Clinical trials: Preterm Neonates
Bronchopulmonary Dysplasia
Azithromycin in the Prevention of Lung Injury in Premature Newborn
The introduction of invasive mechanical ventilation in the treatment of preterm infants works as an adjuvant in the treatment of acute respiratory failure, which has resulted in significantly significant survival rates.
- Trial name
- NCT03485703
- Testing
- Azithromycin
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Hospital de Clinicas de Porto Alegre
Malnutrition, Infant, Enteral Feeding Intolerance
Efficacy and Safety of Numeta G13%E Compared to Compounded Parenteral Nutrition in Preterm Neonates
Preterm (PT, born before 37 weeks of gestation) birth complications are the leading causes of death among children aged under 5 years globally, with nearly one million infant deaths reported in 2013.
- Trial name
- NCT06894446
- Testing
- Numeta G13%E, Compounded Parenteral Nutrition (cPN) solution
- Volunteers
- healthy volunteers welcome
- Sponsor
- Baxter Healthcare Corporation
Bronchopulmonary Dysplasia, Very Low Birth Weight
Preterm Infant Inhaled Albuterol Dosing
The purpose of this study is to help determine the best dose of inhaled albuterol sulfate in premature babies at risk of developing bronchopulmonary dysplasia (BPD).
- Trial name
- NCT02447250
- Testing
- Varied albuterol dose response
- Where
- United States
- Volunteers
- 14 people
- Sponsor
- Oregon Health and Science University
Preterm Birth, Coagulation Protein Disorders
Stratifying Risk for Intracerebral Haemorrhage
This study aims to investigates the role of gestational age on the prevalence of coagulation factors and components of the complement system in preterm- (≤32+0 weeks) and term neonates (≥37+0 weeks) and their role for the…
- Conditions
- Preterm Birth, Coagulation Protein Disorders, Coagulation Disorder Neonatal
- Trial name
- NEW_STRATEGI (NCT04140812)
- Testing
- mass spectrometry (LC-MS/MS)
- Where
- Germany
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- University of Erlangen-Nürnberg Medical School
Breastfeeding
Effects of Music Therapy on Breastfeeding Among Mothers of Premature Newborns
The purpose of this study is to evaluate the impact of music therapy on breastfeeding rates among mothers of premature newborns.
- Trial name
- NCT00930761
- Testing
- Music therapy
- Where
- Brazil
- Volunteers
- 101 people
- Sponsor
- Universidade Federal do Rio de Janeiro
Respiratory Distress Syndrome in Premature Infant
REspiratory MEchanics for Delivering Individualised Exogenous Surfactant
This study is an interventional, non-pharmacological, multicentric, randomized, controlled, superiority, non-profit study. Its primary objective is to evaluate if the administration of surfactant based on FOT assessment will…
- Trial name
- REMEDIES (NCT05791331)
- Testing
- Surfactant administration following lung mechanics assessment in addition to clinical assessment, Surfactant administration following clinical assessment
- Where
- Italy
- Volunteers
- 458 people
- Sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Patent Ductus Arteriosus
Paracetamol And Ibuprofen/Indomethacin in Closing Patent Ductus Arteriosus
The purpose of this pilot trial is to study efficacy and safety of simultaneous intravenous (iv) ibuprofen/indomethacin and paracetamol medications in the closure of patent ductus arteriosus (PDA) in preterm infants.
- Trial name
- PAI (NCT03648437)
- Testing
- Paracetamol 10Mg/mL, 0.45% Sodium Chloride, Ibuprofen
- Where
- 4 sites in Finland
- Volunteers
- 22 people
- Sponsor
- University of Oulu
Preterm Birth, Parent-Child Relations
Skin-to-skin Contact in Neonatal Intensive Care Unit (NICU), Caregiving Touch and Neural Correlates of Slow Stroking Touch in Preterm Infants
Preterm (PT) infants spend their first weeks of life in Neonatal Intensive Care Unit (NICU) where receive little affective physical contact, which plays a crucial role in brain development.
- Trial name
- NCT04293939
- Testing
- Functional Magnetic Risonance Imaging (fMRI) acquisition
- Where
- Italy
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- IRCCS Eugenio Medea
Infant Apnea, Neonatal Abstinence Syndrome
Interventions to Help Infants Recover in the Hospital
This pilot project will evaluate independently two non-pharmacological interventions, 1) Neurosensory, Environmental Adaptive Technology (NEATCAP) and 2) Stochastic Vibrotactile Stimulation (SVS), as adjuvant non-pharmacological…
- Conditions
- Infant Apnea, Neonatal Abstinence Syndrome, Sleep
- Trial name
- NCT03881553
- Testing
- NEATCAP, SVS mattress
- Where
- United States
- Volunteers
- 17 people
- Sponsor
- Elisabeth Salisbury, PhD
Infant, Premature
Non-Nutritive Sucking vs Non-Nutritive Sucking Combined With Breast Milk on the Neonatal Comfort
The aim of the study is to determine the effect of the use of non-nutritive sucking vs non-nutritive sucking combined with breast milk on neonatal comfort during diaper change in preterm infants.
- Trial name
- NCT05097495
- Testing
- Only NNS, NNS Combined with Breast Milk
- Where
- Turkey (Türkiye)
- Volunteers
- 30 people
- Sponsor
- Acibadem University
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
Necrotizing Enterocolitis, Digestive System Abnormalities
Brain Manganese Deposition in High Risk Neonates
Excessive exposure to manganese (Mn) results in Mn deposition in the brain causing adverse neurological effects. Sick infants requiring parenteral nutrition (PN) may be at increased risk of Mn neurotoxicity because neonatal PN…
- Conditions
- Necrotizing Enterocolitis, Digestive System Abnormalities, Cholestasis
- Trial name
- NCT00392977
- Testing
- remove Mn from PN if evidence of increased brain Mn on MRI
- Where
- United States
- Volunteers
- 43 people
- Sponsor
- Vanderbilt University
Neonatal Outcomes, Pregnancy Complications, Infectious
Systematic Screening of Lower Genital Tract Infections
Introduction: The investigation of systematic screening for asymptomatic genital infections in pregnant women is justified by the relevance of these conditions in determining adverse neonatal outcomes, such as prematurity, low…
- Conditions
- Neonatal Outcomes, Pregnancy Complications, Infectious, Premature Birth, Premature Rupture of Fetal Membranes
- Trial name
- NCT07592286
- Testing
- Enhanced microbiological screening, Standard prenatal care
- Volunteers
- 250 people
- Sponsor
- Universidade Federal do Pampa
Intraventricular Hemorrhage Neonatal, Post-hemorrhagic Hydrocephalus
Advanced MRI in IVH
55,000 babies are born prematurely in the UK annually. Bleeding in the fluid spaces of the brain (ventricles) is common after prematurity; in England around 450 babies suffer from severe bleeds every year.
- Trial name
- NCT07412886
- Testing
- Advanced MRI
- Where
- 2 sites in United Kingdom
- Volunteers
- 30 people
- Sponsor
- Great Ormond Street Hospital for Children NHS Foundation Trust
Infant Growth, Mothers' Parental Competence
Nursing and Nurturing Premature Infants
The purpose of this study is to determine whether systematic use of the Newborn Individualized Developmental Care Assessment Program (NIDCAP®) improves the neurologic development of children and the parental competence of mothers.
- Trial name
- NCT00388141
- Testing
- NIDCAP
- Where
- Denmark
- Volunteers
- 90 people
- Sponsor
- University of Aarhus
Intrauterine Growth Restriction, Preterm Birth
Respiratory Morbidity of Late-Preterm Vs Intrauterine Growth Retarded Infants at School Age
Background: It is increasingly recognized that late preterm infants have increased respiratory morbidity in the neonatal period as well as decreased lung function in later life.
- Trial name
- NCT04849494
- Testing
- ATS-DLD-78-C and ISAAC questionnaires
- Volunteers
- 160 people, healthy volunteers welcome
- Sponsor
- Marmara University
Respiratory Distress Syndrome, Newborn
ABCA3 Gene and RDS in Late Preterm and Term Infants
Respiratory distress syndrome (RDS) is the most common respiratory cause of mortality and morbidity in very preterm infants, but it also could be seen in late preterm and term infants.
- Trial name
- NCT04137783
- Testing
- no intervention
- Where
- China
- Volunteers
- 39 people
- Sponsor
- Children's Hospital of Chongqing Medical University
Respiratory Distress Syndrome
Comparison of Aerosol Delivery of Infasurf to Usual Care in Spontaneously Breathing RDS Patients
Study to test the hypothesis that aerosolized Infasurf can decrease the need for intubation and instillation of liquid surfactant to the airway.
- Trial name
- NCT03058666
- Testing
- Aerosolized Calfactant, Solarys
- Where
- 22 sites in United States
- Volunteers
- 477 people
- Sponsor
- ONY
Duchenne Muscular Dystrophy, Becker Muscular Dystrophy
Study of Ataluren (PTC124) in Nonambulatory Participants With Nonsense-Mutation-Mediated Duchenne/Becker Muscular Dystrophy (nmDMD/BMD)
Duchenne/Becker muscular dystrophy (DMD/BMD) is a genetic disorder that develops in boys. It is caused by a mutation in the gene for dystrophin, a protein that is important for maintaining normal muscle structure and function.
- Trial name
- NCT01009294
- Testing
- Ataluren, Chronic Corticosteroid Therapy
- Where
- 6 sites in United States, United Kingdom
- Volunteers
- 6 people
- Sponsor
- PTC Therapeutics
Premature Infants, Very Premature Infants
Anakinra Pilot 2 - A Study to Optimise Dose and Route of Administration of Anakinra in Preterm Infants
A phase 2 randomised, three-arm, parallel-group, dose-ranging trial to determine safety, efficacy and optimal dosing of intravenous anakinra in premature neonates, with subcutaneous pharmacokinetic sub-study.
- Conditions
- Premature Infants, Very Premature Infants, Inflammation
- Trial name
- AP2 (NCT07254000)
- Testing
- Anakinra (Kineret®)
- Where
- 2 sites in Australia, New Zealand
- Volunteers
- 24 people
- Sponsor
- Monash Medical Centre
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