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A clinical trial to determine whether prophylatic administration of Probiotic Bifidobacterium breve to preterm infants reduces the incidence of episodes of Late onset sepsis

Efficacy of Prophylactic administration of BifidoBacterBreve M16 V on decreasing Late onset sepsis among Preterm Neonates 28-32 weeks or Very Low birth weight babies: A Before and after study

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/04/018393
Enrollment
266
Registered
2019-04-02
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: P36- Bacterial sepsis of newborn

Interventions

Intervention1: Probiotics Bifidobacterium Breve M16V: Preterm babies who satisfies inclusion criteria will be supplemented with Bifidobacterium breve M 16v reconstituted with 3 ml of Breast milk until

Sponsors

National Health Mission
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Preterm babies gestational age between 28 weeks and 31 6/7 weeks or less than 1500 grams Age less than 72 hours

Exclusion criteria

Exclusion criteria: Lethal congenital malformation known at trial entry Any known Major gastrointestinal malformation or Medical indication preventing initiation of enteral feed within 72 hours of life. Babies requiring More than two inotropic support Babies with positive CRP or growth in blood culture within 72 hours of life

Design outcomes

Primary

MeasureTime frame
Incidence of blood culture positive Late onset SepsisTimepoint: Everyday continued till subject complets 34 weeks

Secondary

MeasureTime frame
1.Age at achieving full enteral nutrition2.Number of episodes of feed intolerance3.Duration of total parenteral nutrition days4.Incidence of Necrotising Enterocolitis 5.Total number of Deaths before discharge from hospital 6.Total duration of antibiotics received Timepoint: Till the subject completes 34 weeks of gestation

Countries

India

Contacts

Public ContactDr Kamalarathnam C N

Madras Medical College

drkamal.rathnam@gmail.com9841102746

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026