| CTRI Number |
CTRI/2025/08/092866 [Registered on: 12/08/2025] Trial Registered Prospectively |
| Last Modified On: |
11/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
To study association of weight loss on day 3 of life and need of respiratory support on day 7 of life in late preterm and full term babies |
|
Scientific Title of Study
|
Proportions and association of day 3 weight loss and need for non invasive respiratory support on day 7 of life in late preterm and full term neonates - A longitudinal anaytical 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 |
Mayur DR |
| Designation |
Junior resident |
| Affiliation |
Bharati Vidyapeeth (deemed to be university)Medical college, Pune |
| Address |
Department of Neonatology, Bharati Hospital, Pune
Bharati Vidyapeeth (deemed to be university)Medical college, Pune
Pune
MAHARASHTRA
411043
India |
| Phone |
8105990058 |
| Fax |
|
| Email |
mayurdr01@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjay Lalwani |
| Designation |
Professor, Department of Paediatrics, Bharati Vidyapeeth Deemed University |
| Affiliation |
Bharati Vidyapeeth (deemed to be university)Medical college, Pune |
| Address |
Department of Paediatrics, 3rd floor, Bharati Hospital
Department of Paediatrics, Bharati Hospital
Pune
MAHARASHTRA
411043
India |
| Phone |
9822051716 |
| Fax |
|
| Email |
sanjay.k.lalwani@bharatividyapeeth.edu |
|
Details of Contact Person
Public Query
|
| Name |
Mayur DR |
| Designation |
Junior Resident |
| Affiliation |
Bharati Vidyapeeth Deemed University Medical College Pune |
| Address |
Department of Paediatrics, 3rd floor, Bharati Hospital Dhankawadi Pune
Department of Paediatrics, 3rd floor,Bharati Hospital Dhankawadi Pune
Pune
MAHARASHTRA
411043
India |
| Phone |
8105990058 |
| Fax |
|
| Email |
mayurdr01@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bharati Vidyapeeth Deemed University Medical College, 411043 |
|
|
Primary Sponsor
|
| Name |
Bharati Vidyapeeth Deemed University Medical college |
| Address |
Katraj,Dhankawadi, Pune satara road,Pune 411043 |
| 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 Mayur DR |
Bharati hospital |
Department of Paediatrics,3rd floor,Bharati hospital, Dhankawadi, Pune, Maharashtra
Pune
MAHARASHTRA |
8105990058
mayurdr01@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bharati Vidyapeeth Deemed University Medical College Institutional Ethics Comittee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J988||Other specified respiratory disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Weight loss more than 5% |
Try to find out association between Weight loss more than 5% on day 3 of life with need for respiratory support on day 7 of life |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
3.00 Day(s) |
| Gender |
Both |
| Details |
Neonates born between 34 to 42 weeks of gestational age admitted within 24 hours of birth and requiring non invasive respiratory support since birth |
|
| ExclusionCriteria |
| Details |
Surgical conditions like tracheoesophageal fistula,congenital diaphragmatic hernia, congenital malformations |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Need for respiratory support on day 7 of life |
day 7 of life |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="96"
Sample Size from India="96"
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)
|
31/08/2025 |
| 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 Yet Recruiting |
| 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
|
Babies born between 34 and 42 weeks who have respiratory distress at birth and admitted in NICU will be observed till day 3 of life for non invasive respiratory support. If non invasive respiratory support will be there on day 3 of life, then baby will be enrolled into study and will be monitored for respiratory support till day 7 of life. Baby will also be monitored for weight loss till day 7 of life. Feeding will be given as per NICU protocol. |