A clinical trial to determine the effective and safe line of treatment for Hypernatremia In otherwise healthy Neonates
Not Applicable
- Conditions
- Health Condition 1: P742- Disturbances of sodium balance ofnewborn
- Registration Number
- CTRI/2019/02/017676
- Lead Sponsor
- Dr Shrinidhi K
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method on inferiority comparison of the number of babies having safe decline in serum sodium between the two groupsTimepoint: 2 years
- Secondary Outcome Measures
Name Time Method 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