A randomised controlled trial of high or low volume initiation and - PowerPoint PPT Presentation

A randomised controlled trial of high or low volume initiation and rapid or slow advancement of milk feeds for infants ≤ 1000 g (HREC 283/2011) MS Raban 1 , S Santhakumaran 2 , Q Keraan 1 , Y Joolay 1 , S Uthaya 2 , AR Horn 1 , N Modi 2 , MC Harrison 1 1. Department of Neonatal Medicine, Groote Schuur Hospital and University of Cape Town 2. Imperial College ,London, United Kingdom SCAH Research Day 28 October 2014

Introduction • Optimal enteral feeding regimen has not been established • Early studies - early introduction and rapid advancement of enteral feeds may be involved in pathogenesis of NEC • Delay in attaining full enteral nutrition may lead to suboptimal growth and assoc neurodevelopmental delay at 18 – 22 months • Systematic review suggests rapid advancement of feeds is safe • No increase in risk for NEC

Introduction Lango et al described the growth velocity in ELBW infants managed at GSH nursery Mean Growth Velocity was 14.0 g/kg/day

Objectives • Examine the outcomes of both the initiating and advancement enteral feed volumes in infants weighing ≤ 1000 g • Establish safety and efficacy of commencing exclusive breast milk feeds at 24ml/kg/day on the day of birth and advancing feeds at 36ml/kg/day

Methods • 2×2 factorial designed RCT • Infants weighing ≤1000g were randomized to 1 of 4 groups • Recruitment period August 2011 – February 2013 • The primary outcome: Time to attain a weight of 1500g

Results

Assessed for eligibility n=214 Excluded n=14 - Declined participation n=5 Enrolment - Other n=3 - Missed n=2 - Not meeting inclusion criteria n =2 - Excluded for medical reasons n=2 Randomised Allocation n=200 Low/slow n=51 Low/rapid n=47 High/slow n=52 High/rapid n=50 Follow-up 13 deaths (25.5%) 19 deaths (40.4%) 16 deaths (30.8%) 14 deaths (28.0%) 38 discharges (74.5%) 28 discharges (59.6%) 36 discharges (69.2%) 36 discharges (72.0%) Discontinued = 0 Discontinued = 0 Discontinued = 0 Discontinued = 0 Analysis Analysed n=51 Analysed n=47 Analysed n=52 Analysed n=50

Patient characteristics

Time to attain 1500 g

Time to regain birth weight

Time to discharge

Morbidity and Mortality

Discussion - Limitations • Not powered to detect differences in NEC and mortality • The nature of the intervention precluded blinding • The study did not include long-term follow-up • Resource constraints prohibited the concurrent use of PN

Conclusion • Higher initiation feed volumes and larger daily feed increments in infants ≤ 1000 g - well tolerated - increased early weight gain - reduced hospital stay - Mortality and feed-related morbidity, including NEC did not appear to be increased • Justification for larger studies to address the impact on NEC and other adverse outcomes.

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