CTRI/2024/07/069824
Completed
Phase 4
To study the effect of probiotics Supplementation on Morbidities in Indian Preterm Neonates.
RNT Medical College & Hospital, Udaipur1 site in 1 country300 target enrollmentStarted: July 15, 2024Last updated:
Overview
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- RNT Medical College & Hospital, Udaipur
- Enrollment
- 300
- Locations
- 1
- Primary Endpoint
- suspected or confirmed positive Bell stage 2 or more
Overview
Brief Summary
Probiotic supplementation in preterm neonates was safe and associated with modest improvements in weight at discharge and follow-up. However, it did not significantly impact NEC, sepsis, mortality, or hospital stay, with gestational age remaining the strongest predictor of outcomes. Probiotics can be safely incorporated into NICU care for preterm neonates to support growth, but their greatest benefit is likely in extremely preterm and high-risk populations.
Study Design
- Study Type
- Interventional
- Allocation
- Coin toss, Lottery, toss of dice, shuffling cards etc
- Masking
- None
Eligibility Criteria
- Ages
- 1.00 Day(s) to 7.00 Day(s) (—)
- Sex
- All
Inclusion Criteria
- •Gestation Neonates born before less than 34weeks Age at recruitment within 7 days of life Weight low birth weight less than 1800 grams.
Exclusion Criteria
- •Malformation of the gut (omphalocele, gastroschisis, intestinal atresia) Neonates with central venous catheter Any condition that prevents oral or nasogastric intake.
Outcomes
Primary Outcomes
suspected or confirmed positive Bell stage 2 or more
Time Frame: Everyday until the period of hospital stay and further upto 6 weeks of life
Secondary Outcomes
- Culture positive sepsis: blood culture positive(Clinical sepsis: clinical features of sepsis without)
Investigators
Dr Nehal Athreyi R
RNT Medical College & Hospital, Udaipur
Study Sites (1)
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