| 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
|
|
|
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
|
|
|
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
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form Response - Analytic Code
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response (Others) -
- 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.
- 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. |