Clinical trials: Infants, Extremely Premature
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
Infant, Extremely Premature, Length of Stay
Trial of Patterned Oral Somatosensory Entrainment for Shortening Time to Oral Feeding
The primary hypothesis is that the preterm infants (26 0/7 to 30 6/7 weeks gestational age) who undergo the NTrainer System® training will transition to full oral feeds faster than the control group (i.e.
- Conditions
- Infant, Extremely Premature, Length of Stay, Feeding
- Trial name
- NCT01158391
- Testing
- NTrainer® Intervention, Control Intervention
- Where
- 5 sites in United States
- Volunteers
- 210 people, healthy volunteers welcome
- Sponsor
- KC BioMediX, Inc
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
Bronchopulmonary Dysplasia, Intraventricular Hemorrhage
The Efect of Azithromicyn on Bronchopulmonary Displasia in Extremely Preterm and Very Preterm Infant
This study was to see the effectiveness of azithromycin in preventing the incidence of bronchopulmonary dysphasia in extremely preterm and very premature infants.
- Conditions
- Bronchopulmonary Dysplasia, Intraventricular Hemorrhage, Necrotizing Enterocolitis
- Trial name
- NCT05311228
- Testing
- Azithromycin Powder
- Where
- Indonesia
- Volunteers
- 120 people
- Sponsor
- Universitas Indonesia
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
Prematurity, Extreme Prematurity
Use Of Nfant(R) Technology Feeding System For Infants Less Than 30 Weeks GA
The purpose of the study is to utilize the objective data provided by the nfant® suite of products, along with current NICU visual assessment and cue-based feeding practices, in order to determine if feeding performance outcomes…
- Trial name
- NCT04256889
- Testing
- nfant(R) feeding system
- Where
- United States
- Volunteers
- 23 people
- Sponsor
- Woman's
Hemodynamically Significant Patent Ductus Arteriosus
Research on the Individualized Treatment Strategy for Extremely Preterm Infants With hsPDA Based on Biomarkers and Targeted Delivery Systems
This project aims to address the need for individualized precision therapy for hemodynamically significant patent ductus arteriosus (hsPDA) in extremely preterm infants by integrating clinical biomarker screening with the design…
- Trial name
- BTDS-IT-hsPDA- (NCT07374146)
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Peking University Third Hospital
Caregiver Feeling
Feeling of Caregivers After a Palliative Management of Extreme Premature Babies in Delivery Room.
Introduction : The birth of a child is usually a happy event that caregivers working in delivery rooms share with families. Unfortunately, newborns sometimes need palliative care as soon as birth occurs.
- Trial name
- NCT06458114
- Testing
- Assessment of caregiver feeling
- Where
- France
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- CHU de Reims
Infant, Newborn, Infant, Low Birth Weight
Development of Standards for the New Ballard Maturation Score
The primary purpose of this study was to evaluate the accuracy of gestational age (GA) estimates by using the New Ballard Score (NBS) in newborns 24 to 27 weeks GA with accurate obstetric estimates of GA.
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- Ballard (NCT01203449)
- Where
- 11 sites in United States
- Volunteers
- 1,090 people, healthy volunteers welcome
- Sponsor
- NICHD Neonatal Research Network
Bronchopulmonary Dysplasia
MRI in BPD Subjects
The investigators are wanting to learn more about early development of the lungs and to help them better understand prematurity and the development of a breathing disorder call BPD (Bronchopulmonary Dysplasia)
- Trial name
- NCT03657693
- Testing
- NICU MRI, Polysomnography
- Where
- United States
- Volunteers
- 160 people, healthy volunteers welcome
- Sponsor
- Children's Hospital Medical Center, Cincinnati
Bronchopulmonary Dysplasia (BPD)
Lung Ultrasound for Prediction of Bronchopulmonary Dysplasia
Extreme preterm infants (GA ≤ 28+6 weeks) are at high risk for bronchopulmonary dysplasia (BPD) that has been associated with significant long-term impairment.
- Trial name
- NCT04756297
- Where
- 2 sites in Canada
- Volunteers
- 152 people
- Sponsor
- Adel Mohamed
Infant, Newborn, Diseases, Other Preterm Infants
Surfactant Positive Airway Pressure and Pulse Oximetry Trial
This study compared the use of continuous positive airway pressure initiated at birth with the early administration of surfactant administered through a tube in the windpipe within 1 hour of birth for premature infants born at 24…
- Conditions
- Infant, Newborn, Diseases, Other Preterm Infants, Infant, Small for Gestational Age, Premature Birth
- Trial name
- SUPPORT (NCT00233324)
- Testing
- Surfactant, Continuous Positive Airway Pressure (CPAP), Supplemental oxygen with target saturation of 85 to 89%
- Where
- 22 sites in United States
- Volunteers
- 1,316 people
- Sponsor
- NICHD Neonatal Research Network
Respiratory Distress Syndrome, Preterm Birth
LISA vs INSURE in Extremely Low Birth Weight Infants. A Manikin Study
This is an unblinded, randomized, controlled, crossover (AB/BA) trial of surfactant treatment with LISA vs. INSURE in a manikin simulating an extremely low birth weight infant.
- Conditions
- Respiratory Distress Syndrome, Preterm Birth, Surfactant Deficiency Syndrome Neonatal
- Trial name
- NCT04944108
- Testing
- LISA approach, Insure approach
- Where
- 2 sites in Italy
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- University Hospital Padova
Bronchopulmonary Dysplasia
Preservation of Blood in Extremely Preterm Infants
Current clinical protocols for blood sampling and analyses in extremely preterm infants rely on an infrastructure adapted to and developed for adult medicine.
- Trial name
- LIM (NCT04239690)
- Testing
- Micromethods for blood sample analysis
- Where
- Sweden
- Volunteers
- 201 people
- Sponsor
- David Ley
Noninvasive Ventilation
Non-invasive Support in Extremely Preterm Infants
Non-invasive respiratory support is routinely provided to extremely preterm infants following disconnection from mechanical ventilation, in the form of continuous positive airway pressure (CPAP) or non-invasive positive pressure…
- Trial name
- NCT02723123
- Testing
- Recording of cardio-respiratory signals
- Where
- Canada
- Volunteers
- 30 people
- Sponsor
- Guilherme Sant'Anna, MD
Intestinal Perforation
Effect of Early Hydrocortisone on Risk of Gastrointestinal Perforations in Extremely Preterm Infants
A large, randomised control trial, the PREMILOC trial, has established that giving low dose hydrocortisone prophylactically in the first ten days of life reduces the risk of bronchopulmonary dysplasia in babies born before 32…
- Trial name
- NCT06515405
- Testing
- Hydrocortisone
- Where
- United Kingdom
- Volunteers
- 16,000 people
- Sponsor
- Imperial College London
IVH- Intraventricular Hemorrhage, Extreme Prematurity
Delayed Cord Clamping With Oxygen In Extremely Low Gestation Infants
This study is being conducted to compare the incidence of preterm infants (up to 28+6 weeks GA) who achieve a peripheral oxygen saturation of 80 percent by 5 minutes of life (MOL) given mask CPAP/PPV with an FiO2 of 1.0 during…
- Conditions
- IVH- Intraventricular Hemorrhage, Extreme Prematurity, Hypoxia Neonatal, Hyperoxia
- Trial name
- DOXIE (NCT04413097)
- Testing
- Delayed Cord Clamping with Low Oxygen concentration, Delayed Cord Clamping with High Oxygen concentration
- Where
- 3 sites in United States
- Volunteers
- 140 people
- Sponsor
- Sharp HealthCare
Respiratory Insufficiency Syndrome of Newborn
CPAP vs NIPPV: A COMPARATIVE EFFECTIVENESS RESEARCH
Aim: Investigators aim is to conduct two complementary and concurrent CER projects using a pragmatic clinical trial design and registry-based RWD to identify the optimal respiratory management practices for extremely preterm…
- Trial name
- NCT04075123
- Testing
- CPAP
- Where
- Canada
- Volunteers
- 1,829 people
- Sponsor
- Canadian Neonatal Network
Late-Onset Neonatal Sepsis
Clinical Impact of Donor Milk Pasteurized by HTST Treatment in Preterm Infants
Randomized double-blind clinical trial to compare the incidence of microbiological proven late onset sepsis in extremely preterm infants (<1000 grams) that are supplemented with donor milk pasteurized by High Temperature Short…
- Trial name
- NCT04424667
- Testing
- donor milk
- Where
- 2 sites in Spain
- Volunteers
- 211 people
- Sponsor
- Carmen Rosa Pallas
Bronchopulmonary Dysplasia
Outcome of Extremely Preterm Infants Who Received Systemic Postnatal Corticosteroid for Bronchopulmonary Dysplasia
Bronchopulmonary dysplasia is a complication of prematurity. Postnatal corticosteroid is used to treat the inflammatory part of this pathology, in particular to wean premature infants from the ventilator at the end of the first…
- Trial name
- DEPRECOD (NCT05055193)
- Testing
- Evaluation at 24 months corrected age: respiratory outcome, Neurodevelopmental outcome, Growth outcome
- Where
- France
- Volunteers
- 400 people
- Sponsor
- Hospices Civils de Lyon