Clinical trials: Premature Neonates
Breast Feeding, Breast Milk Collection
Effect of Breast Milk Circadian Properties on Infant's Growth Parameters and Absorption of Nutrients
The most ideal method for providing breast milk is breastfeeding. However, it may be necessary to express breast milk for reasons such as the newborn being in an intensive care unit, the mother being hospitalized for any reason…
- Trial name
- The (NCT06342674)
- Testing
- Giving breast milk to the newborn according to the circadian rhythm, Usual care
- Where
- Turkey (Türkiye)
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Sakarya University
Transient Tachypnea of the Newborn, PPHN
Evaluation of the Prevalence of Persistent Pulmonary Hypertension in Neonates
Transient Tachypnea of the Newborn (TTN) is one of the common causes of neonatal respiratory distress as a result of delayed clearance of fetal lung fluid. Neonates with TTN usually require noninvasive respiratory support (e.g.
- Trial name
- PRE-HIFREQ (NCT03499418)
- Testing
- modified Silverman scale, echocardiography
- Where
- Poland
- Sponsor
- Princess Anna Mazowiecka Hospital, Warsaw, Poland
Infant, Premature, Infants, Extremely Premature
The Alberta BLOOM Preterm Neonate Study
This is a prospective, observational clinical cohort study involving 100 mothers and their very preterm infants born at less than 32 weeks gestation.
- Conditions
- Infant, Premature, Infants, Extremely Premature, Microbiota, Gastrointestinal Microbiome
- Trial name
- BLOOM-PTN (NCT03840980)
- Where
- Canada
- Volunteers
- 55 people
- Sponsor
- University of Calgary
Preterm Birth, Parent-Child Relations
Epigenetics and Protective Factors in the Preterm Infant
Preterm infants (PT) spend their first weeks of life in the Neonatal Intensive Care Unit (NICU) where they are exposed to unfavorable conditions with different effects on child development including long-term alterations in…
- Conditions
- Preterm Birth, Parent-Child Relations, Epigenetics
- Trial name
- EPIC (NCT04804280)
- Testing
- DNA methylation of target genes, Functional Magnetic Resonance Imaging (fMRI) acquisition
- Where
- Italy
- Volunteers
- 94 people, healthy volunteers welcome
- Sponsor
- IRCCS Eugenio Medea
Ventilation
Haemodynamic Changes With Different Noninvasive Respiratory Modes for Primary Respiratory Support in Preterm Neonates
to evaluate the efficacy of Nasal high frequency oscillatory ventilation (NHFOV) and Vapotherm in comparison to nasal Continuous positive airway pressure (CPAP) as a primary noninvasive respiratory support in preterm neonates
- Trial name
- RDS (NCT06737003)
- Testing
- Nasal high frequency oscillatory ventilation, Vapotherm Group, Nasal CPAP Group
- Where
- Egypt
- Volunteers
- 90 people
- Sponsor
- Ain Shams University
Neonatal Infection
Experience of Mutaflor Suspension Use in Preterm Infants for Immunity Improvement
EcN has been registered as a medical drug under the brand name Mutaflor® SUSPENSION in Ukraine in 2010. Indications for its clinical use are acute diarrhea in infants and toddlers including those on tube feeding tube, diarrhea in…
- Trial name
- EMSUP (NCT01540162)
- Where
- Ukraine
- Volunteers
- 62 people, healthy volunteers welcome
- Sponsor
- Odessa National Medical University
Ductus Arteriosus, Patent
Adding Paracetamol to Ibuprofen for Treatment of Patent Ductus Arteriosus in Preterm Infants
The purpose of this study is to determine if adding paracetamol to ibuprofen is superior to ibuprofen only for treatment of patent ductus arteriosus (PDA) in preterm infants.
- Trial name
- NCT02002741
- Testing
- Paracetamol
- Where
- Israel
- Volunteers
- 24 people
- Sponsor
- Rambam Health Care Campus
Bronchopulmonary Dysplasia
Inhaled Nitric Oxide (INO) for the Prevention of Bronchopulmonary Dysplasia (BPD) in Preterm Infants
This phase 3, multi-center, double blind, placebo-controlled, randomized clinical trial will attempt to demonstrate if preterm infants who require mechanical ventilation and/or positive pressure support at any point during days 5…
- Trial name
- NCT00931632
- Testing
- Inhaled Nitric Oxide
- Where
- 33 sites in United States, Canada
- Volunteers
- 451 people
- Sponsor
- Mallinckrodt
Preeclampsia, Preterm Birth
Prediction of Preeclampsia and Other Pregnancy Complications Following Combined Iterative Screening
Preterm birth (PTB), preeclampsia (PE), fetal growth restriction (FGR) and intra-uterine fetal death (IUFD) constitutes the main causes of perinatal morbidity and mortality and are called "Great Obstetrical Syndromes".
- Conditions
- Preeclampsia, Preterm Birth, Fetal Growth Restriction, Intra Uterine Fetal Death
- Trial name
- PREDICTION2 (NCT03067298)
- Where
- Canada
- Volunteers
- 805 people, healthy volunteers welcome
- Sponsor
- Emmanuel Bujold
Retinopathy of Prematurity (ROP)
Long-term Safety and Efficacy Outcome Study Comparing Children Previously Enrolled in Study ROPP-2008-01 for the Prevention of Retinopathy of Prematurity (ROP)
The main purpose of this study is to evaluate the long-term efficacy and safety outcomes following short-term exposure to rhIGF-1/rhIGFBP-3 versus standard neonatal care in Study ROPP-2008-01 (NCT01096784).
- Trial name
- PEDAL (NCT02386839)
- Testing
- rhIGF-1/rhIGFBP-3
- Where
- 16 sites in United States, Italy and 4 more
- Volunteers
- 76 people
- Sponsor
- Shire
Infant, Premature, Diseases, Respiratory Tract Diseases
Effect of Volume Guarantee-High Frequency Oscillatory Ventilation on Cerebral Blood Flow in Neonates
A randomized controlled clinical trial evaluates cerebral blood flow changes associated with HFOV-VG in comparison to HFOV alone in preterm neonates with respiratory insufficiency during the period of invasive respiratory support
- Conditions
- Infant, Premature, Diseases, Respiratory Tract Diseases, Cerebral Blood Flow
- Trial name
- NCT05592431
- Testing
- High Frequency Oscillatory Ventilation with Volume Guarantee (SLE6000;SLE), High Frequency Oscillatory Ventilation (SLE6000;SLE)
- Where
- Egypt
- Volunteers
- 60 people
- Sponsor
- Ain Shams University
Transient Tachypnea of the Newborn, Fluid Therapy
Restricted Fluid Therapy for Newborn Breathing Problems
Evidence suggests that increased intravascular and interstitial fluid load in neonates with transient tachypnea of the newborn (TTN) may delay the clearance of fetal alveolar fluid (FAF).
- Trial name
- NCT07549945
- Testing
- restricted fluid regimen, Standart fluid
- Where
- Turkey (Türkiye)
- Volunteers
- 50 people
- Sponsor
- Hitit University
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
Pulmonary Hypertension, Bronchopulmonary Dysplasia
Neolifes Heart - Pulmonary Hypertension in Preterm Children
NeoLifeS is a cohort follow up study that prospectively collects data of regular care of children born preterm in the University Medical Center Groningen (UMCG) and aims to improve the quality of care for these children.
- Trial name
- NCT02729844
- Where
- Netherlands
- Volunteers
- 134 people, healthy volunteers welcome
- Sponsor
- University Medical Center Groningen
Infant, Premature, Diseases, Airway Morbidity
Optimising Ventilation in Preterms With Closed-loop Oxygen Control
Many premature infants require respiratory support in the newborn period. Mechanical ventilation although life-saving is linked to complications for the lungs and other organs and its duration should be kept to a minimum.
- Conditions
- Infant, Premature, Diseases, Airway Morbidity, Mechanical Ventilation Complication
- Trial name
- NCT05030337
- Testing
- Closed-loop automated oxygen control (Oxygenie, SLE 6000)
- Where
- United Kingdom
- Volunteers
- 70 people
- Sponsor
- King's College Hospital NHS Trust
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
HIE - Hypoxic - Ischemic Encephalopathy, Perinatal Anoxic-ischemic Brain Injury
Biomarkers Study in Infants With Prior Neonatal Brain Injury
This research focuses on the long-term cognitive development of children, including healthy infants and those who had a perinatal brain injury.
- Conditions
- HIE - Hypoxic - Ischemic Encephalopathy, Perinatal Anoxic-ischemic Brain Injury, Premature Birth, Healthy Participants
- Trial name
- NCT07413900
- Where
- United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- University of Wisconsin, Madison
Prematurity
Effect of Monitoring Devices on Healthcare Provider Performance During Neonatal Resuscitation
Babies born very early (at less than 32 weeks) usually need help to breath right at birth, also called neonatal resuscitation. Healthcare providers (HCPs) are specially trained to provide this help.
- Trial name
- NCT04521725
- Testing
- Respiratory Function Monitor (RFM), Cerebral Near-Infrared Spectroscopy (NIRS)
- Where
- Canada
- Volunteers
- 51 people
- Sponsor
- University of Alberta
Retinopathy of Prematurity
Incidence of Hypoxia During Intravitreal Anti-VEGF (Vascular Endothelial Growth Factor) Injections for Retinopathy of Prematurity (ROP) Under Topical Anesthesia
Purpose: To evaluate the incidence and severity of hypoxia and address a genuine evidence gap focusing on intraprocedural hypoxia during bedside intravitreal ranibizumab injection for retinopathy of prematurity (ROP), an area…
- Trial name
- NCT07701759
- Testing
- ranibizumab
- Where
- Saudi Arabia
- Volunteers
- 74 people
- Sponsor
- Minia University
Patent Ductus Arteriosus, Surgery
Early Treatment Versus Delayed Conservative Treatment of the Patent Ductus Arteriosus
The primary goal of the trial is to compare two different Patent Ductus Arteriosus (PDA) treatment approaches: 1) an "early treatment" approach or 2) a "conservative" approach.
- Conditions
- Patent Ductus Arteriosus, Surgery, Necrotizing Enterocolitis, Intestinal Perforation
- Trial name
- PDA:TOLERATE (NCT01958320)
- Testing
- pharmacologic treatment of the PDA, no pharmacologic treatment of the PDA, NSAID
- Where
- 18 sites in United States, Sweden and 2 more
- Volunteers
- 202 people
- Sponsor
- University of California, San Francisco
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