes were sepsis syndrome and suspected NEC. We recorded clinical, laboratory and radiologic findings, diseases, and adverse events in a database used for statistical analyses.
Results
Infants in the two groups had similar demographics. We attributed no enteral or organ-specific adverse events to TLf. There were two deaths in the group with TLf (posterior fossa hemorrhage and post-discharge sudden infant death), and one infant given placebo died of necrotizing enterocolitis. Hospital-acquired infections in the group with Tlf were 50% of that observed in infants fed placebo (p<0.04), including fewer blood or line infections, urinary tract infections, and pneumonia. Fourteen infants treated with TLf-weighing <1 kg at birth weight had no Gram-negative infections versus three of 14 infants given placebo. Non-infectious outcomes did not differ statistically in the two arms. No differences in growth or neurodevelopment occurred among infants treated with TLf and placebo during a one-year, post-hospitalization period.
Conclusion
We found no clinical or laboratory toxicity and a trend towards less infectious morbidity in infants treated with TLf.
Trial registration
ClinicalTrials.gov: NCT00854633.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.