Omega Tots Long Term Follow-up

Sarah Keim

Status: Invitation-only

Conditions: Child Development; Preterm Birth

Treatments: Dietary Supplement: Placebo; Drug: Docosahexaenoic Acid + Arachidonic Acid (DHA+AA)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05191823

00001037

R01HD100493 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

This is a continuation study to the Omega Tots trial (NCT01576783). The purpose of this study is to follow-up with participants of the original study to determine the long-term effect a daily fatty acid dietary supplement taken during toddlerhood might have on children born preterm now that they are 8.5-10.5 years old.

Full description

The overall objective with the present study is to determine the long-term effects of docosahexaenoic acid (DHA) plus arachidonic acid (AA) supplementation on general cognitive ability, language, and executive function, and to examine genetic explanations for treatment effects, through one comprehensive study visit with children and parents from the Omega Tots trial cohort (NCT01576783).

Enrollment: 377 estimated patients

Sex: All

Ages: 8 to 10 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Previous participation in Omega Tots (NCT01576783).
• Current age of 8 years, 180 days to 10 years, 180 days.

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

377 participants in 2 patient groups, including a placebo group

Docosahexaenoic Acid + Arachidonic Acid

Experimental group

Description:

Docosahexaenoic Acid + Arachidonic Acid (DHA+AA)

Treatment:

Drug: Docosahexaenoic Acid + Arachidonic Acid (DHA+AA)

Placebo

Placebo Comparator group

Description:

Corn oil supplement

Treatment:

Dietary Supplement: Placebo