Health Condition 1: P293- Persistent fetal circulation
Conditions
Interventions
Intervention1: 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 conce
Sponsors
Bhrajishna Pallapothu
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Oxygenation Index (OI) from baselineTimepoint: 12 hrs | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean arterial pressureTimepoint: 1h, 6h, 12h, and 24h;Treatment failure rate (need for crossover vasopressor or addition of a second-line vasoactive agent)Timepoint: 24 hr;Vasoactive-Inotropic Score (VIS)Timepoint: 6h, 12h and 24h;Duration of invasive ventilationTimepoint: at discharge;Need for iNOTimepoint: At discharge;Time to discontinuation of iNOTimepoint: At discharge;Incidence of hyponatremia (serum Na less than 130 mmol/L)Timepoint: 72h;Incidence of clinically significant arrhythmias requiring interventionTimepoint: At discharge;Incidence of serious adverse events (SAE): NEC (after stage II), grade more than 3 IVH, or peripheral ischemia.Timepoint: At discharge;Oliguria less than 1ml/kg/hr, doubling of serum creatinineTimepoint: 72h;Lacte clearance from baselineTimepoint: 12h and 24h;All-cause mortalityTimepoint: At discharge;Composite outcome of death or need for iNOTimepoint: At discharge | — |
Countries
India
Contacts
Public ContactBhrajishna Pallapothu
Rainbow Childrens Hospital
Outcome results
None listed