A prospective, randomized trial of early versus late administration of a single dose of surfactant-TA

Konishi, Mineo; Fujiwara, Tetsuro; Chida, Shoichi; Maeta, Haruo; Shimada, S.; Kasai, T; Fujii, Yutaka; Murakami, Yoichi

doi:10.1016/0378-3782(92)90164-c

Cited by 41 publications

(24 citation statements)

References 6 publications

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“…C hronic lung disease (CLD) of prematurity has multifactorial etiologies including hyperoxia, 1 barotrauma, 2 surfactant deficiency, 3 nutritional deficiencies, 4,5 fluid overload, 6,7 patent ductus arteriosus (PDA), 8 inflammation of the lungs, 9 and infection. 10 -12 With respect to infection, several microorganisms have been implicated; Chlamydia trachomatis, cytomegalovirus, adenovirus, and Ureaplasma urealyticum.…”

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confidence: 99%

Patterns of Colonization WithUreaplasma urealyticumDuring Neonatal Intensive Care Unit Hospitalizations of Very Low Birth Weight Infants and the Development of Chronic Lung Disease

et al. 2002

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ABSTRACT. Background. Ureaplasma urealyticum and its association with chronic lung disease (CLD) of prematurity has remained a controversial topic. To readdress this question, we performed a longitudinal study using culture and polymerase chain reaction to detect U urealyticum in the respiratory tract of very low birthweight infants throughout their neonatal intensive care unit hospitalizations.Methods. We screened 125 infants weighing <1500 g and/or <32 weeks' gestational age over a 12-month period, collecting endotracheal, nasopharyngeal, and throat specimens on days of age 1, 3, 7, and weekly thereafter. CLD was defined as dependency on supplemental oxygen at 28 days and at 36 weeks' postconceptional age.Results. Forty infants (32%) had 1 or more positive specimens by culture or polymerase chain reaction. We identified 3 patterns of U urealyticum colonization: persistently positive (n ‫؍‬ 18), early transient (n ‫؍‬ 14), and late acquisition (n ‫؍‬ 8). We compared the rates of CLD in each of the 3 colonized groups with the rate of CLD in the noncolonized group. We found a significantly higher rate of CLD at 28 days of age (odds ratio: 8.7; 95% confidence interval: 3.3, 23) and at 36 weeks' postconception (odds ratio: 38.5, 95% confidence interval: 4.0, 374) only for infants with persistently positive colonization.Conclusions. This study demonstrates that the risk of developing CLD varies with the pattern of U urealyticum colonization. Only the persistently positive colonization pattern, which accounted for 45% of the U urealyticumpositive infants, was associated with a significantly increased risk of development of CLD. Pediatrics 2002; 110(4). URL: http://www.pediatrics.org/cgi/content/full/ 110/4/e45; bronchopulmonary dysplasia, chronic lung disease, premature infant, polymerase chain reaction, Ureaplasma urealyticum, very low birth weight infant.

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confidence: 99%

Patterns of Colonization WithUreaplasma urealyticumDuring Neonatal Intensive Care Unit Hospitalizations of Very Low Birth Weight Infants and the Development of Chronic Lung Disease

et al. 2002

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“…Several trials of rescue surfactant therapy have demonstrated the benefits of early surfactant treatment. [1][2][3] The reduction in median time to surfactant for all infants Ͻ37 weeks' gestation to 121 minutes represents a 53% reduction from the pretrial audit and a 44% reduction compared with controls. The benefits were almost exclusively seen for infants of Ͻ28 weeks' gestation who were nearly always intubated before admission.…”

Section: Infants <28 Weeks' Gestationmentioning

confidence: 99%

“…Although this trial was not of sufficient size to have the power to detect clinically important improvements in these respiratory outcomes, the literature adequately documents the benefits of early surfactant in these infants. [1][2][3] An alternative to targeted early rescue therapy using a bedside test of surfactant is to give all preterm infants at risk of RDS surfactant at birth (surfactant prophylaxis). The benefits of early surfactant are supported by the trials of prophylactic versus rescue surfactant in terms of reductions in short-term morbidity and mortality of preterm infants.…”

Section: Infants <28 Weeks' Gestationmentioning

confidence: 99%

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Targeted Early Rescue Surfactant in Ventilated Preterm Infants Using the Click Test

et al. 2000

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ABSTRACT.Objective. To determine whether use of the click test, a rapid bedside test of surfactant function, results in earlier and more appropriate surfactant administration in ventilated preterm infants than does usual early rescue treatment.Study Design. Ventilated preterm infants (n ‫؍‬ 126) with inspired oxygen >25% and mean airway pressure >7 cm H 2 O were randomized in gestational strata (<28 weeks and 28 -36 weeks) to have surfactant therapy determined by the click test or by usual clinical and chest radiograph criteria. The treatment group had the click test performed on a tracheal aspirate as soon as possible after intubation and, if negative or equivocal (surfactant deficient), surfactant was given. The control group had surfactant given as soon as possible based on clinical and chest radiograph diagnoses of respiratory distress syndrome.Results. In infants of <28 weeks' gestation, use of the click test resulted in significantly earlier surfactant therapy (median time: 50 vs 159 minutes) and a reduction in the number of infants receiving surfactant (48% vs 79%). In infants of 28 to 36 weeks' gestation, there was no difference in time to surfactant (median time: 300 vs 268 minutes) or in the number of infants receiving surfactant. Neonatal morbidity and mortality were similar in click test and control groups.Conclusions. Use of the click test in ventilated, extremely premature infants results in significantly earlier and more appropriately targeted administration of surfactant than does early rescue therapy based on clinical and radiograph criteria. A randomized trial of targeted early rescue surfactant therapy versus prophylactic surfactant therapy in infants of <28 weeks' gestation is warranted. The click test has the potential to improve clinical outcomes and reduce costs. Pediatrics 2000;106(3). URL: http://www.pediatrics.org/cgi/content/full/106/3/ e30; click test, hyaline membrane disease, infant-premature, surfactant.

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“…Other studies favoring prophylactic surfactant have found improved survival, decreased morbidity, decreased dependence on oxygen at the expected date of delivery, and lower risk of pneumothorax. 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.…”

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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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A prospective, randomized trial of early versus late administration of a single dose of surfactant-TA

Cited by 41 publications

References 6 publications

Patterns of Colonization WithUreaplasma urealyticumDuring Neonatal Intensive Care Unit Hospitalizations of Very Low Birth Weight Infants and the Development of Chronic Lung Disease

Patterns of Colonization WithUreaplasma urealyticumDuring Neonatal Intensive Care Unit Hospitalizations of Very Low Birth Weight Infants and the Development of Chronic Lung Disease

Targeted Early Rescue Surfactant in Ventilated Preterm Infants Using the Click Test

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

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