Surfactant Application During Spontaneous Breathing With Continuous Positive Airway Pressure (CPAP) in Premature Infants < 27 Weeks
Summary
This study investigates the efficacy of surfactant application during spontaneous breathing with CPAP in avoiding death and chronic lung disease (CLD) in very immature infants with a gestational age of less than 27 weeks.
Description
80 % of extremely preterm infants with a gestational age of less than 27 completed weeks suffer from severe idiopathic respiratory distress syndrome (IRDS). They are still at high risk of mortality and long term morbidity especially of the lung and the brain. At least death and chronic lung disease (CLD) are related to the need and the duration of mechanical ventilation. Continuous positive airway pressure (CPAP) has been shown to be effective to avoid mechanical ventilation in the treatment of IRDS but it often fails in the most immature infants. Early or prophylactic surfactant application is effective in the treatment of IRDS and is the only causal therapy, but it is usually related to intubation and mechanical ventilation that should be avoided.Therefore to overcome the dilemma between need for mechanical ventilation with surfactant administration on the one hand and surfactant withholding with the use of CPAP on the other hand, a strategy was developed to administer surfactant during spontaneous breathing with CPAP (1). In the proposed prospective randomised controlled trial this strategy shall be compared with the recent gold standard in the therapy of extremely preterm infants with IRDS, that is intubation, mechanical ventilation and surfactant administration. Based on the results of a feasibility (1) study and some clinical observations it is hypothesised that the new approach is superior in avoidance of death and chronic lung disease compared to the recent gold standard.
Study Design
Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Respiratory Distress Syndrome, Newborn
Intervention
Curosurf, Curosurf
Location
Klinikum Aschaffenburg, Klinik für Kinder- und Jugendmedizin
Aschaffenburg
Germany
D-63739
Status
Recruiting
Source
University of Cologne
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00751959
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Bronchopulmonary Dysplasia
A chronic lung disease developed after OXYGEN INHALATION THERAPY or mechanical ventilation (VENTILATION, MECHANICAL) usually occurring in certain premature infants (INFANT, PREMATURE) or newborn infants with respiratory distress syndrome (RESPIRATORY DISTRESS SYNDROME, NEWBORN). Histologically, it is characterized by the unusual abnormalities of the bronchioles, such as METAPLASIA, decrease in alveolar number, and formation of CYSTS.
Respiratory Distress Syndrome, Newborn
A condition of the newborn marked by DYSPNEA with CYANOSIS, heralded by such prodromal signs as dilatation of the alae nasi, expiratory grunt, and retraction of the suprasternal notch or costal margins, mostly frequently occurring in premature infants, children of diabetic mothers, and infants delivered by cesarean section, and sometimes with no apparent predisposing cause.
Hyaline Membrane Disease
A respiratory distress syndrome in newborn infants, usually premature infants with insufficient PULMONARY SURFACTANTS. The disease is characterized by the formation of a HYALINE-like membrane lining the terminal respiratory airspaces (PULMONARY ALVEOLI) and subsequent collapse of the lung (PULMONARY ATELECTASIS).
Respiratory Distress Syndrome, Adult
A syndrome characterized by progressive life-threatening RESPIRATORY INSUFFICIENCY in the absence of known LUNG DISEASES, usually following a systemic insult such as surgery or major TRAUMA.
Porcine Reproductive And Respiratory Syndrome
A syndrome characterized by outbreaks of late term abortions, high numbers of stillbirths and mummified or weak newborn piglets, and respiratory disease in young unweaned and weaned pigs. It is caused by PORCINE RESPIRATORY AND REPRODUCTIVE SYNDROME VIRUS. (Radostits et al., Veterinary Medicine, 8th ed, p1048)
Clinical Trials
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Curosurf and Survanta Treatment(CAST)of RDS in Very Premature Infants
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Delivery Room Management Trial of Premature Infants at High Risk of Respiratory Distress Syndrome
The best mode of delivery room stabilization for premature infants at high risk for respiratory distress syndrome is unknown. The protocol evaluates the impact of three distinct methods of...
PubMed Articles
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Abstract Context.-Both nuclear factor κB and Fos-related antigen 1 have been implicated in the pathogenesis of inflammatory lung diseases, including acute lung injury/acute respiratory distress syndr...
Respiratory Morbidity in Late Preterm Births.
CONTEXT: Late preterm births (340/7-366/7 weeks) account for an increasing proportion of prematurity-associated short-term morbidities, particularly respiratory, that require specialized care and prol...
Chickenpox: a cause of acute respiratory distress syndrome to bear in mind.
The authors report a case of chickenpox (varicella) in an adult, complicated by acute respiratory distress syndrome and resulting in death.
Functional disability 5 years after acute respiratory distress syndrome.
There have been few detailed, in-person interviews and examinations to obtain follow-up data on 5-year outcomes among survivors of the acute respiratory distress syndrome (ARDS).
