Bronchopulmonary Dysplasia (BPD)
Conditions
Keywords
BPD, preterm infant, nutrition, ARA, DHA, respiratory support, prematurity
Brief summary
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).
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.
Interventions
DIETARY_SUPPLEMENTEnteral 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.
OTHERStandard 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.
Sponsors
Aristotle University Of Thessaloniki
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Masking description
The statistician will also be masked.
Eligibility
Sex/Gender
ALL
Age
24 Weeks to 29 Weeks
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The presence or absence of bronchopulmonary dysplasia (BPD), as assessed by the need for respiratory support or supplemental oxygen at 36 weeks postmenstrual age. | 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
| Measure | Time frame | Description |
|---|---|---|
| Classification of BPD | 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). |
| The presence of comorbidities such as retinopathy of prematurity, necrotizing enterocolitis, intraventricular haemorrhage, periventricular leukomalacia, patent ductus arteriosus, and late-onset sepsis | Up to 40th week of postmenstrual age | — |
| Need of respiratory support | 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). |
| Mean oxygen demand (FiO2) during respiratory support | Up to 40th week of postmenstrual age | — |
| Mean tidal volume (ml/kg) during respiratory support | Up to 36th week of postmenstrual age | — |
| Mean respiratory rate (RR/min) during respiratory support | Up to 36th week of postmenstrual age | — |
| Use of postnatal steroids (yes/no) | Up to 40th week of postmenstrual age | — |
| Change in weight z-score from birth to 36 weeks of postmenstrual age | Up to 36th week of postmenstrual age | — |
Countries
Greece
Contacts
CONTACTMaria Lithoxopoulou, MD, PhD, MBA, Ass. Prof.
Outcome results
None listed