Enteral Lipid Supplementation and Bronchoplumonary Dysplasia of Premature Infants

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age24-29
SponsorAristotle University Of Thessaloniki

About this 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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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 intervention

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

Treatment groups

74 Participants
are divided into 2 treatment groups
Group A: Enteral supplementationExperimental treatment 1 intervention
Group B: Routine practiceActive comparator 1 intervention

Trial outcomes

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.

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

Secondary outcomes

1

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
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

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
4

Mean oxygen demand (FiO2) during respiratory support

Time frame
Up to 40th week of postmenstrual age

Other outcomes

Sponsors and contacts

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