| CTRI Number |
CTRI/2019/04/018781 [Registered on: 25/04/2019] Trial Registered Prospectively |
| Last Modified On: |
19/05/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare between IV and oral preparations of sildenafil in persistent pulmonary hypertension of newborn |
|
Scientific Title of Study
|
Oral vs IV sildenafil in persistent pulmonary hypertension of newborn (PPHN) : A randomized controlled pilot study |
|
Secondary IDs if Any
|
| Secondary ID |
Registry |
| NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Chinmay Chetan |
| Address |
Neonatology Department
Bharati Hospital
Pune
MAHARASHTRA
411043
India |
| Phone |
9871770076 |
| Fax |
|
| Email |
mechinmay@gmail.com |
|
Details Contact Person
Scientific Query
Modification(s)
|
| Name |
Pradeep Suryawanshi |
| Address |
Bharati Hospital, PUNE
Pune
MAHARASHTRA
411043
India |
| Phone |
9923540500 |
| Fax |
|
| Email |
drpradeepsuryawanshi@gmail.com |
|
Details Contact Person
Public Query
Modification(s)
|
| Name |
Chinmay Chetan |
| Address |
Neonatology Department
Bharati Hospital
Pune
MAHARASHTRA
411043
India |
| Phone |
9871770076 |
| Fax |
|
| Email |
mechinmay@gmail.com |
|
Source of Monetary or Material Support
Modification(s)
|
| Bharati Hospital
Pune Satara road, PUNE - 411043
|
|
|
Primary Sponsor
|
| Name |
Bharati Hospital |
| Address |
Pune-Satara road, Pune 411043 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Contact Person |
Name of Site |
Site Address |
Phone/Fax/Email |
| Chinmay Chetan |
NICU level 3, Bharati Hospital |
Pune-Satara road, PUNE 411043
Pune
|
9871770076
mechinmay@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bharati Vidyapeeth medical college - institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Persistent fetal circulation |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
IV sildenafil |
ROUTE - IV
DOSE - loaded with 0.4mg/kg of sildenafil over 3 hours followed by continuous infusion of 1.6mg/kg/day
DURATION - Tapered once pulmonary artery pressure reduces below 25 mm Hg, and would be omitted within 72 hours
|
| Comparator Agent |
None |
None |
| Intervention |
Oral sildenafil |
ROUTE - oral
DOSE - 1 mg/kg
FREQUENCY - 6 hrly
DURATION - tapered once pulmonary artery pressure reduces to below 25 mmg Hg, and would be omitted within 72 hours |
|
Inclusion Criteria
Modification(s)
|
| Age From |
0.00 Day(s) |
| Age To |
3.00 Day(s) |
| Gender |
Both |
| Details |
Late preterm and term neonates who are echocardiographicaly diagnosed to have PPHN (defined as PAP of more than 25 millimetre of mercury (mm Hg)),
PPHN diagnosed within 72 hrs of life
|
|
| ExclusionCriteria |
| Details |
Congenital heart disease (Except patent ductus arteriosus, patent foramen ovale, atrial septal defect, or a single, small muscular (<4 mm) ventricular septal defect);
Contraindication to oral/IV sildenafil – systemic hypotension, necrotizing enterocolitis (NEC), Gastrointestinal bleed;
Congenital diaphragmatic hernia;
Lethal congenital anomaly;
Babies with severe PPHN directly started on nitric oxide on diagnosis
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| To compare the time to adequate clinical response to oral and IV sildenafil in neonates diagnosed with PPHN in terms of time taken for pulmonary artery pressure (PAP) to decrease below 25 mm Hg |
Every 12 hours
|
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
Compare
Time taken for Oxygenation index (OI)to decrease by 25%;
Duration of mechanical ventilation – both invasive (intubated days), and non-invasive;
Duration of hospital stay;
Mortality;
Improvement in echocardiological findings;
To compare the side effects of IV and Oral sildenafil;
To compare the time to achieve full feeds in both groups
|
12 hrly |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40" |
|
Phase of Trial
|
N/A |
Date of First Enrollment (India)
Modification(s)
|
01/05/2019 |
| Date of First Enrollment (Global) |
No Date Specified |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
NIL |
|
Brief Summary
|
To compare between oral and IV preparations of sildenafil in persistent pulmonary hypertension of newborn in terms of efficacy, side effects and other parameters |
