The goal of the Language and Behavioral Outcomes of Children with Congenital Hearing Loss: Family Perspective Study II project is to prospectively examine the language, communication, behavior and adaptive skills of early identified children with minimal (unilateral or bilateral
Intraventricular hemorrhage (IVH) or hemorrhage into the germinal matrix tissues of the developing brain, results in significant neurodevelopmental handicap. Our multicenter, randomized, placebo-controlled trial demonstrated that indomethacin significantly lowered the evidence and decreased the severity of IVH in those very low birth weight (VLBW) preterm infants with no evidence for IVH at 6 to 12 postnatal hours, our primary analysis population. A secondary trial conducted at the same time showed no effect of indomethacin for the prevention of existing IVH. Indomethacin has recently been demonstrated to have gender-mediated effects. Although a gender-by-indomethacin effect was not an a priori hypothesis of the application, reanalysis of our data demonstrated that the indomethacin-IVH effect occurred exclusively in male infants. Children randomized to indomethacin had better long-term survival, and male indomethacin subjects exhibited better verbal testing scores during their early grade school years than male placebo children, suggesting this neonatal intervention may produce a long-lasting effect on developmental skills in VLBW preterm infants.
The purpose of the study is to understand the learning abilities of children born prematurely who have been participating in our multicenter trial to reduce the incidence of brain hemorrhage in preterm infants. Previous assessments were done at 3, 4-1/2, 6, 8, and for some children at 12 years of age.
A neurological, developmental, behavioral, and attention assessment will be completed at 12 years and 16 years. The neurological assessment evaluates coordination and reflexes. The developmental assessment evaluates language, overall knowledge, perception, attention, memory skills, reading, and mathematics. A psychometrist will administer the tests, and a developmental pediatrician will do the neurological. Most tests are similar to those done at the previous visit. The developmental tests will take 120-180 minutes and the neurological exam will take about 30 minutes. The mother will complete questionnaires about her child's behavior, which will take about 60 minutes. Speech language testing will take 60 to 90 minutes.
The proposal is a reapplication from the Brown Medical School to participate in the Cooperative Multi-Center Neonatal Research Network (RFA-HD-04-010). Abbot Laptook, M.D., will serve as the Principle Investigator, the Co-Investigator (Alternate) will be William Oh, M.D., and the Follow-up Investigator will be Betty Vohr, M.D. The primary teaching hospital of Brown for this proposal is Women and Infants' Hospital of Rhode Island (WIHRI). The Neonatal Intensive Care Unit (NICU) of WIHRI has a 60+ bed capacity and serves as the sole level III NICU in Southeastern New England. Adjoining WIHRI is Hasbro Children's Hospital, which provides all needed specialized pediatric services for radiologic, surgical, and other subspecialty services. There are a number of considerations that justify Brown as one of the sites for the Network. First, Brown is the sole regional provider of perinatal services in Southeastern New England and thus provides a population that represents a geographic region. The stability of the number of deliveries, number of infants with a birth weight