Clinical trials: Preterm
Premature Infant
The Efficiency of Using Supportive Postures and Holding Techniques to Minimize Premature Infant Pain (PAP)
Out of the most commonly performed procedures in neonates, naso-gastric tube insertion is rated as the fifth most painful. The pain is often under estimated due to the frequency with which the procedure is carried out.
- Trial name
- PAPS (NCT03939169)
- Testing
- Installation of a naso-gastric feeding tube
- Where
- France
- Volunteers
- 4 people
- Sponsor
- Centre Hospitalier Régional Metz-Thionville
Ureaplasma, Bacterial Infection
An Open Label Evaluation of the Pharmacokinetics and Safety of Single Dose Intravenous Azithromycin in Preterm Neonates
The purpose of this study is to evaluate the pharmacokinetics and safety of a single dose of IV azithromycin in preterm neonates and confirm that the pharmacokinetics of azithromycin is similar in the 24-<32 week and 32-<37 week…
- Trial name
- NCT00760279
- Testing
- Azithromycin
- Where
- 2 sites in United States
- Volunteers
- 16 people
- Sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Haemophilus Influenzae Type b, Neisseria Meningitidis
Primary & Booster Study to Evaluate the Immunogenicity and Safety of Menitorix Vaccine in Preterm Infants
The purpose of this Phase IIIb study is to evaluate the immunogenicity, reactogenicity \& safety of GSK Biologicals' Hib-MenC vaccine (Menitorix™) when co-administered with GSK Biologicals' DTPa-HBV-IPV vaccine (Infanrix™ penta)…
- Trial name
- NCT00586612
- Testing
- Menitorix™, Infanrix™ penta, Prevenar™
- Where
- 8 sites in Spain
- Volunteers
- 313 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Retinopathy of Prematurity
Pan-VEGF Blockade for the Treatment of Retinopathy of Prematurity
Retinopathy of Prematurity (ROP) is a leading cause of blindness in children in developed countries around the world, and an increasing cause of blindness in developing countries. The retina lines the inside of the eye.
- Trial name
- BLOCK-ROP (NCT00702819)
- Testing
- Bevacizumab
- Where
- 11 sites in United States, Canada
- Volunteers
- 2 people
- Sponsor
- Vision Research Foundation
Infant, Preterm, Respiratory Distress Syndrome (Neonatal)
Pulmonary Volume Changes During Synchonized Noninvasive Positive Pressure Ventilation
Current evidence suggests that noninvasive positive pressure ventilation (NIPPV) is more effective than continuous positive airway pressure (CPAP) in preventing respiratory failure in preterm infants with respiratory distress…
- Conditions
- Infant, Preterm, Respiratory Distress Syndrome (Neonatal), Chronic Lung Disease of Newborn, Respiratory Support
- Trial name
- INSPIRE (NCT07237139)
- Testing
- Electrical Impedance Tomography (EIT)
- Where
- Switzerland
- Volunteers
- 27 people
- Sponsor
- University of Zurich
Intrauterine Growth Retardation (IUGR), Lung Function Tests
Early Lung Function Trajectories: Comparison Between Infants With and Without Intrauterine Growth Restriction.
During intrauterine life, some babies are smaller or grow less than expected. This fetal growth abnormality, called fetal growth restriction (FGR), can be diagnosed by ultrasound.
- Conditions
- Intrauterine Growth Retardation (IUGR), Lung Function Tests, Preterm Infant, Respiratory Monitoring
- Trial name
- ELFIGO (NCT06919757)
- Testing
- fetal ultrasound to assess lungs, heart and diaphragm
- Where
- Italy
- Volunteers
- 54 people
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Premature Infants
Clinical Experience With Numeta in Preterm Infants
The aim of this prospective noninterventional study is to evaluate the clinical application of Numeta® in preterm infants and critically ill neonates in comparison to individualized prescribed parenteral nutrition.
- Trial name
- Numeta (NCT01981057)
- Testing
- Numeta, Individual
- Where
- Austria
- Volunteers
- 50 people
- Sponsor
- Medical University of Vienna
Patent Ductus Arteriosus After Premature Birth
PDA Treatment With Ibuprofen and Changes in Tissue Oxygenation.
Babies who are born very prematurely are often born with murmurs in the heart. In preterm babies, one of the most common causes of murmur is the presence of a PDA.
- Trial name
- NCT05325177
- Testing
- Standard Dose Ibuprofen, High Dose Ibuprofen
- Where
- Canada
- Volunteers
- 30 people
- Sponsor
- Ottawa Hospital Research Institute
Infant, Premature
Prematurity-Related Ventilatory Control: Role in Respiratory Outcomes
The objective of this common multicenter protocol is to test the hypothesis that algorithmic tools using clinical Neonatal Intensive Care Unit (NICU) cardiorespiratory monitoring data can detect ventilatory control instability…
- Trial name
- Pre-Vent (NCT03174301)
- Where
- United States
- Volunteers
- 739 people
- Sponsor
- University of Virginia
Infant, Premature
Impact of Oropharyngeal Administration of Colostrum in the First 48 Hours of Life Term Premature Newborn ≤ 32 Weeks of Amenorrhea
Colostrum is the first milk secreted by the mother when the tight junctions of mammary epithelium open, allowing the cellular transport of a multitude of components and immunological protective derivatives of the maternal…
- Trial name
- COLOSTRUM (NCT02650167)
- Testing
- Colostrum feeding, formula for preterm infants
- Where
- France
- Volunteers
- 140 people
- Sponsor
- Centre Hospitalier Universitaire de Nice
Labor, Premature
Two Dose Regimens of Nifedipine for the Management of Preterm Labor
Preterm birth is one of the most important causes of perinatal morbidity and mortality worldwide. Prevention and treatment of preterm labor is important, not as an end in itself, but as a means of reducing adverse events for the…
- Trial name
- NCT00137501
- Testing
- Nifedipine
- Where
- Lebanon
- Volunteers
- 102 people, healthy volunteers welcome
- Sponsor
- American University of Beirut Medical Center
Retinopathy of Prematurity
Long Term Outcome of Intravitreal Ranibizumab for ROP
premature infants who had a history of intravitreal injection of (Ranibizumab) not less than one year were examined for refractive state and biometry
- Trial name
- NCT04537065
- Testing
- cycloplegic refraction
- Where
- Egypt
- Volunteers
- 140 people
- Sponsor
- Ameera Gamal Abdelhameed
Premature Infant, Oxygen Therapy
Servo Controlled Oxygen Targeting Study
Most premature babies require oxygen therapy. There is uncertainty about what oxygen levels are the best. The oxygen levels in the blood are measured using a monitor called a saturation monitor and the oxygen the baby breathes is…
- Conditions
- Premature Infant, Oxygen Therapy, Hypoxia, Hyperoxia
- Trial name
- SCO2T (NCT04177992)
- Testing
- Servo control
- Where
- United Kingdom
- Volunteers
- 22 people
- Sponsor
- University of Edinburgh
Premature Birth, Ventilator Lung; Newborn
sNIPPV Versus NIV-NAVA in Extremely Premature Infants
The aim of this study is to demonstrate a significant decrease in asynchrony with NIV-NAVA using the Servo n ventilator (Getinge, Sweden), as compared to abdominal triggered (Graseby capsule) synchronized nasal intermittent…
- Trial name
- EASYNNEO (NCT04068558)
- Testing
- VNI-NAVA/sNIPPV, sNIPPV/VNI-NAVA
- Where
- France
- Volunteers
- 14 people
- Sponsor
- Centre Hospitalier Intercommunal Creteil
Sepsis, Necrotizing Enterocolitis
Circulating Markers in Preterm Infants With Perinatal and Neonatal Inflammation
Circulating markers to diagnose complications (sepsis, necrotizing enterocolitis) in preterm infants are often inaccurate, partly due to the lack of comprehensive studies with temporal evaluation from birth until a disease onset.
- Conditions
- Sepsis, Necrotizing Enterocolitis, Chorioamnionitis, Feeding Intolerance
- Trial name
- NEOINFLAM (NCT03320785)
- Where
- China
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Per Torp Sangild
Retinopathy of Prematurity
RAINBOW Study: RAnibizumab Compared With Laser Therapy for the Treatment of INfants BOrn Prematurely With Retinopathy of Prematurity
The purpose of this study was to determine if intravitreal ranibizumab is superior to laser ablation therapy in the treatment of retinopathy of prematurity (ROP).
- Trial name
- RAINBOW (NCT02375971)
- Testing
- Ranibizumab, Laser therapy
- Where
- 86 sites in United States, Austria and 24 more
- Volunteers
- 224 people
- Sponsor
- Novartis Pharmaceuticals
Retinopathy of Prematurity
Telemedicine Approaches to Evaluating Acute-Phase ROP eROP Implementation Project
Evaluating retinopathy of prematurity (eROP) ancillary study Implementation Project is a multi-center observational study will focus on feasibility, and relative cost-effectiveness of an retinopathy of prematurity (ROP)…
- Trial name
- NCT02257307
- Testing
- RetCam retinal imaging used for routine care
- Where
- 5 sites in United States
- Volunteers
- 244 people
- Sponsor
- Children's Hospital of Philadelphia
NEC - Necrotizing Enterocolitis
Multidimensional Dynamic Early Warning System for Neonatal Necrotizing Enterocolitis: A Multicenter Clinical Study
Necrotizing enterocolitis (NEC) is one of the most severe gastrointestinal emergencies in preterm infants, characterized by insidious onset, rapid progression, and high mortality.
- Trial name
- NCT07545993
- Testing
- No Intervention: Observational Cohort
- Volunteers
- 1,050 people
- Sponsor
- Guangzhou Women and Children's Medical Center
Respiratory Distress Syndrome (Neonatal)
Open-label Randomized Controlled Trial of Two Protocols for Weaning From High Frequency Oscillatory Ventilation in Preterm Neonates With Respiratory Distress Syndrome Admitted in the NICU of Mansoura University Children Hospital
Our study is a randomized controlled trial that compares two weaning protocols of preterm infants with respiratory distress syndrome who are ventilated on high frequency oscillatory ventilation in order to establish the best…
- Trial name
- NCT07202299
- Testing
- HFOV weaning protocol 1, HFOV weaning protocol 2
- Where
- Egypt
- Volunteers
- 110 people
- Sponsor
- Mansoura University Children Hospital
Ultrasonic Diagnosis
Lung Ultrasound as a Predictor of Mechanical Ventilation in Neonates Older Than 32 Weeks
Neonatal respiratory distress prognosis may be difficult to estimate at admission. Lung ultrasound is a useful diagnostic tool that is quick, requires little training and is radiation free.
- Trial name
- NCT02449863
- Testing
- Lung ultrasound
- Where
- 2 sites in Spain
- Volunteers
- 105 people
- Sponsor
- Hospital Sant Joan de Deu
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