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

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 ageCurrent controlled trials: ISRCTN76597892; EudraCT Number: 2008-008899-14The risk of significant neurocognitive disabilities in preterm survivors is well recognised, particularly under 26 weeks gestation [1,2]. Although many factors are associated with an increased risk of neurocognitive impairment, postnatal growth failure is now recognized as an important and potentially reversible risk [3-5]. Suboptimal growth is common in very low birthweight infants (VLBWI) [6,7] especially in those under 26 weeks [8]. Head growth is an especially important measure of growth failure because it correlates with brain growth [9]. Hack et al showed that subnormal head size at 8 months was predictive of poorer verbal and performance IQ scores at 3 [10] and 8 years [11]. Brain growth by 28 days after birth and the expected date of delivery are key predictors of long-term brain growth [12,13].Early postnatal growth failure or extrauterine growth restriction describes the severe nutritional deficit that develops in preterm infants in the first fe