Clinical trials: Infants Cardiac Surgery
Congenital Heart Disease
Fibrinogen Concentrate vs Cryoprecipitate
One of the most common hemostatic derangements in pediatric open- heart surgery is an acute acquired hypofibrinogenemia. This compromises fibrin clot generation and platelet aggregation, resulting in increased bleeding and…
- Trial name
- NCT03014700
- Testing
- Fibrinogen Concentrate, Cryoprecipitate
- Where
- 2 sites in United States
- Volunteers
- 60 people
- Sponsor
- Stanford University
ATIII Deficiency
Anti-thrombin III (ATIII) vs Placebo in Children (<7mo) Undergoing Open Congenital Cardiac Surgery
The purpose of this study is to test whether the administration of ATIII during the intra-operative period results in improved anticoagulation for cardiopulmonary bypass (CPB) and an attenuation of the activation of the…
- Trial name
- NCT02103114
- Testing
- Anti-thrombin III
- Where
- United States
- Volunteers
- 45 people
- Sponsor
- Duke University
Thrombosis
Heparin and the Reduction of Thrombosis (HART) Trial
Heparin is frequently used in central venous catheters (CVCs) in post-operative cardiac patients. It remains unclear if a heparin infusion, compared to a normal saline infusion, prevents thrombosis of CVCs after surgery.
- Trial name
- NCT00779558
- Testing
- Heparin sulfate infusion at 10 units/kg/hour
- Where
- United States
- Volunteers
- 90 people
- Sponsor
- Stanford University
Congenital Heart Disease, Disorder of Fetus or Newborn
Corticosteroid Therapy in Neonates Undergoing Cardiopulmonary Bypass
Although cardiopulmonary bypass (heart-lung machine) is a necessary component of heart surgery, it is not without consequences. Cardiopulmonary bypass initiates a potent inflammatory response secondary to the body's recognition…
- Trial name
- NCT01579513
- Testing
- Methylprednisolone
- Where
- 2 sites in United States
- Volunteers
- 190 people
- Sponsor
- Medical University of South Carolina
Respiratory Failure
NAVA Versus BiPAP Non-Invasive Respiratory Support in Infants Following Congenital Heart Surgery
Pediatric patients often require prolonged mechanical ventilation after cardiac surgery which comes with many undesirable effects.
- Trial name
- NAVA (NCT03180385)
- Testing
- Neurally-Adusted Ventilatory Assist (NAVA), Biphasic Positive Airway Pressure Support (BiPAP)
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Children's Hospitals and Clinics of Minnesota
Congenital Heart Disease
Study of Possible Brain Hormone Problems After Open Heart Surgery in Infants
The goal of this study is to evaluate specific hormone levels in children undergoing heart surgery in order to identify patterns associated with any unstable vital signs.
- Trial name
- NCT00850720
- Testing
- Blood draws
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- Emory University
Transposition of Great Vessels, Congenital Heart Disease
N-Acetylcysteine in Neonatal Congenital Heart Surgery (INACT Study)
The purpose of this study is to determine whether intravenous N-acetylcysteine (also known as Acetadote), an antioxidant medication that has been used for years to treat Tylenol overdose, helps prevent heart dysfunction in the…
- Trial name
- NCT00374088
- Testing
- N-acetylcysteine
- Where
- United States
- Volunteers
- 21 people
- Sponsor
- University of Michigan
Congenital Heart Disease, Periventricular Leucomalacia
Randomized Trial of Maternal Progesterone Therapy
Neurodevelopmental disability is now recognized as the most common long-term complication after cardiac surgery in neonates. Research studies have shown that progesterone is critical to the development of the brain and in a…
- Conditions
- Congenital Heart Disease, Periventricular Leucomalacia, Brain Development, Cardiac Surgery
- Trial name
- NCT02133573
- Testing
- Progesterone, Vaginal lubricant
- Where
- United States
- Volunteers
- 102 people
- Sponsor
- Children's Hospital of Philadelphia
Hypofibrinogenemia, Afibrinogenemia
Human Fibrinogen Concentrate in Pediatric Cardiac Surgery
The goal of the study is to determine whether the use of Human Fibrinogen Concentrate (RiaSTAP) will decrease blood loss and the need for component blood therapy in neonates and infants undergoing cardiopulmonary bypass.
- Conditions
- Hypofibrinogenemia, Afibrinogenemia, Bleeding Disorders
- Trial name
- RiaSTAP (NCT02822599)
- Testing
- RiaStAP, Saline
- Where
- 2 sites in United States
- Volunteers
- 30 people
- Sponsor
- Nicklaus Children's Hospital f/k/a Miami Children's Hospital
Heart Defects, Congenital, Cardiopulmonary Bypass
Nesiritide Use Following Cardiac Surgery in Infants
The purpose of this study is to determine the effects of nesiritide on urine output and hemodynamics following cardiopulmonary bypass in infants. Safety and pharmacokinetic data will also be obtained.
- Trial name
- NCT00281671
- Testing
- nesiritide
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- Boston Children's Hospital
Hypoplastic Left Heart, Tetralogy of Fallot
Understanding Dexmedetomidine In Infants Post-Operative From Cardiac Surgery
This study is being conducted to determine what dexmedetomidine does to the body and in turn, what how the body handles the medication.
- Conditions
- Hypoplastic Left Heart, Tetralogy of Fallot, Tricuspid Atresia
- Trial name
- InfantDex (NCT00573066)
- Testing
- Dexmedetomidine
- Volunteers
- 56 people
- Sponsor
- Athena Zuppa
Surgery
Calibration and Validation of Masimo's O3 Regional Oximetry Device in Neonates, Infants and Children
The study will collect cerebral oximetry data from pediatric and neonatal subjects using the Masimo O3 regional oximetry device, for the purposes of device calibration and validation.
- Trial name
- NCT03123354
- Testing
- O3 regional oximeter sensor
- Where
- United States
- Volunteers
- 44 people
- Sponsor
- Masimo Corporation
Patent Ductus Arteriosus, Surgery
Early Treatment Versus Delayed Conservative Treatment of the Patent Ductus Arteriosus
The primary goal of the trial is to compare two different Patent Ductus Arteriosus (PDA) treatment approaches: 1) an "early treatment" approach or 2) a "conservative" approach.
- Conditions
- Patent Ductus Arteriosus, Surgery, Necrotizing Enterocolitis, Intestinal Perforation
- Trial name
- PDA:TOLERATE (NCT01958320)
- Testing
- pharmacologic treatment of the PDA, no pharmacologic treatment of the PDA, NSAID
- Where
- 18 sites in United States, Sweden and 2 more
- Volunteers
- 202 people
- Sponsor
- University of California, San Francisco
Congenital Heart Disease in Children, Inflammatory Response
STeroids to REduce Systemic Inflammation After Infant Heart Surgery
This study's objective is to determine the pharmacokinetics (PK)/pharmacodynamics (PD), safety and efficacy of methylprednisolone in infants undergoing heart surgery with cardiopulmonary bypass.
- Trial name
- STRESS (NCT03229538)
- Testing
- Methylprednisolone, Isotonic saline
- Where
- 23 sites in United States
- Volunteers
- 1,263 people
- Sponsor
- Kevin Hill
Pain
Measuring the Amount of Methadone or Morphine in the Blood of Neonates, Infants & Children After Cardiac Surgery.
Study Population: Neonates, infants and children from birth to 5 years of age undergoing cardiac surgery with CPB. The use of methadone to provide analgesia may be increasing due to advantages compared to other commonly used…
- Trial name
- NCT01094522
- Testing
- Methadone, Morphine
- Where
- 3 sites in United States
- Volunteers
- 47 people
- Sponsor
- Stanford University
Congenital Heart Disease
Paravertebral Nerve Blocks in Neonates
This study is a prospective, randomized, non-blinded clinical trial examining the use of paravertebral peripheral nerve block in the neonatal and infant populations.
- Trial name
- NCT03408340
- Testing
- Paravertebral Nerve Block, Standard of Care Anesthesia
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- Emory University
Congenital Heart Surgery, Cardiopulmonary Bypass
Use of Phenoxybenzamine [PBZ] IV to Assist High Flow Low Pressure Perfusion [HFLPP] on Cardio-pulmonary Bypass
Cardiopulmonary bypass [CPB] in small size bodies can result in decreased peripheral perfusion. This results in anaerobic metabolism as evidenced by lactic acidosis.
- Trial name
- NCT00620945
- Testing
- Phenoxybenzamine
- Volunteers
- 87 people
- Sponsor
- The Cleveland Clinic