Clinical trials: Very Preterm Birth
Breast Milk, Premature Infant
Individualized Fortification of Breast Milk
Objectives: To compare the effects of two different methods of individualized protein fortification of breast milk on the early growth of VLBW preterm infants.
- Trial name
- NCT03324126
- Volunteers
- 32 people
- Sponsor
- Ozgul Bulut
VLBW - Very Low Birth Weight Infant
Feeding Study in VLBW Premature Infants
A multi-center, single-blind, randomized, controlled, parallel-designed, prospective trial to compare growth between preterm infants fed one of three study human milk fortifiers added to human milk
- Trial name
- NCT05744193
- Testing
- Exempt Infant Formula
- Where
- 6 sites in United States
- Volunteers
- 22 people
- Sponsor
- Mead Johnson Nutrition
Preterm Infants
Promoting Full Oral Feeding in Preterm Infants Less Than 30 Weeks Gestational Age
The investigators plan to use a new process to shorten the time of attaining full oral feeding in preterm infants less than 30 weeks gestational age.
- Trial name
- NCT04277806
- Testing
- New Oral feeding process
- Where
- China
- Volunteers
- 120 people
- Sponsor
- Children's Hospital of Fudan University
Neonates and Preterm Infants, Infant Respiratory Distress Syndrome
Duration of Surfactant Administration and Impact on Stabilisation of Vital Parameters in Very Preterm Neonates: 1 Minutes Versus 5 Minutes
Respiratory distress syndrome (RDS) is common in very preterm infants due to surfactant deficiency. Surfactant replacement therapy is lifesaving, and current guidelines recommend the less invasive surfactant administration (LISA)…
- Conditions
- Neonates and Preterm Infants, Infant Respiratory Distress Syndrome, Surfactant Deficiency Syndrome Neonatal, Surfactant
- Trial name
- SurfStab I (NCT07261787)
- Testing
- Poractant alfa (Curosurf®) - 1-minute administration, Poractant alfa (Curosurf®) - 5-minute administration
- Where
- Austria
- Volunteers
- 76 people
- Sponsor
- Medical University of Graz
Early-Onset Sepses, Neonatal, Periventricular Haemorrhage Neonatal
Zinc Supplementation on Very Low Birth Weight Infant
Premature birth is a major cause of neonatal death in addition to neonatal asphyxia and infections. Early in life, premature babies must get aggressive nutrition so that there is no extrauterine growth restriction (EUGR) in the…
- Conditions
- Early-Onset Sepses, Neonatal, Periventricular Haemorrhage Neonatal, Bronchopulmonary Dysplasia, Retinopathy of Prematurity
- Trial name
- NCT04050488
- Testing
- Zinc Sulfate
- Volunteers
- 364 people, healthy volunteers welcome
- Sponsor
- Fakultas Kedokteran Universitas Indonesia
Newborn Complication, Premature
Between Urgency and Efficiency: Assessing the Feasibility of Implementing a Protocol for the Care of Extremely Premature and Very Low Birth Weight Infants During the First Hour of Life: GOLD Study
Premature newborns are a particularly vulnerable population, especially during the first hours of life as they adapt to life outside the womb.
- Trial name
- GOLD (NCT07461623)
- Testing
- Golden Hour protocol
- Sponsor
- Centre Hospitalier Universitaire de Nice
Meconium Ileus
Impact of Visceral Osteopathic Treatment on Meconium Evacuation in Preterm Infants
Timing of the first and last meconium stool is critical for oral feeding tolerance and proper gastrointestinal function. The time until premature infants pass their first meconium ranges from 1 hour to 27 days (median: 43 hours).
- Trial name
- NCT02140710
- Testing
- Osteopathic treatment
- Where
- Austria
- Volunteers
- 41 people, healthy volunteers welcome
- Sponsor
- Medical University of Vienna
Very Preterm Birth
EPIPAGE2 Cohort Study Follow up at Five and a Half Years
Epipage 2 (epidemiologic study on small-for-gestational-age children) is a nationwide study implemented to improve our knowledge of the outcome of preterm children in France.
- Trial name
- EPIPAGE2 (NCT03078439)
- Testing
- Medical and neuropsychological assessments
- Where
- 98 sites in France, French Guiana and 2 more
- Volunteers
- 3,404 people
- Sponsor
- Institut National de la Santé Et de la Recherche Médicale, France
Cerebral Palsy, Infant Development
Associations Between General Movements Assessments and Cognitive Development
High risk infant is defined as infant with a negative history of environmental and biological factors, which can lead to neuromotor development problems.
- Conditions
- Cerebral Palsy, Infant Development, Cognitive Dysfunction, Cognitive Developmental Delay
- Trial name
- GMs (NCT05217056)
- Testing
- measurements
- Where
- Turkey (Türkiye)
- Volunteers
- 63 people
- Sponsor
- Kahramanmaras Sutcu Imam University
Prematurity, Respiratory Distress Syndrome
Curosurf and Survanta Treatment(CAST)of RDS in Very Premature Infants
Approval of surfactant by the FDA in 1989 for the treatment of Respiratory Distress Syndrome (RDS) in premature infants greatly improved survival rates.
- Conditions
- Prematurity, Respiratory Distress Syndrome, Patent Ductus Arteriosus
- Trial name
- CAST (NCT00767039)
- Testing
- Survanta (beractant), Curosurf (poractant)
- Where
- United States
- Volunteers
- 52 people
- Sponsor
- Alan Fujii
Osteopenia of Prematurity
The Effect of Physical Activity on Bone Mineralization and Immune System in Very Low Birth Weight Infants
Studies have demonstrated that brief (5-10 min a day) passive range-of-motion exercise is beneficial for bone development in very low birth weight (VLBW) preterm infants.
- Trial name
- NCT01042639
- Testing
- passive physical activity
- Where
- Israel
- Volunteers
- 45 people
- Sponsor
- Meir Medical Center
Respiratory Distress Syndrome in Preterm Infants
LISA Rigid Catheter vs LISA Soft Catheter in a Very Preterm Manikin
Less invasive surfactant administration (LISA) can be provided using rigid or soft catheters, but possible differences in terms of easiness of use and success of the procedure are unknown.
- Trial name
- NCT05388175
- Testing
- Rigid catheter, Soft catheter
- Where
- 2 sites in Italy
- Volunteers
- 50 people
- Sponsor
- University Hospital Padova
Apnea of Prematurity
Caffeine for Apnea of Prematurity (CAP)
At least 5 of every 1000 live-born babies are very premature and weigh only 500 to 1250 grams at birth. Approximately 30-40% of these high-risk infants either die or survive with lasting disabilities.
- Trial name
- NCT00182312
- Testing
- Caffeine citrate injection
- Where
- 34 sites in United States, Australia and 7 more
- Volunteers
- 2,000 people
- Sponsor
- McMaster University
Preterm Infant
Clinical Impact of Non-invasive Neurally Adjusted Ventilatory Assist in Very Preterm Infants
This is a prospective observational study investigating the impact of NIV-NAVA on short-term clinical outcomes and long-term neurodevelopment in very preterm infants.
- Trial name
- NCT06786039
- Testing
- Non-invasive NAVA
- Where
- 2 sites in South Korea
- Volunteers
- 80 people
- Sponsor
- Korea University Anam Hospital
Preterm Infant, Birth, Preterm
Aeration, Breathing, Clamping Study 3
Delayed cord clamping (DCC) in preterm infants results in a decrease in mortality and a trend towards fewer intraventricular haemorrhages.
- Trial name
- ABC3 (NCT03808051)
- Testing
- Physiological-based cord clamping, Time-based cord clamping
- Where
- 10 sites in Netherlands
- Volunteers
- 689 people
- Sponsor
- Leiden University Medical Center
Very Premature Baby
Effects of a Multisensory Intervention Program on the Term Behavior of the Very Premature Baby
The growth and organization of the cerebral cortex is ensured by the oligodendrocyte-rich subplate, whose proper development depends on both subcortical structures and sensory experiences.
- Trial name
- PIVOT (NCT07903766)
- Testing
- Multisensory intervention program, Standard care
- Volunteers
- 144 people
- Sponsor
- Assistance Publique Hopitaux De Marseille
Hypothermia Neonatal, Premature Birth
Polyethylene Bag vs Prewarmed Blanket for Preventing Neonatal Hypothermia During Transfer
Premature babies can lose body heat quickly after birth, which can lead to serious health problems. This study compared two methods to keep premature babies warm while they were being moved from the delivery room to the neonatal…
- Conditions
- Hypothermia Neonatal, Premature Birth, Neonatal
- Trial name
- NCT07661511
- Testing
- Neonatal Polyethylene Bag, Prewarmed Blanket
- Where
- Mexico
- Volunteers
- 67 people
- Sponsor
- Mario Adrián Tienda Vázquez
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
Extreme Prematurity,Extremely Low Birthweight, Extremely Low Birth Weight
Comparison of the Shukla and UN-1 Formulae in the Placement of the Umbilical Venous Catheter Among Neonates
Umbilical vein catheters (UVC) are commonly inserted in newborns especially neonates admitted to the Neonatal Intensive Care Unit (NICU).These catheters are used since 1959.
- Conditions
- Extreme Prematurity,Extremely Low Birthweight, Extremely Low Birth Weight, Very Low Birth Weight Infant, Neonatal Hypoglycemia
- Trial name
- NCT05022433
- Testing
- UVC insertion
- Where
- Singapore
- Volunteers
- 170 people
- Sponsor
- Singapore General Hospital
Very Preterm and Extremely Preterm Birth
Sodium and Milk Fortification Evaluation of Body Composition Among Very Preterm Infants
The goal of the trial is to learn if targeted sodium supplementation (including blood and urine sodium testing) versus standard milk fortification (including blood sodium testing) improves growth and body composition in very…
- Trial name
- SAFE (NCT07562997)
- Testing
- Urine sodium testing, Serum sodium testing, Milk fortification
- Where
- 3 sites in United States
- Volunteers
- 150 people
- Sponsor
- University of Washington