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A study to compare whether doing early surgery i.e within one week of admission in Infants With a VSD hole in heart with severe lung infection is better than the conventional practice of doing surgery and closing the VSD hole after complete cure of the lung infection.

Early Surgery In Infants With VSD With Pneumonia- A Randomized Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/12/022331
Enrollment
34
Registered
2019-12-12
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: J22- Unspecified acute lower respiratory infection Health Condition 2: Q210- Ventricular septal defect

Interventions

Intervention1: Early surgical Intervention in infants with VSD and pneumonia: All patients fulfilling the inclusion and exclusion criteria will be enrolled after written informed consent. Participant

Sponsors

Janani Shishu Suraksha Karyakaram JSSK Scheme
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1)Patients remaining ventilated at least till 48 hours of hospital stay with moderate to large VSD with severe pneumonia. 2)Patients between 2 months to one year 3)Patients giving written informed consent

Exclusion criteria

Exclusion criteria: 1)Patients with other associated congenital heart disease except small ASD and PDA 2)Down syndrome and other syndromic associations as they have altered immunity 3)Major associated anomaly contributing to chest infection like TEF 4)Renal or hepatic dysfunction 5)Cardiogenic/septic Shock

Design outcomes

Primary

MeasureTime frame
Survival to discharge at 30 days b/w early surgical intervention group and conservative arm of infants of large VSD with severe pneumoniaTimepoint: survival to till 30 days of discharge—

Secondary

MeasureTime frame
Post-operative ventilation duration, duration of Ionotropic requirements, Duration of ICU stay.Timepoint: The patients will be assessed immediately post operatively, after 7 days and during discharge—

Countries

India

Contacts

Public ContactDr Shyamajit Samaddar

All India Institute of Medical Sciences, New Delhi

dr.shyamajit.samaddar@gmail.com8195942475

Outcome results

None listed

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