| 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
|
|
|
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
|
|
|
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
|
|
|
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. |