Clinical trials: Very Preterm Infant
Very Preterm Infants Born < 30 Weeks of Gestation
Quantitative 3D UltraSound Brain Imaging: Development of New Bedside Biomarkers to Better Predict Neurodevelopmental Outcomes in Preterm Infants
Prematurity is a leading cause of neurodevelopmental disorders (NDDs) tightly associated with white matter damage, including punctate white matter lesions (PWMLs).
- Trial name
- QUSBI (NCT07358819)
- Testing
- Cranial ultrasound, Brain MRI, PARCA-R questionnaire
- Where
- France
- Volunteers
- 360 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Very Low Birth Weight Infants
Early Family Based Intervention in Preterm Infants
This is randomized controlled trial investigating the effect of early intervention in very low birth weight infants after discharge from NICU on neurodevelopmental outcome.
- Trial name
- NCT02415530
- Testing
- Combined home visiting and group intervention, No intervention
- Where
- 3 sites in South Korea
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- Seoul National University Hospital
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
Neonatal Sepsis, Early-Onset, Very Low Birth Weight Infant
IgM-Enriched Immunoglobulin for Neonatal Sepsis
This study compares giving prophylactic IgM enriched Intravenous Immunoglobulin (IVIG) with placebo in 1 hour after birth, in neonates with risk factors of Early-Onset Neonatal Sepsis (EONS).
- Conditions
- Neonatal Sepsis, Early-Onset, Very Low Birth Weight Infant, Inflammation, Infant, Newborn, Disease
- Trial name
- NCT04041765
- Testing
- IgM-enriched IVIG
- Volunteers
- 70 people
- Sponsor
- Fakultas Kedokteran Universitas Indonesia
Extreme Prematurity
Protein for Premies
Although expressed breast milk is considered the optimal nutritional source for preterm infants, the macronutrient content is insufficient to enable optimal growth during neonatal intensive care.
- Trial name
- NCT01773902
- Testing
- High Dose Protein (Individualized), High Dose Protein (Standardized), Standard Protein Supplementation
- Where
- Germany
- Volunteers
- 60 people
- Sponsor
- University Hospital Tuebingen
Infant, Premature, Diseases
Impact of Preterm Single Donor Milk in Very Low Birth Weight Infants
Human milk is the best source of enteral nutrition for the preterm infant. However during the infants first hours and days of life breastmilk from the own mother is usually not available.
- Trial name
- NCT02216292
- Testing
- Control Group, Preterm Single Donor Milk Group
- Where
- Austria
- Volunteers
- 300 people
- Sponsor
- Medical University of Vienna
Necrotizing Enterocolitis
Probiotics in the Management of Necrotizing Enterocolitis in HIV-exposed Premature Infants
A randomized, double blind, placebo controlled clinical trial was conducted in the neonatal high care unit of Tygerberg Children's Hospital (TBCH) Cape Town, South Africa for the period July 2011 to August 2012.
- Trial name
- NCT01868737
- Testing
- Probiotic
- Where
- South Africa
- Volunteers
- 184 people, healthy volunteers welcome
- Sponsor
- University of Stellenbosch
Infant, Premature, Diseases, Respiratory Distress Syndrome, Newborn
Exogenous Surfactant in Very Preterm Neonates in Prevention of Bronchopulmonary Dysplasia
Advances in perinatal care have made it possible to improve the survival of the most immature neonates, but at the cost of an increase in the population at risk of developing bronchopulmonary dysplasia (BPD).
- Conditions
- Infant, Premature, Diseases, Respiratory Distress Syndrome, Newborn, Bronchopulmonary Dysplasia
- Trial name
- CURDYS (NCT01039285)
- Testing
- Curosurf, Air
- Where
- 13 sites in France
- Volunteers
- 118 people
- Sponsor
- Jean Michel Hascoet
Respiratory Distress Syndrome, Newborn, Premature Birth
SURFAXIN® Treatment for Prevention of Bronchopulmonary Dysplasia (BPD) in Very Low Birth Weight (VLBW) Infants.
SURFAXIN® (lucinactant) treatment will be examined in very low birth weight infants to prevent development of chronic lung disease, commonly known as bronchopulmonary dysplasia (BPD), in premature infants who have required…
- Conditions
- Respiratory Distress Syndrome, Newborn, Premature Birth, Bronchopulmonary Dysplasia
- Trial name
- NCT00215540
- Testing
- Lucinactant 175 mg/kg, Lucinactant 90 mg/kg
- Where
- United States
- Volunteers
- 136 people
- Sponsor
- Windtree Therapeutics
Bacteremia, Infant, Very Low Birth Weight
Preventing Catheter-related Bacteremia When Administering Injectable Medications in Premature Infants.
This study evaluates the potential interest of a new multi-lumen infusion access device (Edelvaiss® Multiline NEO) in the prevention of catheter-related bacteremia when administering injectable drugs in premature infants.
- Trial name
- MultilineNEO (NCT02633124)
- Testing
- Edelvaiss Multiline NEO, Standard Infusion Set
- Where
- 4 sites in France
- Volunteers
- 87 people, healthy volunteers welcome
- Sponsor
- University Hospital, Lille
Bronchopulmonary Dysplasia
Efficacy and Safety of Inhaled Budesonide in Very Preterm Infants at Risk for Bronchopulmonary Dysplasia
HYPOTHESIS: Early prophylactic inhalation of Budesonide reduces the absolute risk of developing bronchopulmonary dysplasia (BPD) or death in preterm infants born <28 weeks gestational age (GA) by 10%.
- Trial name
- NEuroSIS (NCT01035190)
- Testing
- Budesonide
- Where
- 40 sites in Belgium, Czechia and 6 more
- Volunteers
- 863 people
- Sponsor
- University Children's Hospital Tuebingen
Infant, Very Low Birth Weight, Infant, Premature
Trial of Indomethacin Prophylaxis in Preterm Infants (TIPP)
This trial was to determine whether giving low-dose indomethacin to infants weight 500 to 999 grams (approximately 1 to 2 pounds) at birth improves their survival without cerebral palsy or developmental problems at 18 to 22…
- Conditions
- Infant, Very Low Birth Weight, Infant, Premature, Ductus Arteriosus, Patent
- Trial name
- TIPP (NCT00009646)
- Testing
- indomethacin
- Where
- 9 sites in United States
- Volunteers
- 1,202 people
- Sponsor
- NICHD Neonatal Research Network
Very Preterm Infant, Necrotizing Enterocolitis (NEC)
Effects of Enteral Feeding Regimens on NEC, Mortality, and Neurodevelopment in Very Preterm Infants
The goal of this clinical trial is to evaluate whether supplementing with pasteurized donor human milk (pHDM) or preterm formula (PTF) when own mother's milk (OMM) is insufficient can improve outcomes in very preterm infants born…
- Trial name
- NCT07045844
- Testing
- Pasteurized Donor Milk for Insufficient Breastfeeding, Preterm Formula for Insufficient Breastfeeding, Routine fortification
- Where
- 24 sites in China
- Volunteers
- 2,324 people
- Sponsor
- The Children's Hospital of Zhejiang University School of Medicine
Ductus Arteriosus, Patent, Very Low Birth Weight Infants
Comparing Ibuprofen And Indomethacin For The Treatment Of The Patent Ductus Arteriosus in Very Premature Babies
The purpose of the study is to determine the safety and efficacy of ibuprofen, compared with indomethacin, in the treatment for the closure of the patent ductus arteriosus in premature babies born under 29 weeks gestation
- Trial name
- NCT00470743
- Testing
- Ibuprofen, Indomethacin
- Where
- Singapore
- Sponsor
- KK Women's and Children's Hospital
Chronic Lung Disease of Prematurity, Bronchopulmonary Dysplasia
Relationship Between EIT and Respiratory Status in Very Preterm Infants
Electrical Impedance Tomography (EIT) is a non-invasive imaging technique that can measure lung function in real time. This study will follow premature infants to see if EIT can help predict which infants will be successful in…
- Conditions
- Chronic Lung Disease of Prematurity, Bronchopulmonary Dysplasia, Premature Lungs
- Trial name
- NCT06609135
- Testing
- Sentec LuMon Device (EIT system), Sentec Digital Monitoring System (transcutaneous CO2 monitor)
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Lawrence Rhein
Infant, Very Low Birth Weight, Metabolic Syndrome, Protection Against
Growth, Risks of Allergy and Metabolic Syndrome in 6 Year Old Children Born Preterm Compared to Postdischarge Nutrition
This is a follow-up cohort study of 6 years old children born preterm in Denmark from 2004-2008, and at four different neonatal units. During hospitalisation they received breast milk with fortification.
- Conditions
- Infant, Very Low Birth Weight, Metabolic Syndrome, Protection Against, Allergy, Dietary Modification
- Trial name
- NCT02078687
- Testing
- Enfamil HM fortifier, Mead Johnson, Enfalac Premature Formula, Mead Johnson Nutritionals, Mothers own milk
- Where
- Denmark
- Volunteers
- 239 people
- Sponsor
- University of Southern Denmark
Intraventricular Hemorrhage of Prematurity
Safety of Erythropoietin and Melatonin for Very Preterm Infants With Intraventricular Hemorrhage
Very preterm infants are prone to numerous medical complications with lifelong impact. Amongst the most serious neurologically are white matter injury (WMI), intraventricular hemorrhage (IVH) and the subsequent progression to…
- Trial name
- SCEMPI (NCT05617833)
- Testing
- MLT+EPO
- Where
- 2 sites in United States
- Volunteers
- 60 people
- Sponsor
- Johns Hopkins University
Nutrition of Preterm Infants
Early Total Enteral Feeding Versus Conventional Enteral Feeding in Stable Very Low Birth Weight Infants
The purpose of this study is to compare the effect of early total oral feeding versus conventional oral feeding in stable VLBW infants.
- Trial name
- NCT02187978
- Testing
- Early total enteral feeding (ETEF), Conventional enteral feeding (CEF)
- Where
- India
- Volunteers
- 180 people
- Sponsor
- Lady Hardinge Medical College
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
Infant, Premature, Erythropoietin
High-Dose Erythropoietin in Extremely Premature Infants to Prevent/Attenuate Brain Injury: A Phase II Study
The highest risk for perinatal brain injury occurs among extremely premature infants who weigh less than 1250 grams at birth. Such perinatal brain injury is currently irreversible, associated with neurodevelopmental disability…
- Conditions
- Infant, Premature, Erythropoietin, Brain Injury, Intraventricular Hemorrhage
- Trial name
- NCT00589953
- Testing
- Erythropoietin
- Where
- United States
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Atlantic Health System