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

Not yet recruiting

• Conditions: Bacterial sepsis of newborn, unspecified, (2) ICD-10 Condition: O601||Preterm labor with preterm delivery, (3) ICD-10 Condition: P073||Preterm [premature] newborn [other],

• Registration Number: CTRI/2020/11/029375
• Lead Sponsor: Manipal Academy of Higher Education

Brief Summary

The purpose of this study is to study the colonization pattern of preterm neonates of gestation age <34 weeks,in the first 28 days of life of neonates to determine key insights into the onset of sepsis development, impact, and recovery. Further study aims todetermine the effect of antimicrobial therapy in gut colonization andantimicrobial resistance development.

**Scientific Hypothesis:**

H1: The association between microbiomeand host: whether the composition of the microbiome or “dysbiotic†microbiomeis linked to neonatal sepsis and antibiotic resistance.

H2: Whether microbiome is associated withbiological covariates, the impact of mode of delivery on the microbiome, influenceof feeding practice in IUGR (Intrauterine growth restriction) preterm with andwithout neonatal sepsis.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-09-12
• Last Update Posted: 2020-11-19

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 182

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.	105 weeks
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.	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.	2.Protective role of gut microbiota in modulating of neonatal sepsis.

Trial Locations

Locations (1)

Kasturba Medical College; 🇮🇳 Udupi, KARNATAKA, India

Kasturba Medical College

🇮🇳Udupi, KARNATAKA, India

Faiza Iqbal

Principal investigator

8971455775

faiza.iqbal1@learner.manipal.edu