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Study of a medicine called sildenafil to see how good it is to decrease persistent pressure in vessels of heart supplying lung after birth in newborns selected randomly

A randomised control study for efficacy of sildenafil in persistent pulmonary hypertension in newborn

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2015/05/005797
Enrollment
40
Registered
2015-05-22
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: null- Term newborns with persistent pulmonary hypertension

Interventions

Intervention1: oral sildenafil given: Oral sildenafil tablet 1mg/kg/dose was given 6 hourly through orogastric tube for 5days. Control Intervention1: Oral sildenafil was not given: Control group recei

Sponsors

Vivekananda Institute Of Medical Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: term newborns diagnosed to have persistent pulmonary hypertension on the basis of clinical and echocardiographic criteria .

Exclusion criteria

Exclusion criteria: 1.Preterm with RDS 2.Surgical cases like congenital diaphragmatic hernia 3.Major congenital anomaly including congenital heart disease

Design outcomes

Primary

MeasureTime frame
1.Improvement in DOWNEâ??S score 2.Improvement in oxygenation index in ventilated babies and oxygen requirement in nonventilated babies 3.Echo criteria-decrease in peak pulmonary pressure in terms of tricuspid regurgitation gradient Timepoint: 1.Improvement in DOWNEâ??S score by day 5 of start of therapy 2.Improvement in oxygenation index in ventilated babies and oxygen requirement in nonventilated babies by day 5 of start of therapy 3.Echo criteria-decrease in peak pulmonary pressure in terms of tricuspid regurgitation gradient by day 5 of start of therapy

Secondary

MeasureTime frame
Adverse effects of sildenafil like hypotension,hyperthermiaTimepoint: Two years

Countries

India

Contacts

Public ContactProfAsha Mukherjee

Vivekananda Institute Of Medical Sciences,Ramakrishna Mission Seva Pratisthan

mukherjee31@yahoo.com9831251138

Outcome results

None listed

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