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A study on effect of Sildenafil on mortality of hypoxic babies with persistent pulmonary hypertension

Effect of Sildenafil on mortality in term Neonates with hypoxemic respiratory failure due to persistent pulmonary hypertension - SIPHON

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/11/010688
Enrollment
24
Registered
2017-11-28
Start date
Unknown
Completion date
Unknown
Last updated
2023-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Hypoxic Respiratory failure due to Pulmonary hypertension Health Condition 2: I270- Primary pulmonary hypertension Health Condition 3: I270- Primary pulmonary hypertension

Interventions

Intervention1: Inj. Sildenafil: 0.5mg/kg/dose over 3 hrs three times daily for 3 days or drop in Right ventricular systolic pressure to half the systemic pressure whichever is earlier Control Interven

Sponsors

DrDeepti
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Term neonates on mechanical ventilation with hypoxemic respiratory failure and ECHO demonstration of elevated right ventricular systolic pressure above the mean systemic pressure or right to left shunt via foetal channels in a structurally normal heart. 2. ASD & VSD

Exclusion criteria

Exclusion criteria: 1) Congenital diaphragmatic hernia 2) Surgical lung anomalies 3) Severe external congenital anomalies

Design outcomes

Primary

MeasureTime frame
To determine the effect of Sildenafil treatment on mortality rate in term newborns with hypoxemic respiratory failure due to pulmonary hypertensionTimepoint: 0,24,48, and 72 hrs—

Secondary

MeasureTime frame
To determine the effect of Sildenafil on pulmonary pressures in the first 72 hours of treatment. 2) To determine the effect of Sildenafil treatment on duration of mechanical ventilation in term newborns with hypoxemic respiratory failure due to pulmonary hypertension Timepoint: 0, 24,48 and 72 hrs—

Countries

India

Contacts

Public ContactDr Srinivas Murthy

JSS Medical college, JSS University

drdsrinivasa@gmail.com9980941161

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026