469 - The effect of higher Protein-Energy Intakes and Stimulation of Physical Activity on growth of preterm infants: A Nested Design Randomized Clinical Trial.
Consultant (Neonatology) Azienda Ospedaliero Universitaria delle Marche MACERATA, Marche, Italy
Background: Optimisation of nutritional intakes in order to achieve intra-uterine growth rate has been proven to be a difficult task. Objective: We hypothesized that combining a physical stimulation program to increased nutritional intakes would have improved growth and body composition of preterm infants born before 32 weeks (W) of gestation. Design/Methods: We performed a randomized controlled trial with a 2-by-2 factorial design involving infants born between 24+0W and 31+6W, who were randomly assigned to Standard Nutrition (N0: protein intake 3.6g/kg/d and energy intake 135kcal/kg/d) or Enhanced Nutrition (N+: protein intake 4.6g/kg/d and energy intake 145kcal/kg/d) and to Physical Stimulation (S+: flexion/extension of the 4 limbs and other motion exercises of the shoulder girdle and of the hips 4 times/day at least 5 days a week) or No Physical Stimulation (S0) from birth to 36W postmenstrual age (PMA). Growth and body composition (assessed by skinfold and ultrasound muscle and adipose tissue thickness measurements of limbs) were evaluated until 36W PMA. Brain size at 40 W PMA was assessed by MRI brain segmentation. (ClinicalTrial.gov ID: NCT03374033) Results: One hundred and twenty-seven infants met inclusion criteria and were included in the per protocol final analysis (N+S+=32; N+S0=33; N0S+=30; N0S0=32). No differences were found in demographics and in the main complications of prematurity between the groups. N+ patients showed improved weight gain from birth to 36W PMA (weight gain Birth-36W: 13.8±2.1 vs 12.4±2.3 g∙kg-1∙d-1, N+ vs N0 respectively, p=0.001; delta weight SDS birth-36W PMA: -0.7±0.5 vs -1.0±0.5, N+ vs N0 respectively, p=0.001). Physical stimulation was not associated with any clinically and statistically significant effect on growth. Neither the nutritional intervention, nor the physical stimulation program affected body composition until 36W PMA nor MRI-based brain size at 40W PMA (total brain volume: 371.9±40.7 vs 357.5±39.8 vs 360.4±39.5 vs 356.5±39.1 cm3, N+S+ vs N+S0 vs N0S+ vs N0S0 respectively, p=0.5). No significant interaction was found between nutrition and physical stimulation on somatic growth, brain size and on body composition during the study period.
Conclusion(s): In very preterm infants (240-316 weeks), enhanced nutrition was associated with a higher weight gain from birth to 36W PMA but no other statistically and clinically significant differences were found. We could not demonstrate any growth advantage in receiving the physical stimulation program, nor there was any interaction between nutrition and physical stimulation.