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A Multicenter Randomized Masked Comparison Trial of Synthetic Surfactant Versus Calf Lung Surfactant Extract in the Prevention of Neonatal Respiratory Distress Syndrome
To compare the efficacy and safety of a synthetic surfactant (Exosurf Neonatal, Burroughs Wellcome Co) and a surfactant extract of calf lung lavage (Infasurf, IND #27,169, ONY, Inc) in the prevention of neonatal respiratory distress syndrome (RDS). Ten-center randomized masked comparison trial. Prem...
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| Published in: | Pediatrics (Evanston) 1997-07, Vol.100 (1), p.39-50 |
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| container_title | Pediatrics (Evanston) |
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| creator | Hudak, Mark L Martin, David J Egan, Edmund A Matteson, Elizabeth J Cummings, J Jung, August L Kimberlin, Lois V Auten, Richard L Rosenberg, Adam A Asselin, Jeanette M Belcastro, Marc R Donohue, Pamela K Hamm Jr, Charles R Jansen, Robert D Brody, Alan S Riddlesberger, Merchline M Montgomery, Paul |
| description | To compare the efficacy and safety of a synthetic surfactant (Exosurf Neonatal, Burroughs Wellcome Co) and a surfactant extract of calf lung lavage (Infasurf, IND #27,169, ONY, Inc) in the prevention of neonatal respiratory distress syndrome (RDS).
Ten-center randomized masked comparison trial.
Premature infants (n = 871) |
| doi_str_mv | 10.1542/peds.100.1.39 |
| format | article |
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Ten-center randomized masked comparison trial.
Premature infants (n = 871) <29 weeks gestational age by best obstetric estimate.
Infants were randomly assigned to a course of treatment with Exosurf Neonatal (n = 438) or Infasurf (n = 433) at birth, and if still intubated, at 12 and 24 hours of age. Crossover treatment was allowed within 72 hours of age if severe respiratory failure (defined as two consecutive a/A PO2 ratios </=.10) persisted after three doses of the randomized surfactant.
Three primary outcome measures of efficacy [the incidence of RDS; the incidence of RDS death; and the incidence of survival without bronchopulmonary dysplasia at 28 days after birth] were compared using linear regression techniques.
Of 871 randomized infants, 18 infants did not receive treatment with a study surfactant, and 25 infants did not meet all eligibility criteria. The primary analysis of efficacy was performed in the 846 eligible infants and analysis of safety outcomes in the 853 infants who received study surfactant. Demographic characteristics did not differ between the two treatment groups. Compared with Exosurf, Infasurf treatment resulted in a 62% decrease in the incidence of RDS (Infasurf, 16% vs Exosurf, 42%) and a 70% decrease in RDS death (Infasurf, 1.7% vs Exosurf, 5.4%) but did not increase the incidence of survival without bronchopulmonary dysplasia at 28 days. Treatment with Infasurf resulted in significant improvement in several secondary outcome measures. Infasurf-treated infants had lower average FIO2 (Infasurf, .33 [SEM] vs Exosurf, .42; difference .08; 95% confidence interval [CI], .06 to .11) and average mean airway pressure (Infasurf, 6.0 cm H2O vs Exosurf, 7.1 cm H2O; difference 1.1 cm H2O; 95% CI, .7 to 1.6 cm H2O) for the first 72 hours of life. Crossover surfactant treatment was significantly less frequent in the Infasurf compared with the Exosurf group (Infasurf, 1% vs Exosurf, 6%). Complications (bradycardia, clinical airway obstruction, and transcutaneous arterial desaturation) associated with second and third, but not initial, surfactant treatments were observed more frequently in the Infasurf treatment group. Infasurf-treated infants had significantly less air leak (</=7 days) (Infasurf, 8% vs Exosurf, 14%; adjusted relative risk [ARR] .55; 95% CI, .37 to .81). Severe intraventricular hemorrhage (IVH) (grade 3 and 4) did not differ between the two groups (Infasurf, 11.8% vs Exosurf, 8.3%; ARR 1.41; 95% CI, .94 to 2.09) but total IVH occurred more frequently in Infasurf-treated infants (Infasurf, 39.0% vs Exosurf, 29.9%; ARR, 1.30; 95% CI, 1.08 to 1.57).
Significant reductions in the incidence of RDS, the severity of early respiratory disease, the incidence of pulmonary air leaks associated with RDS, and the mortality attributable to RDS suggest that Infasurf is a more effective surfactant preparation than Exosurf Neonatal in the prophylaxis of RDS. However, Infasurf prophylaxis as used in this study was also associated with a greater risk of total but not severe IVH.</description><identifier>ISSN: 0031-4005</identifier><identifier>EISSN: 1098-4275</identifier><identifier>DOI: 10.1542/peds.100.1.39</identifier><identifier>PMID: 9200358</identifier><identifier>CODEN: PEDIAU</identifier><language>eng</language><publisher>Elk Grove Village, IL: Am Acad Pediatrics</publisher><subject><![CDATA[Age Factors ; Babies ; Biological and medical sciences ; Bronchopulmonary Dysplasia - prevention & control ; Care and treatment ; Cerebral Hemorrhage - prevention & control ; Data Interpretation, Statistical ; Drug Combinations ; Evaluation ; Fatty Alcohols - administration & dosage ; Fatty Alcohols - adverse effects ; Fatty Alcohols - therapeutic use ; Female ; Humans ; Infant, Newborn ; Linear Models ; Lung surfactant, Synthetic ; Lungs ; Male ; Medical research ; Medical sciences ; Pediatrics ; Pharmacology. Drug treatments ; Phosphorylcholine ; Polyethylene Glycols - administration & dosage ; Polyethylene Glycols - adverse effects ; Polyethylene Glycols - therapeutic use ; Pulmonary Surfactants - administration & dosage ; Pulmonary Surfactants - adverse effects ; Pulmonary Surfactants - therapeutic use ; Respiratory diseases ; Respiratory distress syndrome ; Respiratory Distress Syndrome, Newborn - mortality ; Respiratory Distress Syndrome, Newborn - prevention & control ; Respiratory system ; Synthetic lung surfactants ; Time Factors ; Treatment Outcome]]></subject><ispartof>Pediatrics (Evanston), 1997-07, Vol.100 (1), p.39-50</ispartof><rights>1997 INIST-CNRS</rights><rights>COPYRIGHT 1997 American Academy of Pediatrics</rights><rights>Copyright American Academy of Pediatrics Jul 1997</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c527t-d4a7de17167a1cb14c8721c22a949538e5ab8c72fb34b615ea9db09a25bdb8863</citedby><cites>FETCH-LOGICAL-c527t-d4a7de17167a1cb14c8721c22a949538e5ab8c72fb34b615ea9db09a25bdb8863</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,27924,27925</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=2741906$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/9200358$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Hudak, Mark L</creatorcontrib><creatorcontrib>Martin, David J</creatorcontrib><creatorcontrib>Egan, Edmund A</creatorcontrib><creatorcontrib>Matteson, Elizabeth J</creatorcontrib><creatorcontrib>Cummings, J</creatorcontrib><creatorcontrib>Jung, August L</creatorcontrib><creatorcontrib>Kimberlin, Lois V</creatorcontrib><creatorcontrib>Auten, Richard L</creatorcontrib><creatorcontrib>Rosenberg, Adam A</creatorcontrib><creatorcontrib>Asselin, Jeanette M</creatorcontrib><creatorcontrib>Belcastro, Marc R</creatorcontrib><creatorcontrib>Donohue, Pamela K</creatorcontrib><creatorcontrib>Hamm Jr, Charles R</creatorcontrib><creatorcontrib>Jansen, Robert D</creatorcontrib><creatorcontrib>Brody, Alan S</creatorcontrib><creatorcontrib>Riddlesberger, Merchline M</creatorcontrib><creatorcontrib>Montgomery, Paul</creatorcontrib><title>A Multicenter Randomized Masked Comparison Trial of Synthetic Surfactant Versus Calf Lung Surfactant Extract in the Prevention of Neonatal Respiratory Distress Syndrome</title><title>Pediatrics (Evanston)</title><addtitle>Pediatrics</addtitle><description>To compare the efficacy and safety of a synthetic surfactant (Exosurf Neonatal, Burroughs Wellcome Co) and a surfactant extract of calf lung lavage (Infasurf, IND #27,169, ONY, Inc) in the prevention of neonatal respiratory distress syndrome (RDS).
Ten-center randomized masked comparison trial.
Premature infants (n = 871) <29 weeks gestational age by best obstetric estimate.
Infants were randomly assigned to a course of treatment with Exosurf Neonatal (n = 438) or Infasurf (n = 433) at birth, and if still intubated, at 12 and 24 hours of age. Crossover treatment was allowed within 72 hours of age if severe respiratory failure (defined as two consecutive a/A PO2 ratios </=.10) persisted after three doses of the randomized surfactant.
Three primary outcome measures of efficacy [the incidence of RDS; the incidence of RDS death; and the incidence of survival without bronchopulmonary dysplasia at 28 days after birth] were compared using linear regression techniques.
Of 871 randomized infants, 18 infants did not receive treatment with a study surfactant, and 25 infants did not meet all eligibility criteria. The primary analysis of efficacy was performed in the 846 eligible infants and analysis of safety outcomes in the 853 infants who received study surfactant. Demographic characteristics did not differ between the two treatment groups. Compared with Exosurf, Infasurf treatment resulted in a 62% decrease in the incidence of RDS (Infasurf, 16% vs Exosurf, 42%) and a 70% decrease in RDS death (Infasurf, 1.7% vs Exosurf, 5.4%) but did not increase the incidence of survival without bronchopulmonary dysplasia at 28 days. Treatment with Infasurf resulted in significant improvement in several secondary outcome measures. Infasurf-treated infants had lower average FIO2 (Infasurf, .33 [SEM] vs Exosurf, .42; difference .08; 95% confidence interval [CI], .06 to .11) and average mean airway pressure (Infasurf, 6.0 cm H2O vs Exosurf, 7.1 cm H2O; difference 1.1 cm H2O; 95% CI, .7 to 1.6 cm H2O) for the first 72 hours of life. Crossover surfactant treatment was significantly less frequent in the Infasurf compared with the Exosurf group (Infasurf, 1% vs Exosurf, 6%). Complications (bradycardia, clinical airway obstruction, and transcutaneous arterial desaturation) associated with second and third, but not initial, surfactant treatments were observed more frequently in the Infasurf treatment group. Infasurf-treated infants had significantly less air leak (</=7 days) (Infasurf, 8% vs Exosurf, 14%; adjusted relative risk [ARR] .55; 95% CI, .37 to .81). Severe intraventricular hemorrhage (IVH) (grade 3 and 4) did not differ between the two groups (Infasurf, 11.8% vs Exosurf, 8.3%; ARR 1.41; 95% CI, .94 to 2.09) but total IVH occurred more frequently in Infasurf-treated infants (Infasurf, 39.0% vs Exosurf, 29.9%; ARR, 1.30; 95% CI, 1.08 to 1.57).
Significant reductions in the incidence of RDS, the severity of early respiratory disease, the incidence of pulmonary air leaks associated with RDS, and the mortality attributable to RDS suggest that Infasurf is a more effective surfactant preparation than Exosurf Neonatal in the prophylaxis of RDS. However, Infasurf prophylaxis as used in this study was also associated with a greater risk of total but not severe IVH.</description><subject>Age Factors</subject><subject>Babies</subject><subject>Biological and medical sciences</subject><subject>Bronchopulmonary Dysplasia - prevention & control</subject><subject>Care and treatment</subject><subject>Cerebral Hemorrhage - prevention & control</subject><subject>Data Interpretation, Statistical</subject><subject>Drug Combinations</subject><subject>Evaluation</subject><subject>Fatty Alcohols - administration & dosage</subject><subject>Fatty Alcohols - adverse effects</subject><subject>Fatty Alcohols - therapeutic use</subject><subject>Female</subject><subject>Humans</subject><subject>Infant, Newborn</subject><subject>Linear Models</subject><subject>Lung surfactant, Synthetic</subject><subject>Lungs</subject><subject>Male</subject><subject>Medical research</subject><subject>Medical sciences</subject><subject>Pediatrics</subject><subject>Pharmacology. Drug treatments</subject><subject>Phosphorylcholine</subject><subject>Polyethylene Glycols - administration & dosage</subject><subject>Polyethylene Glycols - adverse effects</subject><subject>Polyethylene Glycols - therapeutic use</subject><subject>Pulmonary Surfactants - administration & dosage</subject><subject>Pulmonary Surfactants - adverse effects</subject><subject>Pulmonary Surfactants - therapeutic use</subject><subject>Respiratory diseases</subject><subject>Respiratory distress syndrome</subject><subject>Respiratory Distress Syndrome, Newborn - mortality</subject><subject>Respiratory Distress Syndrome, Newborn - prevention & control</subject><subject>Respiratory system</subject><subject>Synthetic lung surfactants</subject><subject>Time Factors</subject><subject>Treatment Outcome</subject><issn>0031-4005</issn><issn>1098-4275</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>1997</creationdate><recordtype>article</recordtype><recordid>eNptklFv0zAQxyMEGmXwyCOShXjgYSm2EzfxY1XGQOoY2gav0cW5pB6p3dkOrHwiPiaOVpVNqvxwPt_v7m-fL0leMzplIucfNtj4KaPRm2bySTJhVJZpzgvxNJlQmrE0p1Q8T154f0MpzUXBj5IjyWNIlJPk75ycD33QCk1ARy7BNHat_2BDzsH_jGZh1xtw2ltDrp2GntiWXG1NWGFMIleDa0EFMIH8QOcHTxbQt2Q5mO5h7PQuuLgl2pCYSL45_BX1dKwZq31FayDEypfoN9pBsG5LPmofHHo_ajXOrvFl8qyF3uOrnT1Ovn86vV58TpcXZ18W82WqBC9C2uRQNMgKNiuAqZrlqiw4U5yDzKXIShRQl6rgbZ3l9YwJBNnUVAIXdVOX5Sw7Tt7e1904ezugD9WNHZyJkhXnZSY4lyN0cg910GOlTWvH93Vo0EFvDbY6Hs-ZFCXNpYx4egCPq8G1Vof494_4iAS8Cx0M3lfl2fIRenIIVbbvscMqtmZxcegmylnvHbbVxuk1uG3FaDWOUzWOU3SiV2Uj_2bXjaFeY7Ond_MT4-92cfAq_rwDo7TfY7zImaSz_7Ir3a1-a4ejjIbgtPIPtnvZf15J5EU</recordid><startdate>19970701</startdate><enddate>19970701</enddate><creator>Hudak, Mark L</creator><creator>Martin, David J</creator><creator>Egan, Edmund A</creator><creator>Matteson, Elizabeth J</creator><creator>Cummings, J</creator><creator>Jung, August L</creator><creator>Kimberlin, Lois V</creator><creator>Auten, Richard L</creator><creator>Rosenberg, Adam A</creator><creator>Asselin, Jeanette M</creator><creator>Belcastro, Marc R</creator><creator>Donohue, Pamela K</creator><creator>Hamm Jr, Charles R</creator><creator>Jansen, Robert D</creator><creator>Brody, Alan S</creator><creator>Riddlesberger, Merchline M</creator><creator>Montgomery, Paul</creator><general>Am Acad Pediatrics</general><general>American Academy of Pediatrics</general><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>8GL</scope><scope>7TS</scope><scope>7U9</scope><scope>H94</scope><scope>K9.</scope><scope>M7N</scope><scope>NAPCQ</scope><scope>U9A</scope></search><sort><creationdate>19970701</creationdate><title>A Multicenter Randomized Masked Comparison Trial of Synthetic Surfactant Versus Calf Lung Surfactant Extract in the Prevention of Neonatal Respiratory Distress Syndrome</title><author>Hudak, Mark L ; Martin, David J ; Egan, Edmund A ; Matteson, Elizabeth J ; Cummings, J ; Jung, August L ; Kimberlin, Lois V ; Auten, Richard L ; Rosenberg, Adam A ; Asselin, Jeanette M ; Belcastro, Marc R ; Donohue, Pamela K ; Hamm Jr, Charles R ; Jansen, Robert D ; Brody, Alan S ; Riddlesberger, Merchline M ; Montgomery, Paul</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c527t-d4a7de17167a1cb14c8721c22a949538e5ab8c72fb34b615ea9db09a25bdb8863</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>1997</creationdate><topic>Age Factors</topic><topic>Babies</topic><topic>Biological and medical sciences</topic><topic>Bronchopulmonary Dysplasia - prevention & control</topic><topic>Care and treatment</topic><topic>Cerebral Hemorrhage - prevention & control</topic><topic>Data Interpretation, Statistical</topic><topic>Drug Combinations</topic><topic>Evaluation</topic><topic>Fatty Alcohols - administration & dosage</topic><topic>Fatty Alcohols - adverse effects</topic><topic>Fatty Alcohols - therapeutic use</topic><topic>Female</topic><topic>Humans</topic><topic>Infant, Newborn</topic><topic>Linear Models</topic><topic>Lung surfactant, Synthetic</topic><topic>Lungs</topic><topic>Male</topic><topic>Medical research</topic><topic>Medical sciences</topic><topic>Pediatrics</topic><topic>Pharmacology. Drug treatments</topic><topic>Phosphorylcholine</topic><topic>Polyethylene Glycols - administration & dosage</topic><topic>Polyethylene Glycols - adverse effects</topic><topic>Polyethylene Glycols - therapeutic use</topic><topic>Pulmonary Surfactants - administration & dosage</topic><topic>Pulmonary Surfactants - adverse effects</topic><topic>Pulmonary Surfactants - therapeutic use</topic><topic>Respiratory diseases</topic><topic>Respiratory distress syndrome</topic><topic>Respiratory Distress Syndrome, Newborn - mortality</topic><topic>Respiratory Distress Syndrome, Newborn - prevention & control</topic><topic>Respiratory system</topic><topic>Synthetic lung surfactants</topic><topic>Time Factors</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Hudak, Mark L</creatorcontrib><creatorcontrib>Martin, David J</creatorcontrib><creatorcontrib>Egan, Edmund A</creatorcontrib><creatorcontrib>Matteson, Elizabeth J</creatorcontrib><creatorcontrib>Cummings, J</creatorcontrib><creatorcontrib>Jung, August L</creatorcontrib><creatorcontrib>Kimberlin, Lois V</creatorcontrib><creatorcontrib>Auten, Richard L</creatorcontrib><creatorcontrib>Rosenberg, Adam A</creatorcontrib><creatorcontrib>Asselin, Jeanette M</creatorcontrib><creatorcontrib>Belcastro, Marc R</creatorcontrib><creatorcontrib>Donohue, Pamela K</creatorcontrib><creatorcontrib>Hamm Jr, Charles R</creatorcontrib><creatorcontrib>Jansen, Robert D</creatorcontrib><creatorcontrib>Brody, Alan S</creatorcontrib><creatorcontrib>Riddlesberger, Merchline M</creatorcontrib><creatorcontrib>Montgomery, Paul</creatorcontrib><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Gale In Context: High School</collection><collection>Physical Education Index</collection><collection>Virology and AIDS Abstracts</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Algology Mycology and Protozoology Abstracts (Microbiology C)</collection><collection>Nursing & Allied Health Premium</collection><jtitle>Pediatrics (Evanston)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Hudak, Mark L</au><au>Martin, David J</au><au>Egan, Edmund A</au><au>Matteson, Elizabeth J</au><au>Cummings, J</au><au>Jung, August L</au><au>Kimberlin, Lois V</au><au>Auten, Richard L</au><au>Rosenberg, Adam A</au><au>Asselin, Jeanette M</au><au>Belcastro, Marc R</au><au>Donohue, Pamela K</au><au>Hamm Jr, Charles R</au><au>Jansen, Robert D</au><au>Brody, Alan S</au><au>Riddlesberger, Merchline M</au><au>Montgomery, Paul</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>A Multicenter Randomized Masked Comparison Trial of Synthetic Surfactant Versus Calf Lung Surfactant Extract in the Prevention of Neonatal Respiratory Distress Syndrome</atitle><jtitle>Pediatrics (Evanston)</jtitle><addtitle>Pediatrics</addtitle><date>1997-07-01</date><risdate>1997</risdate><volume>100</volume><issue>1</issue><spage>39</spage><epage>50</epage><pages>39-50</pages><issn>0031-4005</issn><eissn>1098-4275</eissn><coden>PEDIAU</coden><abstract>To compare the efficacy and safety of a synthetic surfactant (Exosurf Neonatal, Burroughs Wellcome Co) and a surfactant extract of calf lung lavage (Infasurf, IND #27,169, ONY, Inc) in the prevention of neonatal respiratory distress syndrome (RDS).
Ten-center randomized masked comparison trial.
Premature infants (n = 871) <29 weeks gestational age by best obstetric estimate.
Infants were randomly assigned to a course of treatment with Exosurf Neonatal (n = 438) or Infasurf (n = 433) at birth, and if still intubated, at 12 and 24 hours of age. Crossover treatment was allowed within 72 hours of age if severe respiratory failure (defined as two consecutive a/A PO2 ratios </=.10) persisted after three doses of the randomized surfactant.
Three primary outcome measures of efficacy [the incidence of RDS; the incidence of RDS death; and the incidence of survival without bronchopulmonary dysplasia at 28 days after birth] were compared using linear regression techniques.
Of 871 randomized infants, 18 infants did not receive treatment with a study surfactant, and 25 infants did not meet all eligibility criteria. The primary analysis of efficacy was performed in the 846 eligible infants and analysis of safety outcomes in the 853 infants who received study surfactant. Demographic characteristics did not differ between the two treatment groups. Compared with Exosurf, Infasurf treatment resulted in a 62% decrease in the incidence of RDS (Infasurf, 16% vs Exosurf, 42%) and a 70% decrease in RDS death (Infasurf, 1.7% vs Exosurf, 5.4%) but did not increase the incidence of survival without bronchopulmonary dysplasia at 28 days. Treatment with Infasurf resulted in significant improvement in several secondary outcome measures. Infasurf-treated infants had lower average FIO2 (Infasurf, .33 [SEM] vs Exosurf, .42; difference .08; 95% confidence interval [CI], .06 to .11) and average mean airway pressure (Infasurf, 6.0 cm H2O vs Exosurf, 7.1 cm H2O; difference 1.1 cm H2O; 95% CI, .7 to 1.6 cm H2O) for the first 72 hours of life. Crossover surfactant treatment was significantly less frequent in the Infasurf compared with the Exosurf group (Infasurf, 1% vs Exosurf, 6%). Complications (bradycardia, clinical airway obstruction, and transcutaneous arterial desaturation) associated with second and third, but not initial, surfactant treatments were observed more frequently in the Infasurf treatment group. Infasurf-treated infants had significantly less air leak (</=7 days) (Infasurf, 8% vs Exosurf, 14%; adjusted relative risk [ARR] .55; 95% CI, .37 to .81). Severe intraventricular hemorrhage (IVH) (grade 3 and 4) did not differ between the two groups (Infasurf, 11.8% vs Exosurf, 8.3%; ARR 1.41; 95% CI, .94 to 2.09) but total IVH occurred more frequently in Infasurf-treated infants (Infasurf, 39.0% vs Exosurf, 29.9%; ARR, 1.30; 95% CI, 1.08 to 1.57).
Significant reductions in the incidence of RDS, the severity of early respiratory disease, the incidence of pulmonary air leaks associated with RDS, and the mortality attributable to RDS suggest that Infasurf is a more effective surfactant preparation than Exosurf Neonatal in the prophylaxis of RDS. However, Infasurf prophylaxis as used in this study was also associated with a greater risk of total but not severe IVH.</abstract><cop>Elk Grove Village, IL</cop><pub>Am Acad Pediatrics</pub><pmid>9200358</pmid><doi>10.1542/peds.100.1.39</doi><tpages>12</tpages></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0031-4005 |
| ispartof | Pediatrics (Evanston), 1997-07, Vol.100 (1), p.39-50 |
| issn | 0031-4005 1098-4275 |
| language | eng |
| recordid | cdi_proquest_journals_228352296 |
| source | EZB Electronic Journals Library |
| subjects | Age Factors Babies Biological and medical sciences Bronchopulmonary Dysplasia - prevention & control Care and treatment Cerebral Hemorrhage - prevention & control Data Interpretation, Statistical Drug Combinations Evaluation Fatty Alcohols - administration & dosage Fatty Alcohols - adverse effects Fatty Alcohols - therapeutic use Female Humans Infant, Newborn Linear Models Lung surfactant, Synthetic Lungs Male Medical research Medical sciences Pediatrics Pharmacology. Drug treatments Phosphorylcholine Polyethylene Glycols - administration & dosage Polyethylene Glycols - adverse effects Polyethylene Glycols - therapeutic use Pulmonary Surfactants - administration & dosage Pulmonary Surfactants - adverse effects Pulmonary Surfactants - therapeutic use Respiratory diseases Respiratory distress syndrome Respiratory Distress Syndrome, Newborn - mortality Respiratory Distress Syndrome, Newborn - prevention & control Respiratory system Synthetic lung surfactants Time Factors Treatment Outcome |
| title | A Multicenter Randomized Masked Comparison Trial of Synthetic Surfactant Versus Calf Lung Surfactant Extract in the Prevention of Neonatal Respiratory Distress Syndrome |
| url | http://sfxeu10.hosted.exlibrisgroup.com/loughborough?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2024-12-20T17%3A32%3A44IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-gale_proqu&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=A%20Multicenter%20Randomized%20Masked%20Comparison%20Trial%20of%20Synthetic%20Surfactant%20Versus%20Calf%20Lung%20Surfactant%20Extract%20in%20the%20Prevention%20of%20Neonatal%20Respiratory%20Distress%20Syndrome&rft.jtitle=Pediatrics%20(Evanston)&rft.au=Hudak,%20Mark%20L&rft.date=1997-07-01&rft.volume=100&rft.issue=1&rft.spage=39&rft.epage=50&rft.pages=39-50&rft.issn=0031-4005&rft.eissn=1098-4275&rft.coden=PEDIAU&rft_id=info:doi/10.1542/peds.100.1.39&rft_dat=%3Cgale_proqu%3EA19580499%3C/gale_proqu%3E%3Cgrp_id%3Ecdi_FETCH-LOGICAL-c527t-d4a7de17167a1cb14c8721c22a949538e5ab8c72fb34b615ea9db09a25bdb8863%3C/grp_id%3E%3Coa%3E%3C/oa%3E%3Curl%3E%3C/url%3E&rft_id=info:oai/&rft_pqid=228352296&rft_id=info:pmid/9200358&rft_galeid=A19580499&rfr_iscdi=true |