An interventional study of DHA/AA emulsion supplement for preterm infant in Infant, Premature, Diseases, sponsored by Hospital Universitari Vall d'Hebron Research Institute. Status unknown at 1 site in Spain. Open to participants aged Up to 7 Days, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-19.
Sponsored by Hospital Universitari Vall d'Hebron Research Institute · Not applicable, Interventional, and Prevention
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.
Polyunsaturated fatty acids (PUFAs), especially DHA and AA, are essential fatty acids that have a high relevance in the growth and development of the fetus and newborn. Preterm infants are at high risk of suffering from a deficiency of these essential fatty acids. This deficit would cause serious visual impairments and alterations in neuronal development, as well as an increase in morbidity in these patients.
The external contribution after birth is mainly based on that provided through the mother's own milk (premature milk) and when it is not sufficient, it is supplemented with bank milk. This enteral milk intake is not complete until after the first week of life. In addition, the proportion of bank milk administered in this phase is higher than the mother's own milk. This bank milk has a lower concentration of DHA mainly.
If complete enteral feeding is not achieved until 10 days of age and this is mainly done at the expense of bank milk with a lower DHA content than the mother's premature milk, it seems reasonable to directly supplement the preterm infant with DHA and AA from the first days of life as indicated with other fortifications and thus avoid the risk of deficiency and its consequences. This intake should be similar to that of assimilated intrauterine: 50-60 mg/kg/day. Despite these statements, specific and direct supplementation of DHA and AA is not carried out as standard clinical practice in preterm infants. They have only been carried out in the context of studies.
Enteral supplementation of DHA and AA during the first month of life in the preterm newborn will ensure optimal levels of DHA and AA similar to those achieved in intrauterine life, which will be essential for the correct growth of the newborn and its optimal neuronal development.
This supplementation is not a common healthcare practice in the Neonatology Departments. Our study proposes a safe and effective way to avoid DHA and AA deficiency in the first days of life and its consequences.
103 studies on the registry are indexed under Infant, Premature, Diseases; 18 are open to participants now.
This study's planned enrollment of 80 is above the median of 63 across 67 interventional studies indexed under Infant, Premature, Diseases.
Browse Infant, Premature, Diseases studies →Hospital Universitari Vall d'Hebron Research Institute is the lead sponsor of 275 studies on the registry; 63 are open to participants now.
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The study group will be supplemented with DHA and AA emulsion for 28 days. Patients will be followed up until hospital discharge. The emulsion will be administered by nasogastric or orogastric tube together with the scheduled milk intake (from the bank or the mother's own with a differentiated amount of supplementation depending on the type of milk administered and the infant's weight).
Dietary Supplement: DHA/AA emulsion supplement for preterm infant
The control group will not be supplemented with DHA and AA emulsion. Patients will be followed up until hospital discharge.
Enteral supplementation of DHA/AA emulsion
Percentage comparison of erythrocyte membrane levels of DHA and AA
Compare the percentage erythrocyte membrane levels of DHA and AA during the first month of life between the supplemented group and the control group.
Time frame: 4 weeks
Tolerance of DHA emulsion administration
Number of days when enteral nutrition prescriptions have had to be suspended.
Time frame: 4 weeks
Compare the presence of pathologies in preterm infants between the supplemented group and the control group
Tracking data related to: * Bronchopulmonary dysplasia (BPD) * Retinopathy of prematurity (ROP) * Sepsis * Necrotizing enterocolitis: * Intraventricular hemorrhage and periventricular leukomalacia
Time frame: 4 weeks
Plan to share: No
This study is status unknown, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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