Clinical Trials Logo

Clinical Trial Summary

Acute chest syndrome (ACS) is a frequent complication of sickle cell disease and is diagnosed by having findings on a chest x-ray and one of the following: chest pain, fever, or trouble breathing. Patients with Acute Chest Syndrome can get very sick and require an exchange transfusion (special large blood transfusion) and mechanical ventilation. Bi-level Positive Airway Pressure (also known as BLPAP or BiPAP) is a device that blows air into a patients lungs via a mask that covers the nose. The goal of this study is to determine whether giving children BiPAP when they have ACS, in addition to providing standard clinical care for ACS, alters the clinical course of these patients. The investigators hypothesize that patients receiving effective BiPAP will have milder clinical courses resulting in shorter hospital stays and fewer transfers to the intensive care unit and exchange transfusions.


Clinical Trial Description

Acute chest syndrome (ACS) is a frequent complication of sickle cell disease and is diagnosed by a new infiltrate on chest x-ray and one of the following: chest pain, fever, or respiratory signs or symptoms (tachypnea, cough, new onset hypoxemia, or increased work of breathing.)The treatment for acute chest syndrome is focused on supportive care with hydration, antibiotics, blood transfusions and respiratory support. Unfortunately, despite these treatments many patients fail to have improvements in their respiratory status, or have respiratory decompensation. These patients require more aggressive treatments, which frequently include exchange transfusions, pediatric intensive care unit (PCCU) management, and respiratory support.

The study objective is to perform a prospective double blind randomized control trial to investigate if early initiation of effective BiPAP in addition to providing standard clinical care for ACS alters the clinical course of these patients vs. sham BiPAP and standard clinical care. Investigators hypothesize that participants receiving effective BiPAP will have milder clinical courses resulting in shorter hospital stays and fewer transfers to PCCU and exchange transfusions. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01589926
Study type Interventional
Source Albert Einstein College of Medicine, Inc.
Contact
Status Terminated
Phase N/A
Start date July 2012
Completion date September 8, 2016

See also
  Status Clinical Trial Phase
Completed NCT04134299 - To Assess Safety, Tolerability and Physiological Effects on Structure and Function of AXA4010 in Subjects With Sickle Cell Disease N/A
Completed NCT04581356 - Voxelotor Sickle Cell Exercise Study Phase 4
Completed NCT02712346 - The Role of Endothelin-1 in Sickle Cell Disease Phase 1
Withdrawn NCT02162225 - Study of Beet Juice for Patients With Sickle Cell Anemia Phase 2
Completed NCT01976416 - Novel Use Of Hydroxyurea in an African Region With Malaria Phase 3
Completed NCT01137721 - State Of The Art Functional Imaging In Sickle Cell Disease
Terminated NCT01350232 - Treatment of Sickle Cell Anemia With Stem Cell Transplant N/A
Withdrawn NCT00937144 - Endothelial Function in Patients With Sickle Cell Anemia Before and After Sildenafil Phase 4
Completed NCT00512564 - Clinical and Laboratory Assessment of Iron Overload in Sickle Cell Anemia and Sickle Cell Thalassemia N/A
Completed NCT00512226 - Iron Overload Assesment in Sickle Cell Anemia and Sickle Cell Thalassemia N/A
Completed NCT00004143 - Allogeneic Mixed Chimerism Stem Cell Transplant Using Campath for Hemoglobinopathies & Bone Marrow Failure Syndromes Phase 2
Completed NCT00004412 - Phase II Randomized Trial:Arginine Butyrate Plus Standard Local Therapy in Patients With Refractory Sickle Cell Ulcers Phase 2
Withdrawn NCT01925001 - Phase 2 Study of MP4CO to Treat Vaso-occlusive Sickle Crisis Phase 2
Completed NCT01848691 - Carbon Monoxide Monitor for the Measurement of End-Tidal Carbon Monoxide Levels in Children With or Without Hemolysis N/A
Completed NCT01783990 - Pediatric Hydroxyurea Phase III Clinical Trial (BABY HUG) Follow-up Observational Study II Protocol
Completed NCT00874172 - Effectiveness of New Analgesic Strategy Compared to the Usal Antalgic Strategy N/A
Completed NCT01000155 - Efficacy of Vorinostat to Induce Fetal Hemoglobin in Sickle Cell Disease Phase 2
Completed NCT00236093 - Extension Study of ACTIQ Treatment for Children and Adolescents With Breakthrough Pain Phase 2
Completed NCT00399074 - Sulfadoxine- Pyrimethamine Versus Weekly Chloroquine for Malaria Prevention in Children With Sickle Cell Anemia Phase 3
Completed NCT00004492 - Phase I/II Randomized Study of Hydroxyurea With or Without Clotrimazole in Patients With Sickle Cell Anemia Phase 1/Phase 2