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CTRI Number  CTRI/2026/03/105347 [Registered on: 05/03/2026] Trial Registered Prospectively
Last Modified On: 04/03/2026
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Study Of Blood Sodium Levels In Newborn Babies With Excessive Weight Loss During The First Week After Birth 
Scientific Title of Study   Serum Sodium Levels In Healthy Neonates With Excessive Weight Loss In The First Week Of Life A Cross Sectional Observational Study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Riddhi Jain 
Designation  Senior Resident 
Affiliation  Kasturba Medical College Manipal Karnataka 
Address  Department Of Neonatology
Kasturba Medical College Manipal Academy Of Higher Education
Udupi
KARNATAKA
576104
India 
Phone  9119339118  
Fax    
Email  riddhirajeevjain@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr. Sheila S. Mathai 
Designation  Head of Department 
Affiliation  Department Of Neonatology Kasturba Medical College Manipal 
Address  Department Of Neonatology
Kasturba Medical College Manipal Academy Of Higher Education
Udupi
KARNATAKA
576104
India 
Phone  9930954139  
Fax    
Email  Sheila.mathai@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Dr Riddhi Jain 
Designation  Senior Resident 
Affiliation  Kasturba Medical College Manipal 
Address  Department Of Neonatology
Kasturba Medical College Manipal Academy Of Higher Education
Udupi
KARNATAKA
576104
India 
Phone  9119339118  
Fax    
Email  riddhirajeevjain@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Kasturba Medical College Manipal 
Address  Department Of Neonatology Kasturba Medical College Manipal Academy Of Higher Education Manipal Udupi Karnataka India 576104 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Riddhi Jain  Kasturba Hospital Manipal  Department Of Neonatology Kasturba Hospital Manipal Kasturba Medical College Manipal
Udupi
KARNATAKA 
9119339118

riddhirajeevjain@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Kasturba Medical College And Kasturba Hospital Manipal  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: P742||Disturbances of sodium balance ofnewborn,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  0.00 Day(s)
Age To  7.00 Day(s)
Gender  Both 
Details  Healthy term and late preterm neonates with gestational age greater than or equal to 34 weeks.
Birth weight between 2000 and 4000 grams.
Receiving exclusively or predominantly breast milk feeds.
Neonates with excessive weight loss defined as weight loss greater than or equal to 10 percent of birth weight within the first week of life or greater than or equal to 5 percent within any 24 hour period. 
 
ExclusionCriteria 
Details  Major congenital malformations.
Formula feed or pasteurized donor human milk feed.
Extra mural babies.
Multiple gestation.

Babies who require more than 1 extra feed within any 24 hour period after inclusion will be censored and removed from the study. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Proportion of hypernatremia defined as serum sodium greater than or equal to 145 millimoles per liter among healthy late preterm and term breastfed neonates with excessive weight loss.  Within the first postnatal week up to day 7 of life or discharge whichever occurs earlier. 
 
Secondary Outcome  
Outcome  TimePoints 
Percentage weight loss threshold associated with the presence of hypernatremia.  Within the first postnatal week up to day 7 of life or discharge whichever occurs earlier. 
Strength and direction of correlation between percentage neonatal weight loss and serum sodium levels.  Within the first postnatal week up to day 7 of life or discharge whichever occurs earlier. 
Strength and direction of correlation between maternal breast milk sodium levels and neonatal serum sodium levels.  Within the first postnatal week up to day 7 of life or discharge whichever occurs earlier. 
Frequency and distribution of clinical features observed in neonates with excessive weight loss.  Within the first postnatal week up to day 7 of life or discharge whichever occurs earlier. 
Association between serum sodium and serum creatinine levels and their relationship with clinical features in neonates with excessive weight loss.  Within the first postnatal week up to day 7 of life or discharge whichever occurs earlier. 
Odds of hypernatremia and excessive weight loss in relation to maternal and neonatal factors expressed as odds ratios with 95 percent confidence intervals.  Within the first postnatal week up to day 7 of life or discharge whichever occurs earlier. 
 
Target Sample Size   Total Sample Size="122"
Sample Size from India="122" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/04/2026 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

This is a prospective cross sectional observational study conducted in the Department of Neonatology at a tertiary care teaching hospital. The study aims to evaluate serum sodium levels in healthy late preterm and term breastfed neonates with excessive weight loss during the first postnatal week. Excessive neonatal weight loss is an early indicator of inadequate breastfeeding and may predispose to hypernatremia and dehydration.

Eligible neonates with gestational age greater than 34 weeks and birth weight between 2000 and 4000 grams who are receiving breast milk feeds will be screened by daily weight monitoring from birth until day 7 of life or discharge whichever occurs earlier. Babies with significant weight loss will undergo serum sodium and serum creatinine estimation as per routine unit protocol. No additional blood samples will be collected exclusively for research purposes. Maternal breast milk sodium estimation will be performed through routine laboratory services after obtaining written parental consent.

The primary objective is to determine the incidence of hypernatremia defined as serum sodium greater than or equal to 145 millimoles per liter among neonates with excessive weight loss. Secondary objectives include evaluation of the relationship between neonatal serum sodium levels, maternal breast milk sodium levels, serum creatinine levels, clinical features, and maternal and neonatal risk factors.

The study hypothesis is that excessive neonatal weight loss in the first postnatal week is associated with a higher incidence of hypernatremia and is related to maternal breast milk sodium levels and other clinical variables. The findings may support early identification of at risk neonates and help in developing evidence based screening strategies.


 
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