Skip to content

SAFE-FEED Trial: Gut Ultrasoundâ??Guided vs Conventional Feeding Advancement to Achieve Earlier Full Enteral Feeds in Sick Preterm Neonates (28â??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) - THE SAFE -FEED TRIAL

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/03/105939
Enrollment
248
Registered
2026-03-11
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: P76-P78- Digestive system disorders of newborn

Interventions

Intervention1: 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

Sponsors

IPGMER and SSKM Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
Time to Full Enteral Feeds in daysTimepoint: Time in days of 150 ml per kg per day enteral feeding achieved and sustained for 48 hours

Secondary

MeasureTime frame
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 GainsTimepoint: TILL DISCHARGE

Countries

India

Contacts

Public ContactNIRMALYA SARKAR

IPGMER AND SSKM HOSPITAL

sahaanindya09@gmail.com9830149059

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 29, 2026