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A longitudinal study tracing the evolution of gut flora of preterm neonates and its correlation with neonatal infection

A longitudinal study tracing the evolution of gut microbiome of preterm neonates and its correlation with sepsis

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2020/11/029375
Enrollment
182
Registered
2020-11-25
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: P369- Bacterial sepsis of newborn, unspecified Health Condition 2: O601- Preterm labor with preterm delivery Health Condition 3: P073- Preterm [premature] newborn [other]

Interventions

None listed

Sponsors

Manipal Academy of Higher Education
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1 All inborn preterm babies admitted to the Neonatal Intensive Care Unit. 2 Gestational age 3 Informed consent from the mother. 4 Neonate admitted to NICU for at least 28 days

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
1.Patterned Progression of bacterial population of gut microbiota of preterm neonates and preterm neonates developing a neonatal infection. 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

MeasureTime frame
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. 2.Protective role of gut microbiota in modulating of neonatal sepsis. 3.Gut colonization pattern seen in neonates with resistant strain of bacteria. 4. Effect of antimicrobial therapy on gut microbiota dysbiosis. Timepoint: 105 weeks

Countries

India

Contacts

Public ContactFaiza Iqbal

Manipal Academy of Higher Education

leslie.lewis@manipal.edu9449208476

Outcome results

None listed

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