| CTRI Number |
CTRI/2020/11/029375 [Registered on: 25/11/2020] Trial Registered Prospectively |
| Last Modified On: |
19/11/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
A longitudinal study tracing the evolution of gut flora of preterm neonates and its correlation with neonatal infection |
|
Scientific Title of Study
|
A longitudinal study tracing the evolution of gut microbiome of preterm neonates and its correlation with sepsis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Faiza Iqbal |
| Designation |
Ph.D. Scholar |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
NICU Classroom,
Room No:3,
First Floor,
Neonatology Unit,
Department of Pediatrics,
Women and children Block,
Kasturba Medical college, Manipal Academy of Higher Education, Manipal, Karnataka.
Udupi
KARNATAKA
576104
India |
| Phone |
8971455775 |
| Fax |
|
| Email |
faiza.iqbal1@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Leslie Edward S Lewis |
| Designation |
Professor |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
NICU Classroom,
Room No:1,
First Floor,
Neonatology Unit,
Department of Pediatrics,
Women and children Block,
Kasturba Medical college, Manipal Academy of Higher Education, Manipal, Karnataka.
Udupi
KARNATAKA
576104
India |
| Phone |
9449208476 |
| Fax |
|
| Email |
leslie.lewis@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Faiza Iqbal |
| Designation |
Ph.D. Scholar |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
NICU Classroom,
Room No:3,
First Floor,
Neonatology Unit,
Department of Pediatrics,
Women and children Block,
Kasturba Medical college, Manipal Academy of Higher Education, Manipal, Karnataka.
Udupi
KARNATAKA
576104
India |
| Phone |
8971455775 |
| Fax |
|
| Email |
faiza.iqbal1@learner.manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College and Hospital, Manipal Academy of Higher Education, Manipal. |
|
|
Primary Sponsor
|
| Name |
Manipal Academy of Higher Education |
| Address |
Manipal Academy of Higher Education, Manipal-576104 |
| Type of Sponsor |
Other [Private Institution] |
|
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Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Faiza Iqbal |
Kasturba Medical College |
NICU Classroom,
Room No:3,
First Floor,
Neonatology Unit,
Department of Pediatrics,
Women and children Block,
Kasturba Medical college, Manipal Academy of Higher Education, Manipal, Karnataka.
Udupi
KARNATAKA |
8971455775
faiza.iqbal1@learner.manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: P369||Bacterial sepsis of newborn, unspecified, (2) ICD-10 Condition: O601||Preterm labor with preterm delivery, (3) ICD-10 Condition: P073||Preterm [premature] newborn [other], |
|
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Intervention / Comparator Agent
|
|
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Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
28.00 Day(s) |
| Gender |
Both |
| Details |
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
|
|
| ExclusionCriteria |
| Details |
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.
|
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
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. |
105 weeks |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
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.
|
105 weeks |
|
|
Target Sample Size
|
Total Sample Size="182"
Sample Size from India="182"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
09/12/2020 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not Applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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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 to
determine the effect of antimicrobial therapy in gut colonization and
antimicrobial resistance development. Scientific Hypothesis: H1: The association between microbiome
and host: whether the composition of the microbiome or “dysbiotic†microbiome
is linked to neonatal sepsis and antibiotic resistance. H2: Whether microbiome is associated with
biological covariates, the impact of mode of delivery on the microbiome, influence
of feeding practice in IUGR (Intrauterine growth restriction) preterm with and
without neonatal sepsis.
|