Intrauterine drug exposure is a major public health problem affecting approximately 350,000 U.S. newborns each year. This study is based on the premise that drug-exposed infants are at """"""""double-jeopardy"""""""" for developmental problems due to biological vulnerability of intrauterine exposure to drugs, as well as the postnatal environmental challenges which may interfere with stimulating and effective parenting. Few studies have addressed the specific use of home-based nurse interventions for infants with intrauterine drug exposure. The overall objective of this home-based clinical trial is to enhance health, growth and developmental outcomes in drug-exposed infants over an 18 month period by using pediatric nurse specialists (PNS) to monitor the infant's health status and increase maternal/caregiver effectiveness during frequent home visits. The purpose of this randomized clinical trial is to test the effectiveness of the home-based PNS intervention compared to usual care (CON) for drug- exposed infants and their mothers. The PNS group will be provided with counseling sessions prior to nursery discharge; 16 home visits to monitor infant health status and provide informational and emotional support to the caregiver; provision of lay support by a """"""""support person"""""""" identified by the mother, use of SNUGLI device for carrying infants, and 24 hour availability of the PNS by phone. The 206 infants who meet eligibility criteria will be randomized into the PNS or CON group and followed for 24 months. The primary infant outcome measures include (1) morbidity defined as feeding problems, failure to thrive (equal to or more than -1.5 Z score for weight and weight for height), impaired growth and development, and neurological deficits, (2) health care utilization defined as number of hospitalizations and well child care visits, incomplete immunization status by 24 months of age and (3) psychosocial status defined as protective service (PS) referrals and foster care placement (FCP). Follow- up measures will be collected at 3,6,12,18 and 24 months. Statistical analysis will focus on mean differences in morbidity measures, developmental and neurological test scores, number of hospitalizations, PS and FCP referrals between groups. The final multiple regression analyses will allow for interaction effects and joint analyses of multiple data points including weight,developmental and neurological test scores. This study is significant in that it tests a replicable nurse intervention addressing a major public health problem. It is unique in that the study evaluates the role of environmental manipulation (PNS intervention) in treating drug-exposed infants while incorporating a longitudinal follow- up.
