A longitudinal study tracing the evolution of gut flora of preterm neonates and its correlation with neonatal infectio
Not Applicable
- Conditions
- Health Condition 1: P369- Bacterial sepsis of newborn, unspecifiedHealth Condition 2: O601- Preterm labor with preterm deliveryHealth Condition 3: P073- Preterm [premature] newborn [other]
- Registration Number
- CTRI/2020/11/029375
- Lead Sponsor
- Manipal Academy of Higher Education
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1 All inborn preterm babies admitted to the Neonatal Intensive Care Unit.
2 Gestational age <34 weeks.
3 Informed consent from the mother.
4 Neonate admitted to NICU for at least 28 days
Exclusion Criteria
1 Neonate with Surgical/chromosomal abnormalities.
2.Neonates with necrotizing enterocolitis
3 Neonates undergoing Gastrointestinal surgeries.
4.Culture Negative Sepsis
5 No informed consent is given.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Patterned Progression of bacterial population of gut microbiota of preterm neonates and preterm neonates developing a neonatal infection. <br/ ><br> <br/ ><br>2.Variability of gut microbial patterns due to mode of delivery, Influence of gestational age, antibiotic exposure and feeds in the preterm neonates with and without sepsis.Timepoint: 105 weeks
- Secondary Outcome Measures
Name Time Method 1.The gut microbial colonization pattern of preterm infants, in the first 28 days of life of infant to determine key insights into the onset of sepsis development, impact, and recovery. <br/ ><br>2.Protective role of gut microbiota in modulating of neonatal sepsis. <br/ ><br>3.Gut colonization pattern seen in neonates with resistant strain of bacteria. <br/ ><br>4. Effect of antimicrobial therapy on gut microbiota dysbiosis. <br/ ><br>Timepoint: 105 weeks