Clinical trials: Premature Neonates
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
Retinopathy of Prematurity
Omega-3 Long Chain Polyunsaturated Fatty Acid (LCPUFA) Supplementation in Very Low Birth Weight Infants for The Prevention Retinopathy of Prematurity
Retinopathy of prematurity (ROP) is a blinding disease affecting infants born prematurely. These infants do not have enough essential fatty acids to structurally support the retina, the nerve tissue in the eye which allows us to…
- Trial name
- NCT02486042
- Testing
- Omegaven, Standard lipids (primarily omega-6 fatty acids)
- Where
- United States
- Volunteers
- 48 people
- Sponsor
- University of California, San Diego
Hypothermia
Neonatal Warming to Prevent Hypothermia
Researchers are proposing a pilot randomized controlled trial evaluating the benefit of immediately warming preterm babies using a warming mattress and a plastic wrap, while delaying clamping the umbilical cord at the time of…
- Trial name
- NCT04827394
- Testing
- Neonatal warming mattress, Sterile polyethylene wrap
- Where
- United States
- Volunteers
- 52 people
- Sponsor
- University of Oklahoma
Bronchopulmonary Dysplasia
A Safety Study of IV Stem Cell-derived Extracellular Vesicles (UNEX-42) in Preterm Neonates at High Risk for BPD
A multicenter, placebo-controlled, randomized, dose escalation, safety, and tolerability study of UNEX-42 in infants born at <27 weeks of gestational age (GA) at high risk for bronchopulmonary dysplasia (BPD).
- Trial name
- NCT03857841
- Testing
- UNEX-42, Phosphate-buffered saline
- Where
- 6 sites in United States
- Volunteers
- 3 people
- Sponsor
- United Therapeutics
Meningitis
Lumbar Punctures in Neonates: Improving Success Rates and Minimizing Pain
The purpose of this study is to compare two medications used to numb an infant's back when performing a lumbar puncture. A lumbar puncture (LP) is often needed in newborns to obtain cerebrospinal fluid (CSF).
- Trial name
- NCT01606150
- Testing
- 1% lidocaine, topical lidocaine
- Where
- United States
- Volunteers
- 5 people, healthy volunteers welcome
- Sponsor
- Georgetown University
Neonatal Sepsis
Late-onset Sepsis in Term and Pre-term Neonates and Infants up to 3 Months of Age
This study evaluated the safety, pharmacokinetics and efficacy of ceftobiprole in term and pre-term newborn babies and infants up to 3 months of age with late-onset sepsis (LOS).
- Trial name
- NCT05856227
- Testing
- Ceftobiprole medocaril
- Where
- 14 sites in United States, Bulgaria and 6 more
- Volunteers
- 9 people
- Sponsor
- Basilea Pharmaceutica
Infant, Newborn, Infant, Moderate Preterm
Incubator Weaning of Moderately Preterm Infants
The objective of this proposal is to evaluate whether weaning from an incubator to a crib at lower versus higher weight, 1600g or 1800g will result in shorter length of hospital stay among moderately preterm infants.
- Trial name
- NCT02160002
- Testing
- Weaning from an incubator at a lower weight (1600 grams), Weaning from an incubator at a higher weight (1800 grams)
- Where
- 18 sites in United States
- Volunteers
- 366 people
- Sponsor
- NICHD Neonatal Research Network
Premature Birth
Effect of Presenting Survival Information as Text or Pictograph During Periviable Birth Counseling
Women recruited from the internet will be put in a hypothetical situation of being in labor at 22 weeks of pregnancy, and presented with information on the likelihood of survival and chance of disability for babies born at this…
- Trial name
- NCT04859114
- Testing
- Format of outcome data presentation, Displayed chance of survival
- Where
- United States
- Volunteers
- 1,052 people, healthy volunteers welcome
- Sponsor
- Medical College of Wisconsin
Resuscitation, Neonatal Prematurity
Monitoring Neonatal Resuscitation Trial
This is a randomized trial to determine if a visible respiratory function monitor (RFM) displaying realtime measurements of delivered inflations improves clinical providers ability to perform positive pressure ventilation (PPV)…
- Conditions
- Resuscitation, Neonatal Prematurity, Positive-Pressure Respiration
- Trial name
- MONITOR (NCT03256578)
- Testing
- New Life Box Respiratory Function Monitor
- Where
- United States
- Volunteers
- 288 people
- Sponsor
- University of Pennsylvania
Healthy, Cystic Fibrosis (CF)
MRI for Non-Invasive Imaging in Neonates and Children
The purpose of this study is to develop rapid MRI techniques for imaging the lung with hyperpolarized helium-3 gas as an inhaled contrast agent.
- Conditions
- Healthy, Cystic Fibrosis (CF), Asthma, Bronchopulmonary Dysplasia (BPD)
- Trial name
- NCT02163681
- Testing
- Hyperpolarized Helium-3 MRI of the chest
- Where
- United States
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- University of Virginia
Retinopathy of Prematurity
Bevacizumab Eliminates the Angiogenic Threat for Retinopathy of Prematurity
The purpose of this study was to determine the efficacy and additional advantages of intravitreal bevacizumab in the treatment of ROP for both Zone I and Zone II Posterior.
- Trial name
- BEAT-ROP (NCT00622726)
- Testing
- Bevacizumab, Conventional Laser for ROP
- Where
- 15 sites in United States
- Volunteers
- 150 people
- Sponsor
- The University of Texas Health Science Center, Houston
Patent Ductus Arteriosus (PDA), Acute Kidney Injury (AKI)
Fenoldopam to Prevent Renal Dysfunction in Indomethacin Treated Preterm Infants
The investigators will conduct a prospective, blinded, randomized, placebo-controlled trial with a sample size of 20 patients in each of the two arms (fenoldopam vs placebo) based upon a difference in serum creatinine by one…
- Trial name
- Fenaki (NCT02620761)
- Testing
- Fenoldopam, 0.9%NS
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Medical College of Wisconsin
Infant, Newborn
Darbepoetin Administration to Preterm Infants
Infants born prematurely do not increase production of the primary red cell growth factor, erythropoietin (Epo), and often develop an anemia called the "anemia of prematurity." The anemia of prematurity is the most common anemia…
- Trial name
- NCT00334737
- Testing
- Darbepoetin Alfa Injection, erythropoietin alfa injection
- Where
- 3 sites in United States
- Volunteers
- 102 people
- Sponsor
- University of New Mexico
Chorioamnionitis, Brain Injury
Safety of N-acetylcysteine in Maternal Chorioamnionitis (NAC in Chorio)
The purpose of this trial was to find the best dose of N-acetylcysteine (NAC) to decrease brain injury in babies exposed to intrauterine infection without causing significant side effects.
- Trial name
- NCT00724594
- Testing
- N-acetylcysteine, Control
- Where
- United States
- Volunteers
- 46 people
- Sponsor
- Medical University of South Carolina
Retinopathy of Prematurity
Phase 1 Trial of Bevacizumab Treatment for Severe Retinopathy of Prematurity
The purpose of this study is to find a dose of intravitreal bevacizumab that is lower than currently used for severe retinopathy of prematurity (ROP), is effective in this study, and can be tested in future larger studies.
- Trial name
- ROP1 (NCT02390531)
- Testing
- Bevacizumab
- Where
- 11 sites in United States
- Volunteers
- 120 people
- Sponsor
- Jaeb Center for Health Research
Respiratory Syncytial Virus Infection, Premature Birth
Palivizumab for Prevention of Severe Respiratory Syncytial Virus Infection in Russian Children
100 Russian children of 2 years of age and less in high-risk populations (preterm, and/or with heart and lung problems) will receive palivizumab (Synagis) 15 mg/kg intramuscularly as prophylaxis to severe respiratory syncytial…
- Conditions
- Respiratory Syncytial Virus Infection, Premature Birth, Bronchopulmonary Dysplasia, Congenital Heart Disease
- Trial name
- NCT01006629
- Testing
- palivizumab
- Where
- 19 sites in Russia
- Volunteers
- 100 people
- Sponsor
- Abbott
Respiratory Distress Syndrome, Newborn, Respiratory Tract Diseases
Nasal HFOV Versus Nasal CPAP to Reduce Post-extubation pCO2
To investigate whether nasal high frequency oscillation ventilation (nHFOV) immediately after extubation reduces the arterial partial pressure of carbon dioxide (paCO2) at 72 hours after extubation in comparison with nasal…
- Trial name
- NCT02340299
- Testing
- nHFOV, nCPAP
- Where
- Germany
- Volunteers
- 6 people
- Sponsor
- Charite University, Berlin, Germany
Respiratory Distress Syndrome (RDS)
A Study in Preterm Neonates With Respiratory Distress Syndrome (RDS) Comparing CUROSURF® Administration Through Less Invasive Surfactant Administration (LISA) and Conventional Administration
This study compared the administration of porcine surfactant (poractant alfa, Curosurf®) through a less invasive method (LISA), using a thin catheter, CHF 6440 (LISACATH®), during non-invasive ventilation (CPAP, NIPPV, BiPAP)…
- Trial name
- LISPAP (NCT02772081)
- Testing
- LISA combination product (Curosurf+catheter CHF6440), Curosurf through conventional administration (endotracheal tube)
- Where
- 26 sites in United States
- Volunteers
- 33 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Respiratory Distress Syndrome, Newborn
ABCA3 Gene and RDS in Late Preterm and Term Infants
Respiratory distress syndrome (RDS) is the most common respiratory cause of mortality and morbidity in very preterm infants, but it also could be seen in late preterm and term infants.
- Trial name
- NCT04137783
- Testing
- no intervention
- Where
- China
- Volunteers
- 39 people
- Sponsor
- Children's Hospital of Chongqing Medical University
Upper Extremity Dysfunction
Movement Enhancing Device for Children
The purpose of this study is to assess: 1) how infants move their bodies to explore, play, and solve problems, 2) if this is different in a high-risk group of infants, and 3) if these abilities can be advanced in a high-risk…
- Trial name
- NCT01959581
- Testing
- Movement Enhancing Device
- Where
- 3 sites in United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- University of Delaware