Use of Probiotics to reduce neonatal infections

PROPHYLACTIC PROBIOTIC USE IN PRETERM INFANTS FOR REDUCTION OF LATE ONSET NEONATAL SEPSIS (LONS) AT DISCHARGE IN A TERITARY CARE CENTER, A RANDOMIZED CONTROLLED OPEN LABEL SUPERIORITY TRIAL (PUPIL STUDY) - PUPIL STUDY

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/05/110770

Enrollment

Registered

2026-05-21

Start date

Unknown

Completion date

Unknown

Last updated

2026-06-01

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

Conditions

Health Condition 1: P369- Bacterial sepsis of newborn, unspecified

Interventions

Intervention1: PROBIOTICS: PROBIOTICS CONTAINING BACILLUS CLAUSII 2 BILLION SPORES PER 5 ML AT 1.25 ML TWICE DAILY DOSAGE Control Intervention1: will be provided standard of care: Will be provided st

Eligibility

Inclusion criteria

Inclusion criteria: Inborn babies - All subsequently delivered neonates before 37 weeks of gestation with birth weight of 1500grams and below from day 1 of enteral feeds Outborn babies - babies admitted on or before 72 hours of life with less than 37 weeks of gestation and / or 1500 grams or less, from day 1 of enteral feeds or day 1 of admission whichever is earlier.

Exclusion criteria

Exclusion criteria: Enternal feeds contraindicated babies (Hemodynamically unstable & surgical neonates) and culture positive early onset neonatal sepsis.

Design outcomes

Primary

Measure	Time frame
Reduction in Late onset Neonatal sepsisTimepoint: At diacharge	—

Secondary

Measure	Time frame
All cause mortality, Neonatal Enterocolitis, feed intolerance, time to achieve full feeds, length of stay, stool culture for colonising organismTimepoint: At diacharge	—

Countries

India

Contacts

Public ContactPradeep Kumar Khanikekar

Base Hospital Delhi Cantt

praveen.army@gmail.com7305042868

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 11, 2026