DefinePK

Research Objective

To compare the efficacy of probiotics versus placebo in preventing necrotizing enterocolitis (NEC) in preterm newborns.

Methodology

A randomized controlled trial was conducted with 92 preterm neonates (gestational age 28-32 weeks). Participants were randomly assigned to either a probiotics group (Bifidobacteria, hiflora/gutcare, one sachet daily for 5 days) or a placebo group (placebo for 5 days). Neonates were observed for feeding intolerance, abdominal distension, grossly bloody stools, and erythema of the abdominal skin. NEC was diagnosed if three or more of these features were present in the first 7 days of life. Data was analyzed using SPSS version 26.0, with chi-square tests and stratification for effect modifiers.

Methodology Flowchart

                        graph TD
    A[Recruit 92 Preterm Neonates 28-32 weeks gestation] --> B[Random Assignment];
    B --> C[Probiotics Group n=46];
    B --> D[Placebo Group n=46];
    C --> E[Administer Bifidobacteria hiflora/gutcare daily for 5 days];
    D --> F[Administer Placebo daily for 5 days];
    E --> G[Observe for NEC Symptoms feeding intolerance, distension, bloody stools, erythema];
    F --> G;
    G --> H[Diagnose NEC>=3 symptoms in first 7 days];
    H --> I[Analyze Data SPSS, Chi-square];
    I --> J[Compare NEC Incidence between groups];
    J --> K[Identify Associations with NEC];
    K --> L[Draw Conclusions and Recommendations];                    

Discussion

Preterm neonates have reduced gut microbial diversity, increasing their risk for NEC. This study's findings align with previous research indicating that probiotics can reduce NEC incidence in preterm infants. The observed differences in NEC occurrence between the probiotic and placebo groups suggest a protective role for probiotics. Factors like gestational age, delivery mode, and maternal education were found to influence NEC development in the probiotic group, while birth weight was a significant factor in the placebo group.

Key Findings

The incidence of NEC was significantly lower in the probiotics group (6.52%) compared to the placebo group (23.9%) (p=0.020). In the probiotics group, NEC was associated with gestational age between 31-32 weeks (p=0.012), spontaneous vaginal delivery (p=0.028), and educated maternal status (p=0.006). In the placebo group, NEC was associated with birth weight between 1-1.5 kg (p=0.007).

Conclusion

Probiotics are more effective than placebo in preventing necrotizing enterocolitis in preterm neonates. Routine prophylactic use of probiotics in preterm neonates is recommended to reduce the incidence of NEC.

Fact Check

* The study included 92 preterm neonates, with 46 in each group.
* The incidence of NEC in the probiotics group was 6.52% (3 out of 46 neonates).
* The incidence of NEC in the placebo group was 23.9% (11 out of 46 neonates).

Mind Map