To study the efficacy and safety of single strain versus multi strain probiotics in prevention of late-onset sepsis in preterm neonates

To study the efficacy and safety of single strain versus multi strain probiotics in prevention of late onset sepsis in preterm neonates

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2016/09/007310

Enrollment

270

Registered

2016-09-26

Start date

Unknown

Completion date

Unknown

Last updated

2026-06-22

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

Conditions

Health Condition 1: null- 34 weeks of gestation or birth weight 1500 grams admitted to Surya Children Hospital NICU

Interventions

Intervention1: Multi strain probiotics: To be started as soon as infant is fit for feeds Control Intervention1: Single strain probiotics: To be started as soon as infant is fit for feeds

Eligibility

Inclusion criteria

Inclusion criteria: Neonates with less than 34 weeks of gestation or birth weight less than 1500 grams

Exclusion criteria

Exclusion criteria: 1.Lethal congenital anomalies, malformations, fetal chromosomal anomalies 2.Gastrointestinal or other congenital malformations having significant impact on gastrointestinal motility or function (intestinal atresias, meconium plug syndrome, HirschsprungÃ¢â?¬•s disease; neuronal intestinal hypoplasia; congenital diaphragmatic hernia) 3. Cyanotic congenital heart disease.

Design outcomes

Primary

Measure	Time frame
Incidence of late onset sepsis in both groupsTimepoint: Up to discharge from NICU or 28 days whichever comes later	—

Secondary

Measure	Time frame
1. Definite Necrotising Enterocolitis 2. All cause mortality before hospital discharge 3. Late onset sepsis related mortality prior to discharge 4. Feed intolerance 5.Duration of parenteral nutrition 6. Duration of hospital stay 7.Total duration of antibiotic therapy 8. Time to full enetral feeds 9. Gain in weight at discharge (in g/kg/day) 10. Gain in length at discharge (cm/week) 11. Gain in head circumference at discharge(cm/week) Timepoint: Up to discharge from NICU or 28 days whichever comes later	—

Measure

Time frame

1. Definite Necrotising Enterocolitis 2. All cause mortality before hospital discharge 3. Late onset sepsis related mortality prior to discharge 4. Feed intolerance 5.Duration of parenteral nutrition 6. Duration of hospital stay 7.Total duration of antibiotic therapy 8. Time to full enetral feeds 9. Gain in weight at discharge (in g/kg/day) 10. Gain in length at discharge (cm/week) 11. Gain in head circumference at discharge(cm/week) Timepoint: Up to discharge from NICU or 28 days whichever comes later

—

Countries

India

Contacts

Public ContactDr Jagdish Ashokrao Kathwate

Surya Childrens Hospital

docjagdishkat@gmail.com7666490985

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 27, 2026