| CTRI Number |
CTRI/2024/06/069687 [Registered on: 28/06/2024] Trial Registered Prospectively |
| Last Modified On: |
27/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to find out total number of babies less than 28 weeks gestation with bronchopulmonary dysplasia and the risk factors associated with it |
|
Scientific Title of Study
|
Proportion of bronchopulmonary dysplasia in extreme preterm babies after updated management strategies: A Prospective Observational 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 |
Nabagata Roy |
| Designation |
Senior resident |
| Affiliation |
Kerala Institute of Medical sciences |
| Address |
Room number 3409, Neonatology department, Kerala Institute of Medical sciences, P.B.No.1, Anayara P.O, Trivandrum – 695029, Kerala, India.
Thiruvananthapuram
KERALA
695029
India |
| Phone |
9862150929 |
| Fax |
|
| Email |
Nabagataroy879@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Femitha Pournami |
| Designation |
Senior Consultant |
| Affiliation |
Kerala Institute of Medical sciences |
| Address |
Room number 3409, Neonatology department, Kerala Institute of Medical sciences, P.B.No.1, Anayara P.O, Trivandrum – 695029, Kerala, India.
Thiruvananthapuram
KERALA
695029
India |
| Phone |
9539556593 |
| Fax |
|
| Email |
femi_shifas@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Femitha Pournami |
| Designation |
Senior Consultant |
| Affiliation |
Kerala Institute of Medical sciences |
| Address |
Room number 3409, Neonatology department, Kerala Institute of Medical sciences, P.B.No.1, Anayara P.O, Trivandrum – 695029, Kerala, India.
Thiruvananthapuram
KERALA
695029
India |
| Phone |
9539556593 |
| Fax |
|
| Email |
femi_shifas@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Room number 3409, Neonatology department, Kerala Institute of Medical sciences, P.B.No.1, Anayara P.O, Trivandrum – 695029, Kerala, India. |
|
|
Primary Sponsor
|
| Name |
Kerala Institute of Medical sciences |
| Address |
1, Vinod Nagar Rd, Anayara, Thiruvananthapuram, Kerala, India |
| 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 Nabagata Roy |
KIMSHealth |
P.B.No.1, Anayara P.O, Trivandrum – 695029, Kerala, India.
Thiruvananthapuram
KERALA |
9862150929
nabagataroy879@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KIMS HEALTH Institutional Human Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: P271||Bronchopulmonary dysplasia originating in the perinatal period, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
60.00 Day(s) |
| Gender |
Both |
| Details |
All preterm neonates born during the study period between 22 to 28 weeks of gestation (inborn; or out-born referred within 24 hours of life) at birth who are offered standard care; and complete care in the unit till time point of measurement of primary outcome. |
|
| ExclusionCriteria |
| Details |
1. Babies who were transferred out before completion of care; whose primary outcome is not retrievable after transfer.
2. Babies with major congenital malformations requiring surgical intervention during hospital stay.
3.Those preterm infants between 22-23 weeks who were offered comfort care after shared decision making.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Proportion of extreme preterms with BPD |
at 36 weeks of post menstrual age |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To compare the BPD rates between 2 groups: After updated policy (2024-2026) with the cohort who received care in 2020-2022 (before the care policy was updated)
2. In the study group, to analyse:
a. The profile of those with BPD; with respect to associated co-morbidities (PH, MBD, AOP, airway abnormalities)
b. Risk factors for BPD.
|
at 36 weeks of post menstrual age |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
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)
|
22/07/2024 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Number of premature births worldwide
is on the rise; fortunately, so is survival. Prospective, recent,
regional data regarding
clinically relevant and patient oriented
outcomes of those ≤ 28 weeks are sparse. It is a fact that peri-viable and extreme preterm
neonates require intensive
care, high supports and
specialized practices for long durations. Health care planners and parents need to prepared for these
implications. Data on outcomes of babies who still requires respiratory support
at 36 weeks post menstrual age and also data regarding the associated risk
factors and co-morbidities and their management would drive policies. These
would aid parent
counselling and help in
planning of resource allocation.
Our unit has
reported >60% survival overall in this group. We have been providing intensive care supports after shared
decision making even for periviable gestation. This study is aimed at analysis
of incidence and risk factors of bronchopulmonary dysplasia of extreme preterms (≤ 28 weeks)
after the unit updated
practice policies for this high-risk group. |