Pentaerythrityltetranitrate improves the outcome of children born to mothers with compromised uterine perfusion - 12 months follow-up and safety data of the double blinded randomized PETN-trial.

BACKGROUND: This is a follow up study to the PETN randomized controlled multicenter trial that reports neonatal outcome data of newborns admitted to neonatal intensive care units (NICU) and outcome data of the offspring at 12 months of age.

OBJECTIVE AND STUDY DESIGN: The PETN-trial was a randomized, double blind, placebo-controlled study designed to assess the efficacy and safety of the NO-donor pentaerytrithyltetranitrate (PETN) in the prevention of fetal growth restriction (FGR) and perinatal death in pregnancies complicated by abnormal placental perfusion. We present data on adverse events (AE) reported during the study to document the safety of PETN-treatment during pregnancy. To further evaluate the effects of PETN on neonatal and long-term outcomes we present data from 144 newborns admitted to NICU during the trial and follow up data of 240 children at 12 months of age, including information on height, weight, head circumference, developmental milestones and the presence of chronic disease.

RESULTS: Results at 12 months demonstrated that significantly more children were age appropriately developed without impairments in the PETN group (p = 0.018). Additionally, the presence of chronic disease was lower in the PETN group (p= 0.041). Outcome data of the 144 newborns admitted to the NICU did not reveal differences between the treatment and placebo groups. There were no differences in number or nature of reported AEs between the study groups.

CONCLUSION: The analysis shows that study children born in the PETN cohort have a clear advantage compared to the Placebo group at the age of 12 months, as evidenced by the increased incidence of normal development without the presence of chronic disease. Although safety has been proven, further follow up studies are necessary to justify PETN treatment during pregnancies complicated by impaired uterine perfusion.