A Phase 4 interventional study of Enteral supplementation with ARA and DHA (in a 2:1 ratio) in addition to standard care and feeding and Standard care and feeding in Bronchopulmonary Dysplasia (BPD), sponsored by Aristotle University Of Thessaloniki. Recruiting at 1 site in Greece. Open to participants aged 24 Weeks to 29 Weeks. Per ClinicalTrials.gov, last updated 2026-06-17.
Sponsored by Aristotle University Of Thessaloniki · Phase 4, Interventional, and Prevention
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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).
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.
362 studies on the registry are indexed under Bronchopulmonary Dysplasia; 85 are open to participants now.
This study's planned enrollment of 74 is above the median of 66 across 244 interventional studies indexed under Bronchopulmonary Dysplasia.
Browse Bronchopulmonary Dysplasia studies →Aristotle University Of Thessaloniki is the lead sponsor of 282 studies on the registry; 55 are open to participants now.
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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 .
Study participation requires written informed parental consent within 48h after birth.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Enteral supplementation with ARA and DHA (in a 2:1 ratio) in addition to standard care and feeding.
Dietary Supplement: Enteral supplementation with ARA and DHA (in a 2:1 ratio) in addition to standard care and feeding
Routine clinical care and nutritional support
Other: Standard care and feeding
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.
The control group will receive routine clinical care and nutritional support according to current neonatal unit protocols, without additional ARA/DHA supplementation.
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.
Time frame: Up to 36th week of postmenstrual age
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).
Time frame: 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
Time frame: 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).
Time frame: Up to 40th week of postmenstrual age
Mean oxygen demand (FiO2) during respiratory support
Time frame: Up to 40th week of postmenstrual age
Mean tidal volume (ml/kg) during respiratory support
Time frame: Up to 36th week of postmenstrual age
Mean respiratory rate (RR/min) during respiratory support
Time frame: Up to 36th week of postmenstrual age
Use of postnatal steroids (yes/no)
Time frame: Up to 40th week of postmenstrual age
Change in weight z-score from birth to 36 weeks of postmenstrual age
Time frame: Up to 36th week of postmenstrual age
Plan to share: 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.
Started Mar 2025 (actual). Primary completion is estimated for Nov 2026, 20 months after the start.
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