Clinical trial NCT06281717 - References

Congenital Diaphragmatic Hernia — A Pilot Study on the Role of Fetal Endotracheal Occlusion (FETO) in Fetuses With Severe Congenital Diaphragmatic Hernia

Citation(s)

•   Adzick NS, Outwater KM, Harrison MR, Davies P, Glick PL, deLorimier AA, Reid LM
  Correction of congenital diaphragmatic hernia in utero. IV. An early gestational fetal lamb model for pulmonary vascular morphometric analysis. J Pediatr Surg. 1985 Dec;20(6):673-80. doi: 10.1016/s0022-3468(85)80022-1.
•   Al-Maary J, Eastwood MP, Russo FM, Deprest JA, Keijzer R
  Fetal Tracheal Occlusion for Severe Pulmonary Hypoplasia in Isolated Congenital Diaphragmatic Hernia: A Systematic Review and Meta-analysis of Survival. Ann Surg. 2016 Dec;264(6):929-933. doi: 10.1097/SLA.0000000000001675.
•   Albanese CT, Lopoo J, Goldstein RB, Filly RA, Feldstein VA, Calen PW, Jennings RW, Farrell JA, Harrison MR
  Fetal liver position and perinatal outcome for congenital diaphragmatic hernia. Prenat Diagn. 1998 Nov;18(11):1138-42. doi: 10.1002/(sici)1097-0223(199811)18:113.0.co;2-a.
•   Alcorn D, Adamson TM, Lambert TF, Maloney JE, Ritchie BC, Robinson PM
  Morphological effects of chronic tracheal ligation and drainage in the fetal lamb lung. J Anat. 1977 Jul;123(Pt 3):649-60.
•   Baschat AA, Rosner M, Millard SE, Murphy JD, Blakemore KJ, Keiser AM, Kearney J, Bullard J, Nogee LM, Bembea M, Jelin EB, Miller JL
  Single-Center Outcome of Fetoscopic Tracheal Balloon Occlusion for Severe Congenital Diaphragmatic Hernia. Obstet Gynecol. 2020 Mar;135(3):511-521. doi: 10.1097/AOG.0000000000003692.
•   Bebbington M, Victoria T, Danzer E, Moldenhauer J, Khalek N, Johnson M, Hedrick H, Adzick NS
  Comparison of ultrasound and magnetic resonance imaging parameters in predicting survival in isolated left-sided congenital diaphragmatic hernia. Ultrasound Obstet Gynecol. 2014 Jun;43(6):670-4. doi: 10.1002/uog.13271. Epub 2014 May 5.
•   Belfort MA, Olutoye OO, Cass DL, Olutoye OA, Cassady CI, Mehollin-Ray AR, Shamshirsaz AA, Cruz SM, Lee TC, Mann DG, Espinoza J, Welty SE, Fernandes CJ, Ruano R
  Feasibility and Outcomes of Fetoscopic Tracheal Occlusion for Severe Left Diaphragmatic Hernia. Obstet Gynecol. 2017 Jan;129(1):20-29. doi: 10.1097/AOG.0000000000001749.
•   Boland RE, Nardo L, Hooper SB
  Cortisol pretreatment enhances the lung growth response to tracheal obstruction in fetal sheep. Am J Physiol. 1997 Dec;273(6):L1126-31. doi: 10.1152/ajplung.1997.273.6.L1126.
•   Boloker J, Bateman DA, Wung JT, Stolar CJ
  Congenital diaphragmatic hernia in 120 infants treated consecutively with permissive hypercapnea/spontaneous respiration/elective repair. J Pediatr Surg. 2002 Mar;37(3):357-66. doi: 10.1053/jpsu.2002.30834.
•   Cacciari A, Ruggeri G, Mordenti M, Ceccarelli PL, Baccarini E, Pigna A, Gentili A
  High-frequency oscillatory ventilation versus conventional mechanical ventilation in congenital diaphragmatic hernia. Eur J Pediatr Surg. 2001 Feb;11(1):3-7. doi: 10.1055/s-2001-12204.
•   Deprest J, Jani J, Gratacos E, Vandecruys H, Naulaers G, Delgado J, Greenough A, Nicolaides K; FETO Task Group
  Fetal intervention for congenital diaphragmatic hernia: the European experience. Semin Perinatol. 2005 Apr;29(2):94-103. doi: 10.1053/j.semperi.2005.04.006.
•   Deprest JA, Benachi A, Gratacos E, Nicolaides KH, Berg C, Persico N, Belfort M, Gardener GJ, Ville Y, Johnson A, Morini F, Wielgos M, Van Calster B, DeKoninck PLJ; TOTAL Trial for Moderate Hypoplasia Investigators
  Randomized Trial of Fetal Surgery for Moderate Left Diaphragmatic Hernia. N Engl J Med. 2021 Jul 8;385(2):119-129. doi: 10.1056/NEJMoa2026983. Epub 2021 Jun 8.
•   Deprest JA, Hyett JA, Flake AW, Nicolaides K, Gratacos E
  Current controversies in prenatal diagnosis 4: Should fetal surgery be done in all cases of severe diaphragmatic hernia? Prenat Diagn. 2009 Jan;29(1):15-9. doi: 10.1002/pd.2108. No abstract available.
•   Deprest JA, Nicolaides KH, Benachi A, Gratacos E, Ryan G, Persico N, Sago H, Johnson A, Wielgos M, Berg C, Van Calster B, Russo FM; TOTAL Trial for Severe Hypoplasia Investigators
  Randomized Trial of Fetal Surgery for Severe Left Diaphragmatic Hernia. N Engl J Med. 2021 Jul 8;385(2):107-118. doi: 10.1056/NEJMoa2027030. Epub 2021 Jun 8.
•   Desfrere L, Jarreau PH, Dommergues M, Brunhes A, Hubert P, Nihoul-Fekete C, Mussat P, Moriette G
  Impact of delayed repair and elective high-frequency oscillatory ventilation on survival of antenatally diagnosed congenital diaphragmatic hernia: first application of these strategies in the more "severe" subgroup of antenatally diagnosed newborns. Intensive Care Med. 2000 Jul;26(7):934-41. doi: 10.1007/s001340051284.
•   DiFiore JW, Fauza DO, Slavin R, Peters CA, Fackler JC, Wilson JM
  Experimental fetal tracheal ligation reverses the structural and physiological effects of pulmonary hypoplasia in congenital diaphragmatic hernia. J Pediatr Surg. 1994 Feb;29(2):248-56; discussion 256-7. doi: 10.1016/0022-3468(94)90328-x.
•   Does extracorporeal membrane oxygenation improve survival in neonates with congenital diaphragmatic hernia? The Congenital Diaphragmatic Hernia Study Group
  J Pediatr Surg. 1999 May;34(5):720-4; discussion 724-5. doi: 10.1016/s0022-3468(99)90363-9.
•   Done E, Gucciardo L, Van Mieghem T, Jani J, Cannie M, Van Schoubroeck D, Devlieger R, Catte LD, Klaritsch P, Mayer S, Beck V, Debeer A, Gratacos E, Nicolaides K, Deprest J
  Prenatal diagnosis, prediction of outcome and in utero therapy of isolated congenital diaphragmatic hernia. Prenat Diagn. 2008 Jul;28(7):581-91. doi: 10.1002/pd.2033.
•   Donepudi R, Belfort MA, Shamshirsaz AA, Lee TC, Keswani SG, King A, Ayres NA, Fernandes CJ, Sanz-Cortes M, Nassr AA, Espinoza AF, Style CC, Espinoza J
  Fetal endoscopic tracheal occlusion and pulmonary hypertension in moderate congenital diaphragmatic hernia. J Matern Fetal Neonatal Med. 2022 Dec;35(25):6967-6972. doi: 10.1080/14767058.2021.1932806. Epub 2021 Jun 6.
•   Espinoza J, King A, Shamshirsaz AA, Nassr AA, Donepudi R, Sanz Cortes M, Meholin-Ray AR, Krispin E, Johnson R, Mendez Martinez Y, Keswani SG, Lee TC, Joyeux L, Espinoza AF, Olutoye Ii O, Garcia-Prats JA, Fernandes CJ, Coleman RD, Lohmann P, Rhee CJ, Davies J, Belfort MA
  Characterization of Suboptimal Responses to Fetoscopic Endoluminal Tracheal Occlusion in Congenital Diaphragmatic Hernia. Fetal Diagn Ther. 2023;50(2):128-135. doi: 10.1159/000530549. Epub 2023 Apr 11.
•   Fallon SC, Cass DL, Olutoye OO, Zamora IJ, Lazar DA, Larimer EL, Welty SE, Moise AA, Demny AB, Lee TC
  Repair of congenital diaphragmatic hernias on Extracorporeal Membrane Oxygenation (ECMO): does early repair improve patient survival? J Pediatr Surg. 2013 Jun;48(6):1172-6. doi: 10.1016/j.jpedsurg.2013.03.008.
•   Flageole H, Evrard VA, Piedboeuf B, Laberge JM, Lerut TE, Deprest JA
  The plug-unplug sequence: an important step to achieve type II pneumocyte maturation in the fetal lamb model. J Pediatr Surg. 1998 Feb;33(2):299-303. doi: 10.1016/s0022-3468(98)90451-1.
•   Flake AW, Crombleholme TM, Johnson MP, Howell LJ, Adzick NS
  Treatment of severe congenital diaphragmatic hernia by fetal tracheal occlusion: clinical experience with fifteen cases. Am J Obstet Gynecol. 2000 Nov;183(5):1059-66. doi: 10.1067/mob.2000.108871.
•   Harrison MR, Adzick NS, Bullard KM, Farrell JA, Howell LJ, Rosen MA, Sola A, Goldberg JD, Filly RA
  Correction of congenital diaphragmatic hernia in utero VII: a prospective trial. J Pediatr Surg. 1997 Nov;32(11):1637-42. doi: 10.1016/s0022-3468(97)90472-3.
•   Harrison MR, Adzick NS, Estes JM, Howell LJ
  A prospective study of the outcome for fetuses with diaphragmatic hernia. JAMA. 1994 Feb 2;271(5):382-4.
•   Harrison MR, Adzick NS, Flake AW, Jennings RW, Estes JM, MacGillivray TE, Chueh JT, Goldberg JD, Filly RA, Goldstein RB, et al
  Correction of congenital diaphragmatic hernia in utero: VI. Hard-earned lessons. J Pediatr Surg. 1993 Oct;28(10):1411-7; discussion 1417-8. doi: 10.1016/s0022-3468(05)80338-0.
•   Harrison MR, Adzick NS, Longaker MT, Goldberg JD, Rosen MA, Filly RA, Evans MI, Golbus MS
  Successful repair in utero of a fetal diaphragmatic hernia after removal of herniated viscera from the left thorax. N Engl J Med. 1990 May 31;322(22):1582-4. doi: 10.1056/NEJM199005313222207. No abstract available.
•   Harrison MR, Albanese CT, Hawgood SB, Farmer DL, Farrell JA, Sandberg PL, Filly RA
  Fetoscopic temporary tracheal occlusion by means of detachable balloon for congenital diaphragmatic hernia. Am J Obstet Gynecol. 2001 Sep;185(3):730-3. doi: 10.1067/mob.2001.117344.
•   Harrison MR, Bressack MA, Churg AM, de Lorimier AA
  Correction of congenital diaphragmatic hernia in utero. II. Simulated correction permits fetal lung growth with survival at birth. Surgery. 1980 Aug;88(2):260-8.
•   Harrison MR, Jester JA, Ross NA
  Correction of congenital diaphragmatic hernia in utero. I. The model: intrathoracic balloon produces fatal pulmonary hypoplasia. Surgery. 1980 Jul;88(1):174-82.
•   Harrison MR, Langer JC, Adzick NS, Golbus MS, Filly RA, Anderson RL, Rosen MA, Callen PW, Goldstein RB, deLorimier AA
  Correction of congenital diaphragmatic hernia in utero, V. Initial clinical experience. J Pediatr Surg. 1990 Jan;25(1):47-55; discussion 56-7. doi: 10.1016/s0022-3468(05)80163-0.
•   Harrison MR, Mychaliska GB, Albanese CT, Jennings RW, Farrell JA, Hawgood S, Sandberg P, Levine AH, Lobo E, Filly RA
  Correction of congenital diaphragmatic hernia in utero IX: fetuses with poor prognosis (liver herniation and low lung-to-head ratio) can be saved by fetoscopic temporary tracheal occlusion. J Pediatr Surg. 1998 Jul;33(7):1017-22; discussion 1022-3. doi: 10.1016/s0022-3468(98)90524-3.
•   Harrison MR, Ross NA, de Lorimier AA
  Correction of congenital diaphragmatic hernia in utero. III. Development of a successful surgical technique using abdominoplasty to avoid compromise of umbilical blood flow. J Pediatr Surg. 1981 Dec;16(6):934-42. doi: 10.1016/s0022-3468(81)80849-4.
•   Harrison MR, Sydorak RM, Farrell JA, Kitterman JA, Filly RA, Albanese CT
  Fetoscopic temporary tracheal occlusion for congenital diaphragmatic hernia: prelude to a randomized, controlled trial. J Pediatr Surg. 2003 Jul;38(7):1012-20. doi: 10.1016/s0022-3468(03)00182-9.
•   Hedrick MH, Estes JM, Sullivan KM, Bealer JF, Kitterman JA, Flake AW, Adzick NS, Harrison MR
  Plug the lung until it grows (PLUG): a new method to treat congenital diaphragmatic hernia in utero. J Pediatr Surg. 1994 May;29(5):612-7. doi: 10.1016/0022-3468(94)90724-2.
•   Jani JC, Nicolaides KH, Gratacos E, Valencia CM, Done E, Martinez JM, Gucciardo L, Cruz R, Deprest JA
  Severe diaphragmatic hernia treated by fetal endoscopic tracheal occlusion. Ultrasound Obstet Gynecol. 2009 Sep;34(3):304-10. doi: 10.1002/uog.6450.
•   Jani JC, Nicolaides KH, Gratacos E, Vandecruys H, Deprest JA; FETO Task Group
  Fetal lung-to-head ratio in the prediction of survival in severe left-sided diaphragmatic hernia treated by fetal endoscopic tracheal occlusion (FETO). Am J Obstet Gynecol. 2006 Dec;195(6):1646-50. doi: 10.1016/j.ajog.2006.04.004. Epub 2006 Jun 12.
•   Keller RL, Glidden DV, Paek BW, Goldstein RB, Feldstein VA, Callen PW, Filly RA, Albanese CT
  The lung-to-head ratio and fetoscopic temporary tracheal occlusion: prediction of survival in severe left congenital diaphragmatic hernia. Ultrasound Obstet Gynecol. 2003 Mar;21(3):244-9. doi: 10.1002/uog.44.
•   Luks FI, Wild YK, Piasecki GJ, De Paepe ME
  Short-term tracheal occlusion corrects pulmonary vascular anomalies in the fetal lamb with diaphragmatic hernia. Surgery. 2000 Aug;128(2):266-72. doi: 10.1067/msy.2000.107373.
•   Metkus AP, Filly RA, Stringer MD, Harrison MR, Adzick NS
  Sonographic predictors of survival in fetal diaphragmatic hernia. J Pediatr Surg. 1996 Jan;31(1):148-51; discussion 151-2. doi: 10.1016/s0022-3468(96)90338-3.
•   Muratore CS, Kharasch V, Lund DP, Sheils C, Friedman S, Brown C, Utter S, Jaksic T, Wilson JM
  Pulmonary morbidity in 100 survivors of congenital diaphragmatic hernia monitored in a multidisciplinary clinic. J Pediatr Surg. 2001 Jan;36(1):133-40. doi: 10.1053/jpsu.2001.20031.
•   Muratore CS, Utter S, Jaksic T, Lund DP, Wilson JM
  Nutritional morbidity in survivors of congenital diaphragmatic hernia. J Pediatr Surg. 2001 Aug;36(8):1171-6. doi: 10.1053/jpsu.2001.25746.
•   Nardo L, Hooper SB, Harding R
  Lung hypoplasia can be reversed by short-term obstruction of the trachea in fetal sheep. Pediatr Res. 1995 Nov;38(5):690-6. doi: 10.1203/00006450-199511000-00010.
•   Perrone EE, Abbasi N, Cortes MS, Umar U, Ryan G, Johnson A, Ladino-Torres M, Ruano R; North American Fetal Therapy Network (NAFTNet)
  Prenatal assessment of congenital diaphragmatic hernia at north american fetal therapy network centers: A continued plea for standardization. Prenat Diagn. 2021 Jan;41(2):200-206. doi: 10.1002/pd.5859. Epub 2020 Nov 12.
•   Ruano R, Lazar DA, Cass DL, Zamora IJ, Lee TC, Cassady CI, Mehollin-Ray A, Welty S, Fernandes CJ, Haeri S, Belfort MA, Olutoye OO
  Fetal lung volume and quantification of liver herniation by magnetic resonance imaging in isolated congenital diaphragmatic hernia. Ultrasound Obstet Gynecol. 2014 Jun;43(6):662-9. doi: 10.1002/uog.13223.
•   Ruano R, Peiro JL, da Silva MM, Campos JA, Carreras E, Tannuri U, Zugaib M
  Early fetoscopic tracheal occlusion for extremely severe pulmonary hypoplasia in isolated congenital diaphragmatic hernia: preliminary results. Ultrasound Obstet Gynecol. 2013 Jul;42(1):70-6. doi: 10.1002/uog.12414.
•   Russo FM, Cordier AG, Basurto D, Salazar L, Litwinska E, Gomez O, Debeer A, Nevoux J, Patel S, Lewi L, Pertierra A, Aertsen M, Gratacos E, Nicolaides KH, Benachi A, Deprest J
  Fetal endoscopic tracheal occlusion reverses the natural history of right-sided congenital diaphragmatic hernia: European multicenter experience. Ultrasound Obstet Gynecol. 2021 Mar;57(3):378-385. doi: 10.1002/uog.23115.
•   Saura L, Castanon M, Prat J, Albert A, Caceres F, Moreno J, Gratacos E
  Impact of fetal intervention on postnatal management of congenital diaphragmatic hernia. Eur J Pediatr Surg. 2007 Dec;17(6):404-7. doi: 10.1055/s-2007-989275.
•   Stege G, Fenton A, Jaffray B
  Nihilism in the 1990s: the true mortality of congenital diaphragmatic hernia. Pediatrics. 2003 Sep;112(3 Pt 1):532-5. doi: 10.1542/peds.112.3.532.
•   Style CC, Olutoye OO, Belfort MA, Ayres NA, Cruz SM, Lau PE, Shamshirsaz AA, Lee TC, Olutoye OA, Fernandes CJ, Cortes MS, Keswani SG, Espinoza J
  Fetal endoscopic tracheal occlusion reduces pulmonary hypertension in severe congenital diaphragmatic hernia. Ultrasound Obstet Gynecol. 2019 Dec;54(6):752-758. doi: 10.1002/uog.20216. Epub 2019 Nov 4.
•   Van Calster B, Benachi A, Nicolaides KH, Gratacos E, Berg C, Persico N, Gardener GJ, Belfort M, Ville Y, Ryan G, Johnson A, Sago H, Kosinski P, Bagolan P, Van Mieghem T, DeKoninck PLJ, Russo FM, Hooper SB, Deprest JA
  The randomized Tracheal Occlusion To Accelerate Lung growth (TOTAL)-trials on fetal surgery for congenital diaphragmatic hernia: reanalysis using pooled data. Am J Obstet Gynecol. 2022 Apr;226(4):560.e1-560.e24. doi: 10.1016/j.ajog.2021.11.1351. Epub 2021 Nov 19.
•   VanderWall KJ, Bruch SW, Meuli M, Kohl T, Szabo Z, Adzick NS, Harrison MR
  Fetal endoscopic ('Fetendo') tracheal clip. J Pediatr Surg. 1996 Aug;31(8):1101-3; discussion 1103-4. doi: 10.1016/s0022-3468(96)90096-2.
•   VanderWall KJ, Skarsgard ED, Filly RA, Eckert J, Harrison MR
  Fetendo-clip: a fetal endoscopic tracheal clip procedure in a human fetus. J Pediatr Surg. 1997 Jul;32(7):970-2. doi: 10.1016/s0022-3468(97)90379-1.
•   Vergote S, De Bie FR, Duffy JMN, Bosteels J, Benachi A, Power B, Meijer F, Hedrick HL, Fernandes CJ, Reiss IKM, De Coppi P, Lally KP, Deprest JA
  Core outcome set for perinatal interventions for congenital diaphragmatic hernia. Ultrasound Obstet Gynecol. 2023 Sep;62(3):374-382. doi: 10.1002/uog.26235. Epub 2023 Aug 7.
•   Wild YK, Piasecki GJ, De Paepe ME, Luks FI
  Short-term tracheal occlusion in fetal lambs with diaphragmatic hernia improves lung function, even in the absence of lung growth. J Pediatr Surg. 2000 May;35(5):775-9. doi: 10.1053/jpsu.2000.6067.
•   Wilson JM, DiFiore JW, Peters CA
  Experimental fetal tracheal ligation prevents the pulmonary hypoplasia associated with fetal nephrectomy: possible application for congenital diaphragmatic hernia. J Pediatr Surg. 1993 Nov;28(11):1433-9; discussion 1439-40. doi: 10.1016/0022-3468(93)90426-l.

A Pilot Study on the Role of Fetal Endotracheal Occlusion (FETO) in Fetuses With Severe Congenital Diaphragmatic Hernia

Details for clinical trial NCT06281717