Objective: The purpose of this study is to describe the recruitment and ret
ention strategies as well as the sample demographics for families with infa
nts 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 infant
s who were confined to the neonatal intensive care unit. (NICU) and well ba
bies with at least one risk indicator were targeted for behavioral audiomet
ric follow-up testing. In addition, infants without risk factors from the w
ell-baby nursery, but who failed a newborn test, were also followed. Severa
l variables were evaluated to determine those factors, if any, that might p
redict which families returned for follow-up testing,
Results: Recruitment was achieved as per study design with 4911 high-risk i
nfants and 2348 well-baby nursery infants (without risk indicators for hear
ing) enrolled, Of the 4911 high-risk infants enrolled, 64% were successfull
y recruited into the follow-up portion of the study. This was less than the
projected rate of 80%, Factors predicting noncompliance with the study pro
tocol for follow-up were predominantly sociodemographic and included nonwhi
te race, no insurance, substance abuse, young maternal age, more than two c
hildren at home, and late onset of prenatal care.
Conclusions: Factors related to low socioeconomic status and increased soci
al risk were the strongest predictors of poor study protocol compliance, De
spite retention challenges, 64% of the targeted, high-risk infants subseque
ntly returned for the 8-to 12-mo behavioral hearing assessment protocols fo
r validation purposes.