Meconium stained newborns: Ethics for evidence in resuscitation

Journal of Pediatrics

Volumn 166, Issue 5, 2015, Pages 1109-1112

  Vain, Nestor E ^a   Musante, Gabriel A ^b   Mariani, Gonzalo L ^c  

^a UNIVERSIDAD DE BUENOS AIRES   (Argentina)

^b UNIVERSIDAD AUSTRAL   (Argentina)

^c Clínicas University Institute   (Argentina)

Author keywords

[No Author keywords available]

Indexed keywords

LUNG SURFACTANT; OXYGEN;

AMNION FLUID; DISEASE SEVERITY; EDITORIAL; ENDOTRACHEAL INTUBATION; ENDOTRACHEAL TUBE; FETUS DISTRESS; HUMAN; HYPERCAPNIA; MECONIUM ASPIRATION; NEWBORN; NEWBORN HYPOXIA; OXYGEN THERAPY; POSITIVE END EXPIRATORY PRESSURE; PRIORITY JOURNAL; PROGNOSIS; PULMONARY HYPERTENSION; RANDOMIZED CONTROLLED TRIAL (TOPIC); RESPIRATORY DISTRESS; RESUSCITATION; SUCTION PUMP; THORAX RADIOGRAPHY; CHEMISTRY; FEMALE; MALE; MECONIUM ASPIRATION SYNDROME; PROCEDURES; SUCTION;

AMNIOTIC FLUID; FEMALE; HUMANS; MALE; MECONIUM ASPIRATION SYNDROME; SUCTION;

EID: 84928825377     PISSN: 00223476     EISSN: 10976833     Source Type: Journal    
DOI: 10.1016/j.jpeds.2015.01.050     Document Type: Editorial

References (31)

1. B.S. Carson, R.W. Losey, W.A. Bowes Jr., and M.A. Simmons Combined obstetric and pediatric approach to prevent meconium aspiration syndrome Am J Obstet Gynecol 126 1976 712 715
2. G.A. Gregory, C.A. Gooding, R.H. Phibbs, and W.H. Tooley Meconium aspiration in infants - a prospective study J Pediatr 85 1974 848 852
3. J. Kattwinkel, S. Niermeyer, V. Nadkarni, J. Tibballs, B. Phillips, and D. Zideman An advisory statement from the Pediatric Working Group of the International Liaison Committee on Resuscitation Pediatrics 103 1999 e56
4. A. Ghidini, and C.Y. Spong Severe meconium aspiration syndrome is not caused by aspiration of meconium Am J Obstet Gynecol 185 2001 931 938
5. T.E. Wiswell, C.M. Gannon, J. Jacob, L. Goldsmith, E. Szyld, and K. Weiss Delivery room management of the apparently vigorous meconium-stained neonate: results of the multicenter, international collaborative trial Pediatrics 105 1 Pt 1 2000 1 7
6. N.E. Vain, E.G. Szyld, L.M. Prudent, T.E. Wiswell, A.M. Aguilar, and N.I. Vivas Oropharyngeal and nasopharyngeal suctioning of meconium-stained neonates before delivery of their shoulders: multicenter, randomized controlled trial Lancet 364 2004 597 602
7. Textbook of Neonatal Resuscitation 6th ed. 2011 American Academy of Pediatrics-American Heart Association United States of America
8. J.M. Perlman, J. Wyllie, J. Kattwinkel, D.L. Atkins, L. Chameides, and J.P. Goldsmith Part 11: Neonatal resuscitation: 2010 International Consensus on Cardiopulmonary Resuscitation and Emergency Cardiovascular Care Science with Treatment Recommendations Circulation 122 16 Suppl 2 2010 S516 S538
9. S. Chettri, B. Adhisivam, and B. Vishnu Bhat Endotracheal suctioning for non-vigorous neonates born through meconium stained amniotic fluid: a randomized controlled trial J Pediatr 166 2015 1208 1213
10. Nangia S, Sunder SS, Tiwari S, Saili A. Role of endotracheal suction on the occurrence of meconium aspiration syndrome (MAS) in non-vigorous meconium stained neonates - a randomized controlled trial. E-PAS 2014;4680.1.
11. S. Shankaran, L.A. Papile, L.L. Wright, R.A. Ehrenkranz, L. Mele, and J.A. Lemons The effect of antenatal phenobarbital therapy on neonatal intracranial hemorrhage in preterm infants N Engl J Med 337 1997 466 471
12. A.J. Nopper, K.A. Horii, S. Sookdeo-Drost, T.H. Wang, A.J. Mancini, and A.T. Lane Topical ointment therapy benefits premature infants J Pediatr 128 5 Pt 1 1996 660 669
13. W.H. Edwards, J.M. Conner, and R.F. Soll The effect of prophylactic ointment therapy on nosocomial sepsis rates and skin integrity in infants with birth weights of 501 to 1000 g Pediatrics 113 2004 1195 1203
14. R.J. Lilford, J.G. Thornton, and D. Braunholtz Clinical trials and rare diseases: a way out of a conundrum BMJ 311 1995 1621 1625
15. K.F. Schulz, and D.A. Grimes Sample size calculations in randomised trials: mandatory and mystical Lancet 365 2005 1348 1353
16. M.S. Schreiner, D. Feltman, T. Wiswell, S. Wootton, C. Arnold, and J. Tyson When is waiver of consent appropriate in a neonatal clinical trial? Pediatrics 134 2014 1006 1012
17. N.E. Vain, and K.J. Barrington Feasibility of evaluating treatment of early hypotension in extremely low birth weight infants J Pediatr 161 2012 4 7
18. 2005 International Consensus on Cardiopulmonary Resuscitation and Emergency Cardiovascular Care Science with Treatment Recommendations. Part 7: Neonatal resuscitation Resuscitation 67 2005 293 303
19. B.J. Batton, L. Li, N.S. Newman, A. Das, K.L. Watterberg, and B.A. Yoder Feasibility study of early blood pressure management in extremely preterm infants J Pediatr 161 2012 65 69.e1
20. W.D. Rich, K.J. Auten, M.G. Gantz, E.C. Hale, A.M. Hensman, and N.S. Newman Antenatal consent in the SUPPORT trial: challenges, costs, and representative enrollment Pediatrics 126 2010 e215 e221
21. A. Culbert, and D.J. Davis Parental preferences for neonatal resuscitation research consent: a pilot study J Med Ethics 31 2005 721 726
22. J.S. Tobias, and R.L. Souhami Fully informed consent can be needlessly cruel BMJ 307 1993 1199 1201
23. E. Szyld, A. Aguilar, G.A. Musante, N. Vain, L. Prudent, and J. Fabres Comparison of devices for newborn ventilation in the delivery room J Pediatr 165 2014 234 239.e3
24. P. Allmark, and S. Mason Improving the quality of consent to randomised controlled trials by using continuous consent and clinician training in the consent process J Med Ethics 32 2006 439 443
25. C.G. Rogers, J.E. Tyson, K.A. Kennedy, R.S. Broyles, and J.F. Hickman Conventional consent with opting in versus simplified consent with opting out: an exploratory trial for studies that do not increase patient risk J Pediatr 132 1998 606 611
26. V.L. Katz, and W.A. Bowes Jr. Meconium aspiration syndrome: reflections on a murky subject Am J Obstet Gynecol 166 1 Pt 1 1992 171 183
27. R. Jovanovic, and H.T. Nguyen Experimental meconium aspiration in guinea pigs Obstet Gynecol 73 1989 652 656
28. P.H. Lindenskov, A. Castellheim, G. Aamodt, O.D. Saugstad, and T.E. Mollnes Complement activation reflects severity of meconium aspiration syndrome in newborn pigs Pediatr Res 56 2004 810 817
29. D. Vidyasagar, and A. Zagariya Studies of meconium-induced lung injury: inflammatory cytokine expression and apoptosis J Perinatol 28 Suppl 3 2008 S102 S107
30. R.A. Higgerson, L.E. Olsho, L.M. Christie, K. Rehder, T. Doksum, and R. Gedeit Variability in IRBs regarding parental acceptance of passive consent Pediatrics 134 2014 e496 e503
31. Food and Drug Administration Guidance for institutional review boards CI, and sponsors exception from informed consent requirements for emergency research http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM249673.pdf Accessed January 4, 2015