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A trial to identify Which intravenous fluid is better among the commonly used two types of fluid called dextrose normal saline and half dextrose normal saline respectively in terms of maintaining salt and sugar level maintenance in a child age group between 28 days to 12 months.

DNS versus half DNS as a choice of maintenance fluid in treatment of sick children age group 28 days to 1 year in Pediatrics, a randomized Controlled Trial in a tertiary care center of eastern india - nil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/12/098833
Enrollment
64
Registered
2025-12-10
Start date
Unknown
Completion date
Unknown
Last updated
2026-01-12

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

Conditions

Health Condition 1: R69- Illness, unspecified Health Condition 2: R688- Other general symptoms and signs

Interventions

Intervention1: DNS fluid to those sick children who will be requiring more than 50 percentage of total fluid requirement via intravenous route for more than 24 hours: In stage 1, all the eligible chi

Sponsors

MRINMOY ROY
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Those sick children of the age group 28 days to 12 months who will be admitted for acute illness will require more than 50 percent of their total fluid requirement via the intravenous route for more than 24 hours.

Exclusion criteria

Exclusion criteria: Parents or patients not giving consent or assent, respectively Hemodynamic shock needing boluses or inotropes. Baseline sodium less than 135 mmol per litre or more than 145 mmol per litre, or glucose less than 54 mg per deciliter at presentation. patient receiving sodium therapy for any reason.

Design outcomes

Primary

MeasureTime frame
Changes in serum sodium level is the primary outcome. Dysnatremia is defined as hyponatremia where serum sodium level less than 135 milliequivalent per liter and hypernatremia as serum sodium more than 145 milliequivalent per liter. At any point of dysnatremia the intervention will be stopped, participants will be withdrawn from the study, and the they will be treated as per clinician decision.Timepoint: Monitoring windows will be baseline (0 2 hours), 12 hours,24 hours and 72 hours after initiation of therapy.

Secondary

MeasureTime frame
Serum glucose is the secondary outcome.Dysglycemia is defined as hypoglycemia less than 54 milligram per deciliter, hyperglycemia is defined more than 180 milligram per deciliter. At any point of dysglycemia, the intervention will be stopped and the patient will be treated as per clinician decisionTimepoint: Monitoring windows will be baseline (0 2 hours), 12 hours,24 hours and 72 hours after initiation of therapy.;Weight gain or loss more than 10 percentage or any neurological and gastrointestinal side effects are secondary outcome. If noted, the intervention will be stopped and the patient will be treated as per clinician decision. Any derangements will be documented and corrected as per institutional protocol.Timepoint: Monitoring windows will be baseline (0 2 hours), 12 hours,24 hours and 72 hours after initiation of therapy.

Countries

India

Contacts

Public ContactDr Satyabrata Roy Chowdhoury

IPGMER and SSKM hospital

satamck@gmail.com9433765529

Outcome results

None listed

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