Role of Early hydrocortisone in neonatal shock in neonates with shock on single inotrope and to assess the duration of inotrope requirement post hydrocortisone

Early hydrocortisone in neonatal shock versus standard care,a randomized control trial - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/10/074892

Enrollment

Registered

2024-10-08

Start date

Unknown

Completion date

Unknown

Last updated

2024-10-14

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

Conditions

Health Condition 1: R57- Shock, not elsewhere classified

Interventions

Intervention1: Early Hydrocortisone in neonatal shock: After obtaining approval and clearance from the institutional ethics committee, the patients fulfilling the inclusion criteria will be enrolled f

Eligibility

Inclusion criteria

Inclusion criteria: 1)Patient attenders willing to give informed consent 2)Neonates (age <28 days ) taken into consideration for study 3)Gestational age of 28 weeks to 40 weeks 4)Should fulfill criteria for neonatal shock Clinical features suggestive of shock: Symptoms of decreased peripheral perfusion :Cold,pale skin with delayed capillary refill time ,tachycardia,weak peripheral pulses,Narrow pulse pressure,oliguria Hypotension : MAP <30 mmHg (MEAN ARTERIAL PRESSURE) or MAP < neonate’s gestational age in weeks at time of birth or BP less than fifth centile for gestational age 5) Maximum dose of dopamine 10 mcg/kg/min reached

Exclusion criteria

Exclusion criteria: 1)Patient attenders not willing to give informed consent 2) Neonates with suspected Congenital adrenal hyperplasia 3) Major life threatening congenital malformations 4) Indomethacin usage for treatment of PDA 5) Suspected or proven NEC 6) Hypovolemic shock 7) Obstructive shock

Design outcomes

Primary

Measure	Time frame
1)improvement in shock measured in terms of following parameters A) MAP-mean arterial pressure that lies between 50-90th centile 2)CFT (CAPILLARY REFILL TIME ) less than three seconds 3)Urine output more than 1ml per kg per hour Timepoint: At Baseline	—

Secondary

Measure	Time frame
1)Need for 2nd inotrope 2)Assess Baseline serum cortisol levels 3)Incidence of hyperglycemia,hypertension, 4)Incidence of SIPS (SPONTANEOUS INTESTINAL PERFORATION ) ,NEC (NECROTIZING ENTEROCOLITIS ),Death 5)Duration of hospital stay 6)Incidence of culture positive sepsis Timepoint: Baseline	—

Countries

India

Contacts

Public ContactDr NIRANJAN HS

INDIRA GANDHI INSTITUTE OF CHILD HEALTH

Prathikbh@gmail.com9717235721

Outcome results

None listed

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