Enteral Lipid Supplementation and Bronchoplumonary Dysplasia of Premature Infants (PRELUDE)
11 juni 2026 uppdaterad av: Aristotle University Of Thessaloniki
Enteral Lipid Supplementation and Bronchoplumonary Dysplasia of Premature Infants: A Randomized Controlled Trial (The PRELUDE Trial)
The Impact of Omega-3 (DHA - Docosahexaenoic Acid) and Omega-6 (ARA - Arachidonic Acid) Supplementation on the Development of Bronchopulmonary Dysplasia in Extremely and Very Preterm Infants (24-29 weeks of gestational age).
Studieöversikt
Status
Rekrytering
Betingelser
Detaljerad beskrivning
The intervention group will receive enteral supplementation with ARA and DHA (in a 2:1 ratio) in addition to standard care and feeding, while the control group will receive standard care and feeding.
The intervention will commence within the first three days of life and will continue until 36 weeks postmenstrual age for both groups.
Studietyp
Interventionell
Inskrivning (Beräknad)
74
Fas
- Fas 4
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Maria Lithoxopoulou, MD, PhD, MBA, Ass. Prof.
- Telefonnummer: +30 6932883161
- E-post: mlithoxopoulou@yahoo.com, lithoxopoulou@auth.gr
Studieorter
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Thessaloniki, Grekland
- Rekrytering
- Papageorgiou General Hospital
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Kontakt:
- Maria Lithoxopoulou, MD, PhD, MBA, Ass. Prof.
- Telefonnummer: +30 6932883161
- E-post: mlithoxopoulou@yahoo.com, lithoxopoulou@auth.gr
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Huvudutredare:
- Maria Lithoxopoulou, Assistant Professor
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
Tar emot friska volontärer
Nej
Beskrivning
Inclusion Criteria:
Infants born at Papageorgiou Hospital in Neonatology Department and NICU of Aristotle University of Thessaloniki with GA equal to or less than 29 weeks are eligible to participate in the study.
Exclusion Criteria:
Congenital malformations, chromosomal abnormalities or critical illness with short life expectancy.
Study participation requires written informed parental consent within 48h after birth.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Experimentell: Enteral supplementation
Enteral supplementation with ARA and DHA (in a 2:1 ratio) in addition to standard care and feeding.
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The intervention group will receive enteral supplementation containing arachidonic acid (ARA) and docosahexaenoic acid (DHA) in a 2:1 ratio, in addition to standard care and feeding.
Supplementation will begin within the first three days of life and will continue until 36 weeks postmenstrual age.
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Aktiv komparator: Routine practice
Routine clinical care and nutritional support
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The control group will receive routine clinical care and nutritional support according to current neonatal unit protocols, without additional ARA/DHA supplementation.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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The presence or absence of bronchopulmonary dysplasia (BPD), as assessed by the need for respiratory support or supplemental oxygen at 36 weeks postmenstrual age.
Tidsram: Up to 36th week of postmenstrual age
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The occurrence of BPD will be determined based on the requirement for respiratory support or supplemental oxygen at 36 weeks postmenstrual age.
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Up to 36th week of postmenstrual age
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Classification of BPD
Tidsram: Up to 36th week of postmenstrual age
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Classification of Jensen et al. (2019) proposed a revised definition of BPD based on a modification of the NICHD (2001) criteria, which classifies the severity of bronchopulmonary dysplasia at 36 weeks postmenstrual age according to the level of positive pressure respiratory support, rather than the use of supplemental oxygen.
This classification is independent of the prior duration or current concentration of oxygen therapy and is defined as follows: no BPD (no respiratory support), Grade 1 (nasal cannula ≤2 L/min), Grade 2 (nasal cannula >2 L/min or non-invasive ventilation), and Grade 3 (invasive mechanical ventilation).
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Up to 36th week of postmenstrual age
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The presence of comorbidities such as retinopathy of prematurity, necrotizing enterocolitis, intraventricular haemorrhage, periventricular leukomalacia, patent ductus arteriosus, and late-onset sepsis
Tidsram: Up to 40th week of postmenstrual age
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Up to 40th week of postmenstrual age
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Need of respiratory support
Tidsram: Up to 40th week of postmenstrual age
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The number of days requiring respiratory support (mechanical ventilation, continuous positive airway pressure (CPAP), high flow nasal cannula 3L/min or oxygen therapy).
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Up to 40th week of postmenstrual age
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Mean oxygen demand (FiO2) during respiratory support
Tidsram: Up to 40th week of postmenstrual age
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Up to 40th week of postmenstrual age
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Mean tidal volume (ml/kg) during respiratory support
Tidsram: Up to 36th week of postmenstrual age
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Up to 36th week of postmenstrual age
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Mean respiratory rate (RR/min) during respiratory support
Tidsram: Up to 36th week of postmenstrual age
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Up to 36th week of postmenstrual age
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Use of postnatal steroids (yes/no)
Tidsram: Up to 40th week of postmenstrual age
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Up to 40th week of postmenstrual age
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Change in weight z-score from birth to 36 weeks of postmenstrual age
Tidsram: Up to 36th week of postmenstrual age
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Up to 36th week of postmenstrual age
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- Jobe AH, Bancalari E. Bronchopulmonary dysplasia. Am J Respir Crit Care Med. 2001 Jun;163(7):1723-9. doi: 10.1164/ajrccm.163.7.2011060. No abstract available.
- Jensen EA, Dysart K, Gantz MG, McDonald S, Bamat NA, Keszler M, Kirpalani H, Laughon MM, Poindexter BB, Duncan AF, Yoder BA, Eichenwald EC, DeMauro SB. The Diagnosis of Bronchopulmonary Dysplasia in Very Preterm Infants. An Evidence-based Approach. Am J Respir Crit Care Med. 2019 Sep 15;200(6):751-759. doi: 10.1164/rccm.201812-2348OC.
- Northway WH Jr, Rosan RC, Porter DY. Pulmonary disease following respirator therapy of hyaline-membrane disease. Bronchopulmonary dysplasia. N Engl J Med. 1967 Feb 16;276(7):357-68. doi: 10.1056/NEJM196702162760701. No abstract available.
- Thebaud B, Goss KN, Laughon M, Whitsett JA, Abman SH, Steinhorn RH, Aschner JL, Davis PG, McGrath-Morrow SA, Soll RF, Jobe AH. Bronchopulmonary dysplasia. Nat Rev Dis Primers. 2019 Nov 14;5(1):78. doi: 10.1038/s41572-019-0127-7.
- Higgins RD, Jobe AH, Koso-Thomas M, Bancalari E, Viscardi RM, Hartert TV, Ryan RM, Kallapur SG, Steinhorn RH, Konduri GG, Davis SD, Thebaud B, Clyman RI, Collaco JM, Martin CR, Woods JC, Finer NN, Raju TNK. Bronchopulmonary Dysplasia: Executive Summary of a Workshop. J Pediatr. 2018 Jun;197:300-308. doi: 10.1016/j.jpeds.2018.01.043. Epub 2018 Mar 16. No abstract available.
- Krishnan U, Feinstein JA, Adatia I, Austin ED, Mullen MP, Hopper RK, Hanna B, Romer L, Keller RL, Fineman J, Steinhorn R, Kinsella JP, Ivy DD, Rosenzweig EB, Raj U, Humpl T, Abman SH; Pediatric Pulmonary Hypertension Network (PPHNet). Evaluation and Management of Pulmonary Hypertension in Children with Bronchopulmonary Dysplasia. J Pediatr. 2017 Sep;188:24-34.e1. doi: 10.1016/j.jpeds.2017.05.029. Epub 2017 Jun 20. No abstract available.
- Martin CR, Dasilva DA, Cluette-Brown JE, Dimonda C, Hamill A, Bhutta AQ, Coronel E, Wilschanski M, Stephens AJ, Driscoll DF, Bistrian BR, Ware JH, Zaman MM, Freedman SD. Decreased postnatal docosahexaenoic and arachidonic acid blood levels in premature infants are associated with neonatal morbidities. J Pediatr. 2011 Nov;159(5):743-749.e1-2. doi: 10.1016/j.jpeds.2011.04.039. Epub 2011 Jun 12.
- Marc I, Boutin A, Pronovost E, Perez Herrera NM, Guillot M, Bergeron F, Moore L, Sullivan TR, Lavoie PM, Makrides M. Association Between Enteral Supplementation With High-Dose Docosahexaenoic Acid and Risk of Bronchopulmonary Dysplasia in Preterm Infants: A Systematic Review and Meta-analysis. JAMA Netw Open. 2023 Mar 1;6(3):e233934. doi: 10.1001/jamanetworkopen.2023.3934.
- Jobe AH. Mechanisms of Lung Injury and Bronchopulmonary Dysplasia. Am J Perinatol. 2016 Sep;33(11):1076-8. doi: 10.1055/s-0036-1586107. Epub 2016 Sep 7.
- Isayama T, Lee SK, Yang J, Lee D, Daspal S, Dunn M, Shah PS; Canadian Neonatal Network and Canadian Neonatal Follow-Up Network Investigators. Revisiting the Definition of Bronchopulmonary Dysplasia: Effect of Changing Panoply of Respiratory Support for Preterm Neonates. JAMA Pediatr. 2017 Mar 1;171(3):271-279. doi: 10.1001/jamapediatrics.2016.4141.
- Svedenkrans J, Stoecklin B, Jones JG, Doherty DA, Pillow JJ. Physiology and Predictors of Impaired Gas Exchange in Infants with Bronchopulmonary Dysplasia. Am J Respir Crit Care Med. 2019 Aug 15;200(4):471-480. doi: 10.1164/rccm.201810-2037OC.
- Abman SH, Collaco JM, Shepherd EG, Keszler M, Cuevas-Guaman M, Welty SE, Truog WE, McGrath-Morrow SA, Moore PE, Rhein LM, Kirpalani H, Zhang H, Gratny LL, Lynch SK, Curtiss J, Stonestreet BS, McKinney RL, Dysart KC, Gien J, Baker CD, Donohue PK, Austin E, Fike C, Nelin LD; Bronchopulmonary Dysplasia Collaborative. Interdisciplinary Care of Children with Severe Bronchopulmonary Dysplasia. J Pediatr. 2017 Feb;181:12-28.e1. doi: 10.1016/j.jpeds.2016.10.082. Epub 2016 Nov 28. No abstract available.
- Walsh MC, Wilson-Costello D, Zadell A, Newman N, Fanaroff A. Safety, reliability, and validity of a physiologic definition of bronchopulmonary dysplasia. J Perinatol. 2003 Sep;23(6):451-6. doi: 10.1038/sj.jp.7210963.
- Davidson LM, Berkelhamer SK. Bronchopulmonary Dysplasia: Chronic Lung Disease of Infancy and Long-Term Pulmonary Outcomes. J Clin Med. 2017 Jan 6;6(1):4. doi: 10.3390/jcm6010004.
- Hellstrom A, Nilsson AK, Wackernagel D, Pivodic A, Vanpee M, Sjobom U, Hellgren G, Hallberg B, Domellof M, Klevebro S, Hellstrom W, Andersson M, Lund AM, Lofqvist C, Elfvin A, Savman K, Hansen-Pupp I, Hard AL, Smith LEH, Ley D. Effect of Enteral Lipid Supplement on Severe Retinopathy of Prematurity: A Randomized Clinical Trial. JAMA Pediatr. 2021 Apr 1;175(4):359-367. doi: 10.1001/jamapediatrics.2020.5653.
- Malamas A, Chranioti A, Tsakalidis C, Dimitrakos SA, Mataftsi A. The omega-3 and retinopathy of prematurity relationship. Int J Ophthalmol. 2017 Feb 18;10(2):300-305. doi: 10.18240/ijo.2017.02.19. eCollection 2017.
- Chen H, Deng G, Zhou Q, Chu X, Su M, Wei Y, Li L, Zhang Z. Effects of eicosapentaenoic acid and docosahexaenoic acid versus alpha-linolenic acid supplementation on cardiometabolic risk factors: a meta-analysis of randomized controlled trials. Food Funct. 2020 Mar 26;11(3):1919-1932. doi: 10.1039/c9fo03052b.
- Manley BJ, Makrides M, Collins CT, McPhee AJ, Gibson RA, Ryan P, Sullivan TR, Davis PG; DINO Steering Committee. High-dose docosahexaenoic acid supplementation of preterm infants: respiratory and allergy outcomes. Pediatrics. 2011 Jul;128(1):e71-7. doi: 10.1542/peds.2010-2405. Epub 2011 Jun 27.
- Bernhard W, Raith M, Koch V, Maas C, Abele H, Poets CF, Franz AR. Developmental changes in polyunsaturated fetal plasma phospholipids and feto-maternal plasma phospholipid ratios and their association with bronchopulmonary dysplasia. Eur J Nutr. 2016 Oct;55(7):2265-74. doi: 10.1007/s00394-015-1036-5. Epub 2015 Sep 12.
- Baack ML, Puumala SE, Messier SE, Pritchett DK, Harris WS. What is the relationship between gestational age and docosahexaenoic acid (DHA) and arachidonic acid (ARA) levels? Prostaglandins Leukot Essent Fatty Acids. 2015 Sep;100:5-11. doi: 10.1016/j.plefa.2015.05.003. Epub 2015 Jun 17.
- Carlson SE, Colombo J. Docosahexaenoic Acid and Arachidonic Acid Nutrition in Early Development. Adv Pediatr. 2016 Aug;63(1):453-71. doi: 10.1016/j.yapd.2016.04.011. Epub 2016 Jun 3. No abstract available.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
4 mars 2025
Primärt slutförande (Beräknad)
30 november 2026
Avslutad studie (Beräknad)
1 mars 2027
Studieregistreringsdatum
Först inskickad
30 maj 2026
Först inskickad som uppfyllde QC-kriterierna
11 juni 2026
Första postat (Faktisk)
17 juni 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
17 juni 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
11 juni 2026
Senast verifierad
1 juni 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Urogenitala sjukdomar
- Kvinnliga urogenitala sjukdomar och graviditetskomplikationer
- Obstetrisk förlossning, för tidigt
- Obstetriska förlossningskomplikationer
- Graviditetskomplikationer
- Luftvägssjukdomar
- Lungsjukdomar
- Spädbarn, för tidigt födda, Sjukdomar
- Spädbarn, nyfödda, sjukdomar
- Lungskada
- Ventilator-inducerad lungskada
- Medfödda, ärftliga och neonatala sjukdomar och abnormiteter
- För tidig födsel
- Bronkopulmonell dysplasi
- Administration
- Sjukvårdskvalitet, tillgång och utvärdering
- Hälsovårdskvalitet
- Kvalitetsindikatorer, hälsovård
- Vårdstandard
Andra studie-ID-nummer
- 393/16-01-2025
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
JA
IPD-planbeskrivning
Deidentified Individual Participant Data (IPD) that underline published results, along with related data dictionaries, will be available from 3 months to 36 months following results' publication, only to researchers who will provide a methodologically sound proposal, for types of analyses to achieve aims in the approved proposal or for individual participant data meta-analysis, and only after acceptance of the proposed protocol by our Institution's IRB.
Läkemedels- och apparatinformation, studiedokument
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Nej
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Nej
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