FindTrial
Sign In

Use of probiotics in sick premature infants

Lactobacillus Rhamnosus GG to reduce NEC, sepsis and mortality in VLBW infants –A Randomised Controlled Trial ?

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/03/031724
Enrollment
236
Registered
2021-03-04
Start date
Unknown
Completion date
Unknown
Last updated
2025-04-28

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

Conditions

Health Condition 1: P073- Preterm [premature] newborn [other]

Interventions

Intervention1: Lactobacillus Rhamnosus GG: Lactobacillus Rhamnosus GG is available in form of liquid drops with corn oil as vehicle (sundyota numandis pharmaceuticals private limited). Its first dose

Sponsors

Surya Mother and child superspeciality hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Infants with birth weight 2.Gestational age 3.Hemodynamically stable

Exclusion criteria

Exclusion criteria: 1.Infants who have gastrointestinal anomalies 2.Severe birth asphyxia (defined as APGAR score 3.Cyanotic congenital heart disease 4.Those not started on feeds by 14 day of life 5.Gestational age > 32 weeks 6.Hemodynamically unstable 7.Congenital anomalies

Design outcomes

Primary

MeasureTime frame
Primary outcomes will be composite outcome of sepsis (blood culture positive sepsis) or NEC Stage II (modified bell staging) or mortality.Timepoint: duration of NICU stay—

Secondary

MeasureTime frame
sepsis, NEC Stage II or above, all-cause mortality, feed intolerance episodes defined as above, time to reach full feeds, duration of TPN, duration of hospital stay, growth velocity.Timepoint: duration of NICU stay—

Countries

India

Contacts

Public ContactDr Prerna Pandey

Surya Mother and Child Superspeciality hospital

sshahdoc@gmail.com9689907296

Outcome results

None listed

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