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CTRI Number  CTRI/2021/09/036770 [Registered on: 23/09/2021] Trial Registered Prospectively
Last Modified On: 22/09/2021
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Lung Ultrasound Score and its predictability for need of surfactant and grade of severity of respiratory distress syndrome in premature neonates -a Cohort study Study 
Scientific Title of Study   Point of Care Lung Ultrasound Score (POCUS) to predict the severity of respiratory distress syndrome and surfactant need in preterm neonates - Prospective Cohort Study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Manish Swami 
Designation  DM senior Resident 
Affiliation  AIIMS,Bhubaneswar 
Address  Department of Neonatology AIIMS, Bhubaneswar, Orissa
Sijua, Patrapada, Bhubaneswar, Odisha
Khordha
ORISSA
751019
India 
Phone  9991909318  
Fax    
Email  dmanishswami@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Tapas Kumar Som 
Designation  Assoc. Prof. & Head 
Affiliation  AIIMS,Bhubaneswar 
Address  Department of Neonatology AIIMS, Bhubaneswar, Orissa
Sijua, Patrapada, Bhubaneswar, Odisha
Khordha
ORISSA
751019
India 
Phone  9438884114  
Fax    
Email  neonat_tapas@aiimsbhubaneswar.edu.in  
 
Details of Contact Person
Public Query  
Name  Manish Swami 
Designation  DM senior Resident 
Affiliation  AIIMS,Bhubaneswar 
Address  Department of Neonatology AIIMS, Bhubaneswar, Orissa
Sijua, Patrapada, Bhubaneswar, Odisha

ORISSA
751019
India 
Phone  9991909318  
Fax    
Email  dmanishswami@gmail.com  
 
Source of Monetary or Material Support  
AIIMS, bhubaneswar 
 
Primary Sponsor  
Name  Manish Swami 
Address  Department of Neonatology AIMS, Bhubaneswar 
Type of Sponsor  Other [OTHER (Self)] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Manish Swami  AIIMS,Bhubaneswar  NICU, Dept. of neonatology
Khordha
ORISSA 		 9991909318

dmanishswami@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics committee, AIIMS, Bhubaneswar  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: P220||Respiratory distress syndrome of newborn,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  0.00 Day(s)
Age To  1.00 Day(s)
Gender  Both 
Details  All babies ≤32 weeks/ ≤1250gms with respiratory distress within first 2 hours of life irrespective of type respiratory support or requirement of resuscitation needed at birth. 
 
ExclusionCriteria 
Details  1.Neonates with hemodynamic instabilities (severe sepsis/ refractory shock).
2.Neonates with antenatally detected intrathoracic malformations including congenital heart defects
3.Neonates with other associated respiratory morbidities (air-leaks, MAS, pulmonary haemorrhage)
4.Babies admitted to the NICU after administration of surfactant in the delivery room
5.Consent/ Assent not given by parents
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
1.POCUS Lung score will be assessed in 6 predefined areas of lung fields, Within 2 hours after birth and before administration of surfactant.
2.Requirement of surfactant- when baby on Nasal Continuous Positive Airway Pressure (NCPAP) 5 cm of water with FIO2 requirement ≥0.30 (≤26 weeks), or ≥0.40 (26 weeks) with target SpO2 of 91% – 95% (after 10 min of life)
 		 1.POCUS Lung score will be assessed in 6 predefined areas of lung fields, Within 2 hours after birth and before administration of surfactant.
2.Requirement of surfactant- when baby on Nasal Continuous Positive Airway Pressure (NCPAP) 5 cm of water with FIO2 requirement ≥0.30 (≤26 weeks), or ≥0.40 (26 weeks) with target SpO2 of 91% – 95% (after 10 min of life)
 
 
Secondary Outcome  
Outcome  TimePoints 
1.Oxygenation status-Oxygenation Index (OI),a/A ratio, S/F ratio,PaO2.
2.Nasal CPAP failure and need for invasive mechanical ventilation within the first 72 hours after birth.
3.Severity of RDS on Chest Xray.
4.Severity of RDS based on clinical parameters (Silverman-Andersen score).


 		 1.Oxygenation status-Oxygenation Index (OI),a/A ratio, S/F ratio,PaO2- with in 30 mins of lung ultrasound
2.Nasal CPAP failure and need for invasive mechanical ventilation within the first 72 hours after birth.
3.Severity of RDS on Chest Xray-with in 30 mins of lung ultrasound
4.Severity of RDS based on clinical parameters (Silverman-Andersen score)-with in 30 mins of lung ultrasound 
 
Target Sample Size   Total Sample Size="82"
Sample Size from India="82" 
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)   29/09/2021 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  29/09/2021 
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   Respiratory morbidities are fairly common in preterm newborns. Respiratory distress syndrome (RDS) in preterm neonates is a disease of surfactant deficiency (in premature lungs) that leads to diffuse atelectasis and alveolar collapse shortly after birth with high mortality and morbidity requiring admission and care in NICU. Respiratory distress syndrome (RDS) diagnosis is usually depending on patient’s clinical examination finding and Chest X-ray (CXR) findings. RDS is commonest indication requiring imaging in neonates. Repeated exposure for chest X ray required often for diagnosis, monitoring for therapy leads to ionizing radiation (IR) exposure to such small preterm neonates. Point of care ultrasonography (POCUS) of the lungs is a relatively easy, noninvasive procedure, and is useful to diagnose various lung conditions. Point of care ultrasonography(POCUS) helps in diagnosing, guiding and monitoring the treatment/surfactant administration. 
The POCUS score with six predefined area showed an inverse relation with lung aeration in neonates with respiratory distress syndrome. Each lung is classified into 3 areas (anterior superior, anterior inferior and lateral) with score 0-3, (total score 0-18). This scoring system is according to specific findings on lung ultrasonography. 
All neonates who will meet the inclusion criteria and don’t have any of exclusion criteria, will be eligible and enrolled for the study.
POCUS score will be performed within 2 h of birth and in any case before surfactant administration. LUS Images/Scores will be recorded and saved in separate sheet, for each lung area by the operator (who was not the patient’s physician). These images / records will not be available to treating team. At the end of the study all the LUS images will be reanalyzed and the scores will be rechecked to a physician blinded to the patients’ clinical setting/condition.
During NICU course baby will be managed according to unit NICU protocol and after discharge/ demise data will be collected from record sheets (timing and dose of first surfactant administration, timing and dose of repeat surfactant administration if required, type and duration of respiratory support required, CPAP failure, and final outcome).
Appropriate statistical analysis will be done at the end of study (correlation between POCUS score and severity of RDS, surfactant need).
 
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