| CTRI Number |
CTRI/2022/07/044166 [Registered on: 20/07/2022] Trial Registered Prospectively |
| Last Modified On: |
08/06/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective observational |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Role of lung ultrasound in diagnosing and management of respiratory distress syndrome in 34 weeks neonates |
|
Scientific Title of Study
|
Diagnostic utility of lung ultrasound in predicting the surfactant
therapy for preterm infants |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pari Singh |
| Designation |
DM neonatology Resident |
| Affiliation |
Bharati Vidyapeeth medical College, Pune |
| Address |
Department of Neonatology, Division of ICU, Room NICU, Bharati Hospital, B. V. D. U., Pune
Dhankawadi, Katraj
Pune
MAHARASHTRA
411043
India |
| Phone |
8178646479 |
| Fax |
|
| Email |
parisingh19@icloud.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Pradeep Suryawanshi |
| Designation |
Professor and Head |
| Affiliation |
Bharati Vidyapeeth medical College, Pune |
| Address |
Department of Neonatology, Division of ICU, Room NICU, Bharati Hospital, B. V. D. U., Pune
Dhankawadi, Katraj
Pune
MAHARASHTRA
411043
India |
| Phone |
8178646479 |
| Fax |
|
| Email |
drpradeepsuryawanshi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Pari Singh |
| Designation |
DM neonatology Resident |
| Affiliation |
Bharati Vidyapeeth medical College, Pune |
| Address |
Department of Neonatology, Division of ICU, Room NICU, Bharati Hospital, B. V. D. U., Pune
Dhankawadi, Katraj
Pune
MAHARASHTRA
411043
India |
| Phone |
8178646479 |
| Fax |
|
| Email |
parisingh19@icloud.com |
|
|
Source of Monetary or Material Support
|
| Department of Neonatology, Division of ICU, Room NICU, Bharati Hospital, B. V. D. U., Pune |
|
|
Primary Sponsor
|
| Name |
Bharati Vidyapeeth Medical College |
| Address |
Department of Neonatology, Division of ICU, Room NICU, Bharati Hospital, B. V. D. U., Pune |
| 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 Pari Singh |
Bharati Vidyapeeth Medical College |
Department of Neonatology, Division of ICU, Room NICU, Bharati Hospital, B. V. D. U., Pune
Pune
MAHARASHTRA |
8178646479
parisingh19@icloud.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethical Committee B. V. D. U. Medical College, Pune |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J99||Respiratory disorders in diseasesclassified elsewhere, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
1.00 Day(s) |
| Gender |
Both |
| Details |
< 34 weeks neonates admitted to NICU within 6 hours of life with respiratory distress |
|
| ExclusionCriteria |
| Details |
1. >34 weeks
2. No respiratory distress
3. Admission beyond 6 hours of life to NICU |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To determine the diagnostic accuracy of lung ultrasound score in predicting the need for first dose of surfactant therapy in preterm infants (34weeks) with respiratory distress.
To determine the diagnostic accuracy of lung USG score in predicting the need for second dose of surfactant therapy in preterm infants(34 weeks) with respiratory distress, if indicated clinically |
6 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine the change in LUS score after six hours of surfactant therapy |
six hours after surfactant first dose |
| To determine the distribution of LUS score with corresponding oxygen saturation to fraction oxygenation ratio (S/F) |
admission |
| To determine the distribution of LUS score with corresponding arterial/alveolar oxygenation ratio (PaO2/PAO2) |
at admission |
| To determine the distribution of LUS score with corresponding chest x-ray (CXR)-based classification of RDS as mild, moderate and severe RDS |
admission |
|
|
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)
|
31/07/2022 |
| 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)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is being taken up to predict the the diagnostic accuracy of neonatal lung USG score as a lone marker for evaluating the need for surfactant administration in preterm infants with respiratory distress. We hypothesize that since LUS score reflects lung aeration, it will correlate with requirement of surfactant in preterm babies with respiratory distress. In future, it can prove to be an accurate and early predictor for the need for surfactant therapy in this cohort, thus, allowing timely treatment and as low as reasonably achievable (ALARA) radiation exposure.
|