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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
74
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.
Papageorgiou General Hospital
Thessaloniki, Greece
RECRUITINGThe 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
Maria Lithoxopoulou, MD, PhD, MBA, Ass. Prof.
CONTACT
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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