Infant, Premature, DiseasesNCT06366893
Enteral Supplementation With Docosahexaenoic Acid and Arachidonic Acid (DHA-AA) in Preterm Infants
A study testing DHA/AA emulsion supplement for preterm infant in people with Infant, Premature, Diseases, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 7 daysHealthy volunteers can take part
- Conditions the study is for
- Infant, Premature, Diseases
- What is being tested?
- DHA/AA emulsion supplement for preterm infant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSpain
- Study dates
- 4 Mar 2024to 4 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 7 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- Severe malformation incompatible with life.
- Impossibility of enteral nutrition during the expected duration of the study (30 days).
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Materno Infantil Vall d'Hebron
Barcelona, 08035
Félix Castillo Salinas, Dr., +34 934893899, felix.castillo@vallhebron.cat
Félix Castillo Salinas, Dr.
About this study
Official title: Enteral Supplementation With Docosahexaenoic Acid and Arachidonic Acid (DHA-AA) in Preterm Infants. Single-center, Prospective, Randomized, Controlled, Open-label Clinical Trial
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.
Read the 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 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.
- Conditions
- Infant, Premature, Diseases
- Being tested
- DHA/AA emulsion supplement for preterm infant
- Keywords
- docosahexaenoic acid, arachidonic acid, erythrocyte membrane, preterm infants, supplementation
- Medical subject headings
- Infant, Premature, Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DHA/AA emulsion supplement for preterm infantDietary supplement
Enteral supplementation of DHA/AA emulsion
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | 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). Receives: Dietary Supplement: DHA/AA emulsion supplement for preterm infant |
| Control group | No intervention | The control group will not be supplemented with DHA and AA emulsion. Patients will be followed up until hospital discharge. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks
Secondary outcomes (2)
Tolerance of DHA emulsion administration
Number of days when enteral nutrition prescriptions have had to be suspended.
Measured: 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
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2024
- Study start4 Mar 2024
- Primary completion4 Mar 2025 (estimated)
- Study completion4 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Infant, Premature, DiseasesStudies of the same condition, open and under way.
- More trials run by Hospital Universitari Vall d'Hebron Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Félix Castillo Salinas, Dr., Principal investigator, Hospital Vall d'Hebron
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06366893
- Sponsor's protocol ID
- PR(AG)297/2019
- Status last verified
- Apr 2024
- First submitted
- 31 Jan 2024
- Last updated
- 19 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Castillo Salinas F, Montaner Ramon A, Castillo Ferrer FJ, Domingo-Carnice A, Cordobilla B, Domingo JC. Erythrocyte Membrane Docosahexaenoic Acid (DHA) and Lipid Profile in Preterm Infants at Birth and Over the First Month of Life: A Comparative Study with Infants at Term. Nutrients. 2022 Nov 22;14(23):4956. doi: 10.3390/nu14234956.
PubMed 36500985Castillo F, Castillo-Ferrer FJ, Cordobilla B, Domingo JC. Inadequate Content of Docosahexaenoic Acid (DHA) of Donor Human Milk for Feeding Preterm Infants: A Comparison with Mother's Own Milk at Different Stages of Lactation. Nutrients. 2021 Apr 15;13(4):1300. doi: 10.3390/nu13041300.
PubMed 33920807
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enteral Supplementation With Docosahexaenoic Acid and Arachidonic Acid (DHA-AA) in Preterm Infants. Single-center, Prospective, Randomized, Controlled, Open-label Clinical Trial
- ClinicalTrials.gov ID
- NCT06366893
- Acronym / sponsor ID
- PR(AG)297/2019
- Conditions
- Infant, Premature, Diseases
- Keywords
- docosahexaenoic acid, arachidonic acid, erythrocyte membrane, preterm infants, supplementation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research InstituteUniversity, hospital or other
- Study start
- 4 Mar 2024 (actual)
- Primary completion
- 4 Mar 2025 (estimated)
- Study completion
- 4 Mar 2025 (estimated)
- First posted
- 16 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Dietary Supplement: DHA/AA emulsion supplement for preterm infantThe 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). |
| Control group | No intervention | –The control group will not be supplemented with DHA and AA emulsion. Patients will be followed up until hospital discharge. |
Who may qualify
- Ages
- Up to 7 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- Severe malformation incompatible with life.
- Impossibility of enteral nutrition during the expected duration of the study (30 days).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DHA/AA emulsion supplement for preterm infantEnteral supplementation of DHA/AA emulsion | Dietary supplement | Study group |
Primary outcome
Percentage comparison of erythrocyte membrane levels of DHA and AA
Time frame: 4 weeks
Compare the percentage erythrocyte membrane levels of DHA and AA during the first month of life between the supplemented group and the control group.
2 secondary outcomes
Tolerance of DHA emulsion administration
Time frame: 4 weeks
Compare the presence of pathologies in preterm infants between the supplemented group and the control group
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2024.
- Background: PubMed 36500985Castillo Salinas F, Montaner Ramon A, Castillo Ferrer FJ, Domingo-Carnice A, Cordobilla B, Domingo JC. Erythrocyte Membrane Docosahexaenoic Acid (DHA) and Lipid Profile in Preterm Infants at Birth and Over the First Month of Life: A Comparative Study with Infants at Term. Nutrients. 2022 Nov 22;14(23):4956. doi: 10.3390/nu14234956.
- Background: PubMed 33920807Castillo F, Castillo-Ferrer FJ, Cordobilla B, Domingo JC. Inadequate Content of Docosahexaenoic Acid (DHA) of Donor Human Milk for Feeding Preterm Infants: A Comparison with Mother's Own Milk at Different Stages of Lactation. Nutrients. 2021 Apr 15;13(4):1300. doi: 10.3390/nu13041300.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Félix Castillo Salinas, Dr. principal investigator
Hospital Vall d'Hebron
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DHA/AA emulsion supplement for preterm infant in people with Infant, Premature, Diseases, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Félix Castillo Salinas, Dr. (+34934893899, felix.castillo@vallhebron.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage comparison of erythrocyte membrane levels of DHA and AA (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06366893, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2024.