A Randomized Trial of Fetal Endoscopic Tracheal Occlusion for Severe Fetal Congenital Diaphragmatic Hernia

New England Journal of Medicine

Volumn 349, Issue 20, 2003, Pages 1916-1924

  Harrison, Michael R ^a,b   Keller, Roberta L ^a,b   Hawgood, Samuel B ^a,b   Kitterman, Joseph A ^a,b   Sandberg, Per L ^a,b   Farmer, Diana L ^a,b   Lee, Hanmin ^a,b   Filly, Roy A ^a,b   Farrell, Jody A ^a,b   Albanese, Craig T ^a,b  

^a UNIVERSITY OF CALIFORNIA   (United States)

^b UNIVERSITY OF CALIFORNIA   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; CLINICAL TRIAL; COHORT ANALYSIS; CONGENITAL DIAPHRAGM HERNIA; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; ENDOSCOPIC SURGERY; FEMALE; FETUS; FETUS SURGERY; GESTATIONAL AGE; HEAD; HUMAN; INTERMETHOD COMPARISON; LIVER; MALE; MATERNAL MORBIDITY; NEWBORN MORBIDITY; PREMATURE FETUS MEMBRANE RUPTURE; PREMATURE LABOR; PRIORITY JOURNAL; RANDOMIZATION; RANDOMIZED CONTROLLED TRIAL; SAFETY; SURVIVAL RATE; THORAX; TRACHEA OBSTRUCTION;

ADULT; ENDOSCOPY; FEMALE; FETAL DISEASES; FETAL MEMBRANES, PREMATURE RUPTURE; GESTATIONAL AGE; HERNIA, DIAPHRAGMATIC; HUMANS; INFANT, NEWBORN; INFANT, PREMATURE; MALE; PREGNANCY; PREGNANCY OUTCOME; SEVERITY OF ILLNESS INDEX; SURVIVAL ANALYSIS; TRACHEA; TREATMENT OUTCOME;

EID: 0242658928     PISSN: 00284793     EISSN: None     Source Type: Journal    
DOI: 10.1056/NEJMoa035005     Document Type: Article

References (39)

1. Harrison MR, Adzick NS, Estes JM, Howen LJ. A prospective study of the outcome for fetuses with diaphragmatic hernia. JAMA 1994;271:382-4.
2. Metkus AP, Filly RA, Stringer MD, Harrison MR, Adzick NS. Sonographic predictors of survival in fetal diaphragmatic hernia. J Pediatr Surg 1996;31:148-52.
3. Keller PL, Glidden DV, Paek BW, et al. The lung-to-head ratio and fetoscopic temporary tracheal occlusion: prediction of survival in severe left congenital diaphragmatic hernia. Ultrasound Obstet Gynecol 2003;21:244-9.
4. Albanese CT, Lopoo J, Goldstein RB, et al. Fetal liver position and perinatal outcome for congenital diaphragmatic hernia. Prenat Diagn 1998;18:1138-42.
5. Stege G, Fenton A, Jaffray B. Nihilism in the 1990s: the true mortality of congenital diaphragmatic hernia. Pediatrics 2003;112:532-5.
6. The Congenital Diaphragmatic Hernia Study Group. Does extracorporeal membrane oxygenation improve survival in neonates with congenital diaphragmatic hernia? J Pediatr Surg 1999;34:720-4.
7. Cacciari A, Ruggeri G, Mordenti M, et al. High-frequency oscillatory ventilation versus conventional mechanical ventilation in congenital diaphragmatic hernia. Eur J Pediatr Surg 2001;11:3-7.
8. Desfrere L, Jarreau PH, Dommergues M, et al. 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;26:934-41.
9. Muratore CS, Kharasch V, Lund DP, et al. Pulmonary morbidity in 100 survivors of congenital diaphragmatic hernia monitored in a multidisciplinary clinic. J Pediatr Surg 2001;36:133-40.
10. Muratore CS, Utter S, Jaksic T, Lund DP, Wilson JM. Nutritional morbidity in survivors of congenital diaphragmatic hernia. J Pediatr Surg 2001;36:1171-6.
11. 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;37:357-66.
12. Harrison MR, Jester JA, Ross NA. Correction of congenital diaphragmatic hernia in utero. I. The model: intrathoracic balloon produces fatal pulmonary hypoplasia. Surgery 1980;88:174-82.
13. 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;88:260-8.
14. 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;16:934-42.
15. Adzick NS, Outwater KM, Harrison MR, et al. Correction of congenital diaphragmatic hernia in utero. IV. An early gestational fetal lamb model for pulmonary vascular morphometric analysis. J Pediatr Surg 1985;20:673-80.
16. Harrison MR, Adzick NS, Longaker MT, et al. Successful repair in utero of a fetal diaphragmatic hernia after removal of herniated viscera from the left thorax. N Engl J Med 1990;322:1582-4.
17. Harrison MR, Langer JC, Adzick NS, et al. Correction of congenital diaphragmatic hernia in utero. V. Initial clinical experience. J Pediatr Surg 1990;25:47-55.
18. Harrison MR, Adzick NS, Flake AW, et al. Correction of congenital diaphragmatic hernia in utero. VI. Hard-earned lessons. J Pediatr Surg 1993;28:1411-7.
19. Harrison MR, Adzick NS, Bullard KM, et al. Correction of congenital diaphragmatic hernia in utero. VII. A prospective trial. J Pediatr Surg 1997;32:1637-42.
20. 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;123:649-60.
21. Nardo L, Hooper SB, Harding R. Lung hypoplasia can be reversed by short-term obstruction of the trachea in fetal sheep. Pediatr Res 1995;38:690-6.
22. 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;28:1433-9.
23. 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;29:248-56.
24. Hedrick MH, Estes JM, sullivan KM, et al. Plug the lung until it grows (PLUG): a new method to treat congenital diaphragmatic hernia in utero. J Pediatr Surg 1994;29:612-7.
25. 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;35:775-9.
26. 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;128:266-72.
27. Flageole H, Evrard VA, Piedboeuf B, Laberge JM, Lerut TE, Deprest JA. The plugunplug sequence: an important step to achieve type II pneumocyte maturation in the fetal lamb model. J Pediatr Surg 1998;33:299-303.
28. Albanese CT, Jennings RW, Filly RA, et al. Endoscopic fetal tracheal occlusion: evolution of techniques. Pediatr Endosurg Innovative Tech 1998;2:47-53.
29. VanderWall KJ, Bruch SW, Meuli M, et al. Fetal endoscopic ('Fetendo') tracheal clip. J Pediatr Surg 1996;31:1101-3.
30. 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;32:970-2.
31. Harrison MR, Mychaliska GB, Albanese CT, et al. 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;33:1017-22.
32. 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;183:1059-66.
33. 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;38:1012-20.
34. Harrison MR, Albanese CT, Hawgood SB, et al. Fetoscopic temporary tracheal occlusion by means of detachable balloon for congenital diaphragmatic hernia. Am J Obstet Gynecol 2001;185:730-3.
35. Boland RE, Nardo L, Hooper SB. Cortisol pretreatment enhances the lung growth response to tracheal obstruction in fetal sheep. Am J Physiol 1997;273:L1126-L1131.
36. Chiba T, Albanese CT, Farmer DL, et al. Balloon tracheal occlusion for congenital diaphragmatic hernia: experimental studies. J Pediatr Surg 2000;35:1566-70.
37. Walters DV, Olver RE. The role of catecholamines in lung liquid absorption at birth. Pediatr Res 1978;12:239-42.
38. Lawson EE, Brown ER, Torday JS, Madansky DL, Taeusch HW Jr. The effect of epinephrine on tracheal fluid flow and surfactant efflux in fetal sheep. Am Rev Respir Dis 1978;118:1023-6.
39. Mychaliska GB, Bealer JF, Graf JL, Rosen MA, Adzick NS, Harrison MR. Operating on placental support: the ex utero intrapartum treatment procedure. J Pediatr Surg 1997;32:227-30.