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Open Access Study protocol

SCAMP: standardised, concentrated, additional macronutrients, parenteral nutrition in very preterm infants: a phase IV randomised, controlled exploratory study of macronutrient intake, growth and other aspects of neonatal care

Colin Morgan1*, Shakeel Herwitker2, Isam Badhawi3, Anna Hart4, Maw Tan5, Kelly Mayes6, Paul Newland6 and Mark A Turner1

Author Affiliations

1 Neonatal Intensive Care Unit, Liverpool Women's Hospital, Crown St, Liverpool L8 7SS, UK

2 Department of Pharmacy, Aseptic Manufacturing Unit (MIA 12155), Royal Liverpool and Broadgreen University Hospitals NHS Trust, UK

3 Department of Pharmacy, Liverpool Women's Hospital, Crown St, Liverpool L8 7SS, UK

4 School of Health and Medicine, University of Lancaster, LA1 4YD, UK

5 Community Child Health, Royal Liverpool Children's Hospital, Alder Hey, Liverpool L12 2AP, UK

6 Dept Clinical Chemistry, Royal Liverpool Children's Hospital, Alder Hey, Liverpool L12 2AP, UK

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BMC Pediatrics 2011, 11:53  doi:10.1186/1471-2431-11-53

Published: 10 June 2011

Abstract

Background

Infants born <29 weeks gestation are at high risk of neurocognitive disability. Early postnatal growth failure, particularly head growth, is an important and potentially reversible risk factor for impaired neurodevelopmental outcome. Inadequate nutrition is a major factor in this postnatal growth failure, optimal protein and calorie (macronutrient) intakes are rarely achieved, especially in the first week. Infants <29 weeks are dependent on parenteral nutrition for the bulk of their nutrient needs for the first 2-3 weeks of life to allow gut adaptation to milk digestion. The prescription, formulation and administration of neonatal parenteral nutrition is critical to achieving optimal protein and calorie intake but has received little scientific evaluation. Current neonatal parenteral nutrition regimens often rely on individualised prescription to manage the labile, unpredictable biochemical and metabolic control characteristic of the early neonatal period. Individualised prescription frequently fails to translate into optimal macronutrient delivery. We have previously shown that a standardised, concentrated neonatal parenteral nutrition regimen can optimise macronutrient intake.

Methods

We propose a single centre, randomised controlled exploratory trial of two standardised, concentrated neonatal parenteral nutrition regimens comparing a standard macronutrient content (maximum protein 2.8 g/kg/day; lipid 2.8 g/kg/day, dextrose 10%) with a higher macronutrient content (maximum protein 3.8 g/kg/day; lipid 3.8 g/kg/day, dextrose 12%) over the first 28 days of life. 150 infants 24-28 completed weeks gestation and birthweight <1200 g will be recruited. The primary outcome will be head growth velocity in the first 28 days of life. Secondary outcomes will include a) auxological data between birth and 36 weeks corrected gestational age b) actual macronutrient intake in first 28 days c) biomarkers of biochemical and metabolic tolerance d) infection biomarkers and other intravascular line complications e) incidence of major complications of prematurity including mortality f) neurodevelopmental outcome at 2 years corrected gestational age

Trial registration

Current controlled trials: ISRCTN76597892; EudraCT Number: 2008-008899-14