Randomized, placebo-controlled trial of human surfactant given at birth versus rescue administration in very low birth weight infants with lung immaturity

Merritt, T. Allen; Hallman, Mikko; Berry, Charles C.; Pohjavuori, Maija; Edwards, David K.; Jääskeläinen, J; Grafe, Majorie R.; Vaucher, Yvonne E.; Wozniak, Paul R.; Heldt, Gregory P.; Rapold, Juhanl

doi:10.1016/s0022-3476(05)83387-6

Cited by 134 publications

(45 citation statements)

References 29 publications

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“…Merrit et al 15) found that ROP and PDA occurred more often in prophylactic patients than in rescue patients; however, Kendig et al 16) refuted this observation. Rankin et al 17) reported on the risk of ROP with surfactant instillation, and Holmes et al 18) , Repka et al.…”

Section: Discussionmentioning

confidence: 99%

Comparison of Outcomes between Prophylactic and Rescue Therapy of Surfactant in Premature Infants

et al. 2013

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Purpose:To compare early and later surfactant instillation in neonates with a birth weight of <1,250 g and/or less than 30 weeks' gestation, following the changes in the National Health Insurance policy of the Republic of Korea. Methods: Preterm infants diagnosed with respiratory distress syndrome and instilled with an exogenous surfactant from April 2006 to August 2012 were included in this study. The subjects were divided into the two groups: the prophylactic group (n=19) included neonates who were instilled with surfactant within 30 minutes after birth in the delivery or operating room, and the rescue group (n=27) included neonates who were treated with surfactant from 30 minutes to 10 hours after birth for the treat ment of respiratory distress syndrome. We compared the two groups in terms of short and long term outcomes. Results: The groups showed no significant difference in gestational age and birth weight. The prophylactic group had a shorter duration of mechanical ven tilation of synchronized intermittent mandatory ventilation but longer parenteral nutrition and mechanical ventilation, including continuous positive airway pressure without synchronized intermittent mandatory ventilation. There are significant differences in the occurrence of long term common com plications such as patent ductus arteriosus and parenteral nutrition asso ciated cholestasis. The ventilation index, oxygenation index, mean airway pressure, and arterial to alveolar oxygen pressure ratio were lower in the prophylactic group than in the rescue group. Conclusion: In comparison with late instillation, early surfactant instillation can reduce the period and requirement of mechanical ventilation. It also reduces the occurrence of patent ductus arteriosus and parenteral nutrition associated cholestasis in newborns.

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Section: Discussionmentioning

confidence: 99%

Comparison of Outcomes between Prophylactic and Rescue Therapy of Surfactant in Premature Infants

et al. 2013

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“…[27][28][29][30] A diminished severity of BPD generally has been accepted as a result of surfactant use, although its incidence remains significant in the premature population having had RDS. 11,29,[31][32][33][34] Chronic lung disease (CLD) is not defined uniformly among published studies; thus, we examined it in two ways. First we evaluated an oxygen requirement at 28 days in children who required ventilatory assistance during the first week of life, and then we examined infants having an oxygen requirement at 36 weeks' CGA.…”

Section: Discussionmentioning

confidence: 99%

“…8,[11][12][13] Comparisons of the early neurodevelopmental outcomes of PRx versus RRx also have produced mixed results. An earlier analysis of part of the cohort from the present study demonstrated an advantage of prophylactic therapy, with fewer of the PRx infants having moderate to severe motor delays at 6 to 12 months.…”

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confidence: 99%

“…3,9,10 However, some trials have found no significant advantage of PRx over RRx and recommend RRx because of unnecessary treatment of surfactant-sufficient neonates. 8,[11][12][13] Comparisons of the early neurodevelopmental outcomes of PRx versus RRx also have produced mixed results. An earlier analysis of part of the cohort from the present study demonstrated an advantage of prophylactic therapy, with fewer of the PRx infants having moderate to severe motor delays at 6 to 12 months.…”

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confidence: 99%

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School-age Follow-up of Prophylactic Versus Rescue Surfactant Trial: Pulmonary, Neurodevelopmental, and Educational Outcomes

et al. 1998

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ABSTRACT. Background. Exogenous surfactant replacement has improved survival and reduced pulmonary complications of prematurity. Improved early outcomes for infants of <30 weeks' gestation treated with a strategy of prophylactic versus rescue surfactant, if needed, were demonstrated in a multicenter, randomized trial conducted between 1985 and 1988. We reevaluated a subset of survivors from this trial to determine the pulmonary and neurodevelopmental outcomes at school age.Methods. At 4.5 to 8 years of age, all survivors from one of the three centers were located, and 96% were evaluated. The original randomization included stratification by center and followed an intention-to-treat methodology in assessing the efficacy of prophylactic versus rescue treatment with surfactant. The follow-up test battery included a health-assessment questionnaire, spirometry, 88% saturation test, neurologic examination, and the McCarthy Scales of Children's Abilities (MSCA) and the Conners' Parent Rating Scale-48. Educational achievement was determined by school class placement and teachers' reports of achievement.Results. Of the 192 children originally enrolled, 154 survived. Evaluations were performed on 148 of these infants. An abnormal pulmonary history was found in 45 (30%) of the children: 16 (22%) in the prophylactic group and 29 (39%) in the rescue group. Formal pulmonary function was evaluated in 81 children; 29 (78%) in the prophylactic group and 33 (75%) in the rescue group were considered abnormal. No significant differences were found between the two groups on either cognitive or motor subscales of the MSCA, the Conners' Parent Rating Scale-48, the neurologic examination, the education services received in school, or the teacher ratings of below-average academic performance. Intelligence scores measured on the MSCA were low-normal for both groups. Some level of educational assistance was being provided to 72 (49%) of the cohort studied, and both groups had below average educational performance and increased needs for educational assistance.Conclusions. Prophylactic surfactant administration to infants of <30 weeks' gestation was associated with fewer long-term clinical pulmonary complications than assignment to rescue administration. Formal pulmonary testing at school age did not reveal significant differences between treatment groups in those infants who could be tested. There also were no group differences found on neurologic, cognitive, behavioral, or educational assessments at school age. E xogenous surfactant has become accepted therapy for the prevention and treatment of respiratory distress syndrome (RDS) in small premature infants. [1][2][3][4][5] Multiple studies have demonstrated short-term safety, improved survival, and decreased early morbidity with use of surfactant. 1,7,8 However, important issues concerning surfactant therapy remain unanswered including the optimum timing of its administration and the long-term (school-age) pulmonary, neurodevelopmental, and educational outcome of treated children.Prophy...

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“…Vários ensaios clínicos multicêntricos randomizados têm comparado a abordagem profilática em relação à terapêutica [19][20][21][22][23][24][25] . Nesses estudos, os recém-nascidos com menos de 30 semanas (6 estudos) ou com menos de 32 semanas (1 estudo) foram sorteados para receber uma dose profilá-tica ou tratamento após estabelecido o diagnóstico.…”

Section: Uso De Surfactante No Recém-nascidounclassified

Exogenous surfactant therapy in pediatrics

Freddi¹,

Filho²,

Fiori³

2003

J Pediatr (Rio J)

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ResumoObjetivo: Revisar o estágio atual do conhecimento sobre a utilização do surfactante exógeno nas diferentes doenças pulmonares que levam à insuficiência respiratória aguda em crianças. Fontes dos dados:Este manuscrito baseia-se na experiência clínica dos autores sobre o assunto e na revisão da literatura recente através de consulta aos bancos de dados ONIA, Mdconsult, Medline e Cochrane Database Library. Síntese dos dados:Apesar do sucesso obtido com a utilização do surfactante exógeno na síndrome de desconforto respiratório do recém-nascido, questões permanecem indefinidas, como o momento do seu emprego, muito precoce (profilático), baseado na idade gestacional ou em testes rápidos de maturidade pulmonar, ou então mais tardiamente, após o quadro clínico instalado. Em outras patologias graves que levam à insuficiência respiratória grave com necessidade de suporte ventilatório, o seu uso ainda é controverso, e os dados da literatura são limitados e conflitantes. Porém, relatos de uso clínico em várias destas situações, com sucesso, têm sido freqüentes. A pesquisa em surfactante tem-se centrado ultimamente na sua inativação por várias substâncias que podem estar presentes na via aérea. Nas patologias em que a inativação parece ser um fator importante, novos surfactantes com adição de adjuvantes para reverter a tendência à inativação (por exemplo: polietilenoglicol) estão atualmente em fase de testes. Conclusões:A terapia com surfactante exógeno ainda não é um tema esgotado, nem mesmo na SDR. Os surfactantes podem ser ainda aperfeiçoados, sobretudo para resistir à inibição, e as formas de utilização em outras doenças que não a SDR deverão ser aperfeiçoadas.J Pediatr (Rio J) 2003;79(Supl.2):S205-S212: Surfactante exógeno, insuficiência respiratória, cuidados intensivos, síndrome de desconforto respiratório. AbstractObjective: To review current knowledge about the use of exogenous surfactants in the treatment of different lung diseases causing acute respiratory failure in children. Source of data:This review is based on the authors' experience and on recent data retrieved from ONIA, Mdconsult, Medline and the Cochrane Database Library. Summary of the findings:In spite of the success of the use of exogenous surfactants in Respiratory Distress Syndrome (RDS) of the newborn, some questions remain unanswered, such as the optimal administration timing -either very early (prophylactic), based on gestational age or on quick tests of lung maturity, or later, when the clinical picture becomes unequivocal. In other severe diseases requiring ventilatory support, the use of surfactants is still controversial, and data in the literature are limited and conflicting. However, successful use in several other diseases has been reported. Recent studies have focused on surfactant inactivation by substances that can be found in the airways. New surfactants with the addition of substances to control inhibition, such as polyethyleneglycol, are being tested for diseases in which inactivation seems to be a significant factor. Conclusio...

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Randomized, placebo-controlled trial of human surfactant given at birth versus rescue administration in very low birth weight infants with lung immaturity

Cited by 134 publications

References 29 publications

Comparison of Outcomes between Prophylactic and Rescue Therapy of Surfactant in Premature Infants

Comparison of Outcomes between Prophylactic and Rescue Therapy of Surfactant in Premature Infants

School-age Follow-up of Prophylactic Versus Rescue Surfactant Trial: Pulmonary, Neurodevelopmental, and Educational Outcomes

Exogenous surfactant therapy in pediatrics

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