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Recruitment and retention in a clinical trial for low birth weight, premature infants
W L Constantine1, C W Haynes, D Spiker
1Statewide Office of Family Court Services, Administrative Office of the Courts, San Francisco, California.
Insights
Recruiting premature infants for clinical trials can have biases related to maternal race, birth weight, and education. However, the study found no issues with sample representativeness or treatment group differences.
Area of Science:
- Neonatal research
- Clinical trial methodology
- Pediatric epidemiology
Background:
- Recruiting and retaining participants in clinical trials, especially vulnerable populations like premature infants, presents unique challenges.
- Understanding and mitigating sampling and retention biases are crucial for the validity of clinical trial results.
Purpose of the Study:
- To report on the recruitment and retention processes for a clinical trial involving low birth weight, premature infants.
- To evaluate the presence and impact of sampling and retention biases in this specific cohort.
- To assess the representativeness of the final sample and the balance of treatment groups.
Main Methods:
- Screening of 4551 infants, with 1302 deemed eligible for the trial.
- Obtaining informed consent from 1028 infants, leading to the enrollment of 985 participants (75.7% of eligible).
- Statistical analyses to identify factors associated with nonenrollment (recruitment bias) and participant dropout (retention bias), including interactions with treatment.
Main Results:
- Significant recruitment biases were linked to study site, maternal race, and infant birth weight.
- Retention bias was significantly associated with maternal education level.
- Infant birth weight and maternal age interacted with treatment assignment in predicting dropout.
- Despite identified biases, the final sample was representative of the target population, and treatment groups were balanced on key background variables.
Conclusions:
- While significant recruitment and retention biases were observed in this trial of premature infants, these did not compromise sample representativeness or treatment group comparability.
- Careful monitoring and statistical evaluation are essential for managing biases in clinical trials involving high-risk pediatric populations.
- The findings underscore the importance of addressing socioeconomic and demographic factors in clinical trial design and execution.
Abstract:
We report on recruiting and retaining a sample of low birth weight, premature infants for a clinical trial as well as results of tests evaluating sampling and retention biases. A total of 4551 infants were screened, and 1302 were found eligible. Consent was obtained for 1028 infants. After randomization and the presentation of group assignment, the number of infants enrolled was 985 (75.7% of those eligible). Of these, 92.7% completed the 3-year study. Tests to evaluate recruitment bias revealed significant relationships between nonenrollment and site, maternal race, and infant birth weight. Tests to evaluate retention bias revealed a significant relationship between dropout and maternal education. Additionally, infant birth weight and maternal age interacted with treatment in predicting dropout. Despite these statistically significant recruitment and retention biases, there was no evidence of problems with sample representativeness to the population of interest or of treatment group differences on study-relevant background variables.