Clinical trials: Extreme Prematurity
Patent Ductus Arteriosus After Premature Birth
Indomethacin PK-PD in Extremely Preterm Neonates
This is a phase II open-label study evaluating the pharmacokinetics and pharmacodynamics of targeted early use of indomethacin for PDA treatment in preterm neonates <27 weeks' gestational age.
- Trial name
- INDO (NCT04025177)
- Testing
- Indomethacin Injection
- Where
- 2 sites in Canada
- Sponsor
- University of Manitoba
Oral Disorders
Acquisition of Full Oral Feeding and Further Oral Disorders in Extremely Preterm Infants
Extremely premature infants (born before 29 weeks) frequently present oral disorders. The management of these patients require assisted ventilation, enteral nutrition, and intensive daily care (procedural pain, exposure to pain…
- Trial name
- ORAPREM (NCT06648083)
- Testing
- Food autonomy
- Where
- France
- Volunteers
- 170 people
- Sponsor
- Hospices Civils de Lyon
Infant, Newborn, Infant, Low Birth Weight
Dexamethasone Therapy in VLBW Infants at Risk of CLD
Infants who are on breathing support are often treated with steroids (dexamethasone); however, the best timing of therapy is not known.
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- Dexamethasone (NCT00011362)
- Testing
- Dexamethasone Early, Dexamethasone Late
- Where
- 13 sites in United States
- Volunteers
- 371 people
- Sponsor
- NICHD Neonatal Research Network
Extreme Prematurity - Less Than 28 Weeks, Respiratory Distress Syndrome in Premature Infants
Study of Respiratory Physiology During High Flow Nasal Cannula Treatment in Preterm Neonates.
The most commonly used noninvasive respiratory support in preterm babies is Continuous Positive Airway Pressure (CPAP), which provides extra breathing support to babies who are breathing by themselves).
- Trial name
- NCT02200900
- Testing
- Pharyngeal pressure, Transcutaneous carbon dioxide, Pharyngeal gas concentrations
- Where
- United Kingdom
- Volunteers
- 45 people
- Sponsor
- Newcastle-upon-Tyne Hospitals NHS Trust
Family Members of: Newborns Extremely Premature, Family Members of: New Pediatric Oncology Patients
Impact of Serious Pediatric Illness on Parent and Sibling Health
To estimate the impact of having a child with serious illness (SI) on the health and healthcare of other members of the child's family.
- Conditions
- Family Members of: Newborns Extremely Premature, Family Members of: New Pediatric Oncology Patients, Family Members of: Critical Congenital Heart Defect Patients, Family Members of: Children Severe Neurological Impairment
- Trial name
- NCT03971344
- Where
- United States
- Volunteers
- 161,000 people
- Sponsor
- Children's Hospital of Philadelphia
Anemia of Prematurity
Effects of Transfusion Thresholds on Neurocognitive Outcome of Extremely Low Birth Weight Infants
To compare the effect of restrictive versus liberal red blood cell transfusion thresholds on long-term neurodevelopmental outcome in extremely low birth weight infants.
- Trial name
- ETTNO (NCT01393496)
- Testing
- red blood cell transfusion
- Where
- 32 sites in Denmark, Germany
- Volunteers
- 1,013 people
- Sponsor
- University Hospital Tuebingen
Necrotizing Enterocolitis, Time to Full Enteral Nutrition
Intestinal Lavage to Promote Enteral Feeding and Prevent Necrotizing Enterocolitis in Extremely Preterm Infants
Optimizing enteral nutrition (EN) is challenging in extremely preterm infants due to feeding intolerance that relates to the functional gastrointestinal immaturity.
- Trial name
- NCT03631979
- Testing
- Intestinal lavage with normal saline
- Where
- Sweden
- Volunteers
- 200 people
- Sponsor
- Uppsala County Council, Sweden
Prematurity; Extreme, Inflammation
Anakinra for Preterm Infants Pilot
Phase I/II study of anakinra to prevent the impact of perinatal inflammation in extremely premature infants.
- Trial name
- NCT05280340
- Testing
- Anakinra
- Where
- 2 sites in Australia, New Zealand
- Volunteers
- 25 people
- Sponsor
- Monash Medical Centre
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
Brain Injuries, Congenital Heart Disease
Protecting Brains and Saving Futures - the PBSF Protocol
Background: Multiple neonatal disorders are associated with risks of neurological injury. Thus, management of these infants should involve a coordinated approach to permit early diagnosis with improved clinical care.
- Conditions
- Brain Injuries, Congenital Heart Disease, Newborn Morbidity, Intraventricular Hemorrhage
- Trial name
- PBSF (NCT03786497)
- Where
- 2 sites in Brazil
- Volunteers
- 2,268 people
- Sponsor
- Protecting Brains Saving Futures
Infant, Newborn, Infant, Low Birth Weight
Exosurf Neonatal and Survanta for Treatment of Respiratory Distress Syndrome
The purpose of this study is to compare the efficacy of two surfactants, Exosurf Neonatal (Burroughs Wellcome Co.) and Survanta (Ross Laboratories), for the treatment of neonatal respiratory distress syndrome.
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- Surfactant 1 (NCT01203358)
- Testing
- Exosurf, Survanta
- Where
- 13 sites in United States
- Volunteers
- 617 people
- Sponsor
- NICHD Neonatal Research Network
Infant Behavior, Infant Conditions
The Effects of Different Music Genres on Heart Rate Variability in Extremely and Very Low Birth Weight Newborns
AIM: to investigate the influence of different music genres on Heart Rate Variability (HRV) of preterm infants. Neonates undergo a daily randomized music listening program.
- Conditions
- Infant Behavior, Infant Conditions, Infant Morbidity
- Trial name
- NCT04049526
- Testing
- The influence of different music genres on Heart Rate Variability (HRV) in preterm infants
- Where
- Italy
- Volunteers
- 30 people
- Sponsor
- Ospedale di Circolo - Fondazione Macchi
Prematurity; Extreme, Failure to Thrive in Newborn
Targeted Fortification of Donor Breast Milk in Preterm Infants
This study is a randomized controlled trial comparing standard fortification of donor breast milk to targeted fortification of donor breast milk in preterm infants.
- Conditions
- Prematurity; Extreme, Failure to Thrive in Newborn, Growth Retardation, Growth Failure
- Trial name
- NCT04294368
- Testing
- Similac Human Milk Fortifier Extensively Hydrolyzed Protein Concentrated Liquid, Similac Liquid Protein Fortifier, Nestle Microlipid
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Columbia University
Extremely Low Birthweight Infant, Continuous Tracheal Gas Insufflation
Ventilation of the Extremely Premature Infants Optimized by Dead Space Washout
The Continuous Tracheal Gas Insufflation (CTGI) is a ventilation option of conventional mechanical ventilation that is used to reduce or even eliminate the dead space caused by respiratory prostheses.
- Conditions
- Extremely Low Birthweight Infant, Continuous Tracheal Gas Insufflation, Medical Device, Lung Protection
- Trial name
- Volem (NCT06334523)
- Testing
- Ventilation with Dead Space Washout via Continuous Tracheal Gas Insufflation (CTGI)
- Where
- 4 sites in France
- Volunteers
- 144 people
- Sponsor
- Centre Hospitalier Intercommunal Creteil
Left Ventricular Hypertrophy
Postnatal Steroids Effects on Cardiac Function in Extremely Preterm
Hypothesis/Study question In infants born at less than 29 weeks of estimated gestational age, what are the effects of dexamethasone use on cardiac structure/performance and lung water content? Study objectives To measure effects…
- Trial name
- SPEC (NCT04644094)
- Testing
- Echocardiography (ECHO) and lung ultrasound (LUS) studies before and after Dexamethasone administration
- Where
- Canada
- Volunteers
- 21 people
- Sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
Retinopathy of Prematurity (ROP), Intraventricular Hemorrhage
Safety and Efficacy Outcomes Following Previously Administered Short-Term Treatment With SHP607 in Extremely Premature Infants
The purpose of this study is to evaluate long-term safety and efficacy outcomes following previously administered short-term exposure to SHP607, as compared to a standard neonatal care group.
- Conditions
- Retinopathy of Prematurity (ROP), Intraventricular Hemorrhage, Bronchopulmonary Dysplasia, Chronic Lung Disease of Prematurity
- Trial name
- NCT04506619
- Testing
- No Intervention
- Where
- 8 sites in United States, Italy and 1 more
- Volunteers
- 26 people
- Sponsor
- Oak Hill Bio Ltd
Premature Infant, Ventilation Therapy
High Flow Nasal Cannula for Stabilization of Extremely Premature Infants
A prospective observational study evaluates the safety and efficacy of using High-Flow Nasal Cannula to stabilize extremely preterm infants immediately after birth.
- Conditions
- Premature Infant, Ventilation Therapy, High Flow Nasal Canula
- Trial name
- SIMPLSAFE2 (NCT06683677)
- Testing
- High-Flow Nasal Cannula
- Where
- Czechia
- Volunteers
- 60 people
- Sponsor
- Charles University, Czech Republic
Pneumococcal Infections, Streptococcus Pneumoniae
Immunogenicity of PCV-7 Vaccine in VLBW Infants
Premature infants are at a high risk for pneumonia. The PCV-7 vaccine effectively prevents the invasive disease from Streptococcus pneumoniae in full-term infants, but was not thoroughly studied in premature infants.
- Conditions
- Pneumococcal Infections, Streptococcus Pneumoniae, Infant, Newborn, Infant, Low Birth Weight
- Trial name
- PCV-7 (NCT00273325)
- Where
- 10 sites in United States
- Volunteers
- 368 people, healthy volunteers welcome
- Sponsor
- NICHD Neonatal Research Network
BPD
Effect of Autologous Cord Blood Mononuclear Cells for Treatment of Bronchopulmonary Dysplasia in Extremely Preterm Neonates
This is a non-randomized, case-controlled trial that evaluates the efficacy of autologous cord blood mononuclear cells(ACBMNC) infusion as a Treatment for BPD.
- Trial name
- NCT05071638
- Testing
- autologous cord blood mononuclear cells
- Where
- 2 sites in China
- Volunteers
- 76 people
- Sponsor
- Guangdong Women and Children Hospital
Prematurity; Extreme
Exercise Intervention to Rescue the Adverse Effect of Preterm Birth on Cardiovascular and Pulmonary Health.
In spite of advances in neonatal intensive care allowing the first generation survivors of extreme prematurity to now reach young adulthood, these individuals present with reduced exercise capacity; a strong predictor of later…
- Trial name
- NCT03504215
- Testing
- Exercise Intervention
- Where
- Canada
- Volunteers
- 68 people, healthy volunteers welcome
- Sponsor
- St. Justine's Hospital