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Lactobacillus rhamnosus GG to Reduce Necrotising Enterocolitis, Sepsis, and Mortality in Very Low Birth Weight Infants: A Randomized Controlled Trial.

  • 2026-01-14
  • Indian pediatrics 63(7)
    • Sachin Shah
    • Amita Kaul
    • Prerna Pandey
    • Surabhi Wattal
    • Rajesh Nare

Study Design

Type
Randomized Controlled Trial (RCT)
Sample size
n = 236
Population
very low birth weight (VLBW) infants with gestational age ≤ 32 weeks
Methods
open-label randomized controlled trial; intervention group received LGG from feed initiation till 35 weeks corrected gestational age; control group received only breast milk
Blinding
Open-label
Duration
till 35 weeks of corrected gestational age
Funding
Unclear
  • Large Human Trial

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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