Childhood outcomes after maternal antenatal sildenafil treatment for severe early-onset fetal growth restriction: a randomized trial (STRIDER NZAus)

The GRIT Study Group. A randomised trial of timed delivery for the compromised preterm fetus: short term outcomes and Bayesian interpretation. Br J Obstet Gynaecol. 2003;110:27–32.

Article  Google Scholar 

Shah PS, Ye XY, Synnes A, Rouvinez-Bouali N, Yee W, Lee SK, et al. Prediction of survival without morbidity for infants born at under 33 weeks gestational age: a user-friendly graphical tool. Arch Dis Child Fetal Neonatal Ed. 2012;97:F110–5.

Article  PubMed  Google Scholar 

Schmidt B, Asztalos EV, Roberts RS, Robertson CM, Sauve RS, Whitfield MF. Impact of bronchopulmonary dysplasia, brain injury, and severe retinopathy on the outcome of extremely low-birth-weight infants at 18 months: results from the trial of indomethacin prophylaxis in preterms. JAMA. 2003;289:1124–9.

Article  PubMed  Google Scholar 

Baschat AA, Cosmi E, Bilardo CM, Wolf H, Berg C, Rigano S, et al. Predictors of neonatal outcome in early-onset placental dysfunction. Obstet Gynecol. 2007;109:253–61.

Article  PubMed  Google Scholar 

Merialdi M, Widmer M, Gulmezoglu AM, Abdel-Aleem H, Bega G, Benachi A, et al. WHO multicentre study for the development of growth standards from fetal life to childhood: the fetal component. BMC Pregnancy Childbirth. 2014;14:157.

Article  PubMed  PubMed Central  Google Scholar 

Wareing M, Myers JE, O’Hara M, Baker PN. Sildenafil citrate (Viagra) enhances vasodilatation in fetal growth restriction. J Clin Endocrinol Metab. 2005;90:2550–5.

Article  CAS  PubMed  Google Scholar 

Satterfield MC, Bazer FW, Spencer TE, Wu G. Sildenafil citrate treatment enhances amino acid availability in the conceptus and fetal growth in an ovine model of intrauterine growth restriction. J Nutr. 2010;140:251–8.

Article  CAS  PubMed  Google Scholar 

Sanchez-Aparicio P, Mota-Rojas D, Nava-Ocampo AA, Trujillo-Ortega ME, Alfaro-Rodriguez A, Arch E, et al. Effects of sildenafil on the fetal growth of guinea pigs and their ability to survive induced intrapartum asphyxia. Am J Obstet Gynaecol. 2008;198:127.e1–6.

Article  Google Scholar 

Stanley JL, Andersson IJ, Poudel R, Rueda-Clausen CF, Sibley CP, Davidge ST, et al. Sildenafil citrate rescues fetal growth in the catechol-O-methyl transferase knockout mouse model. Hypertension. 2012;59:1021–8.

Article  CAS  PubMed  Google Scholar 

von Dadelszen P, Dwinnell S, Magee LA, Carleton BC, Gruslin A, Lee B, et al. Sildenafil citrate therapy for severe early-onset intrauterine growth restriction. BJOG. 2011;118:624–8.

Article  Google Scholar 

Panda S, Das A, Md Nowroz H. Sildenafil citrate in fetal growth restriction. J Reprod Infertil. 2014;15:168–9.

PubMed  PubMed Central  Google Scholar 

Lin TH, Su YN, Shih JC, Hsu HC, Lee CN. Resolution of high uterine artery pulsatility index and notching following sildenafil citrate treatment in a growth-restricted pregnancy. Ultrasound Obstet Gynecol. 2012;40:609–10.

Article  CAS  PubMed  Google Scholar 

Dastjerdi MV, Hosseini S, Bayani L. Sildenafil citrate and uteroplacental perfusion in fetal growth restriction. J Res Med Sci. 2012;17:632–6.

PubMed  PubMed Central  Google Scholar 

Groom KM, McCowan LM, Mackay LK, Lee AC, Gardener G, Unterscheider J, et al. STRIDER NZAus: a multicentre randomised controlled trial of sildenafil therapy in early-onset fetal growth restriction. BJOG. 2019;126:997–1006.

Article  CAS  PubMed  Google Scholar 

Sharp A, Cornforth C, Jackson R, Harrold J, Turner MA, Kenny LC, et al. Maternal sildenafil for severe fetal growth restriction (STRIDER): a multicentre, randomised, placebo-controlled, double-blind trial. Lancet Child Adolesc Health. 2017. https://doi.org/10.1016/S2352-4642(17)30173-6.

Pels A, Derks J, Elvan-Taspinar A, van Drongelen J, de Boer M, Duvekot H, et al. Maternal sildenafil vs placebo in pregnant women with severe early-onset fetal growth restriction: a randomized clinical trial. JAMA Netw Open. 2020;3:e205323.

Article  PubMed  PubMed Central  Google Scholar 

von Dadelszen P, Audibert F, Bujold E, Bone JN, Sandhu A, Li J, et al. Halting the Canadian STRIDER randomised controlled trial of sildenafil for severe, early-onset fetal growth restriction: ethical, methodological, and pragmatic considerations. BMC Res Notes. 2022;15:244.

Article  Google Scholar 

Groom KM, Ganzevoort W, Alfirevic Z, Lim K, Papageorghiou AT. Clinicians should stop prescribing sildenafil for fetal growth restriction (FGR): comment from the STRIDER Consortium. Ultrasound Obstet Gynecol. 2018;52:295–6.

Article  CAS  PubMed  Google Scholar 

Terstappen F, Richter AE, Lely AT, Hoebeek FE, Elvan-Taspinar A, Bos AF, et al. Prenatal use of sildenafil in fetal growth restriction and its effect on neonatal tissue oxygenation-a retrospective analysis of hemodynamic data from participants of the Dutch STRIDER Trial. Front Pediatr. 2020;8:595693.

Article  PubMed  PubMed Central  Google Scholar 

Rakhanova Y, Almawi WY, Aimagambetova G, Riethmacher D. The effects of sildenafil citrate on intrauterine growth restriction: a systematic review and meta-analysis. BMC Pregnancy Childbirth. 2023;23:409.

Article  PubMed  PubMed Central  Google Scholar 

Pels A, Ganzevoort W, Kenny LC, Baker PN, von Dadelszen P, Gluud C, et al. Interventions affecting the nitric oxide pathway versus placebo or no therapy for fetal growth restriction in pregnancy. Cochrane Database Syst Rev. 2023;7:CD014498.

PubMed  Google Scholar 

Hitzerd E, Broekhuizen M, Mirabito Colafella KM, Glisic M, de Vries R, Koch BCP, et al. Placental effects and transfer of sildenafil in healthy and preeclamptic conditions. EBioMedicine. 2019;45:447–55.

Article  PubMed  PubMed Central  Google Scholar 

Maher MA, Sayyed TM, Elkhouly N. Sildenafil citrate therapy for oligohydramnios: a randomized controlled trial. Obstet Gynecol. 2017;129:615–20.

Article  CAS  PubMed  Google Scholar 

Turner J, Dunn L, Tarnow-Mordi W, Flatley C, Flenady V, Kumar S. Safety and efficacy of sildenafil citrate to reduce operative birth for intrapartum fetal compromise at term: a phase 2 randomized controlled trial. Am J Obstet Gynecol. 2020;222:401–14.

Article  CAS  PubMed  Google Scholar 

De Bie FR, Basurto D, Kumar S, Deprest J, Russo FM. Sildenafil during the 2nd and 3rd trimester of pregnancy: trials and tribulations. Int J Environ Res Public Health. 2022;19:11207.

Article  Google Scholar 

Cans C, Dolk H, Platt MJ, Colver A, Prasauskiene A, Krageloh-Mann I, et al. Recommendations from the SCPE collaborative group for defining and classifying cerebral palsy. Dev Med Child Neurol (Suppl). 2007;109:35–8.

Article  Google Scholar 

Gioia GA, Espy KA, Isquith PK. Behavior rating inventory of executive function, preschool version (BRIEF-P). Odessa, FL: Psychological Assessment Resources; 2003.

Achenbach TM, Rescorla LA. Manual for the ASEBA preschool forms & profiles. Burlington, VT: University of Vermont, Research Center for Children, Youth, & Families; 2000.

Raat H, Landgraf JM, Oostenbrink R, Moll HA, Essink-Bot ML. Reliability and validity of the Infant and Toddler Quality of Life Questionnaire (ITQOL) in a general population and respiratory disease sample. Qual Life Res. 2007;16:445–60.

Article  PubMed  Google Scholar 

Landgraf JM, Vogel I, Oostenbrink R, van Baar ME, Raat H. Parent-reported health outcomes in infants/toddlers: measurement properties and clinical validity of the ITQOL-SF47. Qual Life Res. 2013;22:635–46.

Article  PubMed  Google Scholar 

WHO Multicentre Growth Reference Study Group. WHO Child Growth Standards based on length/height, weight and age. Acta Paediatr Suppl. 2006;450:76–85.

Article  Google Scholar 

National Heart Lung and Blood Institute. Report of the second task force on blood pressure control in children-1987. Pediatrics. 1987;79:1–25.

Article  Google Scholar 

Spittle AJ, Treyvaud K, Doyle LW, Roberts G, Lee KJ, Inder TE, et al. Early emergence of behavior and social-emotional problems in very preterm infants. J Am Acad Child Adolesc Psychiatry. 2009;48:909–18.

Article  PubMed  Google Scholar 

Torrance HL, Bloemen MC, Mulder EJ, Nikkels PG, Derks JB, de Vries LS, et al. Predictors of outcome at 2 years of age after early intrauterine growth restriction. Ultrasound Obstet Gynecol. 2010;36:171–7.

Article  CAS  PubMed  Google Scholar 

Baschat AA. Neurodevelopment following fetal growth restriction and its relationship with antepartum parameters of placental dysfunction. Ultrasound Obstet Gynecol. 2011;37:501–14.

Article  CAS  PubMed  Google Scholar 

Pierce CM, Zhang MH, Jonsson B, Iorga D, Cheruvu N, Balagtas CC, et al. Efficacy and safety of IV sildenafil in the treatment of newborn infants with, or at risk of, persistent pulmonary hypertension of the newborn (PPHN): a multicenter, randomized, placebo-controlled trial. J Pediatr. 2021;237:154.–61.e3.

Article  CAS  PubMed  Google Scholar 

Jackson W, Gonzalez D, Smith PB, Ambalavanan N, Atz AM, Sokol GM, et al. Safety of sildenafil in extremely premature infants: a phase I trial. J Perinatol. 2022;42:31–6.

Article  CAS  PubMed  Google Scholar 

Harris SL, McKinlay C, Groom K, Beker F, Kochar A, Gill A. Neonatal cardiovascular function after antenatal sildenafil for severe, early-onset intrauterine growth restriction: a substudy of the STRIDER NZAus randomized placebo-controlled trial. J Pediatr X. 2019:1;100009.

PubMed  PubMed Central  Google Scholar 

Yazdani A, Khoja Z, Johnstone A, Dale L, Rampakakis E, Wintermark P. Sildenafil improves brain injury recovery following term neonatal hypoxia-ischemia in male rat pups. Dev Neurosci. 2016;38:251–63.

Article  CAS  PubMed  Google Scholar 

Engels J, Elting N, Braun L, Bendix I, Herz J, Felderhoff-Müser U, et al. Sildenafil enhances quantity of immature neurons and promotes functional recovery in the developing ischemic mouse brain. Dev Neurosci. 2017;39:287–97.

Article  CAS  PubMed  Google Scholar 

Yazdani A, Howidi B, Shi MZ, Tugarinov N, Khoja Z, Wintermark P. Sildenafil improves hippocampal brain injuries and restores neuronal development after neonatal hypoxia-ischemia in male rat pups. Sci Rep. 2021;11:22046.

Article  CAS 

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