CTRI/2026/03/105939 [Registered on: 11/03/2026] Trial Registered Prospectively
Last Modified On:
04/06/2026
Post Graduate Thesis
Yes
Type of Trial
Interventional
Type of Study
Process of Care Changes
Study Design
Randomized, Parallel Group Trial
Public Title of Study
SAFE-FEED Trial: Gut Ultrasound–Guided vs Conventional Feeding Advancement to Achieve Earlier Full Enteral Feeds in Sick Preterm Neonates (28–32 Weeks Gestation)
GUT ULTRASOUND-GUIDED VERSUS CONVENTIONAL CLINICAL PARAMETERS BASED FEEDING ADVANCEMENT TO REDUCE TIME TO FULL ENTERAL FEED IN SICK PRETERM NEONATES (28-32 WEEKS OF
GESTATIONAL AGE) ADMITTED IN TERTIARY CARE CENTER : A
SUPERIORITY RANDOMIZED CONTROLLED TRIAL OF SONOGRAPHIC ASSESSMENT FOR ENTERAL FEEDING (THE SAFE-FEED TRIAL)
Trial Acronym
THE SAFE -FEED TRIAL
Secondary IDs if Any
Secondary ID
Identifier
NIL
NIL
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
DR ANINDYA KUMAR SAHA
Designation
ASSOCIATE PROFESSOR
Affiliation
IPGMER AND SSKM HOSPITAL
Address
DEPARTMENT OF NEONATOLOGY
IPGMER AND SSKM HOSPITAL
KOLKATA 700020
Kolkata WEST BENGAL 700020 India
Phone
9830149059
Fax
Email
sahaanindya09@gmail.com
Details of Contact Person Scientific Query
Name
DR ANINDYA KUMAR SAHA
Designation
ASSOCIATE PROFESSOR
Affiliation
IPGMER AND SSKM HOSPITAL
Address
DEPARTMENT OF NEONATOLOGY
IPGMER AND SSKM HOSPITAL
KOLKATA 700020
Kolkata WEST BENGAL 700020 India
Phone
9830149059
Fax
Email
sahaanindya09@gmail.com
Details of Contact Person Public Query
Name
NIRMALYA SARKAR
Designation
POST DOCTORAL TRAINEE
Affiliation
IPGMER AND SSKM HOSPITAL
Address
SECOND FLOOR
DEPARTMENT OF NEONATOLOGY
IPGMER AND SSKM HOSPITAL
KOLKATA 700020
Kolkata WEST BENGAL 700020 India
Phone
9836611968
Fax
Email
nsarkar1977@gmail.com
Source of Monetary or Material Support
Nil
Primary Sponsor
Name
IPGMER and SSKM Hospital
Address
244 A J C Bose Road
KolKata West Bengal
PIN 700020
India
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 NIRMALYA SARKAR
IPGMER and SSKM Hospital
Department of Neonatology 3rd Floor Neonatology Building
IPGME&R and SSKM Hospital
244 A J C Bose Road Kolkata
PIN 700020
Kolkata WEST BENGAL
9836611968
nsarkar1977@gmail.com
Details of Ethics Committee
No of Ethics Committees= 1
Name of Committee
Approval Status
IPGMER RESEARCH OVERSIGHT COMMITTEE
Approved
Regulatory Clearance Status from DCGI
Status
Not Applicable
Health Condition / Problems Studied
Health Type
Condition
Patients
(1) ICD-10 Condition: P76-P78||Digestive system disorders of newborn,
Intervention / Comparator Agent
Type
Name
Details
Comparator Agent
conventional feeding advancement
Standard Feeding: Feeds ( Mother’s own milk or pasteurised doner human milk )
initiated at 10-20 ml/kg/day
Advancement: Feeds are advanced by 20 ml/kg/day every 12 to 24 hours only if the
neonate is clinically stable and all of the following clinical criteria are met:
1. Gastric Residual Volume (GRV): Non-bilious, less than 50 percentage of previous feed volume.
2. Abdomen: Soft, non-distended, with normal bowel sounds.
3. Abdominal circumference ( Pre Feed) : Measured at the level of the
umbilicus using a non-stretchable tape, less than 2 cm from the base line
4. Stools: Normal pattern
5. Systemic signs: Stable vital signs, absence of vomiting or lethargy.
Feed Reduction/Stoppage: Feeds are stopped or reduced if GRV more than 50 percentage (bilious or nonbilious),
significant pre-feed abdominal distension ( more than 2 cm from base line ) or clinical suspicion of NEC.
Intervention
GUT USG GUIDED FEEDING ADVANCEMENT
Advancement: Feeds are advanced by 20 ml/kg/day every 12 to 24 hours only if the
neonate is clinically stable and both the clinical criteria and the predefined Gut USG
criteria are met.
Performer :USG will be performed by a DM resident (investigator)
Time : Once daily in morning round before feeding advancement decision . It would
be done under all aseptic precaution and as a part of the cluster care for minimal
duration without hampering infant’s respiratory and hemodynamic status
Machine: GE Vivid i (or similar portable high-end system).
Probes:
Linear Probe (12L RS and 5 to 13 MHz): For bowel wall thickness and peristalsis with Pre-pyloric antral area reduction ratio
Micro-Convex / Phased Array (8C-RS, 4-10 MHz): For SMA Doppler (if deeper
penetration needed).
Validation: 20percentage of scans will be blindly cross-verified by the Guide (Senior
Faculty).
Inclusion Criteria
Age From
1.00 Day(s)
Age To
3.00 Day(s)
Gender
Both
Details
a) Gestational Age (GA) at birth: Intramural neonates born between 28 weeks 0 days to
32 weeks 6 days of gestational age
b) Age at enrolment: Within the first 72 hours of life.
c) Sick neonates initiated on full intravenous fluids
d) Written informed consent obtained from the parent/legal guardian.
ExclusionCriteria
Details
a. Major congenital gastrointestinal anomalies (e.g., oesophageal atresia,
intestinal atresia, gastroschisis, omphalocele).
b. Chromosomal anomalies (likeTrisomy 13, 18, 21).
c. Definite NEC (stage 2 or more ) or spontaneous intestinal perforation prior to
randomization.
d. Features of multi organ dysfunction within first 72 hours of life ( any one of
Gastro intestinal bleeding , shock requiring 2or more inotropes , acute renal failure )
e. Need for immediate surgical intervention
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Sequentially numbered, sealed, opaque envelopes
Blinding/Masking
Outcome Assessor Blinded
Primary Outcome
Outcome
TimePoints
Time to Full
Enteral Feeds in days
Time in days of 150 ml per kg per day enteral feeding achieved and sustained for 48 hours
Secondary Outcome
Outcome
TimePoints
1.Incidence of
Feeding
Intolerance
2.Incidence of NEC
Stage 2 OR MORE
3.Duration of iv fluid
OR TPN Use
4.Length of Hospital
Stay
5.Time to regain
birth weight
6.Anthropometric
Gains
TILL DISCHARGE
Target Sample Size
Total Sample Size="248" Sample Size from India="248" 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
Phase 2/ Phase 3
Date of First Enrollment (India)
01/04/2026
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="6" 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
Background and Objectives: Feeding intolerance in sick preterm neonates often delays enteral nutrition, as standard advancement relies on subjective clinical signs. Gut ultrasound offers an objective alternative to assess bowel function and integrity. The primary objective is to evaluate if a gut ultrasound-guided feeding advancement protocol significantly reduces the time to achieve full enteral feeds (150 ml/kg) compared to a conventional clinical protocol in sick preterm neonates (28-32 weeks gestational age).
Methods: This single-center, prospective, superiority, stratified randomized controlled trial will be conducted at Tertiary care Neonatal unit of IPGME&R, Kolkata. It will enroll 248 sick preterm neonates initially on intravenous fluids. Subjects are randomized (1:1) to a control arm, using conventional clinical signs for feeding advancement, or an intervention arm. The intervention utilizes daily point-of-care ultrasound evaluating superior mesenteric artery perfusion, bowel wall thickness, peristalsis, and gastric emptying to guide feed advancement.
Expected Outcomes: The ultrasound-guided protocol is expected to reduce the time to full feeds by preventing unnecessary interruptions due to false clinical alarms. Furthermore, it aims to decrease intravenous fluid duration, reduce postnatal growth failure, and detect severe gut pathology earlier.