RecruitingNot ApplicableNCT06366893

Enteral Supplementation With Docosahexaenoic Acid and Arachidonic Acid (DHA-AA) in Preterm Infants

Enteral Supplementation With Docosahexaenoic Acid and Arachidonic Acid (DHA-AA) in Preterm Infants. Single-center, Prospective, Randomized, Controlled, Open-label Clinical Trial


Sponsor

Hospital Universitari Vall d'Hebron Research Institute

Enrollment

80 participants

Start Date

Mar 4, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

Docosahexaenoic acid (DHA) and arachidonic acid (AA) have a critical effect on the health and neuronal development of the fetus and newborn. Their deficiency has been associated with increased neonatal morbidity, especially in preterm newborns at birth. Direct DHA supplementation during the first few weeks of life could prevent this deficiency. The aim is to increase DHA levels in the red blood cell membrane while maintaining the fetal proportion to AA in preterm infants through enteral administration of DHA/AA in a safe, tolerated, and effective manner. This approach aims to avoid the decline in DHA/AA levels and the consequences of their deficiency. The study is a single-center, prospective, randomized, controlled, open-label study involving preterm infants admitted to the Neonatology Department of Vall d'Hebron University Hospital in Barcelona.


Eligibility

Max Age: 7 Days

Inclusion Criteria1

  • 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 Criteria2

  • Severe malformation incompatible with life.
  • Impossibility of enteral nutrition during the expected duration of the study (30 days).

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Interventions

DIETARY_SUPPLEMENTDHA/AA emulsion supplement for preterm infant

Enteral supplementation of DHA/AA emulsion


Locations(1)

Hospital Materno Infantil Vall d'Hebron

Barcelona, Spain

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NCT06366893


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