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Lactobacillus rhamnosus GG to Reduce Necrotising Enterocolitis, Sepsis, and Mortality in Very Low Birth Weight
Sachin Shah1, Amita Kaul2, Prerna Pandey3
1Department of Neonatal and Pediatric Intensive Care Services, Surya Mother and Child Super Specialty Hospital, Pune Octroi Naka, Sr. No.8, Near Bhujbal Chowk, Wakad Road, Pune, Maharashtra, 411057, India.
Insights
Oral Lactobacillus rhamnosus GG (LGG) did not significantly reduce neonatal enterocolitis (NEC), sepsis, or mortality in very low birth weight (VLBW) infants. This probiotic intervention showed no benefit in the primary composite outcome for these vulnerable infants.
Area of Science:
- Neonatalogy
- Microbiology
- Clinical Trials
Background:
- Very low birth weight (VLBW) infants are at high risk for serious complications.
- Probiotics are explored as a potential intervention to improve outcomes in VLBW infants.
- Lactobacillus rhamnosus GG (LGG) is a commonly studied probiotic strain.
Purpose of the Study:
- To evaluate the efficacy of oral Lactobacillus rhamnosus GG (LGG) in preventing neonatal enterocolitis (NEC), sepsis, and mortality.
- To assess the impact of LGG on feeding milestones and hospital stay duration in VLBW infants.
Main Methods:
- An open-label randomized controlled trial was conducted with enterally-fed VLBW infants (gestational age ≤ 32 weeks).
- Infants were randomized to receive either LGG or no probiotic (control).
- Outcomes including mortality, NEC, and sepsis were compared during hospitalization.
Main Results:
- The composite outcome of sepsis, NEC, or mortality occurred in 30.4% of the LGG group and 27.2% in the control group (RR 0.85; 95%CI 0.48-1.50).
- No significant differences were observed in the time to reach full feeds, time to regain birth weight, duration of hospital stay, mechanical ventilation, or antimicrobial therapy.
- The study included 236 VLBW infants.
Conclusions:
- The use of Lactobacillus rhamnosus GG as a single probiotic agent did not provide significant benefits for the composite outcome of mortality, sepsis, or NEC in VLBW infants.
- Further research may be needed to explore other probiotic strains or combinations for this population.
Objectives:
To evaluate the efficacy of oral Lactobacillus rhamnosus GG (LGG) in reducing neonatal enterocolitis (NEC), sepsis and mortality in very low birth weight (VLBW) infants.
Methods:
This open-label randomized controlled trial included enterally-fed VLBW infants with gestational age ≤ 32 weeks; those with gastrointestinal anomalies, severe birth asphyxia (APGAR score < 3 at 5 min), cyanotic congenital heart disease, and those not started on feeds by 14 days of life were excluded. Participants were randomized to receive either no probiotic (control) group, or probiotic (LGG; intervention) group. The intervention group received the first dose of LGG (probiotic) at feed initiation and was continued till 35 weeks of corrected gestational age. The control group received only breast milk. Clinical outcomes (mortality, NEC, sepsis) were compared in both groups during hospital stay.
Results:
A total of 236 infants were enrolled. The primary composite outcome of sepsis, NEC or mortality was seen in 35 (30.4%) and 33 (27.2%) infants, respectively in the LGG and control groups (RR 0.85; 95%CI 0.48-1.50, P = 0.592). The mean (SD) time to reach full feeds was 11.9 (4.2) and 12.0 (5.5) days in the LGG and control groups, respectively; P = 0.561. The mean (SD) time to regain birth weight was 13.5 (3.9) and 13.6 (3.9) days in the LGG and control groups, respectively (P = 0.982). There was no significant difference in duration of hospital stay, duration of mechanical ventilation, or duration of antimicrobial therapy between the two groups (P > 0.05).
Conclusions:
Use of LGG as single component probiotic in VLBW infants did not confer any significant benefit on the composite outcome of mortality, sepsis or NEC.
Trial Registry:
Clinical Trial Registry of India; Ref. No. CTRI/2021/03/031724 dated Mar 03, 2021.
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