Clinical trials: Preterm Babies
Respiratory Distress Syndrome, Newborn
A Safety and Efficacy Study of Lucinactant for Inhalation in Preterm Neonates 26 to 32 Weeks Gestational Age
This study is to evaluate the safety and efficacy of lucinactant for inhalation in conjunction with nCPAP, in comparison to nCPAP alone, in preterm neonates with RDS, as assessed by the incidence of and time to respiratory…
- Trial name
- NCT04264156
- Testing
- Lucinactant for Inhalation, nCPAP Only
- Where
- 3 sites in Poland
- Volunteers
- 12 people
- Sponsor
- Windtree Therapeutics
Patent Ductus Arteriosus, Neonate
Combination of Acetaminophen and Ibuprofen in the Management of Patent Ductus Arteriosus
Patent ductus arteriosus or PDA is a blood vessel that connects the right and left side of the heart that usually closes after birth but remains open in some premature infants born before 30 weeks' gestation.
- Trial name
- NCT03103022
- Testing
- Acetaminophen, ibuprofen
- Where
- 2 sites in United States
- Volunteers
- 20 people
- Sponsor
- University of Florida
Acute Respiratory Deficiency, Prematurity
Comparison of RAM Cannula Nasal Continuous Positive Airway Pressure Versus Infant Flow Nasal Continuous Positive Airway Pressure (NCPAP)
This study is designed to compare the effectiveness and ease of use of two commonly used NCPAP interfaces: the RAM NC and the Infant Flow prongs and nasal mask.
- Conditions
- Acute Respiratory Deficiency, Prematurity, Assisted Ventilation
- Trial name
- NCT02032511
- Volunteers
- 19 people
- Sponsor
- University of Michigan
Enteral Nutrition, Born Very Premature
Prolonged Minimal Enteral Nutrition Versus Slowly Advancing Enteral Nutrition in Very Low Birth Weight Infants:
Recent studies showed the benefits of early initiation and advancement enteral feeds with daily increments in preterm infants on decreasing invasive infections and early achievement of full enteral feedings.
- Conditions
- Enteral Nutrition, Born Very Premature, Infant, Very Low Birth Weight
- Trial name
- NCT02913677
- Testing
- nutrition
- Where
- Turkey (Türkiye)
- Volunteers
- 199 people
- Sponsor
- Zekai Tahir Burak Women's Health Research and Education Hospital
Early-Onset Neonatal Sepsis, Antibiotic Stewardship
Efficacy And Safety Of Short Course Antibiotic Therapy In Preterm Neonates With Early Onset Sepsis
Objective of the study is to compare the efficacy and safety of 'Short duration antibiotic' (72hrs) and 'Standard duration antibiotic'(5 - 7days) in preterm neonates ( >28weeks and >1000grams ) with culture negative early onset…
- Trial name
- NCT06197269
- Testing
- Short duration antibiotics, Standard duration antibiotics
- Where
- India
- Volunteers
- 75 people
- Sponsor
- Lady Hardinge Medical College
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
Infant, Premature, Hypoperfusion in Newborn
Monitoring of Systemic or Organ Perfusion for Preterm Infants
To investigate biomarker reflects systemic or specific organ perfusion well, we are going to the observational comparison study using several hemodynamic monitoring methods in the premature infants.
- Conditions
- Infant, Premature, Hypoperfusion in Newborn, Necrotizing Enterocolitis of Newborn, Sepsis Newborn
- Trial name
- NCT03136172
- Testing
- NIRS (near Infra-red spectroscopy)
- Where
- South Korea
- Volunteers
- 85 people
- Sponsor
- Inha University Hospital
Small for Gestational Age at Delivery, Low Birth Weight
Effect of a Fortified Balanced Energy-Protein Supplement on Birth Outcome and Child Growth in Houndé District, Burkina Faso.
The 2016 WHO antenatal care guidelines stated that pregnant women in undernourished populations should receive fortified balanced energy-protein (BEP) supplements to reduce the risk of stillbirth and small-for-gestational-age…
- Conditions
- Small for Gestational Age at Delivery, Low Birth Weight, Prematurity, Infant Malnutrition
- Trial name
- MISAME-3 (NCT03533712)
- Testing
- Fortified balanced energy-protein (BEP) supplement, Fe and folic acid supplement
- Where
- Burkina Faso
- Volunteers
- 1,788 people, healthy volunteers welcome
- Sponsor
- University Ghent
Safety Issues, Effect of Drugs
Safety of Autologous Cord Blood Cells for Preterm Infants.
To assess the safety of autologous volume- and red blood cell (RBC)-reduced non-cryopreserved umbilical cord blood (UCB) cell infusion to preterm infants.
- Conditions
- Safety Issues, Effect of Drugs, Neonatal Death
- Trial name
- NCT03760900
- Testing
- Autologous Umbilical Cord Blood Stem Cells Therapy
- Volunteers
- 15 people
- Sponsor
- Guangdong Women and Children Hospital
Infant, Premature, Anticoagulants
Heparin Versus no Heparin on Duration of Peripherally Inserted Central Catheter (PICC) Patency in Neonates
Background: Heparin is an anticoagulant commonly used in the neonatal population as a means to prevent catheter related occlusion and malfunction by thrombosis (clot).
- Conditions
- Infant, Premature, Anticoagulants, Thrombosis
- Trial name
- NCT00879957
- Testing
- heparin, No heparin
- Where
- United States
- Sponsor
- The University of Texas Health Science Center at San Antonio
Apnea of Prematurity, Infant, Premature, Diseases
Effect of High Frequency Oscillatory Highflow Nasal Cannula on Desaturations and Bradycardia in Preterm Infants
This study evaluates the effect of non-invasive high frequency oscillations applied via a highflow nasal cannula ('Osciflow') compared to highflow nasal cannula without oscillations (HF) on desaturations and bradycardia in…
- Trial name
- Osciflow (NCT04327466)
- Testing
- Osciflow, Highflow
- Where
- Switzerland
- Volunteers
- 30 people
- Sponsor
- University of Zurich
Language Delay, Language Development
Combined Oral Motor Stimulation and Language on Preterm Infant Feeding
This is a randomized controlled trial to study an oromotor stimulation in combination with a reading curriculum in the NICU among preterm infants using oral muscle exercises, Language Environment Analysis (LENA) recordings…
- Conditions
- Language Delay, Language Development, Feeding; Difficult, Newborn, Mother-Infant Interaction
- Trial name
- NCT05861531
- Testing
- Oromotor stimulation, Reading curriculum, LENA recording
- Where
- United States
- Volunteers
- 124 people, healthy volunteers welcome
- Sponsor
- Women and Infants Hospital of Rhode Island
Neonatal Disease, Neonatal Disorder
Reducing Pain and Promoting Neurodevelopment Among Preterm Neonates
To determine the effects of multisensory stimulation and soft tissue therapy on procedural pain and neurodevelopment among neonates admitted to the NICU is the aim of the study.
- Trial name
- NCT04366102
- Testing
- Multisensory stimulation with soft tissue therapy, Routine hospital care
- Where
- India
- Volunteers
- 68 people, healthy volunteers welcome
- Sponsor
- Asir John Samuel
Patency of the Ductus Arteriosus Acetaminophen Extreme Prematurity
Long Term Follow-up of the TREOCAPA Study (TREOCAPA-LT)
The ductus arteriosus (DA) is a large channel connecting the main pulmonary trunk with the descending aorta. In extremely preterm infants, the DA frequently fails to close and this results in a condition called patent ductus…
- Trial name
- TREOCAPA-LT (NCT06064825)
- Testing
- 2 year follow-up of neurodevelopment using a parental questionnaire
- Where
- 8 sites in France
- Volunteers
- 500 people
- Sponsor
- Institut National de la Santé Et de la Recherche Médicale, France
Term Delivery With Preterm Labor, Third Trimester, Term Delivery With Preterm Labor, Unspecified Trimester
Tidal Neonatal NO, Vitamins A and D, and Infant Lung Disease - The AD-ON Study
Children born prematurely are of greater risk of developing chronic lung disease (Bronchopulmonary Dysplasia). With an increase in the amount of premature children, we expect an increasing number of children with BPD.
- Conditions
- Term Delivery With Preterm Labor, Third Trimester, Term Delivery With Preterm Labor, Unspecified Trimester, Bronchopulmonary Dysplasia
- Trial name
- NCT01722760
- Testing
- measurements
- Where
- 2 sites in Denmark
- Volunteers
- 1,500 people, healthy volunteers welcome
- Sponsor
- Hillerod Hospital, Denmark
Infant, Premature, Diseases
A Single Blinded Study on the Effect of Saccharomyces Boulardii CNCM I-745 on Growth and Development in Preterm Infants
Immature gastrointestinal functions increase the risk of poor growth as well as nosocomial infections and necrotizing enterocolitis (NEC) in the preterm infant.
- Trial name
- SBP (NCT02310425)
- Testing
- S. boulardii
- Volunteers
- 125 people, healthy volunteers welcome
- Sponsor
- Lingfen Xu, MD
Preterm Infants
Hepatic Function and Bile Acid in Preterm Infants Receiving Parenteral Lipids Emulsion
The etiology of parenteral nutrition-associated cholestasis(PNAC)although elusive is thought to be multifactorial, and proposed theories also include problems arising from lipid emulsions, leading us to explore alternative…
- Trial name
- NCT01786759
- Testing
- ClinOleic, Intralipid
- Where
- China
- Volunteers
- 100 people
- Sponsor
- Shanghai Jiao Tong University School of Medicine
Preterm, Preterm Birth
The Effect of Rocking Bed on Preterm Newborns
The study was planned to determine the effect of rocking bed applied to preterm newborns on comfort, physiological parameters and cerebral oxygenase level (rSO2).
- Conditions
- Preterm, Preterm Birth, Nurse's Role
- Trial name
- NCT05978674
- Testing
- rocking bed group
- Where
- Turkey (Türkiye)
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Selcuk University
Infant, Premature, Diseases, Birth, Preterm
The NEU-STIM Trial
The aim of this study is to determine the effect of repetitive tactile stimulation compared to selective stimulation on oxygenation of the infant at 5 minutes after birth.
- Trial name
- NEU-STIM (NCT05942924)
- Testing
- Repeated tactile stimulation, Selective tactile stimulation
- Where
- 43 sites in Austria, Belgium and 17 more
- Volunteers
- 3,280 people
- Sponsor
- Leiden University Medical Center
Prematurity, Mechanical Ventilation
Comparison of Two Flow Rates of HHHFNC to Prevent Extubation Failure in Preterm Infants
This is a randomized controlled trial (RCT) to evaluate the influence of two flow rates (6 liter/min versus 3 liter/min) of Heated-Humidified High-Flow-Nasal-Cannula (HHHFNC) on rates of extubation failure in mechanically…
- Trial name
- NCT02681315
- Testing
- HHHFNC 6 liter minute, HHHFNC 3 liters/min
- Where
- Egypt
- Volunteers
- 40 people
- Sponsor
- Mansoura University Children Hospital
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