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NCT Number: NCT07652684

Enteral Lipid Supplementation and Bronchoplumonary Dysplasia of Premature Infants

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).

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Key information

Conditions

Bronchopulmonary Dysplasia (BPD) Bronchopulmonary Dysplasia Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases and Pregnancy Complications Infant, Newborn, Diseases Infant, Premature, Diseases Lung Diseases Lung Injury Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Respiratory Tract Diseases Urogenital Diseases Ventilator-Induced Lung Injury

Age range

24 week–29 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Papageorgiou General Hospital

Thessaloniki, Greece

Location status: Recruiting

Location contact

Maria Lithoxopoulou, Assistant Professor

PRINCIPAL_INVESTIGATOR

Maria Lithoxopoulou, MD, PhD, MBA, Ass. Prof.

CONTACT

[email protected], [email protected]

+30 6932883161

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Enteral supplementation with ARA and DHA (in a 2:1 ratio) in addition to standard care and feeding

Dietary 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 feeding

Other

The control group will receive routine clinical care and nutritional support according to current neonatal unit protocols, without additional ARA/DHA supplementation.

Primary outcomes

  1. The presence or absence of bronchopulmonary dysplasia (BPD), as assessed by the need for respiratory support or supplemental oxygen at 36 weeks postmenstrual age.

    Time frame: Up to 36th week of postmenstrual age

    The occurrence of BPD will be determined based on the requirement for respiratory support or supplemental oxygen at 36 weeks postmenstrual age.

Secondary outcomes

  1. Classification of BPD

    Time frame: Up to 36th week of postmenstrual age

    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).

  2. 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

  3. Need of respiratory support

    Time frame: Up to 40th week of postmenstrual age

    The number of days requiring respiratory support (mechanical ventilation, continuous positive airway pressure (CPAP), high flow nasal cannula 3L/min or oxygen therapy).

  4. Mean oxygen demand (FiO2) during respiratory support

    Time frame: Up to 40th week of postmenstrual age

  5. Mean tidal volume (ml/kg) during respiratory support

    Time frame: Up to 36th week of postmenstrual age

  6. Mean respiratory rate (RR/min) during respiratory support

    Time frame: Up to 36th week of postmenstrual age

  7. Use of postnatal steroids (yes/no)

    Time frame: Up to 40th week of postmenstrual age

  8. Change in weight z-score from birth to 36 weeks of postmenstrual age

    Time frame: Up to 36th week of postmenstrual age

Study contacts

Contact information is provided by the study sponsor or research team.

Maria Lithoxopoulou, MD, PhD, MBA, Ass. Prof.

CONTACT

[email protected], [email protected]

+30 6932883161

Sponsors and collaborators

Lead sponsor

Aristotle University Of Thessaloniki

Other

Registry information

Official study title

Enteral Lipid Supplementation and Bronchoplumonary Dysplasia of Premature Infants: A Randomized Controlled Trial (The PRELUDE Trial)

Acronym: PRELUDE

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Jun 17, 2026
Registry last updated
Jun 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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