Document Detail

Patent ductus arteriosus hemodynamics in very premature infants treated with poractant alfa or beractant for respiratory distress syndrome.
MedLine Citation:
PMID:  20336077     Owner:  NLM     Status:  MEDLINE    
OBJECTIVE: Respiratory distress syndrome (RDS), requiring mechanical ventilation and exogenous surfactant treatment, and patent ductus arteriosus (PDA), are common co-morbidities in very premature infants. The effects of intra-tracheal surfactant administration on the cardiovascular and pulmonary systems in very premature infants with RDS and PDAs are not well characterized. We evaluated the effects of poractant alfa and beractant, surfactants with different rapidity of onset and duration of action, in very premature infants with RDS. To assess whether there were differences in PDA hemodynamics in very premature infants with RDS treated with poractant alfa and beractant during the first week of life and to assess whether poractant alfa or beractant had a direct effect on PDAs and PDA hemodynamics following the second dose of surfactant.
STUDY DESIGN: We studied 50 in-born, very premature infants with RDS, 24 0 of 7 to 29 6 of 7 weeks gestation, treated with poractant alfa or beractant, in an open label, 1:1, randomized clinical trial. A subgroup of 16 patients with severe RDS, treated with a second dose of surfactant, had echocardiographical assessments before and 20 to 30 min after the second dose of surfactant.
RESULT: There were 25 infants treated with poractant alfa (27.1±1.6 weeks, birth weight 930±231 g) and 25 treated with beractant (26.7±1.7 weeks, P=0.407 and birth weight 898±282 g, P=0.666). Clinically significant PDAs were diagnosed and treated in 8 of 25 (32%) of the poractant alfa and 19 of 25 (76%) of the beractant group (P=0.002). Indomethacin treatment was slightly earlier (3.4±2.5 days) in the poractant alfa than in the beractant group (5.1±4.9 days, P=0.038). Right ventricle pressure (RVP)/systolic arterial pressure (SAP) ratio in the first week was slightly lower in the poractant alfa (64±20%) than in the beractant (78±26%, P=0.048) group. Following a second dose of surfactant, neither poractant alfa nor beractant changed PDA flow. These hemodynamic observations were associated with less respiratory support in the poractant alfa group, allowing earlier extubation (13 of 25 at 48 h and 15 of 25 at 72 h), than in the beractant group (6 of 25 at 48 h, P=0.044, and 8 of 25 at 72 h, P=0.049).
CONCLUSION: The more rapid improvement in pulmonary function in the poractant alfa-treated infants was associated with a lower RVP/SAP ratio and a corresponding earlier treatment with indomethacin. Neither surfactant had a significant direct effect on PDA hemodynamics. The lower frequency of clinically significant PDAs in the poractant alfa compared with the beractant group may represent an indirect effect of the differences in the pulmonary improvement induced by the two surfactants.
A Fujii; R Allen; G Doros; S O'Brien
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Publication Detail:
Type:  Comparative Study; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't     Date:  2010-03-25
Journal Detail:
Title:  Journal of perinatology : official journal of the California Perinatal Association     Volume:  30     ISSN:  1476-5543     ISO Abbreviation:  J Perinatol     Publication Date:  2010 Oct 
Date Detail:
Created Date:  2010-09-29     Completed Date:  2011-01-20     Revised Date:  2013-06-03    
Medline Journal Info:
Nlm Unique ID:  8501884     Medline TA:  J Perinatol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  671-6     Citation Subset:  IM    
Department of Pediatrics, Boston Medical Center, Boston University School of Medicine, Boston, MA 02118, USA.
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MeSH Terms
Biological Agents / therapeutic use
Ductus Arteriosus, Patent / epidemiology*,  physiopathology*,  therapy
Infant, Newborn
Infant, Premature
Infant, Premature, Diseases / drug therapy*,  epidemiology*,  physiopathology*,  therapy
Lung Compliance / drug effects
Phospholipids / therapeutic use
Prospective Studies
Pulmonary Surfactants / therapeutic use
Respiration, Artificial
Respiratory Distress Syndrome, Newborn / drug therapy*,  epidemiology*,  physiopathology
Reg. No./Substance:
0/Biological Agents; 0/Phospholipids; 0/Pulmonary Surfactants; 108778-82-1/beractant; KE3U2023NP/poractant alfa
Comment In:
J Perinatol. 2010 Oct;30(10):698-9; author reply 698   [PMID:  20877366 ]

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