Clinical trials: Neonatal Surgery
Moderate to Severe Acute Postoperative Pain
Use of Tapentadol Oral Solution for Pain After Surgery in Children From Newborn to Less Than 2 Years Old
This is a multicenter, open-label (all people involved know the identity of the intervention), single dose trial to evaluate the pharmacokinetic (PK) profile (how drugs are absorbed in the body, how are they distributed within…
- Trial name
- NCT02221674
- Testing
- Tapentadol
- Where
- 7 sites in United States, Poland and 1 more
- Volunteers
- 40 people
- Sponsor
- Grünenthal GmbH
Hypofibrinogenemia
A Point-of-care Electrochemical-based Device for Rapid Detection of Fibrinogen on Type A Aortic Dissection Surgery
This study compares the results of the existing fibrinogen concentration monitoring technology to the Electrochemical-based device, a point-of-care and rapid method,using a small amount of extra blood obtained in Type A Aortic…
- Trial name
- NCT06434389
- Testing
- the Electrochemical-based device
- Where
- China
- Volunteers
- 150 people
- Sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
Postoperative Neurogenic Lower Urinary Tract Dysfunction Secondary to Tethered Cord Syndrome
Effectiveness of Electrical Pudendal Nerve Stimulation for Neurogenic Lower Urinary Tract Dysfunction in Pediatric Tethered Cord Syndrome Post-Surgery
The goal of this prospective observational study is to evaluate whether the addition of electrical pudendal nerve stimulation (EPNS) to standard conservative treatment can improve bladder function in pediatric patients with…
- Trial name
- NCT07062133
- Testing
- Electrical pudendal nerve stimulation, Conventional conservative treatment
- Where
- China
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Shanghai Institute of Acupuncture, Moxibustion and Meridian
Mandibular Fractures, Mandible Fracture
Facial iD Customized Mandible Reconstruction Plates
A retrospective post market follow up to confirm the safety and performance of Stryker's Customized Plates for Mandibular Reconstruction.
- Conditions
- Mandibular Fractures, Mandible Fracture, Mandible; Deformity, MANDIBLE
- Trial name
- NCT07245758
- Testing
- Mandibular reconstruction
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Stryker Craniomaxillofacial
Pectus Excavatum, Autonomic Dysfunction
Autonomic Dysfunction in Patients With Pectus Excavatum.
Investigators conducted a pilot study to to evaluate the autonomic function in participants with pectus excavatum before and after Nuss surgery.
- Conditions
- Pectus Excavatum, Autonomic Dysfunction, Surgery
- Trial name
- ADPE (NCT03346876)
- Testing
- Nuss surgery
- Where
- Taiwan
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Premature Infant Disease, Newborn Morbidity
Effects of Confortable Environment, Kangaroo Care and Music Therapy in Newborns in Neonatal Intensive Care Unit
Creating a comfortable environment, implementing kangaroo care, and incorporating music therapy are crucial interventions for newborns hospitalized in the Neonatal Intensive Care Unit (NICU).
- Trial name
- PRE-CARE (NCT06256406)
- Testing
- in the field of rehabilitation and neonatal care: the combination of Kangaroo care method and music therapy
- Where
- Italy
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Policlinico Universitario, Catania
Dentofacial Deformities
Stability of Two Designs of Patient Specific Osteosynthesis For Fixation of LeFort 1 Osteotomy in Orthognathic Surgery
A comparison of the stability of two different designs of patient specific fixation devices for the performance of splintless computer guided le fort 1 osteotomy in orthognathic surgery workflow for the correction of a variety of…
- Trial name
- NCT05522348
- Testing
- Stability of a two piece PSI deign in splintless maxillary orthognathic surgery, Stability of a one piece PSI deign in splintless maxillary orthognathic surgery
- Where
- Egypt
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Cairo University
Hypofibrinogenemia, Surgical Blood Loss
Effectiveness of Different Fibrinogen Preparations in Restoring Clot Firmness
Fibrinogen concentrate is produced by different manufacturers using different purification technologies. The products available in Italy are three: RiaSTAP (CSL Behring), FIBRYGA (Octapharma), and FibCLOT (LFB).
- Conditions
- Hypofibrinogenemia, Surgical Blood Loss, Bleeding, Cardiac Disease
- Trial name
- EDIPORE (NCT05780125)
- Testing
- FibCLOT, RiaSTAP
- Where
- Italy
- Volunteers
- 40 people
- Sponsor
- IRCCS Policlinico S. Donato
Hypoplastic Left Heart Syndrome
Safety Study of Autologous Umbilical Cord Blood Cells for Treatment of Hypoplastic Left Heart Syndrome
This is a Phase I study to determine the safety and feasibility of injections of autologous umbilical cord blood (UCB) cells into the right ventricle of Hypoplastic Left Heart Syndrome (HLHS) children undergoing a scheduled Glenn…
- Trial name
- NCT01883076
- Testing
- autologous cell-based delivery
- Where
- 6 sites in United States
- Volunteers
- 30 people
- Sponsor
- Timothy J Nelson, MD, PhD
Microtia, Microtia, Congenital
Study of Analgesic Efficacy of Nerve Blocks on Otoplastic Surgery
Background: Children with microtia complain of severe postoperative pain during early postoperative days after rib cartilage harvest for auricular reconstruction.
- Trial name
- NCT04192708
- Testing
- intercostal nerve block under direct vision, intercostal nerve block under ultrasound guidance, paravertebral block under ultrasound guidance
- Where
- China
- Volunteers
- 144 people
- Sponsor
- Eye & ENT Hospital of Fudan University
Single-ventricle, Congenital Heart Disease
Fontan Imaging Biomarkers (FIB) Study
The goal of the Fontan Imaging Biomarkers (FIB) study is to identify the associations of blood and urine biomarkers to imaging parameters of ventricular mechanics.
- Trial name
- FIB (NCT03119090)
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- Boston Children's Hospital
Heart Defects, Congenital
Use of the Cardioprotectant Dexrazoxane During Congenital Heart Surgery
Cardiopulmonary bypass and arrest of the heart during cardiac surgery are necessary to allow the surgeon to perform heart operations.
- Trial name
- NCT04997291
- Testing
- Dexrazoxane
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- University of Texas at Austin
Craniopharyngioma, Hypothalamic Obesity
Neuromodulation for Hypothalamic Obesity
The balance between hunger and satiety is imperative for an individual's survival and overall health.). Without this balance, individuals can become morbidly obese or lack adequate nutrition for survival.
- Conditions
- Craniopharyngioma, Hypothalamic Obesity, Metabolic Syndrome
- Trial name
- NCT03708913
- Testing
- Hypothalamic Deep Brain Stimulation
- Where
- Canada
- Sponsor
- University of British Columbia
Cerebral Aneurysm, Arteriovenous Malformations
Exploration of Anticoagulation Program in Cerebral Aneurysm and Arteriovenous Malformations With Hybrid Operation 1
In the stage of registration study, our purpose is to find out the safety range of activated coagulation time level in cerebral aneurysm and arteriovenous malformations with hybrid operation.
- Trial name
- EAPCAAMHO1 (NCT03306823)
- Where
- China
- Volunteers
- 556 people
- Sponsor
- Beijing Tiantan Hospital
Complex Congenital Heart Disease
Noninvasive Measurement of the Cerebral Autoregulation in Neonates and Infants With Complex Congenital Heart Disease
Feasibility of non-invasive cerebral autoregulation measurement at the PICU and impact of changes in oxygen supply
- Trial name
- NCT04810013
- Testing
- non-invasive measurement of cerebral autoregulation
- Where
- Germany
- Volunteers
- 80 people
- Sponsor
- University Hospital Tuebingen
Congenital Heart Disease
NIRS Predict Low Cardiac Output State in Neonates and Infants in Cardiac Surgery
Neonates and infants that have cardiac surgery with cardiopulmonary bypass (CPB) for congenital heart disease are at great risk for experiencing life-threatening low cardiac output syndrome (LCOS) in the first 24 hours after…
- Trial name
- NCT01849120
- Testing
- EQUANOX Advance 8004CB sensor
- Where
- United States
- Volunteers
- 35 people
- Sponsor
- Mayo Clinic
Basal Cell Nevus Syndrome
Trial of Patidegib Gel 2%, 4%, and Vehicle to Decrease the Number of Surgically Eligible Basal Cell Carcinomas in Gorlin Syndrome Patients
Multicenter, double-blind, randomized, vehicle-controlled study that evaluates the efficacy and safety of patidegib gel 2% and 4% in comparison with vehicle in participants at least 18 years of age that meet the diagnostic…
- Trial name
- NCT02762084
- Testing
- Patidegib, Vehicle gel
- Where
- 2 sites in United Kingdom
- Volunteers
- 17 people
- Sponsor
- PellePharm, Inc.
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
Comfort, Newborn, Infant, Disease
The Effect of Position on Gastric Residual Volume and Comfort Level in Newborns
The purpose of this randomized controlled trial is to determine the effect of different positions (supine, prone, right lateral and left lateral) in post-op term newborns staying in Pediatric Cardio Vascular Surgery (PCVS)…
- Conditions
- Comfort, Newborn, Infant, Disease, Position, Residual
- Trial name
- NCT04596202
- Testing
- Supine position, Prone position, Lateral position
- Where
- Turkey (Türkiye)
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Çanakkale Onsekiz Mart University
Necrotizing Enterocolitis, Neonate
Assessment of Score System of Surgery in Necrotizing Enterocolitis(NEC) Patients
Necrotizing enterocolitis(NEC) is one of the most serious disease in the newborn infants, and two and more grades of NEC usually lead to surgery, even death. But, it is difficult to predict when to operate the surgery.
- Conditions
- Necrotizing Enterocolitis, Neonate, Surgery
- Trial name
- NCT04795453
- Testing
- score system to predict the need for surgery, usual method to predict the need for surgery
- Where
- China
- Volunteers
- 800 people
- Sponsor
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
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