Randomized Trial of 42-Day Compared with 9-Day Courses of Dexamethasone for the Treatment of Evolving Bronchopulmonary Dysplasia in Extremely Preterm Infants.

OBJECTIVE: To compare pulmonary and neurodevelopmental outcomes in extremely preterm infants with evolving bronchopulmonary dysplasia treated with either a 42-day course of dexamethasone or 9-day course(s) of dexamethasone. STUDY DESIGN: This was a prospective, randomized study in 59 infants ≤27 weeks of gestation born between October 2006 and December 2010, who at day 10-21 of life had ventilatory support with mean airway pressure ≥8 cm H2O and FiO2 ≥60%. Infants received dexamethasone 0.5 mg/k/day × 3 days followed by a slow taper (42-day group, n = 30) or dexamethasone 0.5 mg/k/day followed by a rapid taper (9-day group, n = 29). Infants in the 9-day group received additional 9-day courses if they again required entry support. The primary outcome was intact survival (normal neurologic examination, IQ >70, and functioning in school without supplemental educational support) at 7 years of age. RESULTS: The 42-day and 9-day groups were similar for mean gestational age (25 weeks) and all baseline characteristics. Nineteen of 29 infants (66%) in the 9-day group received only 1 course of dexamethasone; therefore, the total steroid dose for the 42-day group (7.56 mg/kg) was significantly greater than that for the 9-day group (4.04 mg/kg), P < .001. Infants in the 42-day group had shorter duration of ventilation (25 vs 37 days), P < .005, received fewer transfusions (2 vs 3.5), P < .01, and reached full enteral feeds earlier (40 vs 46 days), P < .05. Intact survival at school age was significantly increased in the 42-day group (75%) compared with the 9-day group (34%), P < .005. CONCLUSION: A 42-day tapering course of dexamethasone in extremely preterm infants at high risk for bronchopulmonary dysplasia decreased hospital morbidities and increased rate of survival without handicap compared with a treatment protocol that attempted to minimize steroid exposure.

Predictive validity of the Bayley, Third Edition at 2 years for intelligence quotient at 4 years in preterm infants.

OBJECTIVE: To determine the predictive validity of the Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III) at age 2 years for cognitive abilities in preschool children born at ≤ 30 weeks' gestation. METHODS: This prospective regional study included all 187 liveborn infants ≤ 30 weeks' gestation born between July 2005 and June 2006. Of the 172 children who survived to 4 years, 156 (91%) were evaluated at 2 and 4 years. A socioeconomically matched term control group also was recruited to provide normative data. The predictive validity of the Bayley-III cognitive and language scales for the Weschler Preschool and Primary Scale of Intelligence-III (WPPSI-III) was examined through correlation coefficients and sensitivity and specificity of the Bayley-III to predict normal and abnormal cognitive outcomes. RESULTS: Correlations of the WPPSI-III intelligence quotient (IQ) score with the Bayley-III cognitive and language scores were .81 and .78, respectively. The preterm children were classified as normal (Bayley Scales of Infant Development-Third Edition [BSID-III] cognitive score or WPPSI-III IQ score not lower than 1 SD below the control group mean), mild to moderately delayed (scores between 1 and 2 SD deviations below the control group mean), or severely delayed (scores greater than 2 SD below the control group mean). At 2 and 4 years, 126 (81%) preterm children retained the same developmental classification. CONCLUSIONS: In contrast with previous editions of the BSID, the Bayley-III has strong predictive validity for WPPSI-III IQ at age 4 years in preterm children. This has important implications for more timely evaluation of perinatal interventions, establishment of guidelines for neonatal care, and counseling parents.

Follow-up at 15 years of preterm infants from a controlled trial of moderately early dexamethasone for the prevention of chronic lung disease.

OBJECTIVE: Postnatal dexamethasone treatment of ventilator-dependent preterm infants results in rapid improvement in lung function and reduction in chronic lung disease. However, limited data are available on long-term outcomes after such therapy. We studied growth, neurodevelopmental, and pulmonary outcomes at adolescence in children who had participated in a double-blind, placebo-controlled trial of dexamethasone beginning at 2 weeks of age for the prevention of chronic lung disease. METHODS: Thirty-six infants (birth weight < or =1250 g and gestational age < or =30 weeks) who were dependent on mechanical ventilation at 2 weeks of age received a 42-day course of dexamethasone, an 18-day course of dexamethasone, or saline placebo. Twenty-two children survived to 15 years (69% of the 42-day dexamethasone group, 67% of the 18-day dexamethasone group and 45% of the control group), and all were evaluated. Intact survival was defined as survival with normal neurologic examination, IQ >70, and receiving education in the regular classroom. RESULTS: There were no differences among groups for growth or incidence of neurologic abnormalities. The mean IQ for the 42-day dexamethasone group was 85 +/- 10 compared with 60 +/- 20 for the 18-day dexamethasone group and 73 +/- 23 for the control group. All children in the 42-day dexamethasone group were receiving education in the regular classroom compared with only 50% of the 18-day dexamethasone group and 40% of the control group. As a result, intact survival was significantly greater for the 42-day dexamethasone group (69%) than for either the 18-day dexamethasone group (25%) or the control group (18%). Pulmonary function was significantly better for the 42-day dexamethasone group compared with the 18-day dexamethasone group (eg, forced expiratory volume in 1 second: 90 +/- 16 vs 71 +/- 15% predicted, respectively). CONCLUSION: A 42-day course of dexamethasone therapy beginning at 2 weeks of age in preterm infants who are at high risk for severe chronic lung disease was associated with improved long-term neurodevelopmental outcome. Although additional research is needed to establish the optimal steroid preparation, dosage, and duration of therapy, these data support the view that moderately early (beginning at 1-2 weeks) corticosteroid treatment is advantageous for a select group of ventilator-dependent preterm infants.