High-dose docosahexaenoic acid supplementation of preterm infants: respiratory and allergy outcomes.
Brett J Manley, Maria Makrides, Carmel T Collins...
https://pubmed.ncbi.nlm.nih.gov/21708809/Actively Recruiting
Led by Aristotle University Of Thessaloniki · Updated on 2026-06-17
74
Participants Needed
1
Research Sites
13 weeks
Total Duration
This research aims to evaluate the effect of supplementing extremely and very preterm infants, born between 24 and 29 weeks of gestational age, with omega-3 DHA and omega-6 ARA fatty acids on the development of bronchopulmonary dysplasia BPD. The study is focused on preventing BPD, a lung condition in premature infants, by comparing infants who receive this supplementation to those who receive standard care. Participants in the intervention group will receive enteral supplementation containing ARA and DHA in a 21 ratio starting within the first three days of life and continuing until 36 weeks postmenstrual age. The control group will receive routine clinical care and nutritional support without the additional supplementation. Both groups will be monitored until 36 weeks postmenstrual age. During the study, infants will be assessed for the presence or absence of BPD based on their need for respiratory support or supplemental oxygen at 36 weeks postmenstrual age. Additional outcomes include the classification of BPD, occurrence of related complications, respiratory support needs, oxygen and ventilation measures, steroid use, and growth changes. The study lasts from birth until 36 to 40 weeks postmenstrual age, with regular clinical evaluations conducted throughout this period.
CONDITIONS
Enteral Lipid Supplementation and Bronchoplumonary Dysplasia of Premature Infants
M
Maria Lithoxopoulou, MD, PhD, MBA, Ass. Prof.
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Aristotle University Of Thessaloniki
Lead Sponsor
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 36 weeks postmenstrual age
Participants receive either enteral supplementation with ARA and DHA or routine clinical care and nutritional support starting within the first three days of life until 36 weeks postmenstrual age.
Regular clinical assessments during hospitalization
Duration - Up to 4 weeks after treatment ends
Researchers monitor participants for the presence or absence of bronchopulmonary dysplasia and related health outcomes up to 40 weeks postmenstrual age.
Clinical evaluations at scheduled intervals
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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Lead Sponsor