| CTRI Number |
CTRI/2024/05/067214 [Registered on: 13/05/2024] Trial Registered Prospectively |
| Last Modified On: |
10/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Predictability of Neonatal Lung Ultrasound Score in preterm neonates with respiratory distress |
|
Scientific Title of Study
|
The predictability of Neonatal Lung Ultrasound Score for surfactant therapy in preterm neonates with respiratory distress-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 |
K S Sivakumar |
| Designation |
DrNB neonatology resident |
| Affiliation |
Dr.Mehats hospitals |
| Address |
Department of Neonatology,
Room no 17 -NICU
Dr.Mehtas hospitals,No2,2/1,2,3,Mc Nicolas road,Chetpet,
Chennai,Tamilnadu
Chennai
TAMIL NADU
600031
India |
| Phone |
9600062062 |
| Fax |
|
| Email |
k.s.sivakumar85@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
V Lakshmi |
| Designation |
Head of the department |
| Affiliation |
Dr.Mehats hospitals |
| Address |
Department of Neonatology
Room no 17 - NICU
Dr.Mehtas hospitals,No2,2/1,2,3,Mc Nicolas road,Chetpet,
Chennai,Tamilnadu
Chennai
TAMIL NADU
600031
India |
| Phone |
9840211742 |
| Fax |
|
| Email |
drlakshmi2008@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
K S Sivakumar |
| Designation |
DrNB neonatology resident |
| Affiliation |
Dr.Mehats hospitals |
| Address |
Department of Neonatology
Room no 17- NICU
Dr.Mehtas hospitals,No2,2/1,2,3,Mc Nicolas road,Chetpet,
Chennai,Tamilnadu
Chennai
TAMIL NADU
600031
India |
| Phone |
9600062062 |
| Fax |
|
| Email |
k.s.sivakumar85@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Neonatology
Dr.Mehtas hospitals,No2,2/1,2,3,Mc Nicolas road,Chetpet,
Chennai,Tamilnadu
600031 |
|
|
Primary Sponsor
|
| Name |
K S Sivakumar |
| Address |
Department of Neonatology
Room 17- NICU
Dr.Mehtas hospitals,No 2, 2/1,2,3,Mc Nichols road,Chetpet
Chennai,Tamilnadu 600031 |
| Type of Sponsor |
Other [Self] |
|
|
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 K S Sivakumar |
Dr.Mehtas hospital |
Department of Neonatology
Room no 17- NICU
N0 2,2/1,2,3 McNichols road,Chetpet,Chennai 600031
Chennai
TAMIL NADU |
9600062062
k.s.sivakumar85@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics committee Mehta Multispeciality hospitals India Private Limited |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: P220||Respiratory distress syndrome of newborn, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
28.00 Day(s) |
| Gender |
Both |
| Details |
1. All preterm neonates born at <34 weeks of gestation with respiratory distress and requiring some form of respiratory support (mechanical ventilation, continuous positive airway pressure, high flow humidified nasal cannula) to maintain target blood oxygen saturation levels and admitted within 48 hours of life will be enrolled in the study group after informed consent from the parents/ guardians.
|
|
| ExclusionCriteria |
| Details |
Neonates with
1.Chromosomal abnormalities or complex congenital malformations
2. Congenital lung diseases
3. Neonates with surgical comorbidities
4. Congenital heart defects
5. Delivery room surfactant administration
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the accuracy of Lung Ultrasound Score in preterm neonates with respiratory distress in predicting the need for surfactant therapy based on European Consensus Guidelines on the Management of Respiratory Distress Syndrome |
6hours, 12 hours, 18hours and 24 hours of surfactant administration. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To predict need for surfactant retreatment based on initial & subsequent LUS score
2.To assess the diagnostic accuracy of LUS for RDS in different gestational age groups
3. To assess the inter-observer variation in performing LUS in preterm neonates with respiratory distress
|
6 hours, 12 hours, 18 hours & 24 hours |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
24/05/2024 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
1.Neonatal lung ultrasound has become an indispensable bedside tool in Neonatology in recent years as it is quick, radiation-free, minimally invasive and holds the characteristics of a point-of-care technique. 2. A lung ultrasound can be used to easily diagnose respiratory distress syndrome, and a semiquantitative score based on ultrasound findings may reveal lung aeration. 3. The objective of our study is to assess the diagnostic accuracy of a neonatal-adapted LUS score to evaluate the need for surfactant administration in preterm neonates with respiratory distress. 4.Now Fio2 requirement is the main factor for deciding surfactant need as per European consensus guideline 2019. By assessing ultrasound score and comparing with Fio2 requirement lung ultrasound score can be used as primary diagnostic in future NICU. |