Kristina Wendel1, Helle Cecilie Viekilde Pfeiffer2,3, Drude Merete Fugelseth2,4, Eirik Nestaas2,5, Magnus Domellöf6, Bjorn Steen Skålhegg7, Katja Benedikte Presto Elgstøen8, Helge Rootwelt8, Rolf Dagfinn Pettersen9, Are Hugo Pripp10, Tom Stiris2,4, Sissel J Moltu2. 1. Department of Neonatal Intensive Care, Oslo University Hospital, Oslo, Norway. krwend@ous-hf.no. 2. Department of Neonatal Intensive Care, Oslo University Hospital, Oslo, Norway. 3. Department of Pediatric Neurology, Oslo University Hospital, Oslo, Norway. 4. Institute of Clinical Medicine, University of Oslo, Oslo, Norway. 5. Department of Pediatrics, Vestfold Hospital Trust, Tønsberg, Norway. 6. Department of Clinical Sciences, Pediatrics, Umea University, Umea, Sweden. 7. Division of Molecular Nutrition, Department of Nutrition, University of Oslo, Oslo, Norway. 8. Department of Medical Biochemistry, Oslo University Hospital, Oslo, Norway. 9. Norwegian National Unit for Newborn Screening, Division of Pediatric and Adolescent Medicine, Oslo University Hospital, Oslo, Norway. 10. Oslo Centre of Biostatistics and Epidemiology, Oslo University Hospital, Oslo, Norway.
Abstract
BACKGROUND: Current nutritional management of infants born very preterm results in significant deficiency of the essential fatty acids (FAs) arachidonic acid (ARA) and docosahexaenoic acid (DHA). The impact of this deficit on brain maturation and inflammation mediated neonatal morbidities are unknown. The aim of this study is to determine whether early supply of ARA and DHA improves brain maturation and neonatal outcomes in infants born before 29 weeks of gestation. METHODS:Infants born at Oslo University Hospital are eligible to participate in this double-blind randomized controlled trial. Study participants are randomized to receive an enteral FA supplement of either 0.4 ml/kg MCT-oil™ (medium chain triglycerides) or 0.4 ml/kg Formulaid™ (100 mg/kg of ARA and 50 mg/kg of DHA). The FA supplement is given from the second day of life to 36 weeks' postmenstrual age (PMA). The primary outcome is brain maturation assessed by Magnetic Resonance Imaging (MRI) at term equivalent age. Secondary outcomes include quality of growth, incidence of neonatal morbidities, cardiovascular health and neuro-development. Target sample size is 120 infants (60 per group), this will provide 80% power to detect a 0.04 difference in mean diffusivity (MD, mm2/sec) in major white matter tracts on MRI. DISCUSSION: Supplementation of ARA and DHA has the potential to improve brain maturation and reduce inflammation related diseases. This study is expected to provide valuable information for future nutritional guidelines for preterm infants. TRIAL REGISTRATION: Clinicaltrials.gov ID: NCT03555019 . Registered 4 October 2018- Retrospectively registered.
RCT Entities:
BACKGROUND: Current nutritional management of infants born very preterm results in significant deficiency of the essential fatty acids (FAs) arachidonic acid (ARA) and docosahexaenoic acid (DHA). The impact of this deficit on brain maturation and inflammation mediated neonatal morbidities are unknown. The aim of this study is to determine whether early supply of ARA and DHA improves brain maturation and neonatal outcomes in infants born before 29 weeks of gestation. METHODS:Infants born at Oslo University Hospital are eligible to participate in this double-blind randomized controlled trial. Study participants are randomized to receive an enteral FA supplement of either 0.4 ml/kg MCT-oil™ (medium chain triglycerides) or 0.4 ml/kg Formulaid™ (100 mg/kg of ARA and 50 mg/kg of DHA). The FA supplement is given from the second day of life to 36 weeks' postmenstrual age (PMA). The primary outcome is brain maturation assessed by Magnetic Resonance Imaging (MRI) at term equivalent age. Secondary outcomes include quality of growth, incidence of neonatal morbidities, cardiovascular health and neuro-development. Target sample size is 120 infants (60 per group), this will provide 80% power to detect a 0.04 difference in mean diffusivity (MD, mm2/sec) in major white matter tracts on MRI. DISCUSSION: Supplementation of ARA and DHA has the potential to improve brain maturation and reduce inflammation related diseases. This study is expected to provide valuable information for future nutritional guidelines for preterm infants. TRIAL REGISTRATION: Clinicaltrials.gov ID: NCT03555019 . Registered 4 October 2018- Retrospectively registered.
Authors: Deanne K Thompson; Claire E Kelly; Jian Chen; Richard Beare; Bonnie Alexander; Marc L Seal; Katherine Lee; Lillian G Matthews; Peter J Anderson; Lex W Doyle; Alicia J Spittle; Jeanie L Y Cheong Journal: Neuroimage Date: 2018-04-13 Impact factor: 6.556
Authors: Svetlana Najm; Chatarina Löfqvist; Gunnel Hellgren; Eva Engström; Pia Lundgren; Anna-Lena Hård; Alexandre Lapillonne; Karin Sävman; Anders K Nilsson; Mats X Andersson; Lois E H Smith; Ann Hellström Journal: Clin Nutr ESPEN Date: 2017-05-03