Factors associated with enrollment in a randomized clinical trial of docosahexaenoic supplementation in toddlers born preterm.
Background/aims: To assess pre- and postnatal factors associated with participation in a randomized clinical trial of daily docosahexaenoic supplementation in toddlers born preterm. We hypothesized that enrolled families would not differ from those who did not participate. Method: Children eligible...
| Published in: | Clinical Trials Vol. 23; no. 1; pp. 99 - 109 |
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| Main Authors: | , , , , |
| Format: | research tables/charts Journal Article |
| Published: |
Sage Publications, Ltd.
Feb2026
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| Online Access: | View this record in EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=191613668&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 191613668 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 17407745 AB6 jtl: Clinical Trials issn: 17407745 maglogo: N pubinfo: dt: Feb2026 vid: 23 iid: 1 pid: 33180 pub: Sage Publications, Ltd. place: <Blank> artinfo: ui: 191613668 190564583 191613668 191613668 10.1177/17407745251387983 191613668 ppf: 99 ppct: 10 formats: tig: atl: Factors associated with enrollment in a randomized clinical trial of docosahexaenoic supplementation in toddlers born preterm. aug: au: Boone, Kelly M Miglin, Amanda Taylor, Paige L Klebanoff, Mark A Keim, Sarah A affil: Center for Biobehavioral Health, Abigail Wexner Research Institute at Nationwide Children's Hospital, Columbus, OH, USA sug: subj: Research Subject Recruitment Randomized Controlled Trials Dietary Supplementation Docosahexaenoic Acids Therapeutic Use Infant, Premature Sociodemographic Factors Funding Source Human Infant, Newborn Prospective Studies Record Review Logistic Regression Odds Ratio Confidence Intervals Caregivers Marital Status Descriptive Statistics Docosahexaenoic Acids Administration and Dosage Drug Compounding Arachidonic Acids Administration and Dosage Corn Oil Administration and Dosage Data Analysis Software Univariate Statistics Birth Weight Infant, Newborn: birth-1 month ab: Background/aims: To assess pre- and postnatal factors associated with participation in a randomized clinical trial of daily docosahexaenoic supplementation in toddlers born preterm. We hypothesized that enrolled families would not differ from those who did not participate. Method: Children eligible for the Omega Tots trial were born at <35 completed weeks' gestation and were 10–16 months of age at recruitment. Eligibility data abstracted from the medical record were linked with the child's birth certificate. The primary outcome was whether the family enrolled, declined, or was non-responsive to recruitment efforts. Log-binomial regression calculated risk ratios (RR). Results: 316 families enrolled, 1089 declined, and 1081 were non-responsive. Enrolling, rather than not enrolling, was negatively associated with caregivers being married (RR = 0.76, 95% CI: 0.62, 0.94), identifying as White (RR = 0.76, 95% CI: 0.60, 0.94), and children being born at later gestational ages (RR1-week = 0.96, 95% CI: 0.92, 0.99); positively associated with children weighing <1500 g at birth (RR = 1.26, 95% CI: 1.01, 1.55), attending a neonatology specialty clinic (RR = 1.46, 95% CI: 1.19, 1.80), family participation in WIC (RR = 1.39, 95% CI: 1.13, 1.72), and living in an urban zip code (RR = 1.68, 95% CI: 1.30, 2.17). Varied associations with enrolling rather than declining, enrolling rather than being non-responsive, and declining rather than being non-responsive were identified. Conclusions: Maternal, child, and socioeconomic characteristics were different for families who enrolled, relative to families who did not enroll. Factors associated with enrollment differed between families who were non-responsive to recruitment attempts and those who declined enrollment, with additional differences identified between families who declined participation and those who were non-responsive. Recruitment initiatives tailored to ensuring enrollees reflect the source population may improve generalizability. pubtype: Academic Journal doctype: research tables/charts Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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