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Role of prophylactic microbial supplements in prevention of blood stream infection and intestinal tract injury in premature neonates

Role of prophylactic probiotics in prevention of necrotising enterocolitis and sepsis in premature neonates

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/04/013401
Enrollment
200
Registered
2018-04-20
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: null- 1. Necrotising enterocolitis 2. Nosocomial sepsis

Interventions

Intervention1: Mixture of lactobacillus acidophilus, lactobacillus rhamnosus, bifidobacterium longum and streptomyces boulardii: Mixture of lactobacillus acidophilus, lactobacillus rhamnosus, bifidob

Sponsors

Gousia mukhtar
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All infants admitted to our nicu with birth weight less than 2 kg or gestational age less than 35 weeks as assessed by EDD and further confirmed by Ballards score who survive the first 24 hrs of life will be enrolled in the study.

Exclusion criteria

Exclusion criteria: 1. sepsis 2. Major congenital anomalies 3. Severe asphyxia 4. Severe IUGR 5. Immunocompromised host like hiv infected infants

Design outcomes

Primary

MeasureTime frame
To compare the safety and efficacy of prophylactic probiotics versus no treatment in prevention of 1.Necrotising colitis 2. Nosocomial sepsis In preterm low birth weight babiesTimepoint: 1st of june 2018

Secondary

MeasureTime frame
1. Duration of hospitalization 2. Time to establish full feeds 3.Episodes of feed intolerance 4. All cause neonatal mortalityTimepoint: 1st of june, 2018

Countries

India

Contacts

Public ContactGousia mukhtar

Professor , Sher i kashmir institute of medical sciences, soura

drmushtaq816@gmail.com9419041796

Outcome results

None listed

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