Clinical trials: Mechanically Ventilated Neonates
Ventilator-associated Pneumonia
Study of Biotene OralBalance Gel for Oral Care in Critically-Ill Mechanically Ventilated Neonates
The goal of this pilot study is to test the hypothesis that mechanically ventilated infants receiving Biotene OralBalance® gel for oral care would have a reduced intubation time compared to infants receiving oral care placebo.
- Trial name
- NCT01314742
- Testing
- Biotene OralBalance® gel, Sterile Water moisten cotton tipped applicator
- Where
- 2 sites in United States
- Volunteers
- 41 people
- Sponsor
- Wake Forest University Health Sciences
Pain, Distress, Emotional
Mother Scented Simulated Hand for Mechanically Ventilated Preterm Neonates During Invasive Procedures?
This study aimed to determine the effect of Mother-Scented Simulated Hand (MSSH) on promoting comfort among mechanically ventilated preterm neonates during invasive procedures.
- Trial name
- Zaky-Hand (NCT05080582)
- Testing
- Mother-Scented Simulated Hand, NICU Standard Care
- Where
- Egypt
- Volunteers
- 62 people, healthy volunteers welcome
- Sponsor
- Alexandria University
Congenital Heart Disease, Cardiopulmonary Bypass
Influence of Personalized Lung Volume Optimization Maneuver on Lung Function and Cardiac Performance in Children
The goal of this randomized interventional clinical trial is to learn if a standardized lung volume optimization maneuver (LVOM) is beneficial in 1.
- Conditions
- Congenital Heart Disease, Cardiopulmonary Bypass, Cardiac Surgery, Mechanical Ventilation
- Trial name
- ILOCO (NCT07193719)
- 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
Hypoxic-Ischaemic Encephalopathy, Perinatal Asphyxia
Hypoxic-Ischemic Encephalopathy Therapy Optimization in Neonates for Better Neuroprotection With Inhalative CO2
This is a Phase I, open-label, single center trial to evaluate the feasibility and safety of low concentration CO2 gas mixture (5% CO2 + 95% air) inhalation in asphyxiated, cooled, mechanically ventilated newborns at risk of…
- Conditions
- Hypoxic-Ischaemic Encephalopathy, Perinatal Asphyxia, Hypocapnia
- Trial name
- HENRIC (NCT02700854)
- Testing
- 5% carbon-dioxide inhalation
- Where
- Hungary
- Volunteers
- 10 people
- Sponsor
- Semmelweis University
Acute Renal Failure, Neonatal Morbidity
SafeBoosC-IIIv - Does Cerebral Oximetry Monitoring Affect Renal Outcomes
Cerebral oximetry monitoring allows clinicians to optimize blood flow to the brain and oxygenation using the SafeBoosC treatment guideline. The guideline's interventions aims to stabilize blood pressure and oxygen levels.
- Trial name
- SBIIIvR (NCT06926946)
- Testing
- Intervention Arm- Cerebral Oximetry + Treatment Guideline
- Where
- India
- Volunteers
- 1,000 people
- Sponsor
- St. John's Research Institute
Fluid Therapy, Hemodynamics
Predicting Fluid Responsiveness in Mechanically Ventilated Critically Ill Children Using Transthoracic Echocardiography
Initial fluid resuscitation remains the first treatment step for most children experiencing circulatory failure and/or systemic hypotension.
- Conditions
- Fluid Therapy, Hemodynamics, Hypovolemia, Shock
- Trial name
- PREDIPEN (NCT05054452)
- Testing
- Echocardiographic assessment
- Where
- France
- Volunteers
- 4 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Mechanical Ventilation Pressure High, Ventilator-Associated Pneumonia (VAP)
Dynamic Airway Resistance & ML: Guide Sputum Suction in Ventilated Patients
Research has shown that timely suctioning not only improves survival rates but also enhances the quality of life in ventilator-dependent patients.
- Conditions
- Mechanical Ventilation Pressure High, Ventilator-Associated Pneumonia (VAP), Respiratory Depression Neonatal
- Trial name
- NCT07375667
- Testing
- The dynamics of airway resistance, conventional suctioning
- Where
- 3 sites in China
- Volunteers
- 258 people
- Sponsor
- Affiliated Hospital of Nantong University
Ventilation Therapy; Complications, Congenital Heart Disease
Influence of Positive-End-Expiratory-Pressure (PEEP) on Cardiac Output in Mechanically Ventilated Children
Interventional Trial to determine the Effect of different PEEP levels on Cardiac output and right-ventricular function in mechanically ventilated children < 5 years of age with congenital heart disease.
- Conditions
- Ventilation Therapy; Complications, Congenital Heart Disease, Children, Only, Hemodynamic Instability
- Trial name
- IPCOM (NCT06270485)
- Testing
- PEEP
- Where
- 2 sites in Germany, Netherlands
- Volunteers
- 58 people
- Sponsor
- Charite University, Berlin, Germany
Sedation
Safety, Efficacy and Pharmacokinetic Study of Dexmedetomidine in Pediatrics Ages ≥28 Weeks to ≤44 Weeks Gestational Age
The purpose of this study is to investigate the safety, efficacy and pharmacokinetics (PK) of dexmedetomidine (DEX) at 3 different dose levels in infants, ages ≥28 weeks to ≤44 weeks gestational age, administered as a loading…
- Trial name
- NCT01159262
- Testing
- Midazolam, Fentanyl/Morphine, Dexmedetomidine
- Where
- 18 sites in United States, Guatemala
- Volunteers
- 36 people
- Sponsor
- Hospira, now a wholly owned subsidiary of Pfizer
Pacifier
Pacifier Use in Mechanically Ventilated Term Newborns
Newborns on mechanical ventilator; It is stated that they need to calm and soothe themselves, their coordination in sucking and swallowing reflexes is not good, they have aspiration risks, their weight gain and discharge are…
- Trial name
- NCT06170957
- Testing
- Modified pacifier
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Hitit University
Hypoxia, Infant, Newborn, Diseases
Safeguarding the Brain of Our Smallest Children-IIIv (SafeBoosC-IIIv)
The objective of the SafeBoosC-IIIv trial is to assess benefits and harms of cerebral oximetry in newborns receiving invasive mechanical ventilation. The hypothesis is that: i.
- Trial name
- SafeBoosC-IIIv (NCT05907317)
- Testing
- Cerebral oximetry monitoring device, Usual care
- Where
- Spain
- Volunteers
- 1,610 people
- Sponsor
- Copenhagen Trial Unit, Center for Clinical Intervention Research
Mechanically Ventilated Neonates, Painful Procedures in Newborns
Codeine in Mechanically Ventilated Neonates
The purpose of this study is to determine the absorption and bioavailability of codeine in relation to postnatal (PNA) and postconceptional (PCA) age; determine the parent drug (codeine), its active metabolites, their formation…
- Trial name
- NCT01322204
- Testing
- Codeine
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Mechanical Ventilation Complication
The Ultrasonographic Changes of Intercostal Muscles and Diaphragm in Mechanically Ventilated Preterm Neonates
Invasive mechanical ventilation induces ventilator induced diaphragmatic dysfunction particularly when used for long time and Intercostal muscles as well contribute to the important work of respiratory movement by expanding the…
- Trial name
- NCT05495763
- Where
- Egypt
- Volunteers
- 30 people
- Sponsor
- Noha Saied Ibrahim
Prematurity, Mechanical Ventilation
Effects of Therapeutic Positioning in Mechanically Ventilated Preterm Infants
This randomized controlled trial evaluated the effects of three therapeutic positions on physiological parameters, pain, and comfort in mechanically ventilated preterm infants.
- Trial name
- NCT07845435
- Testing
- Supine Position, Prone Position, Fetal Position
- Where
- Turkey (Türkiye)
- Volunteers
- 60 people
- Sponsor
- Mustafa Kemal University
Mechanically-ventilated Neonates With Single-organ Respiratory Failure
Dexmedetomidine in Mechanically Ventilated Neonates With Single-Organ Respiratory Failure.
Clinical experience with dexmedetomidine in the paediatric population is limited. Critical illness can affect drug pharmacokinetics and -dynamics; the investigators cannot simply extrapolate adult data for use in children but the…
- Trial name
- NEODEX (NCT01266252)
- Testing
- Dexmedetomidine
- Where
- 3 sites in Belgium
- Volunteers
- 35 people
- Sponsor
- University Hospital, Ghent
Severe Bronchopulmonary Dysplasia
Aerosolized Albuterol Use in Severe BPD
Currently several dose schedules of Albuterol are administered via nebulization to infants in the neonatal and infant intensive care unit (N/IICU).
- Trial name
- NCT02766673
- Testing
- Albuterol Sulfate, Sterile Saline
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- Children's Hospital of Philadelphia
Vitamin C, Postoperative
Role of Vitamin C Infusion in Postoperative Mechanically Ventilated Neonates With Sepsis
This study aims to evaluate the effect of intravenous vitamin C infusion on septic mechanically ventilated full-term neonates who underwent surgical interventions regarding mechanical ventilation parameters, time to wean, and the…
- Conditions
- Vitamin C, Postoperative, Mechanically Ventilation, Sepsis
- Trial name
- NCT06780345
- Testing
- Vitamin C
- Where
- Egypt
- Volunteers
- 50 people
- Sponsor
- Tanta University
Postoperative Pain
Dexmedetomidine Versus Fentanyl for Sedation of Postoperative Mechanically Ventilated Neonates
Newborn infants experience pain after surgical procedures,prevention and management of pain in neonates is important due to its deleterious consequences.
- Trial name
- NCT05324891
- Testing
- Dexmedetomidine, Fentanyl
- Volunteers
- 40 people
- Sponsor
- Mansoura University
Neonatal SEPSIS, Nosocomially Acquired Neonatal Sepsis
A Study on Ventilator-associated Pneumonia as a Risk for Nosocomial Infection in Mechanically Ventilated Neonates In NICU of Assiut University Children Hospital (Nicu Eta)
Abstract Background: Neonatal ventilator associated pneumonia (VAP) is a major hospital-acquired infection in acute care settings, associated with high mortality and poor outcome.
- Trial name
- nicu eta (NCT03310840)
- Testing
- others
- Where
- Egypt
- Volunteers
- 140 people, healthy volunteers welcome
- Sponsor
- Assiut University
Disorders of the Autonomic Nervous System, Cardiovascular Abnormalities
Electrocardiographic Autonomic Function Measures in Mechanically Ventilated Patients
This research proposal has two main objectives. The first is to increase understanding of the underlying physiological interactions that occur between the cardiovascular, pulmonary, and ANS during transition between positive…
- Conditions
- Disorders of the Autonomic Nervous System, Cardiovascular Abnormalities, Respiratory Disorders
- Trial name
- NCT00844935
- Where
- United States
- Sponsor
- University of California, San Francisco