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

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

Dec 24, 2023 895 likes •1.05k views

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

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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 Raban1, S Santhakumaran2, Q Keraan1, Y Joolay1, S Uthaya2, AR Horn1, N Modi2, MC Harrison1

  • 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

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

Introduction

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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

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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
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Results

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Assessed for eligibility n=214 Excluded n=14

  • Declined participation n=5
  • Other n=3
  • Missed n=2
  • Not meeting inclusion criteria n =2
  • Excluded for medical reasons n=2

Randomised

n=200

Low/slow n=51 Low/rapid n=47 High/slow n=52 High/rapid n=50 13 deaths (25.5%) 38 discharges (74.5%) Discontinued = 0 19 deaths (40.4%) 28 discharges (59.6%) Discontinued = 0 16 deaths (30.8%) 36 discharges (69.2%) Discontinued = 0 14 deaths (28.0%) 36 discharges (72.0%) Discontinued = 0 Analysed n=51 Analysed n=47 Analysed n=52 Analysed n=50

Enrolment Allocation Follow-up Analysis

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Patient characteristics

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Time to attain 1500 g

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Time to regain birth weight

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Time to discharge

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Morbidity and Mortality

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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
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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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Thank You