OBJECTIVE: The purpose of this study is to describe the recruitment and retention strategies as well as the sample demographics for families with infants completing the neonatal examination and returning for follow-up. These data are compared to those infants inactivated from the study. DESIGN: This study was a prospective, randomized clinical study. All infants who were confined to the neonatal intensive care unit (NICU) and well babies with at least one risk indicator were targeted for behavioral audiometric follow-up testing. In addition, infants without risk factors from the well-baby nursery, but who failed a newborn test, were also followed. Several variables were evaluated to determine those factors, if any, that might predict which families returned for follow-up testing. RESULTS: Recruitment was achieved as per study design with 4911 high-risk infants and 2348 well-baby nursery infants (without risk indicators for hearing) enrolled. Of the 4911 high-risk infants enrolled, 64% were successfully recruited into the follow-up portion of the study. This was less than the projected rate of 80%. Factors predicting noncompliance with the study protocol for follow-up were predominantly sociodemographic and included nonwhite race, no insurance, substance abuse, young maternal age, more than two children at home, and late onset of prenatal care. CONCLUSIONS: Factors related to low socioeconomic status and increased social risk were the strongest predictors of poor study protocol compliance. Despite retention challenges, 64% of the targeted, high-risk infants subsequently returned for the 8-to 12-mo behavioral hearing assessment protocols for validation purposes.
RCT Entities:
OBJECTIVE: The purpose of this study is to describe the recruitment and retention strategies as well as the sample demographics for families with infants completing the neonatal examination and returning for follow-up. These data are compared to those infants inactivated from the study. DESIGN: This study was a prospective, randomized clinical study. All infants who were confined to the neonatal intensive care unit (NICU) and well babies with at least one risk indicator were targeted for behavioral audiometric follow-up testing. In addition, infants without risk factors from the well-baby nursery, but who failed a newborn test, were also followed. Several variables were evaluated to determine those factors, if any, that might predict which families returned for follow-up testing. RESULTS: Recruitment was achieved as per study design with 4911 high-risk infants and 2348 well-baby nursery infants (without risk indicators for hearing) enrolled. Of the 4911 high-risk infants enrolled, 64% were successfully recruited into the follow-up portion of the study. This was less than the projected rate of 80%. Factors predicting noncompliance with the study protocol for follow-up were predominantly sociodemographic and included nonwhite race, no insurance, substance abuse, young maternal age, more than two children at home, and late onset of prenatal care. CONCLUSIONS: Factors related to low socioeconomic status and increased social risk were the strongest predictors of poor study protocol compliance. Despite retention challenges, 64% of the targeted, high-risk infants subsequently returned for the 8-to 12-mo behavioral hearing assessment protocols for validation purposes.
Authors: Lenore Holte; Elizabeth Walker; Jacob Oleson; Meredith Spratford; Mary Pat Moeller; Patricia Roush; Hua Ou; J Bruce Tomblin Journal: Am J Audiol Date: 2012-05-14 Impact factor: 1.493