Bronchopulmonary Dysplasia (BPD)Phase 4PRELUDENCT07652684
Enteral Lipid Supplementation and Bronchoplumonary Dysplasia of Premature Infants
A Phase 4 study of Bronchopulmonary Dysplasia (BPD), run by Aristotle University Of Thessaloniki at 1 site in Greece.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 24 to 29 weeks
- Conditions the study is for
- Bronchopulmonary Dysplasia (BPD)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteGreece
- Study dates
- 4 Mar 2025to 1 Mar 2027
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 to 29 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- Congenital malformations, chromosomal abnormalities or critical illness with short life expectancy.
- Study participation requires written informed parental consent within 48h after birth.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Maria Lithoxopoulou, MD, PhD, MBA, Ass. Prof. contact
Greece1 site, 1 recruiting
- Recruiting
Papageorgiou General Hospital
Thessaloniki
Maria Lithoxopoulou, MD, PhD, MBA, Ass. Prof., +30 6932883161, mlithoxopoulou@yahoo.com, lithoxopoulou@auth.gr
Maria Lithoxopoulou, Assistant Professor
About this study
Official title: 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).
Read the detailed description
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.
- Conditions
- Bronchopulmonary Dysplasia (BPD)
- Being tested
- Enteral supplementation with ARA and DHA (in a 2:1 ratio) in addition to standard care and feeding, Standard care and feeding
- Keywords
- BPD, preterm infant, nutrition, ARA, DHA, respiratory support, prematurity
- Medical subject headings
- Bronchopulmonary Dysplasia, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enteral supplementation with ARA and DHA (in a 2:1 ratio) in addition to standard care and feedingDietary supplement
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.
Standard care and feedingOther
The control group will receive routine clinical care and nutritional support according to current neonatal unit protocols, without additional ARA/DHA supplementation.
| Study group | Role | What they receive |
|---|---|---|
| Enteral supplementation | Experimental | Enteral supplementation with ARA and DHA (in a 2:1 ratio) in addition to standard care and feeding. Receives: Dietary Supplement: Enteral supplementation with ARA and DHA (in a 2:1 ratio) in addition to standard care and feeding |
| Routine practice | Active comparator | Routine clinical care and nutritional support Receives: Other: Standard care and feeding |
What is being measured
The primary outcome is the main question the study is designed to answer.
The presence or absence of bronchopulmonary dysplasia (BPD), as assessed by the need for respiratory support or supplemental oxygen at 36 weeks postmenstrual age.
The occurrence of BPD will be determined based on the requirement for respiratory support or supplemental oxygen at 36 weeks postmenstrual age.
Measured: Up to 36th week of postmenstrual age
Secondary outcomes (8)
Classification of BPD
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).
Measured: Up to 36th week of postmenstrual age
The presence of comorbidities such as retinopathy of prematurity, necrotizing enterocolitis, intraventricular haemorrhage, periventricular leukomalacia, patent ductus arteriosus, and late-onset sepsis
Measured: Up to 40th week of postmenstrual age
Need of respiratory support
The number of days requiring respiratory support (mechanical ventilation, continuous positive airway pressure (CPAP), high flow nasal cannula 3L/min or oxygen therapy).
Measured: Up to 40th week of postmenstrual age
Mean oxygen demand (FiO2) during respiratory support
Measured: Up to 40th week of postmenstrual age
Mean tidal volume (ml/kg) during respiratory support
Measured: Up to 36th week of postmenstrual age
Mean respiratory rate (RR/min) during respiratory support
Measured: Up to 36th week of postmenstrual age
Use of postnatal steroids (yes/no)
Measured: Up to 40th week of postmenstrual age
Change in weight z-score from birth to 36 weeks of postmenstrual age
Measured: Up to 36th week of postmenstrual age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2026
- Study start4 Mar 2025
- Primary completion30 Nov 2026 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Bronchopulmonary Dysplasia (BPD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aristotle University Of Thessaloniki
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07652684
- Sponsor's protocol ID
- 393/16-01-2025
- Acronym
- PRELUDE
- Status last verified
- Jun 2026
- First submitted
- 30 May 2026
- Last updated
- 17 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 31727986Isayama 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.
PubMed 28114678Jensen 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.
PubMed 30995069Svedenkrans 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.
PubMed 30789787Abman 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.
PubMed 27908648Walsh 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.
PubMed 13679930Jobe 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.
PubMed 11401896Davidson 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.
PubMed 28067830Jobe 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.
PubMed 27603539Northway 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.
PubMed 5334613Krishnan 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.
PubMed 28645441Hellstrom 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.
PubMed 33523106Malamas 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.
PubMed 28251092Marc 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.
PubMed 36943265Chen 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.
PubMed 32175534