Role of Oral zinc and Pre-Probiotics in neonatal sepsis

Completed

• Conditions: All intramural preterm neonates admitted to NICU with proven sepsis

• Registration Number: CTRI/2017/08/009544
• Lead Sponsor: Govt Medical College Aurangabad

Brief Summary

**RESULTS:**

A total of 124 newborns had provensepsis during the study period and all were randomised. Of 124, zinc group had32, pre-probiotics had 32, zinc and pre-probiotics had 29 and control group had31 cases. None of the cases were discharged AMA. No adverse effectreported in any intervention group.

In this study, we found baselinecharacteristics were similar in all four groups (p>0.05).

When the final outcome in all four groupswere compared, we found significantly decrease in mortality in zincand pre-probiotics group (p=0.04).Also, there is significant decrease in need for higher antibiotics in the same(p=0.02). But need for supportivetreatment and duration of hospital stay did not differ significantly in anygroup as compared with control (p>0.05).

Detailed Description

Not available

Study Timeline

• Study Start: 2015-03-12
• Study Completion: 2016-08-31
• Last Update Posted: 2017-08-29

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 120

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 ‘sepsis screen’ i.e. presence of at least two of the following three parameters, namely, Total leucocyte count <5000/mm3, Low absolute neutrophil count (as per standard charts), C-reactive protein>1mg/dl, (b) Radiological evidence of pneumonia (c) Culture positive sepsis (d) Meningitis.

Exclusion Criteria

Parental refusal to consent, neonates < 28 weeks GA, severe birth asphyxia, life threatening congenital malformations, critically ill newborns within 24 hours of life, neonates with necrotizing enterocolitis.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reduction in Mortality	at discharge/30 days of life

Secondary Outcome Measures

Name	Time	Method
Duration of hospital stay	At discharge/ 30 days of life
Need for change to higher (2nd/3rd line) antibiotics	At discharge/ 30 days of life
Need for supportive treatment i.e ventilation, inotropes, blood transfusion	At discharge/ 30 days of life

Trial Locations

Locations (1)

Govt Medical College, Aurangabad; 🇮🇳 Aurangabad, MAHARASHTRA, India

Govt Medical College, Aurangabad

🇮🇳Aurangabad, MAHARASHTRA, India

Dr Atul Londhe

Principal investigator

08275453997

atul.londhe1982@gmail.com