PI(s): Cavallaro Moronta & McNamara
Primary Team Members:
IRB: 202209335 (McNamara, approved)
Funding: Savvy-Ferentz (Cavallaro Moronta)
Status: Recruitment & enrollment
Study Design: Mixed (retrospective & prospective); Preterm infants (GA<32 weeks) with hemodynamically significant PDA. Genotypes compared between infants whose PDA closes after medications vs. those who do not.
Description: In an unborn fetus, the ductus arteriosus is a tiny vessel that connects the main lung artery to the main vessel that supplies blood to the organ and tissues. After babies are born, this small vessel closes in the first few hours to days; however, this might be altered in infants that are born preterm, with a delay of closure. This condition is called Patent Ductus Arteriosus. If the PDA remains open, these infants are at increased risk of complications including lung disease, eye disease, gut perforation, brain bleeds and death. Closure of the PDA may be achieved with medications (like acetaminophen or indomethacin) or surgery. Despite these serious complications, significant controversy in the neonatology field remains regarding when and how to close the PDA. Medications are not always effective as closing PDA; hence, it is crucial to identify patients that respond to medication versus those who should have surgery. The objective of this study is to identify genetic predictors of response to treatment with acetaminophen during the first 2 weeks after birth. Results will inform more precise treatment selection to identify positive responders earlier, eliminate the risk of side effects in predicted non-responders, and guide alternative treatment for babies at high risk for acetaminophen failure.

PI(s): Cavallaro Moronta & McNamara

Primary Team Members:

IRB: 202209335 (McNamara, approved)

Funding: Savvy-Ferentz (Cavallaro Moronta)

Status: Recruitment & enrollment

Study Design: Mixed (retrospective & prospective); Preterm infants (GA<32 weeks) with hemodynamically significant PDA. Genotypes compared between infants whose PDA closes after medications vs. those who do not.

Description: In an unborn fetus, the ductus arteriosus is a tiny vessel that connects the main lung artery to the main vessel that supplies blood to the organ and tissues. After babies are born, this small vessel closes in the first few hours to days; however, this might be altered in infants that are born preterm, with a delay of closure. This condition is called Patent Ductus Arteriosus. If the PDA remains open, these infants are at increased risk of complications including lung disease, eye disease, gut perforation, brain bleeds and death. Closure of the PDA may be achieved with medications (like acetaminophen or indomethacin) or surgery. Despite these serious complications, significant controversy in the neonatology field remains regarding when and how to close the PDA. Medications are not always effective as closing PDA; hence, it is crucial to identify patients that respond to medication versus those who should have surgery. The objective of this study is to identify genetic predictors of response to treatment with acetaminophen during the first 2 weeks after birth. Results will inform more precise treatment selection to identify positive responders earlier, eliminate the risk of side effects in predicted non-responders, and guide alternative treatment for babies at high risk for acetaminophen failure.