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Published on: February 5, 2019
Evaluation of Bovine Lactoferrin for Prevention of Late-Onset Sepsis in Low-Birth-Weight Infants: A Double-Blind
Shabina Ariff1, Sajid Bashir Soofi2, Uswa Jiwani2
1Department of Pediatric and Child Health, Aga Khan University, Karachi 74800, Pakistan.
Insights
Bovine lactoferrin supplementation did not prevent late-onset sepsis in preterm and low birth weight neonates. Further research with larger sample sizes is needed to confirm its efficacy in this vulnerable population.
Area of Science:
- Neonatalogy
- Infectious Diseases
- Nutritional Science
Background:
- Sepsis poses a significant threat to preterm and low birth weight (LBW) neonates, particularly in low- and middle-income countries.
- Lactoferrin, a glycoprotein with antimicrobial properties found in breast milk, is being investigated as a potential intervention.
- Existing research on lactoferrin's impact on late-onset sepsis (LOS) yields conflicting results.
Purpose of the Study:
- To evaluate the effectiveness of two doses of bovine lactoferrin (bLF) in preventing LOS and necrotizing enterocolitis (NEC) in preterm and LBW neonates.
- To assess the safety and efficacy of bLF supplementation in a Pakistani neonatal intensive care unit setting.
Main Methods:
- A three-arm, double-blind, placebo-controlled randomized clinical trial was conducted.
- Eligible neonates received either a placebo, 150 mg bLF, or 300 mg bLF daily for 28 days.
- Primary outcomes included LOS and NEC, with follow-up for 28 days post-intervention.
Main Results:
- Culture-proven sepsis occurred in 7.8% of placebo recipients, 0.98% of the 150 mg bLF group (p=0.020), and 4.9% of the 300 mg bLF group (p=0.390).
- No significant differences in necrotizing enterocolitis (NEC) were observed between the placebo and bLF groups.
- Compliance rates were high across all study arms, and no deaths were attributed to the intervention.
Conclusions:
- Bovine lactoferrin supplementation did not demonstrate efficacy in preventing late-onset sepsis in the studied preterm and LBW neonates.
- The study suggests that larger, more comprehensive trials are necessary to definitively determine the role of bLF in preventing sepsis and NEC in this high-risk population.
Abstract:
Background: Sepsis remains a significant cause of morbidity and mortality in preterm and low birth weight (LBW) neonates, especially in low- and middle-income countries (LMICs). Lactoferrin, a glycoprotein present in breast milk with antimicrobial activity, is a low-cost, readily available, and promising intervention currently under investigation. The available literature presents conflicting results on the impact of lactoferrin on the risk of late-onset sepsis (LOS). This study evaluated the effectiveness of two doses of bovine lactoferrin (bLF) supplementation in preventing LOS and necrotizing enterocolitis (NEC) in preterm and LBW neonates in Pakistan. Methods: A three-arm, double-blind, placebo-controlled, randomized clinical trial in the neonatal intensive care unit of Aga Khan University was conducted from July 2019 to August 2020. Preterm (28 to 36 + 5 weeks gestational age) and low birth weight (≥1000 g to <2500 g) neonates who established enteral feeding by 72 h were eligible. The exclusion criteria included sepsis before randomization, maternal history of chorioamnionitis or group B streptococcus colonization, and congenital anomalies. Enrolled neonates were randomly assigned in a 1:1:1 ratio using a computer-generated random allocation sequence to receive placebo (D-glucose), 150 mg bLF, or 300 mg bLF mixed with breast milk once daily for 28 days. The study staff, parents, and outcome assessors were blinded to the allocation. The primary outcome was late-onset sepsis from the trial entry to 28 days. The secondary outcome was NEC from the trial entry to 28 days. Neonates were followed weekly for 28 ± 2 days, and episodes of LOS and NEC were recorded. Results: Of 305 neonates enrolled, 102, 102, and 101, respectively, were randomized to receive a placebo (arm A), 150 mg bLF (arm B), and 300 mg bLF (arm C), respectively. Outcome data of 291 participants (99 in arm A, 95 in arm B, and 97 in arm C) were available for inclusion in the intention-to-treat analysis. The frequency of culture-proven sepsis was 8/102 (7.8%) in arm A compared to 1/102 (0.98%) (p = 0.020) in arm B and 5/101 (4.9%) in arm C (p = 0.390). We did not find any difference in episodes of NEC between arms A (n = 3, 3%) and B (n = 0, 0%) (p = 0.087) or between arms A and C (n = 2, 2%) (p = 0.650). We reported compliance rates of 79 (79.79%) in arm A, 78 (82.1%) in arm B, and 82 (84.53%) in arm C for investigational products. Arm C recorded two deaths, but neither was attributed to the intervention. Conclusions: Bovine lactoferrin supplementation did not prevent late-onset sepsis in neonates of preterm and low birth weight in our trial. However, given the small sample size, further trials with larger sample sizes are required to investigate its efficacy in these at-risk groups.
