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CTRI Number  CTRI/2020/02/023310 [Registered on: 13/02/2020] Trial Registered Prospectively
Last Modified On: 05/04/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Preventive 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparision of airway administration of drug to open up premature lungs (surfactant) with and without steroids in preventing chronic lung disease in premature babies 
Scientific Title of Study   Comparison Of Intratracheal Administration Of Surfactant With Or Without Budesonide To Prevent Bronchopulmonary Dysplasia - A Randomized Pilot Study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Kiran Vemireddy 
Designation  Senior Registrar 
Affiliation  Rainbow Children’s Hospital 
Address  Neonatal Intensive Care Unit, Second Floor,Rainbow Childrens Hospital, Road No. 2, Banjara Hills, Hyderabad

Hyderabad
TELANGANA
500034
India 
Phone  9010834837  
Fax    
Email  kiran.vemireddy94@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Dinesh Chirla 
Designation  Head of Department 
Affiliation  Rainbow Children’s Hospital 
Address  Neonatal intensive care unit, Second floor, Rainbow Children’s Hospital, Road No. 2, Banjara Hills, Hyderabad

Hyderabad
TELANGANA
500034
India 
Phone  9849790003  
Fax    
Email  dchirla@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Kiran Vemireddy 
Designation  Senior Registrar 
Affiliation  Rainbow Children’s Hospital 
Address  Neonatal intensive care unit, Second floor, Rainbow Children’s Hospital, Road No. 2, Banjara Hills, Hyderabad

Hyderabad
TELANGANA
500034
India 
Phone  9010834837  
Fax    
Email  kiran.vemireddy94@gmail.com  
 
Source of Monetary or Material Support  
Rainbow Childrens Hospital,Road No.2,Banjara Hills,Hyderabad 
 
Primary Sponsor  
Name  NOT APPLICABLE 
Address  NOT APPLICABLE 
Type of Sponsor  Other [NOT APPLICABLE] 
 
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 
Kiran Kumar Reddy V  Rainbow Children’s Hospital  Neonatal intensive care unit, Second floor, Rainbow Children’s Hospital, Road No. 2, Banjara Hills, Hyderabad
Hyderabad
TELANGANA 
9010834837

kiran.vemireddy94@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
RainbowChildren’sHospitalInstitutionalEthicsCommittee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J984||Other disorders of lung,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Surfactant  Control group will receive surfactant only (Curosurf - 200mg/kg initial dose; Chiesi Farmaceutici, Parma, Italy) Repeated administrations of surfactant will be given every 6 hours to infants in the control group, until they required an FIO2 less than 0.3, or received a maximum of three doses 
Intervention  Surfactant With Budesonide  Intervention group will recieve intratracheal Curosurf at dose 200mg/kg initial dose plus budesonide (0.25 mg or 1 ml/kg).Repeated administrations of surfactant/budesonide or surfactant only will be given every 6 hours to infants in the intervention or control group, respectively, until they required an FIO2 less than 0.3, or receive a maximum of three doses 
 
Inclusion Criteria  
Age From  0.00 Day(s)
Age To  1.00 Day(s)
Gender  Both 
Details  1.Less than 6 hours of age
2.Receiving mechanical ventilation via an endotracheal tube or non-invasive respiratory support including CPAP, NIPPV and a clinical decision to treat the infant with exogenous surfactant (first or subsequent dose) for RDS
3.Prospective, written, informed parental/guardian consent obtained  
 
ExclusionCriteria 
Details  1.Extreme preterm <24 weeks of gestation
2.Infant is considered non-viable or is not going to be admitted to intensive care
3.Known or suspected major congenital anomaly that is likely to affect respiratory status (eg: upper airway obstruction, severe pulmonary hypoplasia following oligohydramnios, congenital lung malformation, major congenital heart disease). 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
incidence of BPD or death  36 weeks of gestation age 
 
Secondary Outcome  
Outcome  TimePoints 
Mode of respiratory support (HFOV, MV, CPAP, HFNC)
Need of multiple dose surfactant
Hyperglycemia requiring insulin treatment
-Hypertension requiring treatment
-Need for postnatal systemic steroids 
36 weeks of gestation age 
 
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)   15/02/2020 
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   Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  

Infants will be randomized into either the intervention group or control group, based on an assignment list designed by a statistician. Concealed randomization will be generated by a computer with permuted blocks in random sizes of six with half of the infants assigned to intervention and half to control. The control group will receive surfactant only (Curosurf - 200mg/kg initial dose; subsequent dose 100mg/kg (if applicable), Chiesi Farmaceutici, Parma, Italy) and the intervention group will receive Curosurf dose 200mg/kg initial dose; subsequent dose 100mg/kg (if applicable) plus budesonide (0.25 mg or 1 ml/kg). This dose will provide a concentration ratio of surfactant to budesonide greater than 50:1; this mixture was demonstrated, in an in vitro study using a surfactometer and high- performance liquid chromatography, not to affect the biophysical and  chemical properties of surfactant. Before intratracheal instillation, the syringe will be gently vortexed, and the surfactant or surfactant/budesonide mixture will be administered in a manner similar to that of routine surfactant therapy. Repeated administrations of surfactant/budesonide or surfactant only will be given every 6 hours to infants in the intervention or control group, respectively, until they require an FIO2 less than 0.3, or received a maximum of three doses

 
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