Clinical trials: Preterm Babies
Prematurity, Neurodevelopmental Disorder
Effect of Early L-Carnitine Supplementation on Neurodevelopmental Outcomes in Very Preterm Infants
Preterm infants are vulnerable to brain injury, nutritional deficiencies and poor early growth which places them at increased risk for developmental problems later in life.
- Conditions
- Prematurity, Neurodevelopmental Disorder, Carnitine Deficiency
- Trial name
- NCT01783041
- Testing
- L-carnitine, 5% Dextrose
- Where
- 2 sites in United States
- Volunteers
- 144 people
- Sponsor
- Montefiore Medical Center
Lung Disease
Safety and Efficacy Study of Nitric Oxide for Inhalation on Chronic Lung Disease in Premature Babies
The purpose of this study is to assess the safety and efficacy of inhaled nitric oxide to reduce the risk of chronic lung disease in pre-term infants with respiratory distress, and to assess the long-term effects of the therapy…
- Trial name
- NCT00551642
- Testing
- Nitric oxide
- Where
- 35 sites in Belgium, Finland and 7 more
- Volunteers
- 800 people
- Sponsor
- Mallinckrodt
Premature Birth of Newborn, Family
GPS (Giving Parents Support): Parent Navigation After NICU Discharge
BACKGROUND: Annually >400,000 US newborns require neonatal intensive care unit (NICU) care.1/3 will require ongoing or specialty care after discharge.
- Conditions
- Premature Birth of Newborn, Family, Immature Newborn, Newborn Morbidity
- Trial name
- GPS (NCT02643472)
- Testing
- Parent Navigator, Care Notebook
- Where
- United States
- Volunteers
- 300 people
- Sponsor
- Children's National Research Institute
Respiratory Distress Syndrome, Newborn
Delivery Room Management Trial of Premature Infants at High Risk of Respiratory Distress Syndrome
The best mode of delivery room stabilization for premature infants at high risk for respiratory distress syndrome is unknown. The protocol evaluates the impact of three distinct methods of post-delivery stabilization and…
- Trial name
- NCT00244101
- Testing
- PS Group, NCPAP Group, ISX Group
- Where
- United States
- Volunteers
- 648 people
- Sponsor
- Vermont Oxford Network
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
Essential Fatty Acid Deficiency (EFAD)
Pediatric Study to Evaluate Risk of Developing Essential Fatty Acid Deficiency When Receiving Clinolipid or Standard-of-Care Lipid Emulsion
This will be a descriptive study designed to evaluate the propensity for hospitalized pediatric patients treated adequately with Clinolipid or standard of care for up to 90 days to develop Essential Fatty Acid Deficiency (EFAD).
- Trial name
- NCT02476994
- Testing
- Clinolipid, Intralipid
- Where
- 4 sites in United States
- Volunteers
- 1 people
- Sponsor
- Baxter Healthcare Corporation
Neurocognitive, Neuroprotective
Darbepoetin Trial to Improve Red Cell Mass and Neuroprotection in Preterm Infants
Study Hypothesis: Preterm infants administered weekly Darbe during the neonatal period will have improved neurocognitive outcome at 22-26 months compared to placebo
- Conditions
- Neurocognitive, Neuroprotective, Neonatal, Neurodevelopmental Impairment
- Trial name
- Darbe (NCT03169881)
- Testing
- Darbepoetin
- Where
- 16 sites in United States
- Volunteers
- 650 people
- Sponsor
- NICHD Neonatal Research Network
Infant,Premature, Respiratory Failure
Nasal High-frequency Jet Ventilation (nHFJV) Following Extubation in Preterm Infants
Very low birth weight infants are at increased risk of requiring prolonged duration of mechanical ventilation and multiple intubations, both of which are risk factors for ventilator-induced lung injury and BPD.
- Conditions
- Infant,Premature, Respiratory Failure, Respiratory Insufficiency, Respiratory Distress Syndrome in Premature Infant
- Trial name
- NCT03558737
- Testing
- Nasal high-frequency jet ventilation (nHFJV), Nasal intermittent positive pressure ventilation (NIPPV)
- Where
- 2 sites in United States
- Volunteers
- 4 people
- Sponsor
- University of Utah
Respiratory Distress Syndrome
Cord Blood 25(oh)-Vitamin D Level in Preterm Infants and Associated Morbidities
Experimental and observational studies have shown that vitamin D deficiency may be associated with an increased risk for non-bone diseases and/or abnormal development for the other systems of fetus.
- Trial name
- NCT01812681
- Where
- Turkey (Türkiye)
- Volunteers
- 81 people
- Sponsor
- Dr. Sami Ulus Children's Hospital
Patent Ductus Arteriosus, Prematurity
Early Versus Late Use of Ibuprofen for Patent Ductus Arteriosus (PDA) Closure
The primary objective is to evaluate the Patent Ductus Arteriosus (PDA) closure rate of early vs. late use of Ibuprofen (Ibu). The investigators believe that early use of Ibu will have a higher PDA closure rate than later use of…
- Trial name
- NCT00833365
- Testing
- Ibuprofen
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- University of Utah
Preterm Infant, Early-Onset Neonatal Sepsis
Utility of Placental/Umbilical Cord Blood in Early Onset Neonatal Sepsis in Very Low Birth Weight Infants
This study evaluates the utility of placental/umbilical cord blood (PUCB) to perform the baseline workup testing for EONS in Very Low Birth Weight Infants: CBC (Complete Blood Count) with differential, Immature/Total ratio (I/T…
- Conditions
- Preterm Infant, Early-Onset Neonatal Sepsis, Umbilical Cord
- Trial name
- NCT03694613
- Testing
- Placental/Umbilical Cord Blood sample
- Where
- United States
- Volunteers
- 65 people
- Sponsor
- The University of Texas Medical Branch, Galveston
Prematurity
Brain Imaging and Developmental Follow up of Infants Treated With Erythropoietin
Approximately 60,000 premature infants are born each year who weigh less than 1,500 grams,many of whom sustain brain damage because of their prematurity.
- Trial name
- BRITE (NCT01207778)
- Where
- 3 sites in United States
- Volunteers
- 77 people, healthy volunteers welcome
- Sponsor
- University of New Mexico
Respiratory Distress Syndrome
Feasibility Study of Aerosolized Surfaxin in the Prevention of Respiratory Distress Syndrome (RDS) in Premature Infants
To evaluate the feasibility, safety and tolerability of aerosolized lucinactant delivered by nasal continuous positive airway pressure (nCPAP) for the prevention of respiratory distress syndrome (RDS) in premature infants.
- Trial name
- NCT00807235
- Testing
- Aerosolized lucinactant
- Where
- United States
- Volunteers
- 17 people
- Sponsor
- Windtree Therapeutics
Bronchopulmonary Dysplasia, Bronchopulmonary Dysplasia Associated Pulmonary Hypertension
Enteral L Citrulline Supplementation in Preterm Infants - Safety, Efficacy and Dosing
Oral L-citrulline supplementation may prevent and/or decrease the severity of chronic lung disease associated with pulmonary hypertension in preterm infants.
- Conditions
- Bronchopulmonary Dysplasia, Bronchopulmonary Dysplasia Associated Pulmonary Hypertension, Pulmonary Hypertension, Premature Birth
- Trial name
- NCT03649932
- Testing
- Enteral L-citrulline
- Where
- United States
- Volunteers
- 42 people
- Sponsor
- The University of Texas Medical Branch, Galveston
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
Premature Birth, Sepsis
Characteristics of Cord Blood Immunologic Parameters of Infants <32 Weeks Gestation
Infants in the NICU are at high risk for morbidity and mortality from infections of any onset. Diagnosis of these infections is imperfect at best.
- Trial name
- AOS (NCT00524394)
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- The University of Texas Health Science Center, Houston
Infant, Preterm
Evaluation of Safety and Efficacy of Remifentanil in Pediatric Population
The purpose of this study is to evaluate safety and efficacy of continuous infusion of remifentanil in preterm infant with mechanical ventilator for control of procedural pain using two different dosage of remifentanil.
- Trial name
- NCT01477892
- Testing
- low dose remifentanil
- Where
- South Korea
- Volunteers
- 14 people
- Sponsor
- Seoul National University Hospital
Cerebral Palsy, Prematurity
NEO Rehab Program for Premature Infants at Risk for Cerebral Palsy
The goal of this project is to investigate the acceptability, feasibility and fidelity of an innovative NICU rehabilitation program that will include six multimodal, gestational age (GA) appropriate, parent-administered…
- Conditions
- Cerebral Palsy, Prematurity, Early Intervention, Family Centered Care
- Trial name
- NCT04330859
- Testing
- NeoRehab Bundle, Routine care
- Where
- United States
- Volunteers
- 70 people
- Sponsor
- University of Virginia
Respiratory Compliance, Functional Residual Capacity
Rescue Antenatal Steroids and Pulmonary Function Tests in Preterm Infants
One course of steroids given to a mother before a premature delivery helps the lungs of the premature infant and decreases breathing problems.
- Conditions
- Respiratory Compliance, Functional Residual Capacity, Pulmonary Function Testing
- Trial name
- NCT00669383
- Testing
- betamethasone
- Where
- United States
- Volunteers
- 85 people, healthy volunteers welcome
- Sponsor
- Oregon Health and Science University
Serious Systemic Infections, Necrotizing Enterocolitis
Metronidazole Pharmacokinetics (PK) in Premature Infants
Yearly in the United States over 500,000 newborns are delivered prematurely. This population is at high risk of catastrophic bowel disease known as necrotizing enterocolitis.
- Trial name
- PTN_METRO (NCT01222585)
- Testing
- Metronidazole
- Where
- 3 sites in United States
- Volunteers
- 24 people
- Sponsor
- Michael Cohen-Wolkowiez