Clinical trials: Very Preterm Infant
Preterm Birth, Very Preterm Infant
NICU-to-Home Dyadic Support for Very Preterm Infants and Families
This feasibility study will evaluate delivery of the Supporting Play Exploration and Early Development Intervention after neonatal intensive care unit discharge for very preterm infants and their families.
- Conditions
- Preterm Birth, Very Preterm Infant, Infant Development, Neonatal Intensive Care Unit
- Trial name
- MN-SPEEDI (NCT07820462)
- Testing
- Homebased SPEEDI, Telehealth SPEEDI
- Where
- 2 sites in United States
- Volunteers
- 40 people
- Sponsor
- University of Minnesota
Iron Deficiency, Anemia of Prematurity
Neurodevelopment After Early Iron Supplementation
Background: Iron deficiency in early childhood may impair neurodevelopment. Aim: To examine whether early iron supplementation improved neurodevelopment in preterm infants.
- Conditions
- Iron Deficiency, Anemia of Prematurity, Neurodevelopmental Delay
- Trial name
- NCT00457990
- Testing
- Oral administration of ferrous sulphate
- Where
- Germany
- Volunteers
- 204 people
- Sponsor
- University of Ulm
Bronchopulmonary Dysplasia, Very Low Birth Weight
Preterm Infant Inhaled Albuterol Dosing
The purpose of this study is to help determine the best dose of inhaled albuterol sulfate in premature babies at risk of developing bronchopulmonary dysplasia (BPD).
- Trial name
- NCT02447250
- Testing
- Varied albuterol dose response
- Where
- United States
- Volunteers
- 14 people
- Sponsor
- Oregon Health and Science University
Infant, Newborn, Infant, Low Birth Weight
Benchmarking Initiative to Reduce Bronchopulmonary Dysplasia
This study tested whether Neonatal Intensive Care Unit (NICU) teams trained in benchmarking -- comparing care practices between different NICUs to see which practices prevent bronchopulmonary dysplasia (BPD) -- and quality…
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- Benchmarking (NCT00067613)
- Testing
- Benchmarking Management Practices, Standard Management Practices
- Where
- 17 sites in United States
- Volunteers
- 4,095 people, healthy volunteers welcome
- Sponsor
- NICHD Neonatal Research Network
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
Bronchopulmonary Dysplasia, Gastroesophageal Reflux
Transpyloric Versus Gastric Feeding in Bronchopulmonary Dysplasia
The goal of this clinical trial is to learn if transpyloric tube feeding (feeding directly into the small intestine) versus gastric tube feeding tolerably and effectively reduces gastroesophageal reflux in infants born premature…
- Trial name
- NCT06534359
- Testing
- Transpyloric tube feeding, Gastric tube feeding
- Where
- 4 sites in United States
- Volunteers
- 60 people
- Sponsor
- Children's Hospital of Philadelphia
Other Preterm Infants, Transitory Neonatal Electrolyte Disturbance
Clinical Tolerance of Numeta 13%
Numeta G13% is a triple chamber bag including amino acids plus electrolytes, glucose and lipids, dedicated for parenteral nutrition in preterm newborn infants when oral/enteral nutrition is not possible, insufficient or contra…
- Conditions
- Other Preterm Infants, Transitory Neonatal Electrolyte Disturbance, Disorder of Mineral Metabolism, Failure to Thrive
- Trial name
- BAXTERULG2 (NCT01772927)
- Testing
- Parenteral Nutrition
- Where
- Belgium
- Volunteers
- 30 people
- Sponsor
- University of Liege
Very Preterm Infants, Zinc Deficiency
Higher and Standard Doses of Enteral Zinc Supplementation in Very Preterm Infants
The goal of this randomized clinical trial is to compare the effect of higher (10 mg per day) versus standard (1 mg per day) doses of zinc supplementation The main questions it aims to answer are: Growth velocities and delta…
- Trial name
- ZnVeryPT (NCT06219525)
- Testing
- Higher dose of enteral zinc, Standard dose of enteral zinc
- Where
- Thailand
- Volunteers
- 120 people
- Sponsor
- Prince of Songkla University
Preterm Birth, Blood Transfusion Complication
Blood Warming in Preterm Infants to Decrease Hypothermia
Background/significance: Over 100,000 early preterm infants are born annually in the United States and suffer morbidity and mortality during hospitalization in a neonatal intensive care unit. One such condition is hypothermia.
- Conditions
- Preterm Birth, Blood Transfusion Complication, Hypothermia
- Trial name
- NCT05170633
- Testing
- Ranger blood warmer (3M Healthcare, Oakdale, Minnesota)
- Where
- United States
- Volunteers
- 140 people, healthy volunteers welcome
- Sponsor
- University of South Carolina
Impaired Psychomotor Development
Arachidonic Acid Supplementation in Very Preterm Infants
Long-chain polyunsaturated fatty acids (LCPUFAs), arachidonic acid (AA omega-6; 20:4ω-6), and docosahexaenoic acid (DHA omega-3; 22:6ω-3), are required for the formation of non-myelinated cell membranes in the central nervous…
- Trial name
- NCT02503020
- Testing
- Preterm infants formula A, Preterm infants formula B
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- Health Research Institute of Santiago
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
Feeding Intolerance, Necrotizing Enterocolitis
Bovine Colostrum as a Human Milk Fortifier for Preterm Infants
Very preterm infants (<32 weeks gestation) show the immaturity of organs and have high nutrient requirements for growth and development.
- Conditions
- Feeding Intolerance, Necrotizing Enterocolitis, Postnatal Growth, Late-Onset Neonatal Sepsis
- Trial name
- FortiColos-Ⅱ (NCT03822104)
- Testing
- Bovine Colostrum, FM85
- Where
- 2 sites in China
- Volunteers
- 139 people
- Sponsor
- Per Torp Sangild
Very Low Birth Weight Infant, Premature Infants
Pilot Trial Investigating Every Other Day Dosing of Oral Iron in Premature Infants (IQONic)
Study focuses on determining if daily versus every-other-day (EOD) oral iron at the same dose per kilogram per day will achieve similar incidence of iron replete status at 36 weeks post-menstrual age in premature neonates
- Conditions
- Very Low Birth Weight Infant, Premature Infants, Anemia of Prematurity, Iron Deficiency, Anaemia in Children
- Trial name
- NCT06555315
- Testing
- 6 mg/kg of oral iron as ferrous sulfate administered every other day., 6 mg/kg of oral iron as ferrous sulfate administered every day.
- Where
- United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- CHRISTUS Health
Infant, Newborn, Infant, Low Birth Weight
Delivery Room CPAP in Extremely Low Birth Weight Infants
This pilot study was designed to determine the feasibility of randomizing extremely low birth weight (ELBW) infants <28 weeks' gestation who required resuscitation to one of two resuscitation methods, either: (a) 100% oxygen by…
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- DR-CPAP (NCT01223274)
- Testing
- CPAP/PEEP, Standard management practices
- Where
- 6 sites in United States
- Volunteers
- 104 people
- Sponsor
- NICHD Neonatal Research Network
Infant, Very Low Birth Weight, Growth Failure
Preterm Infants on Early Solid Foods
Introduction: Preterm infants with a birth weight less than 1500 grams have special nutritional needs in comparison to full-term neonates.
- Trial name
- PIES-Project (NCT01809548)
- Testing
- Early intervention group, Late intervention group
- Where
- Austria
- Volunteers
- 177 people
- Sponsor
- Medical University of Vienna
Prematurity, Light-For-Dates
Early Human Milk Fortification After Early, Exclusive, Enteral Nutrition in Very Preterm Infants
In this proposed clinical trial, the investigators will randomize 80 very preterm (VPT) infants to receive either early (between day 4 and 7) or delayed (between day 10 and 14) fortification and determine if providing early…
- Conditions
- Prematurity, Light-For-Dates, Enteral Feeding Intolerance
- Trial name
- ENACT+ (NCT05525585)
- Testing
- Early HMF, Delayed HMF
- Where
- United States
- Volunteers
- 80 people
- Sponsor
- University of Alabama at Birmingham
Premature Birth, Perinatal Mortality
Assessing the Impact of Smoke-free Legislation on Perinatal Health in the Netherlands
The purpose of this study is to investigate whether there has been a change in perinatal outcomes following the phased smoking ban introduction (January 2004 for workplaces; July 2008 for bars and restaurants) workplaces in the…
- Conditions
- Premature Birth, Perinatal Mortality, Infant, Low Birth Weight, Stillbirth
- Trial name
- NCT02189265
- Testing
- Smoke-free legislation
- Where
- 2 sites in Netherlands, United Kingdom
- Volunteers
- 2,069,695 people, healthy volunteers welcome
- Sponsor
- University of Edinburgh
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
Premature Infant, Non-invasive Respiratory Support
Feeding Premature Infants During Non-invasive Respiratory Support
A randomized control trial comparing bolus gavage feeds to continuous feed among premature infants supported by non-invasive respiratory support
- Trial name
- NCT03852641
- Testing
- Length of feeding
- Where
- Israel
- Volunteers
- 100 people
- Sponsor
- Rambam Health Care Campus