Results of the PLUS study presented at Nutrition and Growth Conference 2018
At the 2018 Nutrition and Growth conference in Paris, France Danone Nutricia Research presented the results of the PLUS study, evaluating growth and safety with the use of a Protein Supplement in extremely low birth weight (ELBW; <1000g) preterm infants.
Protein requirements in preterm infants
Preterm infants have increased protein requirements to achieve adequate growth and functional development1. The protein requirements of ELBW preterm infants are particularly increased, with ESPGHAN recommending 3.6-4.1 g protein/100kcal (4.0-4.5 g protein/kg/d), as compared to 3.2-3.6 g protein/100kcal (3.5-4.0 g protein/kg/d) for preterm infants weighing 1,000-1,800 g1. Fortified human milk or preterm formula often do not meet the increased requirements of ELBW preterm infants, and as such a protein supplement may be required.
The PLUS Study
The observational open-label multi-center PLUS study results were presented at the 2018 Nutrition & Growth conference, reporting that the use of a Protein Supplement supports adequate growth in ELBW infants without raising a safety concern. 112 ELBW receiving a Protein Supplement were shown to have non-inferior weight growth velocity, with an indication of higher weight growth velocity compared with a historic control of 112 ELBW infants who did not receive the Protein Supplement (difference 1.12 g/kg/day, with lower limit of 95% CI of 0.09 and predefined non-inferiority margin of -3 g/kg/day). Importantly, no statistically significant differences were observed in occurrences of of necrotising enterocolitis (NEC) or death. The investigators concluded that the use of the Protein Supplement in combination with fortified human milk and/or preterm formula does not raise a safety concern in clinical practice and supports adequate growth in ELBW preterm infants.