Abstract：
This is a follow-up study to the pentaerythrityl tetranitrate randomized controlled multicenter trial that reports neonatal outcome data of newborns admitted to neonatal intensive care units and outcome data of the offspring at 12 months of age.
We present data on adverse events reported during the study to document the safety of pentaerythrityl tetranitrate treatment during pregnancy. To further evaluate the effects of pentaerythrityl tetranitrate on neonatal and long-term outcomes, we present follow up data from of 240 children at 12 months of age, including information on height, weight, head circumference, developmental milestones, and the presence of chronic disease and of 144 newborns admitted to the neonatal intensive care unit during the trial.
The pentaerythrityl tetranitrate trial was a randomized, double-blind, placebo-controlled study designed to assess the efficacy and safety of the nitric oxide-donor pentaerythrityl tetranitrate in the prevention of fetal growth restriction and perinatal death in pregnancies complicated by abnormal placental perfusion.
Results at 12 months demonstrated that significantly more children were age appropriately developed without impairments in the pentaerythrityl tetranitrate group (P=.018). In addition, the presence of chronic disease was lower in the pentaerythrityl tetranitrate group (P=.041). Outcome data of the 144 newborns admitted to the neonatal intensive care unit did not reveal differences between the treatment and placebo groups. There were no differences in the number or nature of reported adverse events between the study groups.
The analysis shows that study children born in the pentaerythrityl tetranitrate cohort have a clear advantage compared with 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 pentaerythrityl tetranitrate treatment during pregnancies complicated by impaired uterine perfusion.
We present data on adverse events reported during the study to document the safety of pentaerythrityl tetranitrate treatment during pregnancy. To further evaluate the effects of pentaerythrityl tetranitrate on neonatal and long-term outcomes, we present follow up data from of 240 children at 12 months of age, including information on height, weight, head circumference, developmental milestones, and the presence of chronic disease and of 144 newborns admitted to the neonatal intensive care unit during the trial.
The pentaerythrityl tetranitrate trial was a randomized, double-blind, placebo-controlled study designed to assess the efficacy and safety of the nitric oxide-donor pentaerythrityl tetranitrate in the prevention of fetal growth restriction and perinatal death in pregnancies complicated by abnormal placental perfusion.
Results at 12 months demonstrated that significantly more children were age appropriately developed without impairments in the pentaerythrityl tetranitrate group (P=.018). In addition, the presence of chronic disease was lower in the pentaerythrityl tetranitrate group (P=.041). Outcome data of the 144 newborns admitted to the neonatal intensive care unit did not reveal differences between the treatment and placebo groups. There were no differences in the number or nature of reported adverse events between the study groups.
The analysis shows that study children born in the pentaerythrityl tetranitrate cohort have a clear advantage compared with 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 pentaerythrityl tetranitrate treatment during pregnancies complicated by impaired uterine perfusion.
摘要：
背景：这是一项对PETN随机对照多中心试验的后续研究，该试验报告了新生儿重症监护病房（NICU）新生儿的新生儿结局数据和12月龄时后代的结局数据。
目的：PETN试验是一项随机试验，双盲,安慰剂对照研究旨在评估NO-供体季戊四醇三硝酸酯（PETN）在预防胎儿生长受限（FGR）和妊娠并发胎盘灌注异常的围产期死亡中的有效性和安全性。我们提供了研究期间报告的不良事件（AE）数据，以记录怀孕期间PETN治疗的安全性。为了进一步评估PETN对新生儿和长期结局的影响，我们提供了在试验期间入住NICU的144名新生儿的数据，并随访了240名12月龄儿童的数据。包括高度信息,体重,头围,发展里程碑和慢性病的存在。
结果：12个月时的结果表明，PETN组明显有更多的儿童年龄发育正常，没有损伤（p=0.018）。此外,PETN组慢性疾病的发生率较低(p=0.041).纳入NICU的144名新生儿的结果数据未显示治疗组和安慰剂组之间的差异。研究组之间报告的AE的数量或性质没有差异。
结论：分析表明，与12个月大的安慰剂组相比，在PETN队列中出生的研究儿童具有明显的优势，在没有慢性疾病存在的情况下，正常发育的发生率增加。虽然安全性已经被证明，需要进一步的随访研究来证明妊娠合并子宫灌注受损期间PETN治疗的合理性.
目的：PETN试验是一项随机试验，双盲,安慰剂对照研究旨在评估NO-供体季戊四醇三硝酸酯（PETN）在预防胎儿生长受限（FGR）和妊娠并发胎盘灌注异常的围产期死亡中的有效性和安全性。我们提供了研究期间报告的不良事件（AE）数据，以记录怀孕期间PETN治疗的安全性。为了进一步评估PETN对新生儿和长期结局的影响，我们提供了在试验期间入住NICU的144名新生儿的数据，并随访了240名12月龄儿童的数据。包括高度信息,体重,头围,发展里程碑和慢性病的存在。
结果：12个月时的结果表明，PETN组明显有更多的儿童年龄发育正常，没有损伤（p=0.018）。此外,PETN组慢性疾病的发生率较低(p=0.041).纳入NICU的144名新生儿的结果数据未显示治疗组和安慰剂组之间的差异。研究组之间报告的AE的数量或性质没有差异。
结论：分析表明，与12个月大的安慰剂组相比，在PETN队列中出生的研究儿童具有明显的优势，在没有慢性疾病存在的情况下，正常发育的发生率增加。虽然安全性已经被证明，需要进一步的随访研究来证明妊娠合并子宫灌注受损期间PETN治疗的合理性.
