Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06366893
Status:
RECRUITING
Last Update Posted:
2024-04-19
First Post:
2024-01-31
Brief Title:
Enteral Supplementation With Docosahexaenoic Acid and Arachidonic Acid DHA-AA in Preterm Infants
Sponsor:
Hospital Universitari Vall dHebron Research Institute
Organization:
Hospital Universitari Vall dHebron Research Institute
Study Overview
Official Title:
Enteral Supplementation With Docosahexaenoic Acid and Arachidonic Acid DHA-AA in Preterm Infants Single-center Prospective Randomized Controlled Open-label Clinical Trial
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 DHAAA in a safe tolerated and effective manner This approach aims to avoid the decline in DHAAA 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 dHebron University Hospital in Barcelona
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 DHAAA in a safe tolerated and effective manner This approach aims to avoid the decline in DHAAA 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 dHebron University Hospital in Barcelona
Detailed Description:
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 mothers 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 mothers 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 mothers 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 mgkgday 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
The external contribution after birth is mainly based on that provided through the mothers 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 mothers 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 mothers 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 mgkgday 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None