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
|
|
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
|
|
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 |