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Title: Exclusive breast milk vs Mixed milk feeding for preterm babies: A randomized controlled trial

A Prospective Randomized Controlled Trial-open labelled to evaluate Exclusive breast milk vs Mixed milk feeding for preterm babies - EBMM

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2016/02/006622
Enrollment
128
Registered
2016-02-10
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: P789- Perinatal digestive system disorder, unspecified

Interventions

Intervention1: FF group: Mixed feeding group (FF) babies are given Protocol based volume advances of enteral feeds with mixed feeds (mothers own milk and formula milk as necessary). Minimal entral nut
if expressed breast is sufficiently not available, mixed feeding or formula feeding will close the gap. Control Intervention1: MM group: Minimal enteral nutrition will be initiated as per protocol w
if expressed breast milk not available, feeding will be delayed and baby will be on parenteral nutrition alone. Once stable, protocol based advances will be made with expressed breast milk(EBM) only
if EBM is sufficiently not available parenteral nutrition will be continued to meet the total fluid volume requirement, accepting delay in enteral feed volume advances.

Sponsors

nil
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All preterm babies with gestational age between 27-32weeks and <1500g, inborn babies and outborn babies admitted to NICU within 24 hours of birth

Exclusion criteria

Exclusion criteria: • Antenatal diagnosed congenital anomalies of GI tract • Major congenital anomalies requiring surgical intervention • Need for extensive resuscitation at birth (chest compression / medications) • Multi-organ dysfunction • Parents not willing to participate • Mother and baby in different hospital

Design outcomes

Primary

MeasureTime frame
Primary objective a. To compare the number of days required to achieve Enteral feed volume of 150 ml / kg/d and remaining stable without evidence of feed intolerance for 3 days after achieving full feeds in group of babies receiving mothers own milk only vs babies on protocol based milk volume advances with mothers milk as available, supplemented with formula milk (mixed feeding group) to close the gap. Timepoint: Till they achieve enteral feed volume of 150 ml / kg/d and remaining stable without evidence of feed intolerance for 3 days

Secondary

MeasureTime frame
to compare the mothers milk only vs mixed feeding group for 1. incidence of suspect or established (stage 2 or 3 NEC, Bells classification) 2. the z scores of babyâ??s weight at 40 weeks post menstrual age (PMA)as per gender specific Fentons chart. 3. the duration of parenteral nutrition 4. the rate of hospital associated infections (HAI) 5. rate of exclusive breast feeding at discharge from NICU Timepoint: till discharge fron Neonatal intensive care unit

Countries

India

Contacts

Public ContactDr Anand N

Kerala Institute of Medical Sciences

naveen_19572@hotmail.com09387814568

Outcome results

None listed

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