Two-Year Outcomes of a Randomized Controlled Trial of Nonintervention Versus Oral Ibuprofen for Patent Ductus Arteriosus in Premature Infants.
Optimal management of patent ductus arteriosus (PDA) in premature infants remains debated, and the long-term impact of different strategies has not been well studied. We previously conducted a randomized clinical trial comparing nonintervention (NI) and oral ibuprofen (IBU) for hemodynamically significant PDA in preterm infants, which showed no significant difference in bronchopulmonary dysplasia or death during hospitalization. In this study, we aimed to present a prespecified longitudinal follow-up investigation to assess the outcomes of persistently open PDA at discharge, as well as growth and neurodevelopmental outcomes at 2 years' corrected age (CA), based on PDA management strategy.
Surviving infants from the original trial were evaluated at 2 years' CA. Examiners blinded to the management group assessed spontaneous ductal closure after hospital discharge, growth parameters, and neurodevelopmental outcomes.
Among 130 survivors, open PDA at discharge was present in 7/66 (11%) NI and 2/64 (3%) IBU infants; spontaneous closure occurred in 3/7 NI infants but 0/2 IBU infants. Device closure occurred in 6% (4/66) of the NI group and 3% (2/64) of the IBU group (P = 0.680) by 2 years' CA. Growth parameters-height, weight, and head circumference-did not differ significantly between groups. Neurodevelopmental impairment-defined as cerebral palsy, hearing or visual loss, or a Bayley Scales of Infant Development II mental or psychomotor development index below 70-was present in 15% (10/66) of the NI group and 22% (14/64) of the IBU group (P = 0.371).
This follow-up study demonstrated that NI for hemodynamically significant PDA in preterm infants resulted in growth and neurodevelopmental outcomes at 2 years' CA similar to those seen with IBU treatment. The high rate of spontaneous PDA closure and lack of significant differences in long-term morbidities support the safety of NI and raise questions about the benefit of routine pharmacologic closure.
Surviving infants from the original trial were evaluated at 2 years' CA. Examiners blinded to the management group assessed spontaneous ductal closure after hospital discharge, growth parameters, and neurodevelopmental outcomes.
Among 130 survivors, open PDA at discharge was present in 7/66 (11%) NI and 2/64 (3%) IBU infants; spontaneous closure occurred in 3/7 NI infants but 0/2 IBU infants. Device closure occurred in 6% (4/66) of the NI group and 3% (2/64) of the IBU group (P = 0.680) by 2 years' CA. Growth parameters-height, weight, and head circumference-did not differ significantly between groups. Neurodevelopmental impairment-defined as cerebral palsy, hearing or visual loss, or a Bayley Scales of Infant Development II mental or psychomotor development index below 70-was present in 15% (10/66) of the NI group and 22% (14/64) of the IBU group (P = 0.371).
This follow-up study demonstrated that NI for hemodynamically significant PDA in preterm infants resulted in growth and neurodevelopmental outcomes at 2 years' CA similar to those seen with IBU treatment. The high rate of spontaneous PDA closure and lack of significant differences in long-term morbidities support the safety of NI and raise questions about the benefit of routine pharmacologic closure.