| CTRI Number |
CTRI/2025/11/097464 [Registered on: 14/11/2025] Trial Registered Prospectively |
| Last Modified On: |
13/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study comparing vasopressin and norepinephrine as the first medicine to treat high lung pressure in newborn babies. |
|
Scientific Title of Study
|
Norepinephrine versus Vasopressin in Persistent Pulmonary Hypertension of
the Newborn : Randomized controlled trial |
| Trial Acronym |
NOVA-PPHN |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Bhrajishna Pallapothu |
| Designation |
Consultant Neonatologist |
| Affiliation |
Rainbow Childrens Hospital |
| Address |
Department of pediatrics, Room no 103
48-10, 12/2A, Service road, Nagarjuna nagar, currency nagar, Vijayawada, Andhra pradesh, India
Krishna
ANDHRA PRADESH
520008
India |
| Phone |
9492491229 |
| Fax |
|
| Email |
dr.bhrajishnap@rainbowhospitals.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Bhrajishna Pallapothu |
| Designation |
Consultant Neonatologist |
| Affiliation |
Rainbow Childrens Hospital |
| Address |
Department of pediatrics, Room no 103
48-10, 12/2A, Service road, Nagarjuna nagar, currency nagar, Vijayawada, Andhra pradesh, India
Krishna
ANDHRA PRADESH
520008
India |
| Phone |
9492491229 |
| Fax |
|
| Email |
dr.bhrajishnap@rainbowhospitals.in |
|
Details of Contact Person
Public Query
|
| Name |
Bhrajishna Pallapothu |
| Designation |
Consultant Neonatologist |
| Affiliation |
Rainbow Childrens Hospital |
| Address |
Department of pediatrics, Room no 103
48-10, 12/2A, Service road, Nagarjuna nagar, currency nagar, Vijayawada, Andhra pradesh, India
Krishna
ANDHRA PRADESH
520008
India |
| Phone |
9492491229 |
| Fax |
|
| Email |
dr.bhrajishnap@rainbowhospitals.in |
|
|
Source of Monetary or Material Support
|
| Rainbow Childrens Hospital, 48-10, 12/2A, Service road, Nagarjuna nagar, Currency nagar, Vijayawada, Andhra pradrsh, India
PIN-520008 |
|
|
Primary Sponsor
|
| Name |
Bhrajishna Pallapothu |
| Address |
Department of pediatrics, Room no 103
48-10, 12/2A, Service road, Nagarjuna nagar, currency nagar, Vijayawada, Andhra pradesh, India |
| Type of Sponsor |
Other [SELF] |
|
|
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 Bhrajishna Pallapothu |
Rainbow Childrens Hospital |
Department of pediatrics, Room no 103
48-10, 12/2A, Service road, Nagarjuna nagar, currency nagar, Vijayawada, Andhra pradesh, India
Krishna
ANDHRA PRADESH |
9492491229
dr.bhrajishnap@rainbowhospitals.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Aayush Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: P293||Persistent fetal circulation, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
norepinephrine |
The infusion will be started at a dose of 0.1 microgram per kilogram per minute and will be increased every 15 minutes by 0.1 microgram per kilogram per minute to achieve a mean arterial pressure equal to or greater than the gestational age in weeks. The maximum dose will be 1 microgram per kilogram per minute, and the infusion will be prepared in the standard NICU concentration. |
| Intervention |
Vasopressin |
- Starting dose: 0.0002 IU/kg/min.
- Titrated every 15 minutes by 0.0002IU/kg/min to target MAP.
- Maximum dose: 0.002 IU/kg/min.
- Infusion prepared in standard NICU concentration. |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
28.00 Day(s) |
| Gender |
Both |
| Details |
1. Gestational age more than or equal to 34 weeks.
2. Echocardiographic evidence of PPHN done by a neonatologist trained in functional
echo or pediatric cardiologist
3. Systemic hypotension defined as mean arterial pressure (MAP) below 3rd centile as
per charts by Giesinger et al.
4. Parental/guardian written informed consent. |
|
| ExclusionCriteria |
| Details |
1. Major critical congenital heart disease (except PDA or PFO).
2. Congenital diaphragmatic hernia.
3. Lethal congenital anomalies.
4. more than 1 hour prior exposure to NE or AVP. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in Oxygenation Index (OI) from baseline |
12 hrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Mean arterial pressure |
1h, 6h, 12h, and 24h |
Treatment failure rate (need for crossover vasopressor or addition of a
second-line vasoactive agent) |
24 hr |
| Vasoactive-Inotropic Score (VIS) |
6h, 12h and 24h |
| Duration of invasive ventilation |
at discharge |
| Need for iNO |
At discharge |
| Time to discontinuation of iNO |
At discharge |
| Incidence of hyponatremia (serum Na less than 130 mmol/L) |
72h |
| Incidence of clinically significant arrhythmias requiring intervention |
At discharge |
Incidence of serious adverse events (SAE): NEC (after stage II), grade more than 3 IVH,
or peripheral ischemia. |
At discharge |
| Oliguria less than 1ml/kg/hr, doubling of serum creatinine |
72h |
| Lacte clearance from baseline |
12h and 24h |
| All-cause mortality |
At discharge |
| Composite outcome of death or need for iNO |
At discharge |
|
|
Target Sample Size
|
Total Sample Size="88"
Sample Size from India="88"
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)
|
01/12/2025 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [dr.bhrajishnap@rainbowhospitals.in].
- For how long will this data be available start date provided 01-03-2029 and end date provided 01-03-2034?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Persistent pulmonary hypertension of the newborn is a life threatening condition in term and late preterm babies where high pulmonary pressure causes poor oxygenation and low blood pressure. Norepinephrine and vasopressin are two commonly used vasopressors in neonatal intensive care units but there is limited evidence comparing their effectiveness and safety in this condition. The NOVA PPHN trial is a single center randomized controlled open label study with blinded outcome assessment conducted at Rainbow Childrens Hospital Vijayawada. Term and late preterm neonates of 34 weeks or more gestation with confirmed PPHN and systemic hypotension requiring vasopressor support will be enrolled. Eligible babies will be randomly assigned to receive norepinephrine or vasopressin infusion along with standard supportive care including ventilation and nitric oxide as needed. The primary outcome is change in oxygenation index from baseline to 12 hours after starting study drug. Secondary outcomes include mean arterial pressure, need for rescue drugs, duration of ventilation, nitric oxide requirement, echocardiographic findings, biochemical safety parameters and mortality before discharge. The study duration is 36 months. This investigator initiated phase four clinical trial aims to identify the safer and more effective first line vasopressor for managing PPHN in newborns. |