Project Details

E.W. "Al" Thrasher

Status: Funded - Open

Treatment of delayed pulmonary transition in extremely preterm infants & broncho-pulmonary dysplasia

Hussnain Mirza, MD, FAAP

Summary

BACKGROUND: Bronchopulmonary Dysplasia (BPD) is the most common complication of prematurity affecting > 15,000 infants every year in the United States. BPD is a multifactorial disease. Early pulmonary hypertension (PH) has been associated with increased risk for death or BPD in extremely preterm infants.

GAP: Inhaled Nitric Oxide (iNO) is widely used to treat PH but it’s efficacy remains unknown in preterm infants. Multiple clinical trials showed lack of any benefit by administering prophylactic iNO to preterm infants. However, no randomized clinical trial has been done to determine if iNO treatment of early PH can decrease the risk for death or BPD in preterm infants.

HYPOTHESIS:

• iNO treatment of extremely preterm infants with early PH defined as echocardiographic evidence of PH at 72 ± 24 hours of age will decrease the incidence of death or BPD.

• iNO treatment of extremely preterm infants with early PH will decrease the pulmonary artery pressure and improve the oxygenation within 72 hours.

METHODS: This study is a Randomized Controlled Trial (RCT). Extremely preterm infants born at ≤ 29 weeks, admitted to the neonatal ICU, and who remain on positive pressure ventilation for 72 + 24 hours of life will be eligible for echocardiographic screening for early PH. Infants with echocardiographic evidence of early PH will be enrolled in the randomized controlled trial for treatment with iNO vs. placebo. Data will be compared to determine the efficacy of iNO to treat preterm infants and to explore any benefit in decreasing the risk for death or BPD.

RESULTS: Pending.

IMPACT: Results of this study will directly influence the clinical practice within a short period. Our data will provide evidence to start screening extremely preterm infants for early PH and treat with iNO to decrease the incidence of death or BPD.