A Study Comparing Early and Late Hydrocortisone Treatment in Newborn Babies with Severe Shock Not Responding to Fluids

Early versus late hydrocortisone therapy in neonates with fluid refractory shock an open label randomised controlled trial - NIL

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/05/110664

Enrollment

Registered

2026-05-20

Start date

Unknown

Completion date

Unknown

Last updated

2026-06-01

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

Conditions

Health Condition 1: P299- Cardiovascular disorder originating in the perinatal period, unspecified

Interventions

Intervention1: Early hydrocortisone: All neonates with fluid refractory neonatal shock will be screened for enrolment. The parents will be approached for consent after applying the inclusion and exclu

Eligibility

Inclusion criteria

Inclusion criteria: All neonates who develop fluid refractory shock and increasing requirement of the first inotrope

Exclusion criteria

Exclusion criteria: Neonates who have received post-natal steroids Neonates with suspected or confirmed congenital adrenal hyperplasia Neonates with major congenital malformations Neonate receiving concurrent indomethacin or ibuprofen Neonates with necrotising enterocolitis If neonate is enrolled in another trial

Design outcomes

Primary

Measure	Time frame
To compare the proportion of neonates with fluid refractory shock achieving a vasoactive inotrope score reduction rate (VRR) of more than 50% within 48 hours from randomisation between early and late hydrocortisone groupsTimepoint: From randomisation to 48 hours post randomisation or mortality whichever is earlier	—

Secondary

Measure	Time frame
All-cause mortality within 7 days of randomisationTimepoint: From randomisation to 7 days later;Proportion of neonates with non-resolution of shock within 72 hours from randomizationTimepoint: From randomisation until stoppage of cardiovascular support;The total length of stay in neonatal intensive care unitTimepoint: From point of randomization till final outcome (discharge/ death/ LAMA/ transfer out/ refer).;The incidence of adverse effects such as as hyperglycemia, GI hemorrhage intestinal perforationTimepoint: From institution till 48 h from last dose of hydrocortisone;To compare the vasoactive inotrope score at standardised time points of 6, 12, 24, 48, 72, and 96 hours from randomisation.Timepoint: From point of randomisation to 96 h later	—

Measure

Time frame

All-cause mortality within 7 days of randomisationTimepoint: From randomisation to 7 days later;Proportion of neonates with non-resolution of shock within 72 hours from randomizationTimepoint: From randomisation until stoppage of cardiovascular support;The total length of stay in neonatal intensive care unitTimepoint: From point of randomization till final outcome (discharge/ death/ LAMA/ transfer out/ refer).;The incidence of adverse effects such as as hyperglycemia, GI hemorrhage intestinal perforationTimepoint: From institution till 48 h from last dose of hydrocortisone;To compare the vasoactive inotrope score at standardised time points of 6, 12, 24, 48, 72, and 96 hours from randomisation.Timepoint: From point of randomisation to 96 h later

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Countries

India

Contacts

Public ContactDr Ankit Verma

All India Institute of Medical Sciences, New Delhi

ankitverma0486@gmail.com8447343609

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 11, 2026