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CTRI Number  CTRI/2023/08/057097 [Registered on: 30/08/2023] Trial Registered Prospectively
Last Modified On: 31/08/2023
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   Representation of postnatal weight loss in healthy newborns using newborn weight loss tool 
Scientific Title of Study   A novel approach on representation of postnatal weight loss in healthy newborns-The Newborn Weight Loss Tool 
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 Anusha P P 
Designation  DNB resident Paediatrics (Post Diploma ) 
Affiliation  Malabar institute of medical sciences, calicut 
Address  Department of Paediatrics and Neonatology, Aster MIMS, Calicut

Kozhikode
KERALA
673016
India 
Phone  9400730151  
Fax    
Email  anusha.pp@asterhospital.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Preetha Remesh 
Designation  Senior consultant and Head, Department of Neonatology 
Affiliation  Malabar Institute of Medical Sciences, Calicut 
Address  Department of Paediatrics and Neonatology Aster MIMS, Calicut

Kozhikode
KERALA
673016
India 
Phone  9995880290  
Fax    
Email  preetha.remesh@asterhospital.com  
 
Details of Contact Person
Public Query
 
Name  Dr Anusha P P 
Designation  DNB resident Paediatrics (post diploma ) 
Affiliation  Malabar institute of medical sciences, calicut 
Address  Department of Paediatrics and Neonatology, Aster MIMS, Calicut

Kozhikode
KERALA
673016
India 
Phone  9400730151  
Fax    
Email  anusha.pp@asterhospital.com  
 
Source of Monetary or Material Support  
Malabar Institute Of Medical Sciences, Calicut 
 
Primary Sponsor  
Name  Malabar Institute of Medical Sciences 
Address  Malabar institute of medical sciences Govindapuram Calicut  
Type of Sponsor  Research institution and hospital 
 
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 Anusha PP  Malabar Institute of Medical Sciences  Department Of Paediatrics and Neonatology, Malabar institute of medical sciences, Govindapuram, Calicut
Kozhikode
KERALA 
9400730151

anusha.pp@asterhospital.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Malabar Institute Of Medical Sciences  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy newborns born at Aster MIMS Calicut will be enrolled in the study after obtaining written informed consent from parents. 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  0.00 Day(s)
Age To  4.00 Day(s)
Gender  Both 
Details  Inborn babies born at aster mims, calicut 
 
ExclusionCriteria 
Details  Babies with major congenital anomalies
Babies requiring NICU admission 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Participants will be visited in the postnatal ward during the hospital stay & data will be extracted on all weights obtained during birth hospitalisation as well as on gestational age, mode of delivery, maternal age, newborn sex, parity, type of feedings. Nomogram will be generated daily using the above inputs
 
48 hours weight monitoring in babies born by vaginal route, & 96 hours in those who are born by LSCS.
 
 
Secondary Outcome  
Outcome  TimePoints 
The trend of weight loss in healthy newborns using the nomogram will help in guiding feeding interventions & also to identify the morbidities associated with significant weight loss in healthy newborns   4 days 
 
Target Sample Size   Total Sample Size="258"
Sample Size from India="258" 
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)   09/09/2023 
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="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response (Others) - 

  6. For how long will this data be available start date provided 06-12-2024 and end date provided 06-12-2030?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Human milk is the optimal source of nutrition for all infants & exclusive breast feeding is recommended for first 6 months of life. After birth newborns typically lose weight steadily  until feeding is established. Weight loss up to 7-10% of birth weight is  encountered. Pronounced weight loss is associated with hyperbilirubinemia and hypernatremic dehydration which constitute two most common causes of readmission. Monitoring a baby’s weight is therefore essential until lactation is established. 

Newborn weight loss tool (NEWT) is a potential solution for detecting newborns who are on a trajectory for excessive weight loss. This tool consist of nomogram that show hour by hour weight loss trajectories during birth hospitalisation for healthy newborns. The newborn weight loss tool is a free, publicly  available website that depicts a newborn’s weight loss  in the context of normative reference nomograms for weight loss at each hour of age. This can be used by manually entering new born data including weight. These nomograms can be used by clinicians to help guide infant feeding decisions. Participants will be visited in postnatal ward during the hospital stay and weight will be monitored daily till discharge; 48 hours in case of babies born by vaginal route and 96 hours in those who are born by LSCS. Following data will be fed as input to the NEWT tool- birth weight, date of birth in MM/DD/YYYY format, birth time in 24 hour clock format and post birth weights and timing of these measurements. Nomogram will be generated using the above inputs up to 48-96 hours.

While growth chart is an established  tool for the assessment of childhood nutrition and growth; a similar plot for the postnatal weight loss is a recent development. Most of the studies on postnatal weight loss are conducted on western population. Literature review revealed no Indian studies. Hence this study will provide insights on Indian population on the same. 


 
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