Clinical trials: Preterm Neonates
Cardiovascular Diseases, Defect, Congenital Heart
Management of Patent Ductus in Premature Infants
To evaluate the effects (up to one year of age) of indomethacin on the clinical course of patent ductus arteriosus (PDA) in premature infants (24 hours old or less) and to assess the relative merits of indomethacin and surgery in…
- Conditions
- Cardiovascular Diseases, Defect, Congenital Heart, Ductus Arteriosus, Patent, Heart Diseases
- Trial name
- NCT00000494
- Testing
- indomethacin, surgery, cardiovascular
- Sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
Preterm Infant, Placental Insufficiency
Effect of Delayed Cord Clamping in Preterm Neonates With Placental Insufficiency
To investigate the effect of delayed cord clamping (DCC) on hematopoietic progenitor cells (HPCs), hematological parameters including haemoglobin concentration and hematocrit value in premature infants (34 weeks gestational age…
- Conditions
- Preterm Infant, Placental Insufficiency, Placental Transfusion
- Trial name
- NCT03731546
- Testing
- Delayed cord clamping
- Where
- Egypt
- Volunteers
- 90 people
- Sponsor
- Mansoura University Children Hospital
Intraventricular Hemorrhage, Periventricular Leukomalacia
Prediction of Brain Injury in Premature Infants
Extremely low birth weight (ELBW), birth weight less than or equal to 1000 g, infants are at high risk for developing brain injury in the first week of life.
- Conditions
- Intraventricular Hemorrhage, Periventricular Leukomalacia, Brain Injury, Extreme Prematurity
- Trial name
- NCT02814383
- Testing
- Brain Monitoring Platform
- Where
- 3 sites in United States
- Volunteers
- 70 people
- Sponsor
- Baylor College of Medicine
Preterm Birth, Extreme Prematurity
Sustained Aeration of Infant Lungs Trial
This study is a 2-arm randomized, controlled, multi-center clinical trial to determine which of two strategies at birth are best to optimally aerate the lung of preterm infants.
- Trial name
- SAIL (NCT02139800)
- Testing
- Sustained Inflation, Standard of Care
- Where
- 21 sites in United States, Australia and 7 more
- Volunteers
- 460 people
- Sponsor
- University of Pennsylvania
Jaundice, Neonatal, Hyperbilirubinemia
Point-of-Care System for Determination of Bilirubin Capacity in Neonates
The aims of this observational bench project are to validate the performance of the miniaturized and modernized hematofluorometer that measures bilirubin capacity into a product and is suitable for operation in various point of…
- Conditions
- Jaundice, Neonatal, Hyperbilirubinemia, Bilirubin-Induced Neurological Dysfunction (BIND)
- Trial name
- NCT02612207
- Testing
- Bilirubin Binding Capacity by Hematofluorometry Validation
- Where
- 2 sites in United States
- Volunteers
- 161 people, healthy volunteers welcome
- Sponsor
- Stanford University
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.
Premature Birth, Respiratory Distress Syndrome, Newborn
High-Flow Nasal Cannula Versus Nasal CPAP as Primary Support in Preterm Respiratory Distress Syndrome
This single-center randomized controlled trial compared heated humidified high-flow nasal cannula (HHHFNC) with nasal continuous positive airway pressure (nCPAP) as primary noninvasive respiratory support in preterm infants…
- Trial name
- NCT07693530
- Testing
- Group 1 Heated humidified high-flow nasal cannula (HHHFNC), Group 2 Nasal continuous positive airway pressure (nCPAP)
- Where
- Turkey (Türkiye)
- Volunteers
- 86 people
- Sponsor
- Kayseri City Hospital
Placental Insufficiency, Preterm Infant
Impact of Umbilical Cord Milking in Preterm Neonates With Placental Insufficiency
To investigate the effect of umbilical cord milking (UCM) on peripheral hematologic parameters including hematopoietic progenitor cells in premature infants ≤ 34 weeks gestational age with placental insufficiency.
- Trial name
- NCT03731611
- Testing
- Umbilical Cord Milking
- Where
- 2 sites in Egypt
- Volunteers
- 90 people
- Sponsor
- Mansoura University Children Hospital
Bronchopulmonary Dysplasia, Very Low Birth Weight Infant
Work of Breathing in Premature Infants at Discharge
The purpose of this study is to compare how premature infants who required oxygen for at least 28 days during their time in the NICU (Neonatal Intensive Care Unit) breathe at discharge compared to premature infants who did not…
- Conditions
- Bronchopulmonary Dysplasia, Very Low Birth Weight Infant, Prematurity
- Trial name
- NCT03682575
- Testing
- Enrollment
- Where
- United States
- Volunteers
- 78 people, healthy volunteers welcome
- Sponsor
- Christiana Care Health Services
Safety Issues
Safety of Immediate Skin-to-Skin Contact After Vaginal Birth in Vigorous Late-Preterm Neonates
Late-preterm neonates are born between 34 and 36 weeks 7 days gestational age (GA). Neonates born less than 34 weeks GA are at increased risk for morbidity and directly admitted to the Neonatal Intensive Care Unit (NICU).
- Trial name
- NCT03585192
- Testing
- Skin Group, Warmer Group
- Where
- United States
- Volunteers
- 47 people, healthy volunteers welcome
- Sponsor
- University Hospitals Cleveland Medical Center
Hemorrhage, Premature Infants
NIRS Monitoring in Premature Infants
This study uses frequency domain near-infrared spectroscopy coupled with diffuse correlation spectroscopy (FDNIRS-DCS) technology for monitoring cerebral blood flow (CBF) and cerebral oxygen metabolism (CMRO2) at the bedside for…
- Conditions
- Hemorrhage, Premature Infants, Newborn, Hydrocephalus
- Trial name
- NCT02601339
- Testing
- ETV/CPC
- Where
- 3 sites in United States
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Boston Children's Hospital
Prematurity; Extreme, Feeding Patterns
To Determine the Best Feeding Practice in Preterm Infants on Non-invasive Ventilation.
To evaluate the duration to reach full feeds by comparing continuous gavage feeds versus bolus feeds in preterm infants who are on non-invasive respiratory support (RAM cannula - short binasal prongs).
- Conditions
- Prematurity; Extreme, Feeding Patterns, Ventilator Lung; Newborn
- Trial name
- NCT05824377
- Testing
- Continuous Feeds, Intermittent Bolus Feeds
- Where
- United States
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- Rajeev Kumar
Infant, Very Low Birth Weight
Liquid Preterm Formula Versus Powdered Human Milk Fortifier in VLBW Infants
This study aims to compare the short-term effects on growth and feeding tolerance of a liquid high calorie formula added to human milk versus powdered human milk fortifier in small preterm infants.
- Trial name
- NCT00760942
- Testing
- Similac special care 30, Similac human milk fortifier
- Where
- United States
- Volunteers
- 84 people
- Sponsor
- University of Oklahoma
Persistent Ductus Arteriosus
The Best Treatment Strategy: Surgical vs Pharmacological to Close the Ductus Arteriosus Persistent in Preterm Infants
The decision to treat patent ductus arteriosus in preterm infants, varies from a conservative, medical or immediate surgical treatment; although, at present, there is some controversy about this decision.
- Trial name
- NCT02602054
- Testing
- Surgical treatment, Control group
- Where
- Mexico
- Volunteers
- 40 people
- Sponsor
- Hospital General Naval de Alta Especialidad - Escuela Medico Naval
Infant, Premature, Diseases, Bronchopulmonary Dysplasia
A Trial of Infant Flow Biphasic Nasal Continuous Airway Pressure (NCPAP) Versus Infant Flow NCPAP for the Facilitation of Extubation in Infants </= 1250 Grams
The purpose of this study is to compare two methods of delivering Nasal Continuous Airway Pressure (NCPAP): Biphasic Mode and a continuous mode, to see which is better in getting babies off the ventilator and decreasing lung…
- Conditions
- Infant, Premature, Diseases, Bronchopulmonary Dysplasia, Apnea of Prematurity
- Trial name
- NCT00308789
- Testing
- Biphasic Infant flow NCPAP, CPAP
- Where
- Canada
- Volunteers
- 136 people
- Sponsor
- Mount Sinai Hospital, Canada
Breastfeeding, Retinopaty of Prematurity
The Effect of Breast Milk on Pain and Stress
This study aimed to examine the effect of breast milk on pain and stress during Retinopathy of Prematurity (ROP) examinations. This randomized controlled experimental study was conducted with premature infants (N = 154)…
- Conditions
- Breastfeeding, Retinopaty of Prematurity, Pain, Stress
- Trial name
- NCT07127679
- Testing
- Two minutes before the ROP examination, 2 mL of freshly expressed breast milk was administered to infants in the experimental group using a syringe, placing the milk on the front of the tongue. As par
- Where
- Turkey (Türkiye)
- Volunteers
- 36 people
- Sponsor
- Ege University
RDS of Prematurity
Sustained Lung Inflation With CPAP in Preterm Neonates (SI-CPAP)
Neonatal respiratory distress syndrome (RDS) is the most common cause of respiratory failure in the first few days in life. It is characterized by the tendency of alveoli and terminal bronchioles to collapse due to the lack of…
- Trial name
- SI-CPAP (NCT03916523)
- Testing
- Sustained lung inflation, Continuous positive airway pressure (CPAP), Mechanical ventilation
- Volunteers
- 100 people
- Sponsor
- Ain Shams University
Premature Birth, Newborn
Pain Management in Neonatal Intensive Care Units by Studying the Autonomic Balance
Fight against the pain caused by the disease or by the diagnostic and therapeutic procedures is a daily and essential concern for the caregiver neonatologist.
- Trial name
- NIPE-DOL (NCT02764424)
- Testing
- NIPE (MDoloris®)
- Where
- France
- Volunteers
- 29 people, healthy volunteers welcome
- Sponsor
- Centre Hospitalier Universitaire de Saint Etienne
Apnea of Prematurity, Preterm Infant
Detection of Respiratory Events Using Acoustic Monitoring in Extremely Preterm Infants
Extremely preterm infants, born before 29 weeks of pregnancy, often face breathing difficulties, also known as respiratory events, due to their undeveloped lungs and respiratory systems.
- Conditions
- Apnea of Prematurity, Preterm Infant, Periodic Breathing, Hypopnea
- Trial name
- DREAM 2 (NCT07552025)
- Testing
- Wireless acoustic sensor, Semi-structured interview, Nox T3s portable sleep monitoring device
- Where
- Canada
- Volunteers
- 50 people
- Sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
Apnea, Infant, Premature
Randomized Trial of Nasal Continuous Positive Airway Pressure or Synchronized Nasal Ventilation in Premature Infants.
Very premature infants uniformly do not have mature functioning lungs to breathe well nor mature regulation mechanisms to breathe regularly. Assistance with a mechanical respirator is common.
- Conditions
- Apnea, Infant, Premature, Bronchopulmonary Dysplasia
- Trial name
- NCT00188968
- Testing
- Nasal Continuous Positive Airway Pressure, Synchronized Nasal Positive Pressure Ventilation
- Where
- 2 sites in Canada
- Volunteers
- 48 people
- Sponsor
- University of Manitoba
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