Enteral Lipid Supplementation and Bronchoplumonary Dysplasia of Premature Infants (PRELUDE)
11 juni 2026 bijgewerkt door: 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).
Studie Overzicht
Toestand
Werving
Conditie
Gedetailleerde beschrijving
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.
Studietype
Ingrijpend
Inschrijving (Geschat)
74
Fase
- Fase 4
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: Maria Lithoxopoulou, MD, PhD, MBA, Ass. Prof.
- Telefoonnummer: +30 6932883161
- E-mail: mlithoxopoulou@yahoo.com, lithoxopoulou@auth.gr
Studie Locaties
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Thessaloniki, Griekenland
- Werving
- Papageorgiou General Hospital
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Contact:
- Maria Lithoxopoulou, MD, PhD, MBA, Ass. Prof.
- Telefoonnummer: +30 6932883161
- E-mail: mlithoxopoulou@yahoo.com, lithoxopoulou@auth.gr
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Hoofdonderzoeker:
- Maria Lithoxopoulou, Assistant Professor
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Kind
Accepteert gezonde vrijwilligers
Nee
Beschrijving
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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: 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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Actieve vergelijker: 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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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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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.
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Classification of BPD
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: Up to 36th week of postmenstrual age
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Up to 36th week of postmenstrual age
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Algemene publicaties
- 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.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
4 maart 2025
Primaire voltooiing (Geschat)
30 november 2026
Studie voltooiing (Geschat)
1 maart 2027
Studieregistratiedata
Eerst ingediend
30 mei 2026
Eerst ingediend dat voldeed aan de QC-criteria
11 juni 2026
Eerst geplaatst (Werkelijk)
17 juni 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
17 juni 2026
Laatste update ingediend die voldeed aan QC-criteria
11 juni 2026
Laatst geverifieerd
1 juni 2026
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
- Urogenitale ziekten
- Vrouwelijke urogenitale ziekten en zwangerschapscomplicaties
- Verloskundige arbeid, voortijdig
- Verloskundige arbeidscomplicaties
- Zwangerschap Complicaties
- Ziekten van de luchtwegen
- Longziekten
- Zuigelingen, prematuren, ziekten
- Baby, pasgeborene, ziekten
- Longletsel
- Door beademing veroorzaakt longletsel
- Aangeboren, erfelijke en neonatale ziekten en afwijkingen
- Voortijdige geboorte
- Bronchopulmonale dysplasie
- Health Services Administration
- Kwaliteit, toegang en evaluatie van de gezondheidszorg
- Kwaliteit van de gezondheidszorg
- Kwaliteitsindicatoren, gezondheidszorg
- Zorgstandaard
Andere studie-ID-nummers
- 393/16-01-2025
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
JA
Beschrijving IPD-plan
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.
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .