Randomized Comparison of Two Models of Post-NICU Care for Preterm Infants With Neonatal Chronic Lung Disease

METHODS Study design A randomized equivalence trial was designed to compare community-based follow up with medical-center based follow up. The primary outcome was assessed at one year adjusted age.

Study participants Infants were recruited in five neonatal intensive care units in northwest North CArolina. These were the only sites providing neonatal intensive care in a twenty-county region in northwest North Carolina. Infants were born between March 1996 and September 1999. Infants were eligible for the study if they were born before 33 weeks gestational age, required supplemental oxygen at 36 weeks gestational age, and were discharged home after neonatal intensive care. Neonates who had major congenital anomalies and/ or had tracheostomy tubes were excluded. Also excluded were families in which the mother did not speak English, because the intervention depended on verbal communication with the nurse specialist, and families who lived more than 150 miles from our clinic because such families typically are referred to regional neonatal center closer to their home.

Randomization A randomization list was prepared by a biostatistician who was not involved in data collection or clinical care of the infants. Lists of randomization assignments, which were kept in a sealed envelope in a locked drawer, were prepared for each of the five sites at which participants were recruited. Randomization assignments were made in blocks sizes of two and four. Once a study participant arrived home from the neonatal intensive care unit, a research assistant uncovered the next assignment on the randomization list, which was kept in a sealed envelope in a locked drawer.

Intervention If the family did not have telephone service at the time of the infant's discharge, a telephone was installed at no cost to the family, within one week of the infant's discharge from the hospital. Research funds were used to reimburse all families for the cost of local phone service for the duration of the study. Families assigned to either intervention could contact the nurse specialist on a toll-free long distance line with voice mail which recorded messages when the phone was not attended.

The intervention team consisted of two neonatologists, a pediatric social worker, and a nurse specialist.