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Full volume feeding in preterm babies with birth weight of 750-1250 grams

Early total enteral feeding (ETEF) versus Conventional enteral feeding (CEF) in neonates with birth weight between 750-1250 grams: a Randomized Control Trial ? - ETEF vs CEF

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/09/057882
Enrollment
128
Registered
2023-09-20
Start date
Unknown
Completion date
Unknown
Last updated
2023-10-16

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

Conditions

Health Condition 1: P929- Feeding problem of newborn, unspecified Health Condition 2: P073- Preterm [premature] newborn [other]

Interventions

Intervention1: “Early total enteral feeding (ETEF): This will be an Open Label Randomized Control Trial comparing the time of attainment of full enteral feeds (in completed days) in preterm neonates

Sponsors

Lady Hardinge Medical college
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1) Preterm neonate with birth weight between 750- 1250 grams 2) Infants

Exclusion criteria

Exclusion criteria: 1)Antenatally diagnosed Gastrointestinal malformation 2)Baby born with absence or reversal of end diastolic flow on antenatal umbilical artery Doppler. 3)Presence of major congenital anomalies at birth 4)Need of vasopressor support at the time of randomization 5)Requiring Positive Pressure Ventilation > 60 sec with APGAR score

Design outcomes

Primary

MeasureTime frame
To determine the time of attainment of full enteral feeds (in completed days) in preterm neonates with birth weight between 750-1250 grams started on early total enteral feeding (ETEF) as compared to those started on conventional enteral feeding (CEF)Timepoint: Daily till discharge or death

Secondary

MeasureTime frame
1. Magnitude of feed intolerance, Sepsis, Necrotising Enterocolitis any stage, all- cause mortalityTimepoint: Daily till discharge or death;2.Duration of intravenous fluid use (in days)Timepoint: Daily till discharge or death;3.Time in days to regain birth weight & weight gain in grams per kg per day at one month of ageTimepoint: Daily till discharge or death;4.Total duration of hospital stays (in days)Timepoint: Daily till discharge or death;5.Proportion of extrauterine growth retardationTimepoint: Daily till discharge or death

Countries

India

Contacts

Public ContactDr M Kiran Kumar

Lady Hardinge Medical College

drsnangia@gmail.com9810838181

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026