Effect of Enteral Lipid Supplement on Severe Retinopathy of Prematurity A Randomized Clinical Trial

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Effect of Enteral Lipid Supplement on Severe Retinopathy of Prematurity A Randomized Clinical Trial

Hellström, Ann, 1959 (författare): University of Gothenburg,Gothenburg University,Göteborgs universitet,Institutionen för neurovetenskap och fysiologi, sektionen för klinisk neurovetenskap,Institute of Neuroscience and Physiology, Department of Clinical Neuroscience

Nilsson, Anders K., 1982 (författare): University of Gothenburg,Gothenburg University,Göteborgs universitet,Institutionen för neurovetenskap och fysiologi, sektionen för klinisk neurovetenskap,Institute of Neuroscience and Physiology, Department of Clinical Neuroscience

Wackernagel, D. (författare): Karolinska Institutet,Karolinska Institute,Karolinska University Hospital

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Pivodic, Aldina, 1978 (författare): University of Gothenburg,Gothenburg University,Göteborgs universitet,Institutionen för neurovetenskap och fysiologi, sektionen för klinisk neurovetenskap,Institute of Neuroscience and Physiology, Department of Clinical Neuroscience

Vanpee, M. (författare): Karolinska Institutet,Karolinska Institute,Karolinska University Hospital

Sjöbom, Ulrika (författare): University of Gothenburg,Gothenburg University,Göteborgs universitet,Institutionen för vårdvetenskap och hälsa,Institutionen för neurovetenskap och fysiologi, sektionen för klinisk neurovetenskap,Institute of Health and Care Sciences,Institute of Neuroscience and Physiology, Department of Clinical Neuroscience

Hellgren, Gunnel, 1961 (författare): University of Gothenburg,Gothenburg University,Göteborgs universitet,Institutionen för biomedicin,Institutionen för neurovetenskap och fysiologi, sektionen för klinisk neurovetenskap,Institute of Biomedicine,Institute of Neuroscience and Physiology, Department of Clinical Neuroscience

Hallberg, B. (författare): Karolinska Institutet,Karolinska Institute,Karolinska University Hospital

Domellöf, Magnus, 1963- (författare): Umeå universitet,Pediatrik,Norrland University Hospital

Klevebro, Susanna (författare): Karolinska Institutet,Karolinska Institute,University of Gothenburg,Gothenburg University,Göteborgs universitet,Institutionen för neurovetenskap och fysiologi,Institute of Neuroscience and Physiology,Stockholm South General Hospital

Hellström, William (författare): University of Gothenburg,Gothenburg University,Göteborgs universitet,Institutionen för kliniska vetenskaper, Avdelningen för pediatrik,Institute of Clinical Sciences, Department of Pediatrics

Andersson, Mats, 1954 (författare): University of Gothenburg,Gothenburg University,Göteborgs universitet,Institutionen för neurovetenskap och fysiologi,Institute of Neuroscience and Physiology

Lund, Anna-My (författare): Sahlgrenska University Hospital

Löfqvist, Chatarina, 1964 (författare): University of Gothenburg,Gothenburg University,Göteborgs universitet,Institutionen för vårdvetenskap och hälsa,Institutionen för neurovetenskap och fysiologi,Institute of Health and Care Sciences,Institute of Neuroscience and Physiology

Elfvin, Anders, 1971 (författare): University of Gothenburg,Gothenburg University,Göteborgs universitet,Institutionen för kliniska vetenskaper, Avdelningen för pediatrik,Institute of Clinical Sciences, Department of Pediatrics,Sahlgrenska University Hospital

Sävman, Karin, 1960 (författare): University of Gothenburg,Gothenburg University,Göteborgs universitet,Institutionen för kliniska vetenskaper, Avdelningen för pediatrik,Institute of Clinical Sciences, Department of Pediatrics,Sahlgrenska University Hospital

Hansen-Pupp, Ingrid (författare): Lund University,Lunds universitet,Pediatrik, Lund,Sektion V,Institutionen för kliniska vetenskaper, Lund,Medicinska fakulteten,Neonatalogi,Forskargrupper vid Lunds universitet,Paediatrics (Lund),Section V,Department of Clinical Sciences, Lund,Faculty of Medicine,Neonatology,Lund University Research Groups,Skåne University Hospital

Hård, Anna-Lena, 1949 (författare): University of Gothenburg,Gothenburg University,Göteborgs universitet,Institutionen för neurovetenskap och fysiologi, sektionen för klinisk neurovetenskap,Institute of Neuroscience and Physiology, Department of Clinical Neuroscience

Smith, L. E. H. (författare): Boston Children's Hospital,Harvard University

Ley, David (författare): Lund University,Lunds universitet,Pediatrik, Lund,Sektion V,Institutionen för kliniska vetenskaper, Lund,Medicinska fakulteten,Neonatalogi,Forskargrupper vid Lunds universitet,Paediatrics (Lund),Section V,Department of Clinical Sciences, Lund,Faculty of Medicine,Neonatology,Lund University Research Groups,Skåne University Hospital

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American Medical Association (AMA), 2021
2021
Engelska.
Ingår i: JAMA Pediatrics. - : American Medical Association (AMA). - 2168-6203 .- 2168-6211. ; 175:4, s. 359-367

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IMPORTANCE Lack of arachidonic acid (AA) and docosahexaenoic acid (DHA) after extremely preterm birth may contribute to preterm morbidity, including retinopathy of prematurity (ROP). OBJECTIVE To determine whether enteral supplementation with fatty acids from birth to 40 weeks' postmenstrual age reduces ROP in extremely preterm infants. DESIGN, SETTING, AND PARTICIPANTS The Mega Donna Mega trial, a randomized clinical trial, was a multicenter study performed at 3 university hospitals in Sweden from December 15, 2016, to December 15, 2019. The screening pediatric ophthalmologists were masked to patient groupings. A total of 209 infants born at less than 27 weeks' gestation were tested for eligibility, and 206 infants were included. Efficacy analyses were performed on as-randomized groups on the intention-to-treat population and on the per-protocol population using as-treated groups. Statistical analyses were performed from February to April 2020. INTERVENTIONS Infants received either supplementation with an enteral oil providing AA (100mg/kg/d) and DHA (50mg/kg/d) (AA:DHA group) or no supplementation within 3 days after birth until 40 weeks' postmenstrual age. MAIN OUTCOMES AND MEASURES The primary outcomewas severe ROP (stage 3 and/or type 1). The secondary outcomes were AA and DHA serum levels and rates of other complications of preterm birth. RESULTS A total of 101 infants (58 boys [57.4%]; mean [SD] gestational age, 25.5 [1.5] weeks) were included in the AA:DHA group, and 105 infants (59 boys [56.2%]; mean [SD] gestational age, 25.5 [1.4] weeks) were included in the control group. Treatment with AA and DHA reduced severe ROP compared with the standard of care (16 of 101 [15.8%] in the AA:DHA group vs 35 of 105 [33.3%] in the control group; adjusted relative risk, 0.50 [95% CI, 0.28-0.91]; P =.02). The AA:DHA group had significantly higher fractions of AA and DHA in serum phospholipids compared with controls (overall mean difference in AA:DHA group, 0.82 mol% [95% CI, 0.46-1.18 mol%]; P <.001; overall mean difference in control group, 0.13 mol% [95% CI, 0.01-0.24 mol%]; P =.03). There were no significant differences between the AA:DHA group and the control group in the rates of bronchopulmonary dysplasia (48 of 101 [47.5%] vs 48 of 105 [45.7%]) and of any grade of intraventricular hemorrhage (43 of 101 [42.6%] vs 42 of 105 [40.0%]). In the AA:DHA group and control group, respectively, sepsis occurred in 42 of 101 infants (41.6%) and 53 of 105 infants (50.5%), serious adverse events occurred in 26 of 101 infants (25.7%) and 26 of 105 infants (24.8%), and 16 of 101 infants (15.8%) and 13 of 106 infants (12.3%) died. CONCLUSIONS AND RELEVANCE This study found that, compared with standard of care, enteral AA:DHA supplementation lowered the risk of severe ROP by 50% and showed overall higher serum levels of both AA and DHA. Enteral lipid supplementation with AA:DHA is a novel preventive strategy to decrease severe ROP in extremely preterm infants.

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MEDICIN OCH HÄLSOVETENSKAP: MEDICIN OCH HÄLS ...; och Klinisk medicin; och Pediatrik

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Artiklar i publikationen: JAMA Pediatrics

Av lärosätet: Göteborgs universitet; Umeå universitet; Lunds universitet; Karolinska Institutet

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Effect of Enteral Lipid Supplement on Severe Retinopathy of Prematurity A Randomized Clinical Trial

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