To assess the role of probiotics usage on the morbidity (necrotizing enterocolitis, blood stream infections, meningitis), length of hospital stay and mortality in preterm and low birth weight neonates in a tertiary care centre

Assessing the role of probiotics usage on the morbidity and mortality in preterm and low birth weight neonates in a tertiary care centre- A Randomized Control Study - nil

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/01/061429

Enrollment

112

Registered

2024-01-12

Start date

Unknown

Completion date

Unknown

Last updated

2024-01-22

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

Conditions

Health Condition 1: P071- Other low birth weight newborn

Interventions

Intervention1: Probiotic administration (Bacillus clausii): dose- 2.5ml route- per oral frequency- twice daily duration- till neonate is admitted in nicu or completed 36 weeks of age Control Interve

Eligibility

Inclusion criteria

Inclusion criteria: 1. Preterm neonates between 28 weeks to 36 weeks of Gestation 2. Birth Weight of less than 1800 gm admitted in NICU at Sharda Hospital 3. Newborns on OG feeds or KS feeds 4. Inborns and outborns

Exclusion criteria

Exclusion criteria: 1. Neonates shifted to mother side 2. Sick newborn with prohibited feeding (NPO)

Design outcomes

Primary

Measure	Time frame
To assess the role of probiotics usage on the morbidity (necrotizing enterocolitis, blood stream infections, meningitis), length of hospital stay and mortality in preterm and low birth weight neonates in a tertiary care centre. Timepoint: baseline and 4 weeks	—

Secondary

Measure	Time frame
To assess the role of probiotics usage on the morbidity (necrotizing enterocolitis, blood stream infections, meningitis), length of hospital stay & mortality in preterm & low birth weight neonates in a tertiary care centreTimepoint: 6 weeks & 8 weeks	—

Countries

India

Contacts

Public ContactDr Ranjit Ghuliani

School of Medical Sciences & Research

ranjit.ghuliani@sharda.ac.in9910857392

Outcome results

None listed

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