Enteral Lipid Supplementation and Bronchoplumonary Dysplasia of Premature Infants (PRELUDE)

June 11, 2026 updated by: 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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

74

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Greece
      • Thessaloniki, Greece
        • Recruiting
        • Papageorgiou General Hospital
        • Contact:
        • Principal Investigator:
          • Maria Lithoxopoulou, Assistant Professor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Enteral supplementation
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
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.
Active Comparator: Routine practice
Routine clinical care and nutritional support
Other: Standard care and feeding
The control group will receive routine clinical care and nutritional support according to current neonatal unit protocols, without additional ARA/DHA supplementation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 36th week of postmenstrual age

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
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
Up to 40th week of postmenstrual age
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).
Up to 40th week of postmenstrual age
Mean oxygen demand (FiO2) during respiratory support
Time Frame: Up to 40th week of postmenstrual age
Up to 40th week of postmenstrual age
Mean tidal volume (ml/kg) during respiratory support
Time Frame: Up to 36th week of postmenstrual age
Up to 36th week of postmenstrual age
Mean respiratory rate (RR/min) during respiratory support
Time Frame: Up to 36th week of postmenstrual age
Up to 36th week of postmenstrual age
Use of postnatal steroids (yes/no)
Time Frame: Up to 40th week of postmenstrual age
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
Up to 36th week of postmenstrual age

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aristotle University Of Thessaloniki

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 4, 2025

Primary Completion (Estimated)

November 30, 2026

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

May 30, 2026

First Submitted That Met QC Criteria

June 11, 2026

First Posted (Actual)

June 17, 2026

Study Record Updates

Last Update Posted (Actual)

June 17, 2026

Last Update Submitted That Met QC Criteria

June 11, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 393/16-01-2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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