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Probiotics for Preterm Infants in India - Systematic Review and Meta-Analysis of Randomized Controlled Trials
Haribalakrishna Balasubramanian1, Anitha Ananthan2, Shripada Rao3,4
1Department of Neonatology, Surya Mother and Child Care Hospital, Mumbai, India.
Insights
Probiotic supplementation significantly reduces the risk of necrotizing enterocolitis, sepsis, and mortality in preterm infants in India. This meta-analysis of randomized controlled trials (RCTs) supports their use for improved infant outcomes.
Area of Science:
- Neonatal Medicine
- Microbiology
- Clinical Trials
Background:
- Preterm infants are vulnerable to serious complications like necrotizing enterocolitis (NEC) and sepsis.
- Gut microbiota plays a crucial role in infant health, and probiotics may modulate this.
- Evidence on probiotic efficacy in Indian preterm infants requires systematic evaluation.
Purpose of the Study:
- To systematically review and meta-analyze randomized controlled trials (RCTs) evaluating probiotic use in preterm infants in India.
- To assess the impact of probiotics on key neonatal outcomes, including NEC, sepsis, mortality, and feeding milestones.
Main Methods:
- Systematic review adhering to Cochrane methodology and PRISMA guidelines.
- Meta-analysis of 9 RCTs involving 1514 preterm infants.
- Fixed effects model employed for statistical analysis.
Main Results:
- Probiotics significantly reduced the risk of necrotizing enterocolitis (NEC) ≥ Stage II (RR: 0.36, p=0.0009).
- Reduced risk of late-onset sepsis (RR: 0.56, p<0.00001) and mortality (RR: 0.62, p=0.03) observed.
- Probiotic use shortened time to full feeds (MD: -4.09 days) and duration of hospital stay (MD: -2.00 days).
Conclusions:
- Current evidence strongly supports probiotic supplementation for improving outcomes in preterm infants in India.
- Probiotics offer a safe and effective intervention to mitigate major morbidities and reduce hospital stay.
- Further research may explore specific probiotic strains and optimal dosing for diverse neonatal populations.
Abstract:
The objective of the present study is to review current evidence from randomized controlled trials (RCTs) of probiotics for preterm infants in India. A systematic review of RCTs of probiotics for preterm infants in India was conducted using Cochrane methodology and PRISMA guidelines. Fixed effects model was used for meta-analysis. Nine RCTs (n = 1514) were included. Meta-analysis showed reduced risk of necrotizing enterocolitis (NEC) ≥ Stage II {Risk ratio (RR): 0.36 [95% confidence interval (CI): 0.20, 0.66], p = 0.0009, (9 RCTs)}, late onset sepsis [RR: 0.56 (95% CI: 0.45, 0.71), p < 0.00001, (7 RCTs)] and mortality [RR: 0.62 (95% CI: 0.41, 0.95, p = 0.03 (8 RCTs)] in the probiotic group. Probiotics also reduced the time to full feeds [Mean difference (MD): -4.09 d (95% CI: -4.52, -3.65), p < 0.00001, 5 RCTs] and duration of hospital stay [Fixed effects model (FEM): MD: -2.00 d (95% CI: -2.46, -1.53), p < 0.00001, 6 RCTs]. Current evidence from RCTs supports probiotic supplementation for optimizing outcomes of preterm infants in India.
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