| CTRI Number |
CTRI/2024/06/069130 [Registered on: 18/06/2024] Trial Registered Prospectively |
| Last Modified On: |
29/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
A comparative study of oral microbiota in infants with complete cleft lip-palate with that of normal infants aged 6 months to 1 year. A hospital based one year case control study |
|
Scientific Title of Study
|
A comparative study of oral microbiota in infants with complete cleft lip-palate with that of normal infants aged 6 months to 1 year. A hospital based one year case control study |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shirisha K N |
| Designation |
MD Paediatrics |
| Affiliation |
Jawaharlal nehru medical college,kle university |
| Address |
Department of paediatrics Jawaharlal Nehru Medical College Nehru Nagar KLe Hospital
Belgaum
Karnataka
590010
India
Belgaum
KARNATAKA
590001
India |
| Phone |
8660154023 |
| Fax |
|
| Email |
knshirisha32@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mrs Niranjana S Mahantashetti |
| Designation |
Principal and Professor of Paediatrics |
| Affiliation |
Jawaharlal nehru medical college,kle university |
| Address |
Department of paediatrics Jawaharlal Nehru Medical College Nehru Nagar KLe Hospital
Belgaum
Karnataka
590010
India
Belgaum
KARNATAKA
590010
India |
| Phone |
9448157237 |
| Fax |
|
| Email |
niranjanasn@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mrs Niranjana S Mahantashetti |
| Designation |
Principal and Professor of Paediatrics |
| Affiliation |
Jawaharlal nehru medical college,kle university |
| Address |
Department of paediatrics Jawaharlal Nehru Medical College Nehru Nagar KLe Hospital
Belgaum
Karnataka
590010
India
Belgaum
KARNATAKA
590010
India |
| Phone |
9448157237 |
| Fax |
|
| Email |
niranjanasn@yahoo.com |
|
|
Source of Monetary or Material Support
|
| KLEs Dr Prabhakar Kore Hosital,Jawaharlal Nehru Medical Colege,KLE University,Belgavi |
|
|
Primary Sponsor
|
| Name |
Jawaharlal Nehru Medical College KLE University Belgavi |
| Address |
Department Of Paediatrics Jawaharlal Nehru Medical College Nehru Nagar KLE Hospital Road Belgaum Karnataka 590010 |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Dr Shirisha KN |
KLEs Dr Prabhakar Kore Hospital Belgavi |
Department Of Paediatrics Opd Number 8 Jawaharlal Nehru Medical College Nehru Nagar KLE Hospital Road
Belgaum
Karnataka
Belgaum
KARNATAKA |
8660154023
knshirisha32@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JNMC Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Q378||Unspecified cleft palate with bilateral cleft lip, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
6.00 Month(s) |
| Age To |
1.00 Year(s) |
| Gender |
Both |
| Details |
Group 1
Complete cleft lip-palate
Gestational age over 37 weeks at birth
Birth weight of 2000g
Age group 6 months-1 year
Group 2
Normal infants 6months-1year
No congenital anomalies on clinical examination
mother willing to sign for consent
|
|
| ExclusionCriteria |
| Details |
Group 1
Syndromic clefts
presurgical oral orthopedic devices
Faliure to appear for follow up
Acute infections
Group 2
Acute infections |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study oral microbiota in infants with complete cleft lip-palate with that of normal infants aged 6 months to 1 year |
To study oral microbiota in infants with complete cleft lip-palate with that of normal infants aged 6 months to 1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the preoperative oral microbiota in infants with cleft lip-palate to that of post operative 6 weeks after lip repair |
The study will be conducted over a span of one year |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
24/06/2024 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Study is to compare the oral microbiota of infants with cleft lip-palate to that of normal infants in the age group 6 months to 1 year and the relation of their oral microbiota to the infections occuring in cleft lip-palate infants. The secondary purpose of this study is to compare the oral microbiota of cleft lip-palate infants preoperatively and 6 weeks postoperatively |