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A clinical trial to determine the effective and safe line of treatment for Hypernatremia In otherwise healthy Neonates

Feeds alone Vs Feeds and Intravenous fluids for Treatment of Hypernatremia In otherwise healthy Neonates- Open labelled Randomized controlled non Inferiority trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/02/017676
Enrollment
170
Registered
2019-02-14
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: P742- Disturbances of sodium balance ofnewborn

Interventions

Intervention1: Non inferiority comparison of number of babies having safe decline in serum sodium between 2 groups: Newborns with hypernatremia will be grouped into two with one group receiving feeds

Sponsors

Dr Shrinidhi K
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1)singleton baby,2)gestational age more than or equal to 36 weeks,3) birth weight 2000 to 5000 grams,4)postnatal age less than or equal to 7 days,5)roomed in with the mother for atleast 48hours for breastfeeding,6)serum sodium 150 to 155 mEq per litre

Exclusion criteria

Exclusion criteria: 1)congenital anomaly which may interfere with adequate oral feed intake,2)culture proven sepsis,3) NICU stay for more than 24 hours,4)IV fluid therapy in prior occasion, 5) endocrine, metabolic, renal or any systemic illness which may cause fluid and electrolyte abnormality

Design outcomes

Primary

MeasureTime frame
Non inferiority comparison of the number of babies having safe decline in serum sodium between the two groupsTimepoint: 2 years

Secondary

MeasureTime frame
complications during treatment like feed intolerance, extravasation or thrombophlebitis, altered mental status,seizures,focal neurological deficitTimepoint: 1 week;duration of treatment and duration of hospital stayTimepoint: variable;Percentage of weight gain at the end of treatmentTimepoint: 1 week;superiority comparison of the volume of IV fluids and or feeds requiredTimepoint: 1 week;treatment failureTimepoint: 1 week

Countries

India

Contacts

Public ContactDr K Neelakandan

The Tamilnadu Dr.MGR Medical University

drsramesh95@gmail.com9962823975

Outcome results

None listed

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