ANTENATAL LATE PRETERM STEROIDS CLINICAL TRIAL (ALPS)
Principal Investigator: Elizabeth Thom, Ph.D.
This trial is funded by NHLBI, it is conducted by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Maternal-Fetal Medicine Units (MFMU) Network.
Preterm birth is the predominant cause of infant morbidity and death. The prevalence of preterm birth, defined as birth before 37 weeks of gestation, is a major public health problem in the United States. Despite many advances in the practice of obstetrics, the preterm birth rate has continued to rise. Almost three quarters of preterm births are between 34 and 36 weeks of gestation, known as "late preterm" birth. Until recently, many obstetricians considered morbidity and mortality in this group of patients to be similar to that of term infants. This has led to a willingness to deliver women for fetal and medical indications or even electively in the late preterm period. However, recent data have shown that late preterm infants do have an increased risk of neonatal and longer term morbidity. Although the risk of death is low, late preterm infants have also been shown to have a higher mortality rate than term infants.
The fetal lung is one of the last organ systems to mature, making respiratory morbidity the most common complication noted in preterm infants. While the probability of a late preterm infant requiring ventilator support in low compared with those born very early, the large number of such births leads to a significant overall disease burden. Antenatal corticosteroids administered as two 12 mg injections of betamethasone 24 hours apart are given as standard of care to enhance fetal lung maturation in women at risk for preterm birth before 34 weeks, and in that population have been shown to reduce neonatal mortality, RDA and intraventicular hemorrhage (IVH). Although data are suggestive of a benefit after 34 weeks, there is not currently sufficient evidence to support the use at 34 weeks or later. This double masked multi-center randomized trial is designed to determine whether a course of antenatal steroids can improve the outcomes, especially respiratory outcomes, of late preterm infants.
The principal objectives are as follows: 1. To determine whether administration of corticosteroids to women with a singleton gestation at risk for delivery in the late preterm period (34 weeks 0 days to 36 weeks 6 days of gestation) reduces the need for neonatal respiratory support; 2. To evaluate whether the administration of antenatal corticosteroids decreases neonatal respiratory and non-respiratory morbidities and mortality; 3. To evaluate whether administration of antenatal corticosteroids decreases admission to the neonatal intensive care unit (NICU) or intermediate care nursery; 4. To evaluate whether administration of antenatal corticosteroids decreases hospital re-admission, ER and unscheduled visits after neonatal discharge up to 6 months of age. Funded by NHLBI Cooperative Agreement 1-U01-HL098354-01, 2010-2013.)