| CTRI Number |
CTRI/2024/08/072475 [Registered on: 13/08/2024] Trial Registered Prospectively |
| Last Modified On: |
29/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
WEIGHT PATTERNS OF HEALTHY NEONATES AFTER BIRTH BORN BETWEEN 37 WEEKS TO 42 WEEKS OF PREGNANCY |
|
Scientific Title of Study
|
POST NATAL WEIGHT PATTERNS IN HEALTHY NEONATES |
| 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 Mayank Gupta |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical college, MAHE, Manipal |
| Address |
Department of Paediatrics, Women and child Block , Kasturba Medical College. Madhav Nagar, Eshwar Nagar, Manipal, Karnataka 576104
Udupi
KARNATAKA
576104
India |
| Phone |
9108601642 |
| Fax |
|
| Email |
mayankguptadps@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR LESLIE EDWARD S LEWIS |
| Designation |
PROFESSOR AND HOD |
| Affiliation |
Kasturba Medical college, MAHE, Manipal |
| Address |
Department of Paediatrics, Women and child Block , Kasturba Medical College. Madhav Nagar, Eshwar Nagar, Manipal, Karnataka 576104
Udupi
KARNATAKA
576104
India |
| Phone |
9449208476 |
| Fax |
|
| Email |
leslie.lewis@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
DR SUBHODH SHETTY |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
Kasturba Medical college, MAHE, Manipal |
| Address |
Department of Neonatology , Women and child Block , Kasturba Medical College. Madhav Nagar, Eshwar Nagar, Manipal, Karnataka 576104
Udupi
KARNATAKA
576104
India |
| Phone |
9901838220 |
| Fax |
|
| Email |
pedsshetty@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kasturba Hospital , Kasturba Medical College, MAHE, Manipal, |
|
|
Primary Sponsor
|
| Name |
NOT APPLICABLE |
| Address |
NOT APPLICABLE |
| Type of Sponsor |
Other [nil ] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| NOT APPLICABLE |
NOT APPLICABLE |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Mayank Gupta |
Kasturba medical college and hospital |
Dept of Pediatrics, women and child Block , Madhav Nagar, Eshwar Nagar, Manipal, Karnataka 576104
Udupi
KARNATAKA |
9108601642
mayankguptadps@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE KMC MANIPAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy neonates aged between 0 to 28 days of life |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
28.00 Day(s) |
| Gender |
Both |
| Details |
All term (between 37 weeks-42 weeks of gestation) healthy breast fed neonates in post natal ward . |
|
| ExclusionCriteria |
| Details |
All preterms under 37 weeks of gestation, Neonates requiring NICU Admission , neonates having congenital orofacial anomalies |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study factors which lead to physiological or excessive weight loss or gain in term healthy neonates |
1) Weight checking from day 1 of birth till the day of discharge from hospital.
2) Day 14 of birth
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| factors affecting weight patterns in neonates during hospital stay in post natal wards |
0th day till 14th day of birth |
|
|
Target Sample Size
|
Total Sample Size="254"
Sample Size from India="254"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="1014" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/08/2024 |
| Date of Study Completion (India) |
23/02/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
A Term Neonate normally loses 10-12% of body weight in the 1st week of life as a result of excess extravascular fluids and limited nutritional intake. Neonates regain or excess birth weight by 2 weeks of age and should grow approximately 30g/day in the 1st month. There are several factors which cause excessive weight loss for example 1.LSCS delivery, Inadequate Breast feeding, Higher Maternal Age, Primiparity, Maternal diabetes Mellitus, etc. Factors which cause lesser weight loss are - IUGR babies, Formula feeds, Post term Pregnancy. Aim- To study Post natal weight patterns in term healthy breastfed neonates.Primary objectives are - 1. To study weight patterns from birth till discharge & 2. to study weight patterns of term healthy neonates with excessive loss at follow up. Secondary objectives is to study factors affecting weight patterns in neonates during hospital stay. Justification of study-1.- to study weight patterns of neonates in coastal areas post birth. 2. To identify factors which causes excessive weight loss. 3. To identify whether excessive weight loss during hospital stay is associated with poor weight gain during follow up. Sample size is 254 according to formula Lemeshow et all 1990. |