Factors associated with enrollment in a randomized clinical trial of docosahexaenoic supplementation in toddlers born preterm
These videos have been matched automatically. Contact us if they are not relevant.
These videos have been matched automatically. Contact us if they are not relevant.
View abstract on PubMed
Summary
This summary is machine-generated.Factors like caregiver marital status and race, birth weight, and socioeconomic status influenced enrollment in a preterm infant clinical trial. Tailored recruitment strategies are needed to ensure trial participants reflect the broader population.
Area Of Science
- Clinical Trials
- Neonatal Research
- Nutritional Science
Background
- Preterm infants require specialized care and nutritional interventions.
- Docosahexaenoic acid (DHA) supplementation is studied for its benefits in preterm infants.
- Understanding factors influencing clinical trial participation is crucial for generalizability.
Purpose Of The Study
- To identify pre- and postnatal factors associated with participation in a randomized clinical trial of DHA supplementation in preterm infants.
- To compare characteristics of families who enrolled versus those who declined or were non-responsive.
Main Methods
- A randomized clinical trial (Omega Tots) enrolled infants born at <35 weeks' gestation.
- Eligibility data were linked with birth certificates.
- Log-binomial regression analyzed factors associated with enrollment, decline, and non-responsiveness.
Main Results
- Enrollment was negatively associated with caregivers being married or identifying as White, and later gestational age.
- Enrollment was positively associated with low birth weight (<1500g), neonatology clinic attendance, WIC participation, and urban residence.
- Distinct factors influenced enrollment, decline, and non-responsiveness.
Conclusions
- Maternal, child, and socioeconomic characteristics significantly differed between enrolled and non-enrolled families.
- Recruitment strategies must be tailored to enhance participant diversity and improve trial generalizability.
- Addressing disparities in participation is essential for equitable research outcomes.
These videos have been matched automatically. Contact us if they are not relevant.
These videos have been matched automatically. Contact us if they are not relevant.
Related Concept Videos
Drug absorption involves the movement of drugs from the point of administration into the systemic circulation. Initially, Gastrointestinal (GI) motility propels the drug through the digestive tract and into the stomach. However, the stomach's high acidity and limited surface area restrict its role in drug absorption for most drugs. The drug then moves from the stomach to the small intestine via gastric emptying, which can be slowed by various factors, including interactions with other...
When it comes to infants and young children, they are typically administered smaller doses of medication in comparison to adults. This is primarily because their organ functions still need to fully develop, meaning their bodies are not as efficient at metabolizing or eliminating drugs. Additionally, their blood-brain barrier is more permeable than in adults. As a result, high concentrations of drugs can easily penetrate the central nervous system (CNS), potentially leading to neurological...
Pediatric patient dosages diverge from adults due to disparities in body surface area, total body water, and extracellular fluid per kilogram of body weight. The dosing regimen considers the variations in pharmacokinetics and pharmacology across distinct age groups, encompassing preterm newborns, infants, young children, older children, and adolescents. Calculation of pediatric patient doses is predicated on determining body surface area, which exhibits a superior correlation with the child's...
Understanding the physiological differences in the pediatric population is crucial for effective pharmacotherapy. Neonates, infants, and children exhibit significant variations in gastric pH, gastric emptying time, intestinal transit time, and biliary function. These variations profoundly affect oral drug absorption, necessitating a nuanced approach to pediatric dosing.Neonates present with a unique physiological profile, having a gastric pH greater than 4 and faster and more irregular gastric...
Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
Therapeutic Drug Monitoring (TDM) is the clinical practice of measuring specific drug levels in a patient's blood or body tissues to manage and optimize therapy. TDM is crucial for drugs with narrow therapeutic windows, like warfarin and phenytoin, where incorrect doses can lead to treatment failure or severe side effects. This monitoring ensures the dosage administered is within a safe and effective range. The factors affecting therapeutic drug monitoring include:Patient-Specific Factors:a.