DHA + AA Supplements for Premature Birth Development

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Sarah Keim

Disqualifiers: Child in custody

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how a daily supplement of fatty acids, specifically Docosahexaenoic Acid and Arachidonic Acid (DHA+AA), given to toddlers born preterm, might affect their development now that they are between 8.5 and 10.5 years old. The researchers aim to determine if this supplement provides any long-term benefits for these children. Participants will either continue with the DHA+AA treatment or receive a placebo (a corn oil supplement). Children who participated in the original Omega Tots study and are currently within the specified age range are suitable candidates for this trial. As an unphased trial, this study offers a unique opportunity to contribute to understanding the long-term developmental benefits of DHA+AA supplementation.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether participants need to stop taking their current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that DHA and AA supplements are generally safe for preterm babies. In several studies, babies and toddlers who received these fatty acids grew and developed well. For example, one study found that preterm babies who took DHA and AA had better movement and coordination skills. Another study noted that babies with these supplements grew faster in both height and head size.

These studies reported no major safety issues or negative effects from the supplements, suggesting they are well-tolerated. While the studies mainly focused on growth and development benefits, the absence of negative reports indicates good safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about DHA + AA supplements for premature birth development because they introduce a unique combination of fatty acids that are vital for brain and eye development. Unlike standard treatments, which may focus on overall nutritional support or medications for immediate health concerns, DHA (Docosahexaenoic Acid) and AA (Arachidonic Acid) specifically target neurological and visual development, potentially offering more focused benefits. This combination aims to enhance developmental outcomes more effectively by providing essential building blocks for the rapidly developing nervous system in premature infants.

What evidence suggests that DHA + AA supplements might be an effective treatment for premature birth development?

This trial will compare the effects of Docosahexaenoic Acid + Arachidonic Acid (DHA+AA) supplements with a placebo on the development of infants born prematurely. Research has shown that DHA and AA supplements are crucial for the development of infants, particularly those born early. These fatty acids are essential for the immune system and brain growth. One study found that preterm toddlers who received DHA and AA for 180 days showed improved growth and body composition. Another study suggested that these supplements might enhance brain connectivity, which is vital for learning and processing information. Additionally, DHA and AA supplements may improve breathing in preterm infants, indicating overall health benefits. ^{1 6 7 8 9}

Who Is on the Research Team?

Sarah Keim, PhD

Principal Investigator

Nationwide Children's Hospital

Are You a Good Fit for This Trial?

This trial is for children aged between 8 years and 6 months to 10 years and 6 months who were born prematurely and took part in the original Omega Tots study. Children under the care of child services during their eligibility period cannot participate.

Inclusion Criteria

I am between 8 years, 6 months and 10 years, 6 months old.

Previous participation in Omega Tots (NCT01576783)

Exclusion Criteria

Child in custody of children's services for their window of eligibility

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Follow-up

Participants from the original Omega Tots trial are assessed for long-term effects of DHA+AA supplementation on cognitive and behavioral outcomes

Single study visit

1 visit (in-person)

Data Analysis

Data collected from the follow-up visit is analyzed to determine the long-term effects of supplementation

Ongoing

What Are the Treatments Tested in This Trial?

Interventions

• Docosahexaenoic Acid + Arachidonic Acid (DHA+AA)
• Placebo

Trial Overview The study is examining the long-term effects of a daily dietary supplement containing fatty acids (DHA+AA) given during toddlerhood on the development of children born preterm, now that they are older.

How Is the Trial Designed?

Group I: Docosahexaenoic Acid + Arachidonic Acid Experimental Treatment 1 Intervention

Docosahexaenoic Acid + Arachidonic Acid (DHA+AA)

Group II: Placebo Placebo Group 1 Intervention

Corn oil supplement

Who Is Running the Clinical Trial?

Sarah Keim

Lead Sponsor

Trials

6

Recruited

1,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7443757/

Docosahexaenoic and Arachidonic Acid Supplementation ... The aim of the trial was to examine the effects of supplementing toddlers born preterm with DHA and arachidonic acid (AA) for 180 d on growth and adiposity.

2. clinicalnutritionjournal.com clinicalnutritionjournal.com/article/S0261-5614(23)00416-8/fulltext

Arachidonic and docosahexaenoic acid supplementation ... This study suggests that supplementation with ARA and DHA at doses matching estimated fetal accretion rates improves WM maturation compared to ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36473425/

Effect of arachidonic and docosahexaenoic acid ... Conclusions: Supplementation with ARA and DHA to preterm infants was safe and might have a beneficial effect on respiratory outcomes. Clinical trial ...

4. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/183204

Neurodevelopmental Outcomes of Preterm Infants Fed ... Context Uncertainty exists about the benefit of dietary docosahexaenoic acid (DHA) on the neurodevelopment of preterm infants.

5. sciencedirect.com sciencedirect.com/science/article/pii/S0261561424001055

Arachidonic acid and docosahexaenoic acid levels ... AA and DHA play key roles in infant development, including immune system maturation and neurodevelopment. The content of LCPUFAs in cell membranes influences ...

6. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2784994

Association of Docosahexaenoic Acid and Arachidonic ... Very preterm infants who received formula with 2:1 AA to DHA during their first year of life had better psychomotor development than infants who ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S0261561423004168

Arachidonic and docosahexaenoic acid supplementation ... In our study, the ARA:DHA supplemented infants exhibited significantly faster linear growth from birth to TEA. Head circumference growth was also faster, but ...

8. nature.com nature.com/articles/pr2005116

Body Composition in Preterm Infants Who Are Fed Long ... The results of the present study suggest that DHA- and ARA-supplemented infant formulas can be fed to preterm infants for their neurodevelopment and visual ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8517742/

Association of Docosahexaenoic Acid and Arachidonic Acid ... In this study, higher DHA levels were associated with less severe ROP in infants with sufficiently high AA levels.