The unproven value of neonatal follow-up programs compromises their support, particularly for indigent high-risk infants who have a high mortality and morbidity throughout their first year. Our primary aim is to assess whether a follow-up program specially designed for these infants reduces their mortality by 50% and total days of pediatric intensive care by 33% between nursery discharge and one year. We will also assess whether a) the intervention reduces loss to follow-up by 75% and emergency room visits by 33%, b) the cost of the intervention is totally or largely offset by savings in intensive care days, and c) cost-effectiveness expressed as estimated incremental cost per additional survivor is much less than that reported for newborn intensive care at the same birth weight. Our hypotheses are supported by findings at 1 year for 121 infants in clinical trial for which local funding will cease. For a power > 0.80 (alpha error = 0.05), we propose to assess 762 infants 1001-1500 g at birth with respiratory failure in the first 24 h or < 1000 g at birth. (This large sample of high risk infants is feasible within the study period because our center is responsible for all indigent patients in a population of 1.84 million). 74% of study infants are Black or Mexican American, 51% have mothers with < 12 years education, and > 20% of the mothers abuse drugs or alcohol; with conventional follow-up care, 40% of the infants are lost to follow-up, 33% are rehospitalized, and 10% die after nursery discharge. Infants are randomized to our conventional care (including well baby care, developmental assessment, and care for chronic disorders) or to the intervention which also includes special measures to establish maternal rapport before the first clinic visit; foster grandmothers when needed (from the same socioeconomic background), assurance of transportation to the clinic, and primary care from an experienced and well supervised nurse practitioner or child health associate, available in the clinic 5 d/wk and by phone 24 hrs/d. Emphasis is placed on preventing mild to moderate problems from becoming life threatening. To avoid biased results, both groups receive care from the same personnel, treatment regimens are carefully standardized, compliance is monitored, and outcome is assessed by blinded evaluators using coroner and local hospital records. Demonstration that the intervention is life saving and cost effective would facilitate improved access to and higher quality of follow-up care for indigent high- risk populations.
