| CTRI Number |
CTRI/2026/03/105445 [Registered on: 05/03/2026] Trial Registered Prospectively |
| Last Modified On: |
05/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
A study comparing gut ultrasound findings in newborn babies with infection and those without infection |
|
Scientific Title of Study
|
Comparison of point-of-care gut ultrasound markers in septic and non-septic neonates: a prospective 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 GOKULRAM S |
| Designation |
Senior resident - DM Neonatology |
| Affiliation |
Bharati Vidyapeeth Deemed University Medical College, Pune |
| Address |
NICU, Second floor, Bharati Hospital, Dhankawadi, Pune
Pune
MAHARASHTRA
411043
India |
| Phone |
9894148410 |
| Fax |
|
| Email |
gokulramselvaraj@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr PRADEEP SURYAWANSHI |
| Designation |
Professor, Department of Neonatology |
| Affiliation |
Bharati Vidyapeeth Deemed University Medical College, Pune |
| Address |
NICU, Second floor, Bharati Hospital, Dhankawadi, Pune
Pune
MAHARASHTRA
411043
India |
| Phone |
9923540500 |
| Fax |
|
| Email |
drpradeepsuryawanshi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr GOKULRAM S |
| Designation |
Senior resident - DM Neonatology |
| Affiliation |
Bharati Vidyapeeth Deemed University Medical College, Pune |
| Address |
NICU, Second floor, Bharati Hospital, Dhankawadi, Pune
Pune
MAHARASHTRA
411043
India |
| Phone |
9894148410 |
| Fax |
|
| Email |
gokulramselvaraj@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bharati Vidyapeeth Deemed University Medical College,
Bharati Hospital,NICU, second floor, , Dhankawadi,
Pune
MAHARASHTRA
411043
India, |
|
|
Primary Sponsor
|
| Name |
Bharati Vidyapeeth Deemed University Medical College |
| Address |
NICU, Bharati Hospital, Pune-Satara Road, Dhankawadi, Pune - 411 043, Maharashtra, |
| 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 GOKULRAM S |
Bharati Hospital, Pune |
Department of Neonatology,
Bharati Hospital, Dhankawadi,
Pune
MAHARASHTRA
Pune
MAHARASHTRA |
9894148410
gokulramselvaraj@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bharati Vidyapeeth Deemed University Medical College Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K638||Other specified diseases of intestine, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
28.00 Day(s) |
| Gender |
Both |
| Details |
All neonates with suspected late-onset neonatal sepsis |
|
| ExclusionCriteria |
| Details |
1. Major congenital gastrointestinal anomalies, (gastroschisis, omphalocele, intestinal atresia)
2. Previous abdominal surgery
3. Established diagnosis of NEC at time of enrolment
4. Chromosomal abnormalities affecting gastrointestinal development
5. Critical congenital heart diseases
6. Evidence of perinatal asphyxia requiring significant resuscitation
7. Parents declining consent or unavailable for consent
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To describe the spectrum of gut ultrasound parameters (including bowel wall perfusion, bowel wall edema, ascites, pneumatosis, portal vein gas or pneumoperitoneum) using point-of-care ultrasound in neonates with late-onset sepsis and to compare with gestational age-matched infants without sepsis |
At the time of the features of sepsis |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
• To determine the temporal evolution of gut ultrasound findings in septic neonates
• To determine the superior mesenteric artery (SMA) doppler variability in neonates with late-onset neonatal sepsis (LONS)
• To compare gut ultrasound and SMA Doppler patterns between: culture positive and culture negative LONS, and preterm and term neonates with LONS
|
At the end of the 7th day of sepsis |
|
|
Target Sample Size
|
Total Sample Size="106"
Sample Size from India="106"
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)
|
18/03/2026 |
| 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="0"
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
|
We aim to explore the spectrum impact of late onset sepsis on the neonatal gut, assessed by point of care gut ultrasound, in neonates with sepsis and compare it to gestational age matched controls. We also aim to determine the temporal evolution of gut ultrasound findings in septic neonates, to determine the superior mesenteric artery doppler variability in neonates with late onset sepsis and compare gut ultrasound and SMA doppler patterns between culture positive and culture negative septic neonates. |