Clinical trials: Preterm Neonates
Respiratory Distress Syndrome in Premature Infant
Surfactant Therapy Via Supraglottic Airway to Preterm Neonates With RDS in Vietnam
Preterm babies often have trouble breathing because their lungs are not fully developed. This condition is called respiratory distress syndrome (RDS). A medicine called surfactant helps their lungs open up and work better.
- Trial name
- NEOSURF (NCT07098910)
- Testing
- Surfactant Administration Through Laryngeal or Supraglottic Airways (SALSA), Intubation - Surfactant administration - Extubation (INSURE)
- Where
- Vietnam
- Volunteers
- 440 people
- Sponsor
- Karolinska Institutet
Pain, Retinopathy of Prematurity
Proparacaine and Mydriatic Eye Drops
In this study, we will be evaluating whether premedication with an anesthetic eye drops leads to a decreased sensation of pain when given dilating eye drops prior to eye examinations to evaluate for retinopathy of prematurity in…
- Trial name
- NCT01266824
- Testing
- Proparacaine Hydrochloride Ophthalmic Solution
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- Children's Hospital of Philadelphia
Feeding Patterns, Feeding; Difficult, Newborn
Neoneur Feeding System Functionality in the Clinic
Prospective data collection using the Neoneur Feeding System to demonstrate device functionality, correlation to historic data, and prepare for a more extensive phase II SBIR trial
- Conditions
- Feeding Patterns, Feeding; Difficult, Newborn, Feeding Disorder Neonatal
- Trial name
- NN200 (NCT05525091)
- Testing
- Feeding Evaluation
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Neoneur LLC
Bronchopulmonary Dysplasia
Efficacy and Safety of Inhaled Budesonide in Very Preterm Infants at Risk for Bronchopulmonary Dysplasia
HYPOTHESIS: Early prophylactic inhalation of Budesonide reduces the absolute risk of developing bronchopulmonary dysplasia (BPD) or death in preterm infants born <28 weeks gestational age (GA) by 10%.
- Trial name
- NEuroSIS (NCT01035190)
- Testing
- Budesonide
- Where
- 40 sites in Belgium, Czechia and 6 more
- Volunteers
- 863 people
- Sponsor
- University Children's Hospital Tuebingen
Neonatal Late Onset Sepsis
Pentoxifylline Dose Optimization in Neonatal Sepsis
Sepsis is a very important cause of death and morbidity in preterm infants. There are strong indications that preterm neonates with sepsis could benefit, next to antibiotics, from treatment with pentoxifylline (PTX).
- Trial name
- NCT04152980
- Testing
- Pentoxifylline
- Where
- 2 sites in Netherlands, Poland
- Volunteers
- 30 people
- Sponsor
- Erasmus Medical Center
Respiratory Distress Syndrome, Preterm Birth
LISA vs INSURE in Extremely Low Birth Weight Infants. A Manikin Study
This is an unblinded, randomized, controlled, crossover (AB/BA) trial of surfactant treatment with LISA vs. INSURE in a manikin simulating an extremely low birth weight infant.
- Conditions
- Respiratory Distress Syndrome, Preterm Birth, Surfactant Deficiency Syndrome Neonatal
- Trial name
- NCT04944108
- Testing
- LISA approach, Insure approach
- Where
- 2 sites in Italy
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- University Hospital Padova
Infant, Very Low Birth Weight, Neonatal Hypoglycemia
Continuous Glucose Monitoring and Preterm Infants
Neonatal hypoglycemia is associated with brain injury and impaired neurodevelopment outcomes in very low birth weight infants (VLBWI).
- Trial name
- CGM&VLBWI (NCT02583776)
- Testing
- Unblinded - CGM, Blinded - CGM
- Where
- 3 sites in United States, Italy
- Volunteers
- 50 people
- Sponsor
- University Hospital Padova
Infant, Newborn, Infant, Low Birth Weight
Delivery Room CPAP in Extremely Low Birth Weight Infants
This pilot study was designed to determine the feasibility of randomizing extremely low birth weight (ELBW) infants <28 weeks' gestation who required resuscitation to one of two resuscitation methods, either: (a) 100% oxygen by…
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- DR-CPAP (NCT01223274)
- Testing
- CPAP/PEEP, Standard management practices
- Where
- 6 sites in United States
- Volunteers
- 104 people
- Sponsor
- NICHD Neonatal Research Network
Sepsis Newborn
The Effect of Melatonin as an Adjuvant Therapy for Preterm Neonates With Sepsis
The goal of this clinical trial is to assess the effect of melatonin on MDA serum, IL-6, IL-8 levels, ANC, and sepsis score in preterm neonates with sepsis.
- Trial name
- NCT06191523
- Testing
- Control Group, Treatment Group
- Where
- Indonesia
- Volunteers
- 42 people
- Sponsor
- Universitas Sebelas Maret
Persistent Ductus Arteriosus, Complication of Prematurity
The Preterm Infants' Paracetamol Study
Present randomized, controlled, double-blind trial investigates the efficacy and safety of early (<24 h) intravenous paracetamol therapy for pain medication in very small premature infants.
- Conditions
- Persistent Ductus Arteriosus, Complication of Prematurity, Pain or Discomfort in Intensive Care of Preterm Infants
- Trial name
- PreParaS (NCT01938261)
- Testing
- paracetamol, 0.45 % saline solution
- Where
- Finland
- Volunteers
- 120 people
- Sponsor
- University of Oulu
Respiratory Failure
Low and High Flow Suctioning in Intubated Infants
Preterm and term intubuted infants in the NICU will undergo two sequential suctioning procedures: a new, FDA-approved suction device called EXSALTA (ED) and the standard conventional wall (SCW).
- Trial name
- NCT06443970
- Testing
- Exsalta Suction Device
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Columbia University
Premature Newborn
Conditions of Realization of the Echocardiography in Newborns
Experimental nociceptive stimulation of the fetus and neonate induces pulmonary artery vasoconstriction. The investigators assessed whether echocardiography for Ductus arteriosus screening may generate this hemodynamic response…
- Trial name
- NCT02893956
- Testing
- echocardiography with postural support, echocardiography with standard condition (usual)
- Where
- France
- Volunteers
- 30 people
- Sponsor
- University Hospital, Montpellier
Patent Ductus Arteriosus
Comparision Between Paracetamol and Ibuprofen in Closure of Patent Ductus Arteriosus
To compare efficacy and safety of paracetamol and ibuprofen for the pharmacological closure of patent ductus arteriosus (PDA) in preterm infants.
- Trial name
- NCT06152796
- Testing
- Paracetamol, Ibuprofen
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Assiut University
Respiratory Distress Syndrome, Newborn, Bronchopulmonary Dysplasia
Work of Breathing During Non-invasive Ventilation in Premature Neonates
Background: Non-invasive forms of respiratory support have been developed to manage respiratory distress and failure in premature newborns without exposing them to the risks associated with invasive mechanical ventilation.
- Trial name
- NCT02788110
- Testing
- Noninvasive neurally adjusted ventilatory assist (NIV NAVA), Nasal intermittent positive pressure ventilation (NIPPV)
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Arkansas Children's Hospital Research Institute
Skin to Skin, Premature Newborns
Skin-to-skin Contact During the Transfer From the Delivery Room to the Neonatal Intensive Care Unit: Impact on Very Preterm Infants and Their Parents
Developmental care are recognized as a standard of care for preterm infants in neonatal intensive care units. Regular skin-to skin contacts during the neonatal stay show short and long-term beneficial effects on preterm infants…
- Trial name
- TRANSPAPNEO (NCT05820386)
- Testing
- Skin-to-skin Contact (SSC), Incubator
- Where
- 4 sites in France
- Volunteers
- 118 people
- Sponsor
- University Hospital, Tours
Infant, Premature, Diseases, Infant, Newborn, Disease
Noninvasive High Frequency Oscillatory Ventilation as a Post-extubation Respiratory Support in Neonates
A randomized controlled trial comparing Noninvasive high frequency oscillatory ventilation (NHFOV) and Noninvasive positive pressure ventilation (NIPPV) as post-extubation respiratory support in preterm neonates with respiratory…
- Conditions
- Infant, Premature, Diseases, Infant, Newborn, Disease, Respiratory Tract Diseases, RDS
- Trial name
- NCT05493527
- Testing
- noninvasive high frequency oscillatory ventilation, noninvasive positive pressure ventilation
- Where
- Egypt
- Volunteers
- 60 people
- Sponsor
- Ain Shams University
Necrotizing Enterocolitis
Clostridium and Neonatal Necrotizing Enterocolitis Pathophysiology : Clinical and Molecular Approaches
The clinical study involves a French network of 20 neonatology centres created as part of the EPIFLORE project. Investigators propose including all premature babies with confirmed necrotizing enterocolitis (NEC) diagnosis (Bell…
- Trial name
- CLOSNEC (NCT02444624)
- Where
- France
- Volunteers
- 170 people
- Sponsor
- Nantes University Hospital
Retinopathy of Prematurity
Safety and Efficacy of Propranolol Eye Drops in Treating Retinopathy of Premature
The aim of the present study is to evaluate the safety and efficacy of propranolol eye drops in preterm newborns with a precocious stage of retinopathy of prematurity (ROP).
- Trial name
- DROP-PROP (NCT02014454)
- Testing
- Propranolol eye drops
- Where
- 2 sites in Italy
- Volunteers
- 23 people
- Sponsor
- Meyer Children's Hospital IRCCS
Late-Onset Neonatal Sepsis
Model-based Dose Versus Empirical Dose of Piperacillin/Tazobactam in Preterm Neonates With Late-onset Sepsis.
This study aims to compare the clinical outcomes, safety and PD target attainment of the model-based dose and empirical dose of piperacillin/tazobactam in the treatment of LOS in premature neonates, so as to optimize the…
- Trial name
- PIP/TAZO (NCT05981079)
- Testing
- Piperacillin/tazobactam
- Where
- 10 sites in China
- Volunteers
- 332 people
- Sponsor
- Shandong University
Sepsis, Neonatal
Comparison Between Split Septum and Mechanical Valve Needleless Connector in Preterm Babies
The goal of this clinical trial study is to compare the effectiveness between split septum and mechanical valve needleless connector in very preterm babies (or under 1500 grams) The main questions it aims to answer are: What is…
- Trial name
- NCT06414174
- Testing
- Split septum needleless connector, Mechanical valve needleless connector
- Where
- Indonesia
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Universitas Indonesia
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