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PEDIATRICS Vol. 103 No. 3 March 1999, pp. 684-685

AMERICAN ACADEMY OF PEDIATRICS:
Surfactant Replacement Therapy for Respiratory Distress Syndrome

Committee on Fetus and Newborn


    ABSTRACT
Top
Abstract
Recommendation
References

Respiratory failure secondary to surfactant deficiency is a major cause of morbidity and mortality in low birth weight immature infants. Surfactant therapy substantially reduces mortality and respiratory morbidity for this population. The statement summarizes the indications for surfactant replacement therapy. Because respiratory insufficiency may be a component of multiorgan dysfunction in sick infants, surfactant should be administered only at institutions with qualified personnel and facilities for the comprehensive care of sick infants.

Exogenous surfactant replacement has been established as an appropriate preventive and treatment therapy for prematurity-related surfactant deficiency. Surfactant therapy also may be indicated for more mature infants with primary pulmonary hypertension or meconium aspiration syndrome. Single and multicenter randomized controlled trials using synthetic, modified animal, purified animal, and human surfactants have shown that the use of surfactant replacement in preventive or treatment modes has been safe and efficacious.1-18 Reduced mortality rates and improved short-term respiratory status for preterm infants with surfactant-deficiency respiratory distress have been confirmed. However, coexistent morbidity, such as necrotizing enterocolitis, nosocomial infections, patent ductus arteriosus, intraventricular hemorrhage, and chronic lung disease, appear primarily unaffected. Reports of long-term outcome for infants enrolled in the randomized surfactant trials and evaluated at 1 to 2 years of age have shown neither beneficial nor adverse effects of surfactant use on growth and/or neurodevelopmental parameters.19-26

Current studies continue to address refinements in surfactant use that may optimize its effectiveness. New products, timing, dosage, methods of administration, and modification for particular gestational age groups are among the issues that may improve the effect of surfactants. Two surfactants, one synthetic and the other modified bovine, have been licensed and are available commercially in the United States.

Universal availability of these products raises the concern that surfactants may be used to address the respiratory component of multisystem disorders that affect high-risk, low birth weight infants when other diseases cannot be addressed appropriately. This is a critical issue because the target population for surfactant therapy is primarily the high-risk, low birth weight infants who may have multisystem disorders that are not affected beneficially by treatment with surfactants. Caring for these infants in nurseries without the full range of capabilities required may affect the overall outcome adversely.27,28 As systems of neonatal health care adapt to modified patterns of disease in low birth weight infants, the following recommendations should be incorporated.

    RECOMMENDATIONS
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Abstract
Recommendation
References

1.  Surfactant replacement therapy should be directed by physicians qualified and trained in its use and administration. Qualifications should include experience in management of the respiratory care of low birth weight infants, particularly those on mechanical ventilation.
2.  Nursing and respiratory therapy personnel experienced in the management of low birth weight infants, including mechanical ventilation, should be available within the unit at the bedside when surfactant therapy is administered.
3.  Equipment necessary for managing and monitoring the condition of low birth weight infants, including that needed for mechanical ventilation, should be available on-site when surfactant therapy is administered. Radiology and laboratory support to manage a broad range of needs of these infants should be available.
4.  More important, surfactant therapy should be used only in institutions in which facilities and personnel are available for the management of multisystem disorders and low birth weight infants.
5.  An institutionally approved surfactant therapy protocol, which is a mandatory component of the quality assurance program for neonates, should exist.
6.  In the institutions not satisfying recommendations 2 through 5, and when timely transfer to an appropriate institution cannot be achieved, surfactant therapy may be given, but only by a physician skilled in endotracheal intubation. Under these circumstances, consultation with a subspecialty center should be obtained. Infants should be transferred from such institutions if appropriate and when feasible to a center with appropriate facilities and staff trained to care for multisystem morbidity in low birth weight infants.

COMMITTEE ON FETUS AND NEWBORN, 1998-1999
James A. Lemons, MD, Chairperson
Lillian R. Blackmon, MD
William P. Kanto, Jr, MD
Hugh M. MacDonald, MD
Carol A. Miller, MD
Lu-Ann Papile, MD
Warren Rosenfeld, MD
Craig T. Shoemaker, MD
Michael E. Speer, MD

LIAISON REPRESENTATIVES
Michael F. Greene, MD
  American College of Obstetricians and Gynecologists
Patricia Johnson, RN, MS, NNP
  American Nurses Association, Association of Women's Health, Obstetric and Neonatal Nurses,
  National Association of Neonatal Nurses
Douglas D. McMillan, MD
  Canadian Paediatric Society
Solomon Iyasu, MBBS, MPH
  Centers for Disease Control and Prevention
Linda L. Wright, MD
  National Institutes of Health

SECTION LIAISONS
Richard Molteni, MD
  Section on Perinatal Pediatrics
Jacob C. Langer, MD
  Section on Surgery

CONSULTANTS
Marilyn Escobedo, MD
Avroy Fanaroff, MD

    FOOTNOTES

The recommendations in this statement do not indicate an exclusive course of treatment or serve as a standard of medical care. Variations, taking into account individual circumstances, may be appropriate.

    REFERENCES
Top
Abstract
Recommendation
References
  1. Bloom BT, Kattwinkel J, Hall RT, Comparison of Infasurf (calf lung surfactant extract) to Survanta (Beractant) in the treatment and prevention of respiratory distress syndrome. Pediatrics 1997; 100:31-38 [Abstract/Free Full Text]
  2. Corbet A, Bucciarelli R, Goldman S, Decreased mortality rate among small premature infants treated at birth with a single dose of synthetic surfactant: a multicenter controlled trial. J Pediatr. 1991; 118:277-284 [CrossRef][Medline]
  3. Enhorning G, Shennan A, Possmayer F, Dunn M, Chen C, Milligan J Prevention of neonatal respiratory distress syndrome by tracheal instillation of surfactant: a randomized clinical trial. Pediatrics. 1985; 76:145-153 [Abstract/Free Full Text]
  4. Hoekstra RE, Jackson JC, Myers TF, Improved neonatal survival following multiple doses of bovine surfactant in very premature neonates at risk for respiratory distress syndrome. Pediatrics. 1991; 88:10-18 [Abstract/Free Full Text]
  5. Horbar JD, Wright LL, Soll RF, A multicenter randomized trial comparing two surfactants for the treatment of neonatal respiratory distress syndrome. J Pediatr 1993; 123:757-766 [Medline]
  6. Hudak ML, Martin DJ, Egan EA, A multicenter randomized masked comparison trial of synthetic surfactant versus calf lung surfactant extract in the prevention of neonatal respiratory distress syndrome. Pediatrics 1997; 100:39-50 [Abstract/Free Full Text]
  7. Kattwinkel J, Bloom BT, Delmore P Prophylactic administration of calf lung surfactant extract is more effective than early treatment of respiratory distress syndrome in neonates of 29 through 32 weeks' gestation. Pediatrics. 1993; 92:90-98 [Abstract/Free Full Text]
  8. Kendig JW, Notter RH, Cox C, A comparison of surfactant as immediate prophylaxis and as rescue therapy in newborns of less than 30 weeks' gestation. N Engl J Med 1991; 324:865-871 [Abstract]
  9. Liechty EA, Donovan E, Purohit D, Reduction of neonatal mortality after multiple doses of bovine surfactant in low birth weight neonates with respiratory distress syndrome. Pediatrics. 1991; 88:19-28 [Abstract/Free Full Text]
  10. Long W, Corbet A, Cotton R, A controlled trial of synthetic surfactant in infants weighing 1250 grams or more with respiratory distress syndrome. N Engl J Med 1991; 325:1696-1703 [Abstract]
  11. Long W, Thompson T, Sundell H, Effects of two rescue doses of a synthetic surfactant on mortality rate and survival without bronchopulmonary dysplasia in 700-1350 gram infants with respiratory distress syndrome. J Pediatr. 1991; 118:595-605 [CrossRef][Medline]
  12. Merritt TA, Hallman M, Berry C, Randomized, placebo-controlled trial of human surfactant given at birth versus rescue administration in very low birth weight infants with lung immaturity. J Pediatr 1991; 118:581-594 [CrossRef][Medline]
  13. Repka MX, Hudak ML, Parsa CF, Tielsch JM Calf lung surfactant extract prophylaxis and retinopathy of prematurity. Ophthalmology. 1992; 99:531-536 [Medline]
  14. Schwartz RM, Luby AM, Scanlon JW, Kellogg RJ Effect of surfactant on morbidity, mortality, and resource use in newborn infants weighing 500 to 1500 g. N Engl J Med. 1994; 330:1476-1480 [Abstract/Free Full Text]
  15. Shapiro DL, Notter RH, Morin C, Double-blind randomized clinical trial of a calf lung surfactant extract administered at birth to very premature infants to prevent respiratory distress syndrome. Pediatrics. 1985; 76:593-599 [Abstract/Free Full Text]
  16. Soll RF. 1. Prophylactic administration of synthetic surfactant. 2. Prophylactic administration of natural surfactant. 3. Synthetic surfactant treatment of RDS. 4. Natural surfactant treatment of RDS. In: Chalmers I, ed. Oxford Database of Perinatal Trials. Version 1.1, Desk Issue 3; February 1990
  17. Soll RF, Hoekstra RE, Fangman JJ, Multicenter trial of single-dose modified bovine surfactant extract (Survanta) for prevention of respiratory distress syndrome. Pediatrics. 1990; 85:1092-1102 [Abstract/Free Full Text]
  18. Vermont-Oxford Neonatal Network: A multicenter, randomized trial comparing synthetic surfactant with modified bovine surfactant in the treatment of neonatal respiratory distress syndrome. Pediatrics. 1996;97:1-6
  19. Casiro O, Bingham W, MacMurray B, One-year follow-up of 89 infants with birth weights of 500-749 grams and respiratory distress syndrome randomized to two rescue doses of synthetic surfactant or air placebo. J Pediatr 1995; 126:553-560
  20. Ferrara TB, Hoekstra RE, Couser RJ, Survival and follow-up of infants born at 23 to 26 weeks of gestational age: effects of surfactant therapy. J Pediatr. 1994; 124:119-124 [CrossRef][Medline]
  21. Gunkel JH, Banks PL Surfactant therapy and intracranial hemorrhage: review of the literature and results of new analyses. Pediatrics. 1993; 92:775-786 [Abstract/Free Full Text]
  22. Palta M, Weinstein MR, McGuinness G, Gabbert D, Brady W, Peters ME Mortality and morbidity after availability of surfactant therapy. Arch Pediatr Adolesc Med. 1994; 148:1295-1301 [Abstract]
  23. Bregman J, Kimberlin LV Developmental outcome in extremely premature infants: impact of surfactant. Pediatr Clin North Am. 1993; 40:937-953 [Medline]
  24. Collaborative European Multicentre Study Group: a 2-year follow-up of babies enrolled in a European multicentre trial of porcine surfactant replacement for severe neonatal respiratory distress syndrome. Eur J Pediatr. 1992;151:372-376
  25. Corbet A, Long W, Schumacher R, Double-blind developmental evaluation at 1-year corrected age of 597 premature infants with birth weights from 500 to 1350 grams enrolled in three placebo-controlled trials of prophylactic synthetic surfactant. J Pediatr 1995; 126:S5-S12 [CrossRef][Medline]
  26. Dunn MS, Shennan AT, Hoskins EM, Enhorning G Two-year follow-up of infants enrolled in a randomized trial of surfactant replacement therapy for prevention of neonatal respiratory distress syndrome. Pediatrics 1988; 82:543-547 [Abstract/Free Full Text]
  27. March of Dimes Birth Defects Foundation, Committee on Perinatal Health. Toward Improving the Outcome of Pregnancy: The "90s and Beyond. White Plains, NY: March of Dimes Birth Defects Foundation; 1993
  28. Phibbs CS, Bronstein JM, Buxton E The effects of patient volume and level of care at the hospital of birth and neonatal mortality. JAMA. 1996; 27:1054-1059

Pediatrics (ISSN 0031 4005). Copyright ©1999 by the American Academy of Pediatrics

The following policy statement is a revision:

Surfactant-Replacement Therapy for Respiratory Distress in the Preterm and Term Neonate
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This Article
Right arrow Abstract Freely available
Right arrow Full Text (PDF)
Services
Right arrow E-mail this article to a friend
Right arrow Similar articles in this journal
Right arrow Similar articles in PubMed
Right arrow Download to citation manager
Citing Articles
Right arrow Citing Articles via HighWire
Right arrow Citing Articles via Google Scholar
Google Scholar
Right arrow Search for Related Content
PubMed
Right arrow PubMed Citation


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