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a study to prevent low sodium in neonates with infection

Comparison of two regimens of intravenous sodium administration for prevention of hyponatremia among neonates with shock due to late onset sepsis-a Randomized Controlled Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/10/009961
Enrollment
204
Registered
2017-10-03
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- septic shock in neonates due to late onset sepsis

Interventions

Intervention1: sodium as 3 mmol/kg/day: sodium as 3 mmol/kg/day in intravenous fluids in septic shock due to late onset sepsis Control Intervention1: sodium as 2 mmol/kg/day: sodium intake as 2 mmol/k

Sponsors

jipmer hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Neonates with birth weight of more than 1500 grams with septic shock due to late onset sepsis (sepsis presentation after 72 hours of life). Only neonates born to adult parents will be included in study

Exclusion criteria

Exclusion criteria: Neonates with shock due to other etiology Birth weight less than 1500 grams Congenital heart disease Acute kidney injury at admission Hyponatremia at admission Major surgical conditions and lethal congenital anomalies

Design outcomes

Primary

MeasureTime frame
To evaluate the incidence of hyponatremia in neonates with septic shock when administering sodium intravenously at the rate of 3mmol/kg/day vs 2 mmol/kg/day.Timepoint: the study will be terminated when shock resolves or hyponatremia develops

Secondary

MeasureTime frame
To assess the duration of septic shock in these neonates To assess the mortality among these neonates with septic shock Timepoint: the study will be terminated when shock resolves or hyponatremia develops

Countries

India

Contacts

Public Contactdr chetan khare

jipmer hospital

adhisivam1975@yahoo.co.uk09488822113

Outcome results

None listed

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