Lung Diseases Clinical Trial
To determine if surfactant administration at birth in infants at high risk for respiratory distress syndrome (RDS) modified the clinical course of the syndrome.
BACKGROUND:
Respiratory distress syndrome affects more than 40,000 infants annually in the United
States. The overall mortality rate exceeds 20 percent and in infants weighing less than 1500
grams at birth, RDS is responsible for or contributes to the 30-70 percent mortality,
depending on birthweight. The present customary treatment of RDS with intermittent mandatory
ventilation is accompanied by sequelae such as extra-alveolar air leaks, intraventricular
hemorrhage, and bronchopulmonary dysplasia in approximately 50 percent of survivors.
The respiratory distress syndrome of the newborn is a disorder in which the pulmonary
surfactant is deficient. It has not been possible to completely replace natural components
of surfactant with synthetic components and achieve a mixture which functions
physiologically like pulmonary surfactant. Therefore, studies of replacement therapy for
surfactant deficiency have used complete natural surfactants or derivatives of natural
surfactant which contain the defined components of surfactant. The surfactant used in the
clinical trial was derived from human amniotic fluid.
Two basic different strategies for surfactant treatment of respiratory distress syndrome
have emerged: prophylactic, or preventilatory, treatment at or shortly after birth versus
rescue treatment after the initiation of mechanical ventilation in instances of clinically
confirmed respiratory distress syndrome. Although treatment at birth has the theoretic
advantage of delivering surfactant more uniformly to the airways before mechanical
ventilation, it has the disadvantages of delaying physiologic stabilization after birth and
resulting in unnecessary treatment, at considerable cost, of 20 percent to 40 percent of
infants born at or less than 30 weeks of gestation. Rescue therapy permits early physiologic
stabilization and confirmation of respiratory distress syndrome, but with the theoretic
disadvantages of early lung injury from mechanical ventilation in the surfactant-deficient
lung and less uniform surfactant distribution. Previous comparative trials have been biased
by incomplete study enrollment and inclusion of infants in preventilation treatment groups
without evidence of surfactant deficiency or immaturity. In addition, outcomes have varied
in placebo-treated infants.
DESIGN NARRATIVE:
Randomized, placebo-controlled. Singleton infants were assigned to receive a placebo (air),
prophylactic surfactant treatment given intratracheally, or rescue surfactant treatment.
Multiple birth infants received either prophylactic or rescue treatment. Of 282 potentially
eligible infants, 246 received treatments at birth and 200 had respiratory distress syndrome
and received the full course of surfactant therapy. Preterm infants randomly assigned to
receive prophylactic treatment received surfactant soon after birth; those assigned to
receive rescue surfactant had instillation at a mean age of 220 minutes if the
lecithin-sphingomyelin ratio was _ 2.0 and no phosphatidylglycerol was detected in either
amniotic fluid or initial airway aspirate, oxygen requirements were a fraction of inspired
oxygen of > 0.5 and mean airway pressure was _ 7 cm H20 from 2 to 12 hours after birth. Up
to four treatment doses were permitted within 48 hours; approximately 60 percent of
surfactant-treated infants required two or more doses. Endpoints included the mortality rate
at 28 days of age, the incidence of bronchopulmonary dysplasia at 28 days after birth and at
38 weeks to adjust for differences in gestational age, the incidence of pulmonary air leaks,
and the severity of respiratory distress syndrome as assessed by requirement for
supplemental oxygen and mechanical ventilation.
The study completion date listed in this record was obtained from the Query/View/Report
(QVR) System.
;
Allocation: Randomized, Primary Purpose: Prevention
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05563701 -
Evaluation of the LVivo Image Quality Scoring (IQS)
|
||
Completed |
NCT04908397 -
Carnitine Consumption and Augmentation in Pulmonary Arterial Hypertension
|
Phase 1 | |
Terminated |
NCT03309358 -
A Study of the Safety and Tolerability of Inhaled SNSP113 in Healthy Subjects and Subjects With Stable Cystic Fibrosis
|
Phase 1 | |
Completed |
NCT03682354 -
ESPB Versus INB With PCIA in Video-assisted Thoracic Surgery
|
N/A | |
Enrolling by invitation |
NCT03683186 -
A Study Evaluating the Long-Term Efficacy and Safety of Ralinepag in Subjects With PAH Via an Open-Label Extension
|
Phase 3 | |
Completed |
NCT03626519 -
Effects of Menthol on Dyspnoea in COPD Patients
|
N/A | |
Recruiting |
NCT06004440 -
Real World Registry for Use of the Ion Endoluminal System
|
||
Completed |
NCT04874948 -
Absorption, Elimination and Safety of 14C-labeled Radioactive BTZ-043, a New Compound in TB Treatment
|
Phase 1 | |
Completed |
NCT02926768 -
Phase I/II Study of CK-101 in NSCLC Patients and Other Advanced Solid Tumors
|
Phase 1 | |
Completed |
NCT01443845 -
Roflumilast in Chronic Obstructive Pulmonary Disease (COPD) Patients Treated With Fixed Dose Combinations of Long-acting β2-agonist (LABA) and Inhaled Corticosteroid (ICS)
|
Phase 4 | |
Completed |
NCT00281216 -
Innate and Adaptive Immunity in Individuals Experiencing Chronic Obstructive Pulmonary Disease Exacerbations
|
N/A | |
Completed |
NCT00269256 -
Stress, Environment, and Genetics in Urban Children With Asthma
|
N/A | |
Terminated |
NCT00233207 -
IC14 Antibodies to Treat Individuals With Acute Lung Injury
|
Phase 2 | |
Recruiting |
NCT00129350 -
Assessment of Heart and Heart-Lung Transplant Patient Outcomes Following Pulmonary Rehabilitation
|
Phase 1 | |
Active, not recruiting |
NCT00115297 -
Montelukast for Early Life Wheezing
|
Phase 2/Phase 3 | |
Completed |
NCT00094276 -
Intervention for Improving Asthma Care for Minority Children in Head Start
|
N/A | |
Completed |
NCT00091767 -
Genetic Studies in Difficult to Treat Asthma: TENOR
|
N/A | |
Completed |
NCT00089752 -
Continuous Positive Airway Pressure to Improve Milder Obstructive Sleep Apnea
|
N/A | |
Completed |
NCT00233168 -
Effectiveness of Public Health Model of Latent Tuberculosis Infection Control for High-Risk Adolescents
|
N/A | |
Completed |
NCT00069823 -
Study of Acid Reflux in Asthma
|
Phase 3 |