Supplementing preterm infants with DHA and AA for better health
Enteral Supplementation With Docosahexaenoic Acid and Arachidonic Acid (DHA-AA) in Preterm Infants. Single-center, Prospective, Randomized, Controlled, Open-label Clinical Trial
NA · Hospital Universitari Vall d'Hebron Research Institute · NCT06366893
This study is testing if giving preterm babies extra DHA and AA in their first weeks of life can improve their health and brain development.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | N/A to 7 Days |
| Sex | All |
| Sponsor | Hospital Universitari Vall d'Hebron Research Institute (other) |
| Locations | 1 site (Barcelona) |
| Trial ID | NCT06366893 on ClinicalTrials.gov |
What this trial studies
This study aims to address the deficiency of docosahexaenoic acid (DHA) and arachidonic acid (AA) in preterm infants, which is critical for their health and neuronal development. By providing enteral supplementation of DHA and AA during the first weeks of life, the study seeks to increase the levels of these essential fatty acids in the red blood cell membranes of preterm infants. The study is a single-center, prospective, randomized, controlled, open-label design conducted at Vall d'Hebron University Hospital in Barcelona, focusing on infants born between 23 and 32 weeks of gestation.
Who should consider this trial
Good fit: Ideal candidates for this study are preterm infants born between 23 and 32 weeks of gestation who are admitted to the Neonatology Department.
Not a fit: Patients with severe malformations incompatible with life or those unable to receive enteral nutrition during the study period will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce neonatal morbidity and improve developmental outcomes in preterm infants.
How similar studies have performed: While specific supplementation of DHA and AA in preterm infants is not standard practice, similar approaches have shown promise in improving outcomes in other studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Newborns with a gestational age between 23 and 32 weeks admitted to the Neonatology Service of the Vall d'Hebron University Hospital and with informed consent signed by the parents or legal guardians. Exclusion Criteria: * Severe malformation incompatible with life. * Impossibility of enteral nutrition during the expected duration of the study (30 days).
Where this trial is running
Barcelona
- Hospital Materno Infantil Vall d'Hebron — Barcelona, Spain (RECRUITING)
Study contacts
- Principal investigator: Félix Castillo Salinas, Dr. — Hospital Vall d'Hebron
- Study coordinator: Félix Castillo Salinas, Dr.
- Email: felix.castillo@vallhebron.cat
- Phone: +34934893899
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Infant, Premature, Diseases, docosahexaenoic acid, arachidonic acid, erythrocyte membrane, preterm infants, supplementation