| CTRI Number |
CTRI/2024/04/065447 [Registered on: 09/04/2024] Trial Registered Prospectively |
| Last Modified On: |
22/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Single center, prospective, observational study |
| Study Design |
Other |
|
Public Title of Study
|
A study to find out the relation between the inflammatory markers and severity of meconium aspiration disease in newborns and its outcome. |
|
Scientific Title of Study
|
A prospective single centre study of correlation between inflammatory markers and various severity grades of meconium aspiration syndrome (mas) & their outcome |
| 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 Deepali shukla |
| Designation |
DNB Pediatric Resident |
| Affiliation |
Bhaktivedanta Hospital and Research Institute |
| Address |
4th floor NICU,Srishti Bhaktivedanta Swami Marg, Mira road, thane, 401107
Thane
MAHARASHTRA
401107
India |
| Phone |
9591572045 |
| Fax |
|
| Email |
shukladeepali001@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr samrat mehta |
| Designation |
head of department |
| Affiliation |
Bhaktivedanta Hospital and Research Institute |
| Address |
4th floor NICU,Srishti Bhaktivedanta swami marg, Mira road, thane, 401107
Mumbai
MAHARASHTRA
401107
India |
| Phone |
9321701322 |
| Fax |
|
| Email |
samratbvh@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deepali Shukla |
| Designation |
DNB Pediatric Resident |
| Affiliation |
Bhaktivedanta Hospital and Research Institute |
| Address |
4th floor NICU,Srishti Bhaktivedanta Swami Marg, Mira road, thane, 401107
Mumbai
MAHARASHTRA
401107
India |
| Phone |
9321701322 |
| Fax |
|
| Email |
shukladeepali001@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bhaktivedant Hospital and Research Institute, Srishti Complex, Bhaktivedanta Swami Marg,Mira Road(East), Thane - 401107 |
|
|
Primary Sponsor
|
| Name |
Bhaktivedanta Hospital and Research Institute |
| Address |
Srishti Complex, Bhaktivedanta Swami Marg, Mira Road(East),Thane-401107 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Deepali shukla |
Bhaktivedanta Hospital and Research Institute |
4TH Floor NICU,Srishti Complex, Bhkativedanta Swami Marg, Mira Road(EAST), Thane, 401107
Thane
MAHARASHTRA |
9591572045
shukladeepali001@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bhaktivedanta Hospital Ethesics Committe forBiomedical and Health Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: P240||Meconium aspiration, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
5.00 Day(s) |
| Gender |
Both |
| Details |
Term and post term neonates with meconium stained amniotic fluid &/or MAS will be included. |
|
| ExclusionCriteria |
| Details |
1.Preterms
2.Term neonates with:Transient tachypnoea of new-born, Hypoxic ischemic encephalopathy, congenital heart disease, congenital defects of any other organ, Inborn Error of metabolism surgical Pathology, New-born with hyaline membrane disease
Infant of diabetic mother, Polycythaemia
New born with respiratory distress with any other etiology or confounding factors other than MAS |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Changes in the inflammatory markers with severity grades of MAS.
Value of inflammatory markers in respect to outcome parameters- nicu stay of child, associated complications-PPHN, pnemothorax, O2days,Ventilator days, cpap days,inotropes days, need of surfactant, need of HFO, ECMO, history of fetal distress, APGAR score at 1min and 5 mins. |
24hrs, 48hrs, 5th day of birth |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.coincidence of sepsis with MAS with their respective inflammatory markers
2.value of inflammatory markers in MSAF |
48hrs of birth |
|
|
Target Sample Size
|
Total Sample Size="69"
Sample Size from India="69"
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)
|
16/04/2024 |
| 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="2"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is prospective, single centre ,
observational study at Bhakti Vedanta Hospital and research institute. Full
term and post term neonates with meconium-stained amniotic fluid and MAS
patients reqiring nicu admission are included. patients will be excluded based
on the exclusion criteria. Inflammatory markers at 24, 48hrs and 5th day of
life will obtained and at 48hrs for those who do not require nicu
admission. Changes in the inflammatory markers with severity grades
of MAS and various outcome parameters will be observed as primary
outcome. Coincidence of sepsis with MAS with their respective inflammatory
markers will be studied. Value of inflammatory markers in masf not requiring
nicu admission will be studied.
|