A comparative study between two groups of randomly chosen newborn babies to see the effects of hydrocortisone in shock when given early (along with first line vasopressor agents) versus standard timing (failure of vasopressor drugs to maintain blood pressure).

Early vs Standard Hydrocortisone therapy in Neonatal shock- A Double Blind Randomized controlled trial.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2016/09/007276

Enrollment

Registered

2016-09-15

Start date

Unknown

Completion date

Unknown

Last updated

2023-06-26

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

Conditions

Health Condition 1: null- Neonates with shock

Interventions

Intervention1: Early Steroid group: Will receive stress dose hydrocortisone (1mg/kg/dose) intravenously along with first line vasopressor agents. And thereafter, a complete course of hydrocortisone fo

Eligibility

Inclusion criteria

Inclusion criteria: Any neonate less than 44 weeks post-menstural age, presenting with clinical shock.

Exclusion criteria

Exclusion criteria: a) Clinical setting of dehydration/ obvious blood loss b) Hypoxic ischemic encephalopathy- moderate to severe c) Suspected or proven duct dependent systemic/pulmonary circulation d) Neonates received postnatal steroids in the past 7 days e) Suspected or proven congenital adrenal hyperplasia

Design outcomes

Primary

Measure	Time frame
All cause mortalityTimepoint: Within 14 days of onset of shock.	—

Secondary

Measure	Time frame
Abdominal distension, Altered aspirates, hematemesis, hyperglycemia or hypertensionTimepoint: Within 72 hours of drug administration;Functional echocardiographic markers of systolic and diastolic functions viz left ventricular systolic functions (Cardiac output, Ejection Fraction, Fractional Shortening, End Systolic Wall Stress (ESWS), Heart Rate corrected velocity of circumferential fiber shortening (VCFc), E:A ratio, and IVRT)Timepoint: At baseline (Preferably before initiation of vasopressor drugs or within one hour of their initiation) and 4-6 hours after giving trial drug.;Incidence of Catecholamine resistant shockTimepoint: During that episode of shock;Incidence of definite NEC, ROP, BPD and PVLTimepoint: During the hospital stay;Inotrope score and duration of inotropes/ vasopressorsTimepoint: During that episode of shock	—

Measure

Time frame

Abdominal distension, Altered aspirates, hematemesis, hyperglycemia or hypertensionTimepoint: Within 72 hours of drug administration;Functional echocardiographic markers of systolic and diastolic functions viz left ventricular systolic functions (Cardiac output, Ejection Fraction, Fractional Shortening, End Systolic Wall Stress (ESWS), Heart Rate corrected velocity of circumferential fiber shortening (VCFc), E:A ratio, and IVRT)Timepoint: At baseline (Preferably before initiation of vasopressor drugs or within one hour of their initiation) and 4-6 hours after giving trial drug.;Incidence of Catecholamine resistant shockTimepoint: During that episode of shock;Incidence of definite NEC, ROP, BPD and PVLTimepoint: During the hospital stay;Inotrope score and duration of inotropes/ vasopressorsTimepoint: During that episode of shock

—

Countries

India

Contacts

Public ContactSankalp Dudeja

PGIMER, Chandigarh

sajansaini1@gmail.com9501112646

Outcome results

None listed

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