Clinical trials: Preterm Neonates, open to volunteers
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
Bronchopulmonary Dysplasia (BPD), Premature Births
PK, Safety and Preliminary Efficacy Study of Montelukast in Critically Ill Infants With Developing Bronchopulmonary Dysplasia
The purpose of the study is to learn how safe montelukast may be in premature infants at significant risk for Bronchopulmonary Dysplasia (BPD) and to determine how much and how quickly montelukast moves from the stomach into the…
- Conditions
- Bronchopulmonary Dysplasia (BPD), Premature Births, Critical Illness
- Trial name
- PRISM (NCT07101640)
- Testing
- montelukast 4 mg granule
- Where
- 5 sites in United States
- Volunteers
- 28 people
- Sponsor
- Duke University
Prematurity, Respiratory Disease
Caffeine as an Adjuvant Therapy for Late Preterm Infants With Respiratory Distress
Use of caffeine citrate in late-preterm infants with respiratory distress is questionable. Oliphant and colleagues found in a recently published study that caffeine therapy use in late-preterm infants at a loading dose of 20 and…
- Conditions
- Prematurity, Respiratory Disease, Ventilator Lung; Newborn
- Trial name
- CAT/LPT (NCT06026163)
- Testing
- Caffeine citrate
- Where
- 2 sites in Saudi Arabia
- Volunteers
- 134 people
- Sponsor
- Ministry of Health, Saudi Arabia
Neonatal Respiratory Failure
Flow and Grow - The Ideal Time to Wean CPAP Off In Extremely Low Birth Weight Infants
Preterm neonates born at less than 30 weeks' gestation are commonly maintained on invasive or non-invasive respiratory support to facilitate gas exchange.
- Trial name
- Flow&Grow (NCT06123143)
- Testing
- Standardized/structured CPAP weaning protocol
- Where
- 5 sites in United States
- Volunteers
- 130 people
- Sponsor
- University of California, San Diego
Paravalvular Leak
A Multicenter, International, Prospective and Retrospective, Follow-up Registry to Monitor the Efficacy and Safety of the Occlutech Paravalvular Leak Device (PLD) in Patients With Mitral or Aortic Paravalvular Leaks
This is an international, multicenter, retrospective and prospective post-marketing follow-up registry designed to monitor the safety and efficacy of the Occlutech Paravalvular Leak Device (PLD) in patients with clinically…
- Trial name
- PLD REGISTRY (NCT07037446)
- Testing
- Transcatheter paravalvular leak closure device
- Where
- 22 sites in France, Germany and 4 more
- Volunteers
- 200 people
- Sponsor
- Occlutech International AB
Preterm Birth
The Social Determinants of Health Screening and Referral Project
Up to a quarter of the families with preterm infants have unmet social needs, such as housing or job insecurity, which represent adverse social determinants of health (SDOH).
- Trial name
- NCT06582147
- Testing
- Implementation of social determinants of health screening and referral
- Where
- 7 sites in United States
- Volunteers
- 882 people
- Sponsor
- University of Massachusetts, Worcester
Infant, Premature, Intubation, Intratracheal
Fentanyl and Rocuronium for Tracheal Intubation in Newborns
Tracheal intubation is a common and critical procedure in neonatal intensive care units (NICU). Despite its clinical importance, first-attempt success rates remain low (approximately 50%), and adverse events - including oxygen…
- Conditions
- Infant, Premature, Intubation, Intratracheal, Respiratory Distress Syndrome, Newborn, Apnea of Prematurity
- Trial name
- NEORIN (NCT07650552)
- Testing
- Rocuronium Bromide 10 MG/ML, Fentanyl 1 mcg/kg IV, single dose, administered before non-emergent tracheal intubation.
- Where
- Brazil
- Volunteers
- 102 people
- Sponsor
- UEA - Universidade Do Estado Do Amazonas
Vitamin D Supplementation
Efficacy of Higher Dose Enteral Vitamin D Supplementation in Preterm 28 - 34 Weeks of Gestational Age
The goal of this clinical trial is to learn about the effective dosage of enteral vitamin D supplementation in preterm infants with gestational age fom 28 to 34 weeks.
- Trial name
- NCT06674122
- Testing
- Enteral vitamin D supplementation of 800 IU/day, Enteral vitamin D supplementation of 400 IU/day
- Where
- Indonesia
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Universitas Indonesia
Bronchopulmonary Dysplasia (BPD), Preterm Birth Complication
Parent Perceptions of OptiPAP Junior
To evaluate how different forms of respiratory support affect parent interaction, how parents feel about different methods of support, and how their child's current respiratory support level is perceived in the setting of…
- Conditions
- Bronchopulmonary Dysplasia (BPD), Preterm Birth Complication, Pulmonary, CPAP
- Trial name
- NCT07837700
- Testing
- Nasal CPAP interface: OptiPAP Junior, Nasal CPAP interface: FlexiTrunk
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Sharp HealthCare
Sleep, Newborn
Effects of Music-Based Interventions on Sleep Patterns and Physiological Responses in Premature Newborns: A Systematic Review and Meta-Analysis
Sleep in the neonatal period is a fundamental biological requirement for regulating growth, neurodevelopment, and the immune system.
- Trial name
- NCT07127419
- Volunteers
- 1,415 people, healthy volunteers welcome
- Sponsor
- Istanbul University - Cerrahpasa
Extubation Failure, Bronchopulmonary Dysplasia
The Diaphragmatic Initiated Ventilatory Assist (DIVA) Trial
DIVA is a pragmatic randomized clinical trial (RCT) to determine: among (P) preterm infants born 23 0/7-28 6/7 weeks gestation undergoing extubation from mechanical ventilation, whether (I) Non-invasive neurally adjusted…
- Conditions
- Extubation Failure, Bronchopulmonary Dysplasia, Death
- Trial name
- DIVA (NCT05446272)
- Testing
- NIV-NAVA, NS-NIPPV
- Where
- 20 sites in United States, Canada
- Volunteers
- 478 people
- Sponsor
- University of Pennsylvania
Extreme Prematurity, Anemia of Prematurity
Folic Acid Supplementation to Reduce Anemia in Extremely Preterm Infants
Anemia of Prematurity (AOP) is very common in extremely preterm infants and often leads to blood transfusions. Folic acid, essential for growth and DNA synthesis, is deficient in premature infants.
- Trial name
- FASCINATE (NCT06220461)
- Testing
- Folic acid
- Where
- Canada
- Volunteers
- 90 people
- Sponsor
- University of Calgary
Sleep Disordered Breathing, Apnea of Prematurity
The PARS Study: Paediatric Advanced Respiratory Service Study - An Observational Diagnostic Feasibility Study
Diagnostic investigations in paediatric respiratory and sleep medicine are often challenging due to patient size (due to prematurity), tolerability, and compliance with "gold standard equipment".
- Conditions
- Sleep Disordered Breathing, Apnea of Prematurity, Respiratory Rate, Sudden Unexpected Death in Epilepsy
- Trial name
- PARS (NCT06292299)
- Testing
- Pneumowave
- Where
- 2 sites in United Kingdom
- Volunteers
- 225 people
- Sponsor
- NHS Greater Clyde and Glasgow
Lung Diseases, Interstitial, Pulmonary Alveolar Proteinosis
European Management Platform for Childhood Interstitial Lung Diseases - chILD-EU Register and Biobank
Generation of a common European database and biobank Continous assessment and implementation of guidelines and treatment protocols Establishment of a large observational cohort of chILD patients Determination the value of…
- Conditions
- Lung Diseases, Interstitial, Pulmonary Alveolar Proteinosis, Pulmonary Eosinophilia, Pulmonary Fibrosis
- Trial name
- chILD-EU (NCT02852928)
- Where
- 3 sites in Germany, Turkey (Türkiye) and 1 more
- Volunteers
- 1,000 people
- Sponsor
- Matthias Griese
Bronchopulmonary Dysplasia
Use of Mesenchymal Stem Cells in Pre-term Patients With Bronchopulmonary Dysplasia.
Bronchopulmonary dysplasia (BPD) is a disease that affects preterm newborn patients, preventing their lungs from developing properly.
- Trial name
- NCT06270199
- Testing
- Control, Allogenic fetal mesenchymal stem cells from umbilical cord - three infusions, Allogenic fetal mesenchymal stem cells from umbilical cord - six infusions
- Where
- 7 sites in Spain
- Volunteers
- 75 people
- Sponsor
- Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Neonatal İntensive Care, Nutrition With A Chronobiological Approach
The Effect of PIOMI and Chronobiological Nutrition on Readiness for Feeding, Full Transition to Oral Feeding and Body Weight
This is a randomized controlled experimental study evaluating the effects of oral motor intervention and chronobiological approach to feeding model applied to preterm infants on feeding readiness, transition to total oral feeding…
- Conditions
- Neonatal İntensive Care, Nutrition With A Chronobiological Approach, Readiness For Feding, Body Weight
- Trial name
- PIOMI (NCT07306793)
- Testing
- PIOMI study group, Nutrition Study Group with a Chronobiological Approach, Control group
- Where
- Turkey (Türkiye)
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Aydin Adnan Menderes University
Preterm Birth, Inadequate Milk Production
Milk Volume Outcomes Following Oral Nicotinamide Riboside Supplementation in Mothers of Extremely Preterm Infants
This study aims to evaluate the feasibility and effects of nicotinamide riboside (NR) supplementation in lactating mothers of infants expected to be hospitalized in the neonatal intensive care unit (NICU) for at least four weeks.
- Trial name
- MOONRISE (NCT04614714)
- Testing
- Nicotinamide Riboside (NR)
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- University of California, Davis
Hypoxic-Ischemic Encephalopathy, Neonatal Encephalopathy
Nephroprotection Following Perinatal Asphyxia: Randomized Controlled Trial
The aim of this study is to determine the value of Pentoxifylline for nephroprotection in these neonates with perinatal asphyxia, using cystatin C, regional oxygenation measured near infrared spectroscopy and renal Doppler…
- Conditions
- Hypoxic-Ischemic Encephalopathy, Neonatal Encephalopathy, Pentoxifylline Adverse Reaction
- Trial name
- NCT07088328
- Testing
- Pentoxifylline
- Volunteers
- 30 people
- Sponsor
- Alexandria University
Oral Feeding Outcomes, Neurodevelopment Outcome
Impact of Hospital to Home: Optimizing Preterm Infant Environment for Surgical Neonates and Their Parents (H-HOPE)
Infants born with congenital defects may require major surgery in the neonatal period. These infants are at risk for neurodevelopmental impairments.
- Trial name
- H-HOPE (NCT07372898)
- Testing
- H-HOPE
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Ann & Robert H Lurie Children's Hospital of Chicago
Respiratory Distress Syndrome (RDS), PreTerm Neonate
Breathing Patterns in Infants Before and After Extubation
The primary objective of this study is to compare work of breathing indices before and after extubation in intubated premature infants admitted to the Christiana Care Neonatal Intensive Care Unit.
- Trial name
- NCT07542301
- Testing
- Observation
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Christiana Care Health Services