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Role of Oral zinc and Pre-Probiotics in neonatal sepsis

Use of Zinc and Pre-Probiotics as a therapeutic adjunct in neonatal sepsis in preterms- An Open label randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/08/009544
Enrollment
120
Registered
2017-08-30
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- All intramural preterm neonates admitted to NICU with proven sepsis

Interventions

Intervention1: Zinc: Zinc group was given oral zinc 10 mg once a day irrespective of age of newborn till discharge. Intervention2: Pre-Probiotics: Pre-Probiotics group was given as Syrup 5ml per day

Sponsors

Govt Medical College Aurangabad
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All intramural preterm neonates from 28wk1day to 36wk6days admitted to NICU at GMCH Aurangabad with proven sepsis during the study period, whose parents consented to be part of the study were included. Diagnostic criteria for sepsis was (a) Positive â??sepsis screenâ?? i.e. presence of at least two of the following three parameters, namely, Total leucocyte count 1mg/dl, (b) Radiological evidence of pneumonia (c) Culture positive sepsis (d) Meningitis

Exclusion criteria

Exclusion criteria: Parental refusal to consent, neonates severe birth asphyxia, life threatening congenital malformations, critically ill newborns within 24 hours of life, neonates with necrotizing enterocolitis

Design outcomes

Primary

MeasureTime frame
Reduction in MortalityTimepoint: at discharge/30 days of life

Secondary

MeasureTime frame
Duration of hospital stayTimepoint: At discharge/ 30 days of life;Need for change to higher (2nd/3rd line) antibioticsTimepoint: At discharge/ 30 days of life;Need for supportive treatment i.e ventilation, inotropes, blood transfusionTimepoint: At discharge/ 30 days of life

Countries

India

Contacts

Public ContactDr Atul Londhe

Govt Medical College, Aurangabad

atul.londhe1982@gmail.com08275453997

Outcome results

None listed

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