Clinical trials: Neonates and Preterm Infants
Apnea of Prematurity
Detection of CardioRespiratory Events Using Acoustic Monitoring in Preterm Infants on CPAP
This is an observational, proof-of-concept, feasibility study where 50 preterm infants with gestational age < 32+0 weeks will be recruited from the neonatal intensive care unit (NICU) at the Montreal Children's Hospital.
- Trial name
- DREAM (NCT05196646)
- Testing
- Respiratory Acoustic Sensors, Nasal thermistor, Respiratory Inductive Plethysmography
- Where
- Canada
- Volunteers
- 50 people
- Sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
Neonatal Intensive Care Unit, PreTerm Neonate
Effects of a Structured Maternal Voice Program on Premature Infant Responses and Maternal-Infant Attachment in the Neonatal Intensive Care Unit
This study evaluates the effects of a Structured Maternal Voice Program (SMVP). on premature infant responses and maternal-infant attachment in the intensive care unit (NICU) .
- Conditions
- Neonatal Intensive Care Unit, PreTerm Neonate, Healthy
- Trial name
- SMVP-NICU (NCT06839534)
- Testing
- Structured Maternal Voice Program (SMVP)
- Where
- Thailand
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Chulalongkorn University
Bronchopulmonary Dysplasia
Neonatal Intensive Care (NICU) Course and Hospital Outcome of Infants With BPD Treated Using Inhaled Nitric Oxide
This is a chart review study of neonates admitted to Primary Children's Medical Center or University of Utah NICU who had or developed a diagnosis of bronchopulmonary dysplasia (BPD) and were treated for this condition with…
- Trial name
- NCT00757146
- Where
- United States
- Volunteers
- 18 people
- Sponsor
- University of Utah
Preterm, Premature
Effects of Kinesiotaping on Respiratory Muscles in Very Preterm Infants
This study aimed to evaluate the effects of kinesio taping on blood gas parameters, respiratory rate, heart rate, oxygen saturation, and pressure limits in preterm infants with RDS who are on NIV.
- Conditions
- Preterm, Premature, Infant, Newborn, Diseases, Respiratory Distress Syndrome
- Trial name
- NCT06285669
- Testing
- kinesiotaping application
- Where
- Turkey (Türkiye)
- Volunteers
- 26 people
- Sponsor
- Ondokuz Mayıs University
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
Infant, Premature, Diseases, Infant, Newborn, Diseases
Pulmonary Function Using Non-invasive Forced Oscillometry
The purpose of this observational study is to measure pulmonary function in term and preterm infants with and without pulmonary disease including respiratory distress syndrome, bronchopulmonary dysplasia, transient tachypnea of…
- Conditions
- Infant, Premature, Diseases, Infant, Newborn, Diseases, Bronchopulmonary Dysplasia, Respiratory Distress Syndrome, Newborn
- Trial name
- PUFFOR (NCT03346343)
- Testing
- Non-invasive forced airway oscillometry
- Where
- United States
- Volunteers
- 600 people, healthy volunteers welcome
- Sponsor
- University of Alabama at Birmingham
Apnea of Prematurity, Apneic Spells of Newborn Nos
Cardio-respiratory Events in Preterm Infants During Transition
Cardio-respiratory events (CRE), defined as intermittent episodes of hypoxemia and/or bradycardia, are particularly common among preterm infants.
- Conditions
- Apnea of Prematurity, Apneic Spells of Newborn Nos, Patent Ductus Arteriosus, Premature Birth
- Trial name
- NCT04123691
- Testing
- pulse oximetry monitoring
- Where
- Italy
- Volunteers
- 32 people
- Sponsor
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
Premature Birth, Obstetric Labor, Premature
Family Nurture Intervention in the NICU
The purpose of this study is to compare neurodevelopment and activity in infants born very preterm (26 to 33 6/7 weeks gestational age (GA)) receiving Standard Care (SC) or Family Nurture Intervention (FNI) in the neonatal…
- Trial name
- NCT02710474
- Testing
- Family Nurture Intervention, Standard Care
- Where
- 2 sites in United States
- Volunteers
- 461 people
- Sponsor
- Columbia University
Sepsis Newborn
The Effects of Two Different Intravenous Lipid Emulsions on the Outcomes of Preterm Infants With Sepsis
Introduction and objectives: Lipid emulsions play an important role in parenteral nutrition in preterm infants. We aim to evaluate the effect of two different intravenous lipid emulsions on the outcomes of neonatal sepsis in…
- Trial name
- NCT03275090
- Testing
- Smoflipid ®
- Where
- Egypt
- Volunteers
- 40 people
- Sponsor
- Mansoura University Children Hospital
Pregnancy Complications, Preterm Labor
Strengthening Facility-based Intrapartum/Immediate Newborn Care to Reduce Mortality of Preterm Infants in Migori County, Kenya and Busoga Region, Uganda
The purpose of this study is to determine whether a combination of evidence-based strategies can improve intrapartum and newborn care in facilities to reduce mortality among preterm infants.
- Conditions
- Pregnancy Complications, Preterm Labor, PreTerm Birth, Stillbirth
- Trial name
- PTBi-KE-UG (NCT03112018)
- Testing
- data strengthening, modified Safe childbirth checklist - control, modified Safe childbirth checklist - enhanced
- Where
- 2 sites in Kenya, Uganda
- Volunteers
- 102,988 people, healthy volunteers welcome
- Sponsor
- University of California, San Francisco
Preterm Birth, Preterm Labor
Impact of the PREEMI Package on Neonatal Mortality
The purpose of this Quality Improvement initiative is to reduce severe morbidity and mortality among premature infants through proven and cost-effective clinical management during the antenatal, intrapartum, and postpartum…
- Conditions
- Preterm Birth, Preterm Labor, Neonatal Death
- Trial name
- PREEMI (NCT03923023)
- Where
- 2 sites in Zambia
- Volunteers
- 11,195 people, healthy volunteers welcome
- Sponsor
- University of Alabama at Birmingham
Bronchopulmonary Dysplasia
Fluid Filled Lung Oxygenation Assistance Trial
The primary study objective is to assess the safety and feasibility of perfluorooctylbromide (PFOB) partial liquid ventilation (PLV) in infants with severe Bronchopulmonary Dysplasia (BPD).
- Trial name
- FFLOAT (NCT03041740)
- Testing
- Perfluorooctyl Bromide
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- Children's Hospital of Philadelphia
Bronchopulmonary Dysplasia
Intratracheal Umbilical Cord-derived Mesenchymal Stem Cell for the Treatment of Bronchopulmonary Dysplasia (BPD)
Umbilical Cord-derived Mesenchymal stem cell has been proven effective in the experimental bronchopulmonary dysplasia (BPD).A multi-center study was designed to evaluate the safety and efficacy of the cellular therapy in…
- Trial name
- IUMTB (NCT03645525)
- Testing
- Human Umbilical Cord-derived Mesenchymal stem cell
- Where
- 3 sites in China
- Sponsor
- Children's Hospital of Fudan University
Patent Ductus Arteriosus After Premature Birth, Hyper Bilirubinemia
The Effects of Phototherapy in Preterm Infants Pda
The study was designed to assess whether chest shielding during phototherapy reduces the incidence of PDA, as assessed by serial echocardiographic examinations, in a population of extremely preterm infants born at lower 30 week…
- Trial name
- NCT03675425
- Testing
- Group 1: non chest shielding, Group 2: chest shielding
- Where
- Turkey (Türkiye)
- Volunteers
- 54 people
- Sponsor
- Zekai Tahir Burak Women's Health Research and Education Hospital
Premature Birth of Newborn, Infant, Very Low Birth Weight
Delayed Cord Clamping in Preterm Neonates
Delayed cord clamping (DCC) from 30 to 60 seconds allows blood to continue to flow from the placenta through the umbilical cord to the infant, thus resulting in a placental transfusion.
- Conditions
- Premature Birth of Newborn, Infant, Very Low Birth Weight, Delayed Separation of Umbilical Cord, Placental Transfusion
- Trial name
- DCC (NCT02478684)
- Testing
- 30 Seconds of placental blood transfusion, 60 Seconds of placental blood transfusion
- Where
- United States
- Volunteers
- 105 people
- Sponsor
- Weill Medical College of Cornell University
Premature Birth of Newborn
Kangaroo Care and Premature Infant Sleep
90 preterm infants were randomly assigned to kangaroo care (skin-to-=skin, chest-to-chest) group (n=50) or control (remained in incubator, prone (n=40) for a pretest period of 2- 3 hours, then fed, then KC group was placed in KC…
- Trial name
- NCT02473055
- Testing
- Kangaroo Care
- Where
- United States
- Volunteers
- 90 people
- Sponsor
- Case Western Reserve University
Infant, Newborn, Diseases, Infant Development
Probiotics and the Neurodevelopment in the Premature Infant <32 Weeks Gestational Age and <1500g
Unicentric, quasi-experimental, cohort study to evaluate the effect of combining two probiotics (Bifidobacterium bifidum NCDO 2203 and Lactobacillus acidophilus NCDO 1748) in the neurodevelopment of preterm neonates below 32…
- Trial name
- NCT05945017
- Testing
- Infloran® -Berne, Switzerland- (Bifidobacterium bifidum NCDO 2203 and Lactobacillus acidophilus NCDO 1748
- Where
- Spain
- Volunteers
- 233 people
- Sponsor
- Fundacion Clinic per a la Recerca Biomédica
Premature Babies
BEADI - The Bliss Cluster Randomised Control Trial on the Effects of Active Dissemination of Information (BEADI)
BEADI is a dissemination trial, on standards of care of premature babies. The main objective of BEADI is to assess whether an innovative 'active' strategy for the dissemination of neonatal information (evidence reviews…
- Trial name
- BEADI (NCT00831168)
- Testing
- Effects of Active Dissemination
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Confidential Enquiry into Maternal and Child Health
Bronchopulmonary Dysplasia
Genetic Susceptibility for Bronchopulmonary Dysplasia in Preterm Infants
Despite considerable obstetric and neonatal advances in the care of very low birth weight (VLBW) neonates, bronchopulmonary dysplasia (BPD) continues to occur among 20 to 40% of surviving infants, and new ways for combatting this…
- Trial name
- GENBPD (NCT00904774)
- Where
- France
- Volunteers
- 800 people
- Sponsor
- Centre Hospitalier Intercommunal Creteil
Infant, Newborn, Infant, Low Birth Weight
Single-Dose Intravenous Inositol Pharmacokinetics in Preterm Infants
This pilot study was a randomized, placebo-controlled, clinical trial to measure changes in blood and urine levels of inositol in premature infants at high risk for retinopathy of prematurity (ROP) following a single intravenous…
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- INS-1 (NCT00349726)
- Testing
- Inositol lower volume, Inositol higher volume
- Where
- 11 sites in United States
- Volunteers
- 74 people
- Sponsor
- NICHD Neonatal Research Network