Clinical trials: Preterm Neonates
Retinopathy of Prematurity
Fasudil Eye Drop in Retinopathy Of Prematurity(ROP)
Eligible eyes are randomly assigned into two groups. Group A receive Fasudil eye drops (concentration 0.5 percent) twice daily. Group B, receive artificial tears drop with the same frequency.
- Trial name
- NCT04191954
- Testing
- Fasudil eye drops (concentration 0.5 percent), receive artificial tears drop
- Where
- Iran
- Volunteers
- 184 people, healthy volunteers welcome
- Sponsor
- Shahid Beheshti University of Medical Sciences
Preterm Infant, Brain Injuries
Cerebral Regional Tissue Oxygen Saturation to Guide Oxygen Delivery in Preterm Neonates During Immediate Transition
The aim of the COSGOD Phase III trial is to examine, if it is possible to increase survival without cerebral injury in preterm neonates <32 weeks of gestation by monitoring the cerebral tissue oxygen saturation in addition to…
- Conditions
- Preterm Infant, Brain Injuries, Birth Hypoxia
- Trial name
- COSGOD (NCT03166722)
- Testing
- Control group, Study group
- Where
- 12 sites in Austria, Canada and 5 more
- Volunteers
- 655 people
- Sponsor
- Medical University of Graz
Bronchopulmonary Dysplasia, BPD
Follow-up Study of Safety and Efficacy in Subjects Who Completed PNEUMOSTEM® Phase II (MP-CR-012) Clinical Trial
This is a follow-up study to investigate the long-term safety and efficacy of PNEUMOSTEM® versus placebo, for the treatment of BPD in premature infants.
- Trial name
- NCT04003857
- Testing
- PNEUMOSTEM®, normal saline
- Where
- 2 sites in South Korea
- Volunteers
- 60 people
- Sponsor
- Medipost Co Ltd.
PPROM, Preterm
Preterm Rupture of Membranes Optimising Antibiotics Trial
The goal of this clinical trial is to learn which antibiotic regimen works best to prevent infection in pregnant women whose waters break early (preterm, pre-labour rupture of membranes, or PPROM) and assess the health outcomes…
- Trial name
- PROMOAT (NCT06906757)
- Testing
- Erythromycin 250mg and Amoxicillin 500mg
- Volunteers
- 3,900 people
- Sponsor
- University of Melbourne
Single-ventricle, Infant Conditions
PK/PD of Digoxin in Infants With SVHD
The primary participant will be an infant with single ventricle heart disease. This is a research study to learn more about how the medication digoxin, which is routinely prescribed to infants and children with heart disease in…
- Conditions
- Single-ventricle, Infant Conditions, Infant, Newborn, Diseases, Infant, Premature, Diseases
- Trial name
- Digoxin R01 (NCT06613477)
- Testing
- PK/PD Model Based Dosing of Digoxin in Infants with Single Ventricle Heart Disease
- Where
- 2 sites in United States
- Volunteers
- 24 people
- Sponsor
- Duke University
Necrotizing Enterocolitis
SMA Flow Patterns in Neonatal Transfusion
This study aims to measure the changes induced by packed red blood cell (PRBC) transfusion in the superior mesenteric artery (SMA) flow velocity and intestinal oxygenation indices in premature neonates.
- Trial name
- SPARTAN (NCT02347475)
- Testing
- Observational Study
- Where
- Canada
- Volunteers
- 7 people
- Sponsor
- University of Calgary
Infant, Newborn, Hypoxia, Brain
Preemie Hypothermia for Neonatal Encephalopathy
This study is a randomized, controlled trial to assess safety and effectiveness of whole body hypothermia for 72 hours in preterm infants 33-35 weeks gestational age (GA) who present at <6 hours postnatal age with moderate to…
- Conditions
- Infant, Newborn, Hypoxia, Brain, Hypoxia-Ischemia, Brain, Encephalopathy, Hypoxic-Ischemic
- Trial name
- NCT01793129
- Testing
- Hypothermia, Normothermic Control
- Where
- 18 sites in United States
- Volunteers
- 168 people
- Sponsor
- NICHD Neonatal Research Network
Patent Ductus Arteriosus
Safety/Efficacy Study of Optimizing Ibuprofen Dosing to Achieve Higher PDA Closure Rates
The purpose of this study is to determine if increasing the ibuprofen dose will increase the likelihood of closing the patent ductus arteriosus in premature babies.
- Trial name
- OIDS (NCT00961753)
- Testing
- optimized ibuprofen, Standard Ibuprofen
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- OSF Healthcare System
Respiratory Distress Syndrome (RDS), Bronchopulmonary Dysplasia (BPD)
Can Betamethasone Given After Birth Help Extremely Premature Babies Come Off Breathing Support Safely and Effectively?
The goal of this study is to determine if giving a steroid medication (specifically, betamethasone) after birth can help extremely premature babies (born before 28 weeks) come off breathing machines safely and reduce their risk…
- Trial name
- NCT07447739
- Testing
- Betamethasone
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Khang Nguyen
Metabolic Acidosis, Neonatal Disease
Prevention of Metabolic Acidosis in Preterm Neonates by Replacing Sodium Chloride With Sodium Acetate in Parenteral Nutrition
The goal of this clinical trial is to learn if the addition of sodium acetate in neonatal PN works to prevent and treat metabolic acidosis and associated comorbidities in preterm neonates.
- Conditions
- Metabolic Acidosis, Neonatal Disease, Neonatal Complication
- Trial name
- PROTECT (NCT06545565)
- Testing
- sodium acetate group will receive sodium acetate in the neonatal PN., sodium chloride group will receive sodium chloride in the neonatal PN.
- Where
- Pakistan
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Aga Khan University Hospital, Pakistan
Retinopathy of Prematurity (ROP)
Efficacy and Safety of Low-dose Conbercept for Retinopathy of Prematurity Therapy
Evaluating the Optimal Effective Dose and Safety of Conbercept in Treating Retinopathy of Prematurity (ROP)
- Trial name
- NCT06717412
- Testing
- Conbercept
- Where
- 3 sites in China
- Volunteers
- 146 people
- Sponsor
- Wang Yusheng
Premature Birth
Preterm Newborn's Behavioral Responses During Feeding With Gastric Tube
Preterm infants need aims of a tube named oral or naso gastric to grow until they acquire autonomy in suction-swallowing. In fact, several modes feed by a gastric tube exist : using an electric syringe pump (continuous…
- Trial name
- PREMALIM (NCT06634329)
- Testing
- Oro or Nasogastric tube feeding
- Where
- France
- Volunteers
- 50 people
- Sponsor
- University Hospital, Strasbourg, France
Preterm Infant, BPD - Bronchopulmonary Dysplasia
Comparison of Primary Extubation Failure Between NIPPV and NI-NAVA
Extubation failure is a significant problem in preterm neonates and prolonged intubation is a well-documented risk factor for development of chronic lung disease.
- Conditions
- Preterm Infant, BPD - Bronchopulmonary Dysplasia, Barotrauma
- Trial name
- NCT03242057
- Testing
- NAVA, NIPPV
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- University of Florida
Practice Guideline of Erythrocyte Transfusion in Preterm Infant
Red Blood Cell Transfusion in Very Premature Infants and HAS 2014 Guideline
The indications that motivated the decision to transfuse (or not) were analyzed to verify compliance with HAS recommendations. Medical records from 57 premature infants < 32 weeks hospitalized between 2016 -2017 were…
- Trial name
- RBCPREM (NCT03599167)
- Where
- France
- Volunteers
- 57 people
- Sponsor
- Centre Hospitalier Universitaire, Amiens
Retinopathy of Prematurity
Use of Pan-vascular Endothelial Growth Factor Receptor (Pan-VEGF) Blockade for the Treatment of Retinopathy of Prematurity (ROP) (Compassionate Use BLOCK-ROP)
The purpose of this study is to provide access to intravitreal injection of Avastin in high-risk infants who do not otherwise qualify for study NCT00702819, an investigational multi-site study examining Avastin use for…
- Trial name
- NCT00870636
- Testing
- Bevacizumab (Avastin)
- Where
- United States
- Sponsor
- Children's Hospital Los Angeles
Infantile Respiratory Distress Syndrome, Ventilator Lung; Newborn
Automatic Oxygen Control (SPOC) in Preterm Infants
Single-center, randomised controlled, cross-over clinical trial in preterm infants born at gestational age below 34+1/7 weeks receiving supplemental oxygen and respiratory support (continous positive airway pressure (CPAP) or…
- Trial name
- optimalSPOC (NCT03785899)
- Testing
- SPOCnew, 8s SpO2 averaging, SPOCold
- Where
- Germany
- Volunteers
- 24 people
- Sponsor
- University Hospital Tuebingen
Retinopathy of Prematurity
Evaluation of the Frequency, Risk Factors, and Outcomes of ROP in Infants With a BW >1500 Grs or GA ≥33 Wks in Turkey.
The study includes preterm infants who are being screened for ROP between August 1,2023 and August 1, 2024 in 94 neonatal intensive care units (NICUs) in Turkey.
- Trial name
- TR-ROP-2 (NCT06265363)
- Where
- Turkey (Türkiye)
- Volunteers
- 1,000 people
- Sponsor
- Baskent University Ankara Hospital
Ureaplasma Infections
Trial of Intravenous Azithromycin to Eradicate Ureaplasma Respiratory Tract Infection in Preterm Infants
The purpose of this study is to determine whether intravenous azithromycin is effective in eradicating Ureaplasma respiratory tract infection in preterm infants born at 24 to 28 weeks gestation.
- Trial name
- AZIPIII (NCT01778634)
- Testing
- Azithromycin
- Where
- 7 sites in United States
- Volunteers
- 121 people
- Sponsor
- University of Maryland, Baltimore
Bronchopulmonary Dysplasia, Healthy
Impact of an Exercise Program for Children Aged 4 to 6 Years With Bronchopulmonary Dysplasia
The purpose of this study is to determine the effects of a physical activity program for children with Bronchopulmonary Dysplasia.
- Trial name
- NCT02523521
- Testing
- Physical activity program
- Where
- Spain
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- Hospital de Nens de Barcelona
Bronchopulmonary Dysplasia
Respiratory Oscillometry for the Prediction of Bronchopulmonary Dysplasia
The goal of this observational study is to learn about the correlation between respiratory system reactance, as assessed by respiratory oscillometry, and respiratory outcomes in preterm infants born before 32 weeks of gestation.
- Trial name
- REACT (NCT05986032)
- Testing
- Respiratory Oscillometry
- Where
- 6 sites in Austria, Italy and 3 more
- Volunteers
- 150 people
- Sponsor
- Fondazione IRCCS San Gerardo dei Tintori
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