Patient, Family, and Center-Based Factors Associated with Attrition in Neonatal Clinical Research: A Prospective Study.

BACKGROUND: Attrition, or loss to follow-up, presents a significant threat to the integrity and validity of longitudinal clinical research. Little is known about predictors of attrition in neonatal clinical research, and no prior studies have examined how families' experiences participating in research with their infants influences study compliance. OBJECTIVE: To identify novel factors that were associated with attrition over 1 year of study follow-up among preterm infants enrolled in the multicenter Prematurity and Respiratory Outcomes Program (PROP) observational study. METHODS: At discharge, research coordinators estimated the likelihood of attrition. The parents completed questionnaires about their experience with the study at discharge and at 1 year corrected age. The primary endpoint was completion of 4 PROP interviews during the first year. Logistic models were used to evaluate the associations between infant, family, and center-based characteristics and attrition. RESULTS: Among 318 children, 283 (89%) met the primary endpoint. In bivariate analyses, lower maternal education, more people in the household, public insurance, and site were associated with attrition (p < 0.05). Parent survey responses, infant characteristics, and site characteristics were unrelated to attrition. Coordinators' prediction of attrition was associated with completion of early study interviews; this effect waned over time. In multivariable analyses, lower maternal education and more people in the household were the factors most strongly associated with attrition. CONCLUSION: Future neonatal research should evaluate novel strategies to decrease the burden associated with study participation and reinforcement of study goals with families who have lower educational levels to facilitate participation and decrease attrition bias.

Developmental outcomes of children with congenital diaphragmatic hernia: a multicenter prospective study.

PURPOSE: To determine developmental outcomes and associated factors in patients with congenital diaphragmatic hernia (CDH) at 2 years of age. METHODS: This is a multicenter prospective study of a CDH birth cohort. Clinical and socioeconomic data were collected. Bayley Scales of Infant Development (BSID-III) and Vineland Adaptive Behavior Scales (VABS-II) were performed at 2 years of age. RESULTS: BSID-III and VABS-II assessments were completed on 48 and 49 children, respectively. The BSID-III mean cognitive, language, and motor scores were significantly below the norm mean with average scores of 93 ± 15, 95 ± 16, and 95 ± 11. Ten percent (5/47) scored more than 2 standard deviations below the norm on one or more domains. VABS-II scores were similar to BSID-III scores with mean communication, daily living skills, social, motor, adaptive behavior scores of 97 ± 14, 94 ± 16, 93 ± 13, 97 ± 10, and 94 ± 14. For the BSID-III, supplemental oxygen at 28 days, a prenatal diagnosis, need for extracorporeal membrane oxygenation (ECMO) and exclusive tube feeds at time of discharge were associated with lower scores. At 2 years of age, history of hospital readmission and need for tube feeds were associated with lower scores. Lower socioeconomic status correlated with lower developmental scores when adjusted for significant health factors. CONCLUSION: CDH patients on average have lower developmental scores at 2 years of age compared to the norm. A need for ECMO, oxygen at 28 days of life, ongoing health issues and lower socioeconomic status are factors associated with developmental delays.