Clinical trials: Very Preterm Infant
Necrotizing Enterocolitis, Very Low Birth Weight Infants
Splanchnic Oxygenation After the First Enteral Feed in Preterm Infants: Prediction of Feeding Tolerance.
Enteral nutrition of preterm and intrauterine growth-restricted (IUGR) infants is still a challenge for neonatologists. Due to the immaturity of the gastrointestinal tract, preterm infants are at high risk of developing feeding…
- Trial name
- NIRS-SO (NCT02383264)
- Where
- Italy
- Volunteers
- 61 people
- Sponsor
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
Ductus Arteriosus, Patent
Patent Ductus Arteriosus (PDA) Screening Trial
The ductus arteriosus directs blood away from the pulmonary circulation and toward the systemic circulation during fetal life, then closes after birth.
- Trial name
- NCT01031316
- Testing
- Nondisclosure of screening echocardiogram results, Disclosure of screening echocardiogram results
- Where
- 2 sites in United States
- Volunteers
- 88 people
- Sponsor
- University of Pennsylvania
Breast Milk Production, Human Milk Feeding
Efficacy of Herbal Galactagogue Silitidil After Preterm Birth
After preterm birth mothers often suffer from hypogalactia. Herbal galactogogues can be used in order to increase milk production.
- Conditions
- Breast Milk Production, Human Milk Feeding, Hypogalactia, Preterm Infant Nutrition
- Trial name
- NCT03577587
- Testing
- Silitidil for 21 days
- Where
- Germany
- Volunteers
- 106 people, healthy volunteers welcome
- Sponsor
- Waldkrankenhaus Protestant Hospital, Spandau
Infant, Newborn, Infant, Low Birth Weight
Delayed Cord Clamping in VLBW Infants
This study tested the feasibility of conducting a randomized controlled trial to vary the timing that doctors clamp the umbilical cord after birth in extremely low birthweight infants.
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- NCT01222364
- Testing
- Standard Cord Clamping, Delayed Cord Clamping
- Where
- 4 sites in United States
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- NICHD Neonatal Research Network
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
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
Prematurity, Very Preterm Maturity of Infant
Sleep in SNOO Smart Sleeper Bassinet in Preterm Infants
The goal of this clinical trial is to compare sleeping in a SNOO Smart Sleeper bassinet (SNOO) with sleeping in traditional bassinet conditions in premature infants. The main questions it aims to answer are: 1.
- Trial name
- NCT05711927
- Testing
- SNOO Smart Sleeper, Traditional bassinet
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Columbia University
Central Line Bloodstream Infections
The Effectiveness of Silver Alginate (Algidex) Patch in the Prevention of Central Line Infections in Very Low Birth Weight Infants
The purpose of this study is to determine whether silver alginate (Algidex) patch is effective in the prevention of central line infections in very low birth weight infants.
- Trial name
- NCT00964093
- Testing
- Silver Alginate
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Baylor Research Institute
Very Preterm Infants
Feeding the Preterm Gut Microbiota - Impact of Infant-feeding on Preterm Gut Microbiota Development
Preterm infants are especially vulnerable to gut microbiota disruption and dysbiosis since their early gut microbiota is less abundant and diverse.
- Trial name
- FEEDMI (NCT03663556)
- Testing
- Infant-feeding
- Where
- 2 sites in Portugal
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Universidade do Porto
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
Late-Onset Neonatal Sepsis, Extreme Prematurity
Dopamine vs. Norepinephrine for Hypotension in Very Preterm Infants With Late-onset Sepsis
Fluid-unresponsive hypotension needing cardiotropic drug treatment is a serious complication in very preterm neonates with suspected late-onset sepsis (LOS; defined as culture positive or negative bloodstream infection or…
- Conditions
- Late-Onset Neonatal Sepsis, Extreme Prematurity, Neonatal Hypotension
- Trial name
- NCT05347238
- Testing
- Dopamine, Norepinephrine
- Where
- 22 sites in United States, Canada and 3 more
- Volunteers
- 550 people
- Sponsor
- Mount Sinai Hospital, Canada
Sleep
Body Movements Analysis During Sleep in Very Premature Infants
Sleep is a key factor for normal brain development of the newborn. However, it is poorly studied and little is known about its characterization, especially in premature infants.
- Trial name
- DODOPREMA (NCT03432182)
- Testing
- electroencephalography
- Where
- France
- Volunteers
- 68 people
- Sponsor
- Central Hospital, Nancy, France
Very Preterm Infant, Very Low Birthweight
LIFT-UP: Randomized Controlled Trial of Fortification of Human Milk
The goal of the LIFT-UP randomized controlled trial is to evaluate the efficacy of feeding routinely and fortified human milk using a standardized clinical protocol to very low birthweight (VLBW) or very preterm (VPT) infants in…
- Trial name
- LIFT-UP RCT (NCT06765863)
- Testing
- Human Milk Fortifier, Volume targets
- Where
- 4 sites in India
- Volunteers
- 776 people, healthy volunteers welcome
- Sponsor
- Harvard School of Public Health (HSPH)
Premature Infant
Calmer Brains in Very Preterm Infants
Very preterm infants in the neonatal intensive care unit (NICU) need lifesaving medical procedures which can be stressful and affect brain development.
- Trial name
- NCT07262385
- Testing
- Calmer
- Where
- Canada
- Volunteers
- 20 people
- Sponsor
- University of British Columbia
Pulmonary Arterial Hypertension (PAH), Premature Infants
PNEUMOSTEM® for Improving Respiratory Outcomes in Very Premature Infants Diagnosed With Early Pulmonary Arterial Hypertension
The goal of this clinical trial is to evaluate the safety and potential efficacy of PNEUMOSTEM® for improving respiratory outcomes in very premature infants diagnosed with Early Pulmonary Arterial Hypertension.
- Trial name
- REVIVE-PH (NCT07368088)
- Testing
- PNEUMOSTEM®
- Where
- South Korea
- Volunteers
- 12 people
- Sponsor
- Samsung Medical Center
Very Low Birth Weight Infant
Pharmacokinetic Study of Fluconazole in Premature Infants
The purpose of this study is to investigate the pharmacokinetics of fluconazole which is used as prophylaxis of invasive fungal infection in premature infants.
- Trial name
- NCT01683760
- Testing
- Fluconazole
- Where
- South Korea
- Volunteers
- 80 people
- Sponsor
- Seoul National University Hospital
Cerebral Palsy, Infant, Premature, Diseases
Associations Between Early Neonatal Neuroimaging, Hammersmith Infant Neurological Examination and General Movements
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, Premature, Diseases, Infant Development, Neurologic Disorder
- Trial name
- highrisk (NCT05217186)
- Testing
- Measurements
- Where
- Turkey (Türkiye)
- Volunteers
- 63 people
- Sponsor
- Kahramanmaras Sutcu Imam University
Premature Birth
Therapeutic Effects of Maternal Melatonin Administration on Brain Injury and White Matter Disease
Neurocognitive sequelae observed in preterm represent a major health problem for which there is no preventive treatment approved to date.
- Trial name
- PREMELIP (NCT02395783)
- Testing
- Melatonin 10 µg, Melatonin 20 µg
- Where
- France
- Volunteers
- 14 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Infant Premature, Growth and Development
NEOVIDEO : Impact of Monitoring Motor Activity by Video Analysis on the Sleep of Very Preterm Infants
Very premature birth and the necessary hospitalization expose to a risk of morbidity and mortality which impacts the neurodevelopmental prognosis. Sleep and behavior monitoring have not been developed in the neonatal units.
- Conditions
- Infant Premature, Growth and Development, Neurologic Disorder, Sleep Fragmentation
- Trial name
- NCT04624347
- Testing
- Access to video and movement curves
- Where
- 2 sites in France
- Volunteers
- 74 people
- Sponsor
- Rennes University Hospital
Infant, Newborn, Infant, Low Birth Weight
Single-Dose Intravenous Inositol Pharmacokinetics in Preterm Infants
This pilot study was a randomized, placebo-controlled, clinical trial to measure changes in blood and urine levels of inositol in premature infants at high risk for retinopathy of prematurity (ROP) following a single intravenous…
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- INS-1 (NCT00349726)
- Testing
- Inositol lower volume, Inositol higher volume
- Where
- 11 sites in United States
- Volunteers
- 74 people
- Sponsor
- NICHD Neonatal Research Network