MIDAS Study

Patent Ductus Arteriosus (PDA) is needed for fetal circulation, and is supposed to close after birth. When it doesn’t close in preterm infants, a PDA is associated with increased risk for long term heart and lung problems. Doctors try to help close the PDA with conservative medical management, and surgical or device closure when it fails. When the PDA is closed with a device or surgery, post ligation cardiac syndrome (PCLS) can occur within 8-12 hours after closure from left heart dysfunction. Left heart dysfunction is treated with a blood pressure medicine called milrinone. Doctors are unsure if giving milrinone can prevent PCLS after PDA closure in premature infants. This study compares giving milrinone or not (placebo) to prevent PCLS after PDA closure in extremely preterm infants.

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Purpose & Aim

Population of the study: Extremely preterm infants <27 6/7 weeks’ gestation AND <3 months old
Intervention: Milrinone with normal saline solution vs. Normal saline (placebo)
Outcome: PCLS or Death within 7 days of PDA closure

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Trial Information

Target Enrollment: 318
Funder: NIH NHLBI (through NICHD Neonatal Research Network)

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Study Principal Investigator

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Links

clinicaltrials.gov