Clinical trials: Neonatal Surgery, open to volunteers
Heart Diseases, ASD - Atrial Septal Defect
Abbott Structural Heart Device Registry
The Abbott Structural Heart (SH) Registry is being conducted to confirm the safety and performance of Abbott's SH devices in a post-market, real-world setting.
- Conditions
- Heart Diseases, ASD - Atrial Septal Defect, VSD - Muscular Ventricular Septal Defect, PFO - Patent Foramen Ovale
- Trial name
- SH-Registry (NCT06590467)
- Testing
- Amplatzer™ Occlusion Devices, Epic™ Surgical Tissue Heart Valve devices
- Where
- 36 sites in United States, Denmark and 8 more
- Volunteers
- 2,500 people
- Sponsor
- Abbott Medical Devices
Fetal Congenital Abnormalities, Fetoscopy
Fetoscopic Robotic Open Spina Bifida Treatment
Fetal spina bifida is a common birth defect that results in hydrocephalus, motor-, bowel-, bladder- and sexual dysfunction in the child. The condition is progressive in utero.
- Conditions
- Fetal Congenital Abnormalities, Fetoscopy, Fetal Surgery, Robotic Surgical Procedure
- Trial name
- FROST (NCT06907732)
- Testing
- Fetoscopic robotic open spina bifida closure
- Volunteers
- 15 people
- Sponsor
- Mount Sinai Hospital, Canada
Craniosynostoses, Hypovolemia
Hemodynamic Monitoring During Craniosynostosis Surgery: Comparing Traditional and Newer Technology Monitors (CRASY-PRAM)
Hemodynamic evaluation during pediatric anesthesia is essential to care management. Intraoperative cardiovascular instability is frequent in major surgeries, and appropriate monitoring is necessary to ensure safe anesthetic…
- Conditions
- Craniosynostoses, Hypovolemia, Hemorrhage, Hemodynamic Instability
- Trial name
- CRASY-PRAM (NCT06263075)
- Testing
- Intraoperative monitoring
- Where
- Italy
- Volunteers
- 30 people
- Sponsor
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
Neonatal Acidemia and Hypoxia
Hypoxia Profiles Identified in Term Newborns With Cord pH <7.00
Severe neonatal acidosis is an identified risk factor for neonatal encephalopathies and severe neurological sequelae such as cerebral palsy.
- Trial name
- RCFHypA (NCT07333599)
- Where
- France
- Volunteers
- 400 people
- Sponsor
- University Hospital, Strasbourg, France
Congenital Heart Disease (CHD)
Impact of Vitamin C Supplementation on Hospital Outcomes in Children Undergoing Corrective Heart Surgery for Congenital Heart Diseases
Vitamin C will be given before admission in the immediate preoperative preceding 7 days (the dose 30 -45 mg per day ) in oral drops preparations Inflammatory markers including CRP , TLC ,PNI , GPS NLR will be checked on admission…
- Trial name
- RCT (NCT06789640)
- Testing
- Vitamin C
- Volunteers
- 20 people
- Sponsor
- Cairo University
Breast Reconstruction, Breast Cancer
Evaluation of Well Being and Patient Reported Outcomes After Robotic Single-port Nipple Sparing Mastectomy and Implant Reconstruction
This study is being carried out to better understand how different types of mastectomy surgeries affect women's recovery, satisfaction, and overall well-being after breast cancer surgery and reconstruction.
- Conditions
- Breast Reconstruction, Breast Cancer, Hereditary Breast/Ovarian Cancer (brca1, brca2), Robotic Surgery
- Trial name
- Reborn-i (NCT07236359)
- Testing
- Intervention, Standard open nipple sparing mastectomy with immediate implant-based reconstruction
- Volunteers
- 108 people
- Sponsor
- Beaumont Hospital
Postoperative Complication, Recovery, Physiological
Assessment of the Impact of Intestinal Gas Emission Quality on the Postoperative Course After Abdominal Surgery
The recovery of transit after surgery is an important parameter in postoperative evaluation. It generally reflects simple postoperative outcomes and allows the patient to return home.
- Trial name
- FLATQUAL (NCT06675097)
- Where
- 2 sites in France
- Volunteers
- 200 people
- Sponsor
- University Hospital, Angers
Cervical Spine Fusion
Multifidus Cervicis Plane Block Vs. Sham Block For Posterior Cervical Spine Fusion Surgery
The goal of this randomized, double-blinded, clinical trial is to assess the benefit of administering a Multifidus Cervicis Plane (MCP) block compared to a sham block as a method of postoperative pain control in patients…
- Trial name
- MCP (NCT05996133)
- Testing
- Bupivacaine Hcl 0.25% Inj, Normal saline
- Where
- United States
- Volunteers
- 38 people
- Sponsor
- Hartford Hospital
Dentofacial Deformities, Dentofacial Anomalies [Including Malocclusion] and Other Disorders of Jaw (M26-M27)
Effect of Proximal Segment Positioning on Postoperative Condylar Remodeling in Bimaxillary Orthognathic Surgery
Bimaxillary orthognathic surgery is a surgical procedure that involves simultaneous corrections to both the maxilla (upper jaw) and mandible (lower jaw).
- Trial name
- NCT06897787
- Testing
- manuel positioning group, mandibular basis osteotomy
- Where
- Turkey (Türkiye)
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Bezmialem Vakif University
Fuchs' Endothelial Dystrophy, Cataract
The Effects of Ripasudil in Patients With FED Undergoing Femtosecond Laser Assisted Cataract Surgery
The purpose of this research is to investigate the effects of ripasudil administered as an ophthalmic solution in patients with FED after femtosecond laser assisted cataract surgery.
- Trial name
- NCT06048380
- Testing
- Ripasudil
- Where
- Singapore
- Volunteers
- 120 people
- Sponsor
- Singapore Eye Research Institute
Intracerebral Hemorrhage
Rapid Evacuation and Access of Cerebral Hemorrhage Registry
The goal of this observational study is to quantify the real-world effect of minimally invasive surgery (MIS) in patients with acute spontaneous supratentorial intracerebral hemorrhage.
- Trial name
- REACH (NCT07651631)
- Where
- United States
- Volunteers
- 2,500 people
- Sponsor
- Emory University
Congenital Heart Disease, Cardiopulmonary Bypass
Influence of Lung Volume Optimization Maneuver on Cardiac Output and Lung Compliance in Ventilated Children With Congenital Heart Disease Undergoing Surgical Repair
The aim of this randomized interventional multi-center clinical trial is to determine whether a standardized lung volume optimization maneuver (LVOM), including PEEP titration, improves outcomes in children undergoing…
- Conditions
- Congenital Heart Disease, Cardiopulmonary Bypass, Mechanical Ventilation, Peep Titration in Lung Protective Ventilation
- Trial name
- ILOCO-CHD (NCT07486167)
- Testing
- End-expiratory lung volume optimization maneuver with PEEP titration, Standard Care (in control arm)
- Where
- Germany
- Volunteers
- 80 people
- Sponsor
- Charite University, Berlin, Germany
Delirium - Postoperative, Sleep Problems
Preoperative Sleep Disorders and Postoperative Delirium in Children Undergoing Congenital Heart Surgery
The investigators are going to conduct a prospective observational cohort study in pediatric patients aged 28 days to 14 years old scheduled for elective cardiac surgery with cardiopulmonary bypass.
- Conditions
- Delirium - Postoperative, Sleep Problems, Congenital Heart Disease (CHD)
- Trial name
- NCT06686550
- Testing
- This is a observational study and there is no intervention.
- Volunteers
- 435 people
- Sponsor
- Yan Fuxia
Choledochal Cyst
Timing of Operation in Children With a Prenatal Diagnosis of Choledochal Cyst
In this prospective study, we tried to select the operation time according to the cyst size and evaluate the treatment effect.
- Trial name
- CDCPS (NCT05620485)
- Testing
- laparoscopic-assisted CDC excision and hepaticojejunostomy
- Volunteers
- 30 people
- Sponsor
- Guangzhou Women and Children's Medical Center
Esophageal Cancer
Outside the Cage (OTC) Robotic Esophagectomy
The goal of this clinical trial is to evaluate the feasibility and safety of a novel non-intercostal robotic approach for minimally invasive esophagectomy (OTC MIE) in the treatment of esophageal cancer.
- Trial name
- NCT06735638
- Testing
- OTC MIE Esophagectomy
- Where
- Canada
- Volunteers
- 31 people
- Sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)
Congenital Disorders, Cerebral Desaturation
International Study of Cerebral Oxygenation and Electrical Activity During Major Neonatal Surgery
The goal of this observational study is to determine the incidence of perioperative cerebral desaturation in neonates undergoing surgery for congenital malformations. The main questions it aims to answer are: 1.
- Conditions
- Congenital Disorders, Cerebral Desaturation, Neonatal Surgery
- Trial name
- NCT05673499
- Testing
- NIRS/EEG monitoring
- Where
- 15 sites in United States, Australia and 5 more
- Volunteers
- 900 people
- Sponsor
- Children's Hospital of Philadelphia
Idiopathic Toe Walking, Cerebral Palsy
The Effect of Targeting the Plantaris Muscle-tendon in Surgical Correction of Ankle Equinus in Children
Tight ankle muscles can produce ankle equinus (limited ability to pull the foot upward) and occur often in children, significantly impacting their ability to walk.
- Conditions
- Idiopathic Toe Walking, Cerebral Palsy, Hereditary Spastic Paraparesis, Traumatic Brain Injury
- Trial name
- Plantaris Sx (NCT07090057)
- Testing
- Tendoachilles (TA) lengthening or gastrocnemius (GN) recession, then Plantaris tenotomy, Plantaris tenotomy, then Tendoachilles (TA) lengthening or gastrocnemius (GN) recession
- Where
- Canada
- Volunteers
- 42 people
- Sponsor
- University of Alberta
Sinus Venosus Defect, Congenital Heart Disease
OPTImal Treatment of Sinus VENOSUS Defect
Sinus venosus defect (SVD) accounts for 10% of atrial septal defects and is characterized by an anomalous pulmonary venous return in the superior vena cava associated with a high situated atrial septal defect.
- Conditions
- Sinus Venosus Defect, Congenital Heart Disease, Sinus Venosus Atrial Septum Defect
- Trial name
- OPTIVENOSUS (NCT05865119)
- Testing
- OPTIMUS covered stent, Surgical correction of a SVD
- Where
- 13 sites in France
- Volunteers
- 60 people
- Sponsor
- Centre Chirurgical Marie Lannelongue
Hemophilia A
Nuwiq Dosing and Outcomes In the ManagEment of Women/Girls With Haemophilia A Needing FVIII Treatment for Surgery
Recombinant factor VIII for the prevention of bleeding in women/girls with haemophilia A undergoing major surgery
- Trial name
- NCT05936580
- Testing
- Nuwiq
- Where
- 16 sites in United States, Finland and 8 more
- Volunteers
- 28 people
- Sponsor
- Octapharma
Hirschsprung Disease
Surgical Approach for the Treatment of Hirschsprung Disease Using the Swenson Technique (SMILES)
Hirschsprung disease (HD) is a rare congenital disorder of the enteric nervous system, affecting approximately 1 in 5,000 live births.
- Trial name
- SMILES (NCT07468565)
- Testing
- transanal or laparoscopy assisted Swenson coloanal pullthrough
- Volunteers
- 70 people
- Sponsor
- University Hospital, Angers