Clinical trials: Very Preterm Infants
Severe Intra-uterine Growth Restriction, Preterm Birth
Impact of Early and Severe Fetal Growth Restriction on Neurodevelopmental Outcomes in Preterm Infants
Very early onset intra uterine growth restriction (IUGR) affects 5-10% of pregnancies and is the second leading cause of perinatal mortality.
- Conditions
- Severe Intra-uterine Growth Restriction, Preterm Birth, Neurodevelopmental Disorders, Placental Insufficiency
- Trial name
- NCT05381272
- Volunteers
- 20 people
- Sponsor
- Central Hospital, Nancy, France
Infant, Newborn, Infant, Low Birth Weight
Glutamine Supplementation to Prevent Death or Infection in Extremely Premature Infants
This large multicenter double-masked clinical trial tested whether supplementation of standard neonatal parenteral nutrition with glutamine would reduce the risk of death or late-onset sepsis in extremely-low-birth-weight (ELBW…
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- Glutamine (NCT00005775)
- Testing
- Glutamine
- Where
- 15 sites in United States
- Volunteers
- 1,433 people
- Sponsor
- NICHD Neonatal Research Network
Bronchopulmonary Dysplasia, Respiratory Distress Syndrome in Premature Infant
Intratracheal Budesonide With Surfactant to Prevent Bronchopulmmonary Dysplasia.
This study is designed to determine whether intratracheal administration of budesonide combined with surfactant, as compared to surfactant alone, will modify ecographic (lung ultrasound score) and biological markers (IL-6…
- Conditions
- Bronchopulmonary Dysplasia, Respiratory Distress Syndrome in Premature Infant, Prematurity
- Trial name
- BuS (NCT04862377)
- Testing
- Poractant Alfa Intratracheal Suspension [Curosurf], Budesonide 0.5 MG/ML
- Volunteers
- 50 people
- Sponsor
- Hospital Clinic of Barcelona
Infant, Newborn, Infant, Low Birth Weight
Laparotomy vs. Drainage for Infants With Necrotizing Enterocolitis
This study will compare the effectiveness of two surgical procedures -laparotomy versus drainage - commonly used to treat necrotizing enterocolitis (NEC) or isolated intestinal perforations (IP) in extremely low birth weight…
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- NEST (NCT01029353)
- Testing
- Laparotomy, Drainage
- Where
- 22 sites in United States
- Volunteers
- 529 people
- Sponsor
- NICHD Neonatal Research Network
Infant, Low Birth Weight
A Randomized Clinical Trial on Supplementation of DHA and AA to Preterm Infants
A randomized, double-blind trial of docosahexaenoic and arachidonic acid supplementation in breast-fed preterm infants Background: Docosahexaenoic acid (DHA) and arachidonic acid (AA) are essential for preterm infants.
- Trial name
- NCT00226187
- Testing
- Supplement of fatty acid (DHA and AA)
- Where
- Norway
- Volunteers
- 140 people
- Sponsor
- University of Oslo
Infant, Newborn, Infant, Low Birth Weight
Early Blood Pressure Management in Extremely Premature Infants
This trial tests the feasibility of enrolling 60 extremely preterm infants in a randomized, double-blinded study of blood pressure management within 12 months.
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- ELGAN BP (NCT00874393)
- Testing
- Dopamine, Hydrocortisone
- Where
- 17 sites in United States
- Volunteers
- 10 people
- Sponsor
- NICHD Neonatal Research Network
Bronchopulmonary Dysplasia, Child Development
Enteral High-dose DHA Supplementation on Bronchopulmonary Dysplasia in Very Preterm Infants: a Collaborative Study
This one-stage individual participant data (IPD) meta-analysis study will aim to determine whether high-dose docosahexaenoic acid (DHA) enteral supplementation during the neonatal period is associated with the risk for severe…
- Conditions
- Bronchopulmonary Dysplasia, Child Development, Neonatal and Perinatal Conditions
- Trial name
- NCT05915806
- Testing
- High-dose DHA, Control
- Where
- Canada
- Volunteers
- 1,801 people, healthy volunteers welcome
- Sponsor
- CHU de Quebec-Universite Laval
Infection
Dynamics of the Microbiome in the Premature Infant
The purpose of the study is to describe the dynamics of the microbiome in the premature infant as a means to adapt the premature infant gut to affect better health outcomes.
- Trial name
- NCT02121938
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Duke University
Nutrition Intervention, Quality Improvement
Optimizing Early Nutrition Management of Extremely and/or Very Preterm Infants
A clinical quality improvement bundle on early nutrition supplementation is developed to improving the clinical outcomes (including growth, organ function, and neurodevelopment outcomes) of extremely and/or very preterm infants.
- Conditions
- Nutrition Intervention, Quality Improvement, Preterm Infant
- Trial name
- NCT07538999
- Testing
- A nutritional improving bundle for the intervention group, Routine nutritional strategies for the control group
- Where
- China
- Volunteers
- 200 people
- Sponsor
- Children's Hospital of Fudan University
Preterm Birth, Very Low Birth Weight Infant
Assessment of Body Composition in Premature Children Submitted to an Early Stimulation Program
This is a cross-sectional study of a randomized clinical trial to investigate nutritional aspects of pre-scholar aged children born preterm submitted to an early stimulation program versus conventional care program.
- Conditions
- Preterm Birth, Very Low Birth Weight Infant, Early Intervention, Parent-Child Relations
- Trial name
- NCT05399667
- Testing
- Early stimulation, Conventional care
- Where
- Brazil
- Volunteers
- 180 people, healthy volunteers welcome
- Sponsor
- Hospital de Clinicas de Porto Alegre
Premature; Infant, Enteral Nutrition
Human Milk Fortification in Very Low Birth Neonates
The purpose of this study to find out how safely we can add extra nutrients to human milk at different feeding volume.
- Conditions
- Premature; Infant, Enteral Nutrition, Human Milk, Fortification
- Trial name
- NCT01988792
- Testing
- Human milk fortifiers
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- University of Tennessee
Preterm Birth, Premature Lungs
Effect of Nasal CPAP Versus NIPPV On Diaphragm Electrical Activity (Edi) In VLBW Preterm Infants
Background: In premature babies, many organ systems are not fully grown and developed, including the lungs and respiratory muscles, so they will need breathing support to help them to breathe by preventing their tiny air sacs to…
- Conditions
- Preterm Birth, Premature Lungs, Respiratory Distress Syndrome in Premature Infant
- Trial name
- NCT06295484
- Testing
- Alternating traditional CPAP, NIPPV, and high CPAP
- Where
- Canada
- Volunteers
- 24 people
- Sponsor
- Sunnybrook Health Sciences Centre
Very Low Birth Weight Infant
Cord Milking Impacts Neurodevelopmental Outcomes in Very Low Birth Weight Infants
Premature birth is a major risk factor for perinatal brain damage and cerebral palsy (CP) with 47% of all CP cases occurring in infants with birth weight less than 2500 g.
- Trial name
- Cordmilking (NCT02987764)
- Testing
- cord milking
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- University of California, Los Angeles
Preterm Infant, Morbidity;Infant
To Research the Relation Between Neonatal Morbidities and Poor Outcome in Preterm Infants
From November 2014 to October 2015, a multi-centers retrospective study was conducted to collect compliance, and 8 three-level hospitals from China were included.
- Conditions
- Preterm Infant, Morbidity;Infant, Outcome, Fatal
- Trial name
- NCT03104946
- Testing
- Mental Development Index;Auditory Brainstem Response;okineticnystagmus
- Volunteers
- 834 people
- Sponsor
- yangjie
Hypothermia, Preterm Infant
Heat Loss Prevention in Very Preterm Infants in Delivery Rooms: A Multicenter, Randomized, Controlled Trial of Polyethylene Occlusive Total Body Skin Wrapping
Hypothermia after delivery is a world-wide problem associated with morbidity and mortality. The conventional approach of drying the baby with a pre-warmed towel and radiant warmers is unsuccessful in a large proportion of very…
- Trial name
- NCT01671241
- Testing
- Polyethylene wrap
- Where
- Italy
- Volunteers
- 80 people
- Sponsor
- University of Padova
Prematurity, Neurodevelopmental Disorder
Effect of Early L-Carnitine Supplementation on Neurodevelopmental Outcomes in Very Preterm Infants
Preterm infants are vulnerable to brain injury, nutritional deficiencies and poor early growth which places them at increased risk for developmental problems later in life.
- Conditions
- Prematurity, Neurodevelopmental Disorder, Carnitine Deficiency
- Trial name
- NCT01783041
- Testing
- L-carnitine, 5% Dextrose
- Where
- 2 sites in United States
- Volunteers
- 144 people
- Sponsor
- Montefiore Medical Center
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
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
RDS - Infants, RDS of Prematurity
Real Time Evaluation of Dynamic Changes of the Lungs During Respiratory Support of VLBW Neonates Using EIT
Electric Impedance Tomography (EIT) is a lung monitoring technique based on the injection of small currents and voltage measurements using electrodes on the skin surface generating cross-sectional images representing impedance…
- Conditions
- RDS - Infants, RDS of Prematurity, Respiratory Failure, Prematurity
- Trial name
- NCT04542096
- Testing
- Lung electrical impedance tomography monitoring
- Where
- Lithuania
- Volunteers
- 72 people
- Sponsor
- Vilnius University
Cerebral Palsy, Prematurity
Best Practices Fo Early Diagnosis of Cerebral Palsy
In this research, the investigators are using an implementation science approach to enhance the uptake of a clinical practice guideline for earlier diagnosis of cerebral palsy (i.e.
- Trial name
- CP (NCT06537622)
- Testing
- Implementation group, Standard of care
- Where
- Canada
- Volunteers
- 2,000 people, healthy volunteers welcome
- Sponsor
- St. Justine's Hospital