Clinical trials: Preterm Infants
Feeding Intolerance, Necrotizing Enterocolitis
Evaluation of Feeding Intolerance in Premature Infants Using Near Infrared Spectroscopy
Nowadays feeding intolerance (FI) is a common condition among preterm infants. It has been estimated that 16%-29% of premature infants admitted to neonatal intensive care units (NICUs) develop feeding intolerance at some point…
- Conditions
- Feeding Intolerance, Necrotizing Enterocolitis, Premature Infant
- Trial name
- NIRS/NICU2 (NCT02534090)
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Brigham and Women's Hospital
Other Preterm Infants, Vitamin D Deficiency
The Effect of Vitamin D Administration to Premature Infants on Vitamin D Status and Respiratory Morbidity
This trial objective is to assess whether doubling the daily intake of vitamin D improves serum vitamin D levels and serves as primary prevention of respiratory infections and asthma in premature infants.
- Conditions
- Other Preterm Infants, Vitamin D Deficiency, Bronchiolitis, Asthma
- Trial name
- NCT02404623
- Testing
- Vitamin D
- Where
- Israel
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Soroka University Medical Center
Mother-Child Relations, Preterm Birth
The 2015 Pelotas (Brazil) Birth Cohort Study
This is the fourth birth cohort to be carried out in the city of Pelotas (Brazil) including more than 4 thousand children followed-up since the pre-natal period to study maternal-child health.
- Conditions
- Mother-Child Relations, Preterm Birth, Infant Development, Breast Feeding
- Trial name
- NCT03271723
- Testing
- Observational study
- Where
- Brazil
- Volunteers
- 4,275 people, healthy volunteers welcome
- Sponsor
- Federal University of Pelotas
Respiratory Syncytial Virus Infections
Study to Evaluate the Efficacy and Safety of Suptavumab (REGN2222) for the Prevention of Medically Attended RSV (Respiratory Syncytial Virus) Infection in Preterm Infants
The purpose of this study was to evaluate the efficacy, safety, pharmacokinetics (PK), and immunogenicity of suptavumab (REGN2222) in infants born no more than 35 weeks, 6 days gestational age who are no more than 6 months of age…
- Trial name
- NCT02325791
- Testing
- Suptavumab 30 mg/kg, Suptavumab 30 mg/kg- 1 Dose, Suptavumab 30 mg/kg - 2 Doses
- Where
- 205 sites in United States, Australia and 17 more
- Volunteers
- 1,177 people, healthy volunteers welcome
- Sponsor
- Regeneron Pharmaceuticals
Hypovitaminosis D
Vitamin D Status and the Adequacy of Vitamin D Intake in Early Preterm Infants
Vitamin D is an essential nutrient. Deficiency of vitamin D is widespread. The prevalence of vitamin D deficiency in early preterm infants is unknown.
- Trial name
- NCT01793402
- Where
- United States
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Children's Hospital Medical Center, Cincinnati
Safety Issues, Effect of Drugs
The Treatment of Premature Infants With Brain Injury by Autologous Umbilical Cord Blood Stem Cells
To study the safety and effect of autologous umbilical cord blood stem cells for treatment brain injury
- Trial name
- NCT03696745
- Testing
- autologous umbilical cord blood stem cells, 0.9% Sodium-chloride
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Guangdong Women and Children Hospital
Bronchopulmonary Dysplasia, Prematurity
Impact of Extended CPAP on Bronchopulmonary Dysplasia
The purpose of this pilot study is to compare if keeping infants on CPAP (continuous positive airway pressure) support for an extended period of time until they are 32 weeks corrected gestational age or 1250 grams (approximately…
- Trial name
- NCT05547139
- Testing
- Protocolized weaning of respiratory support
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Christiana Care Health Services
Preterm Infant, Umbilical Cord Milking
Effect of Intact Umbilical Cord Milking on Neonatal and First Year Neurodevelopmental Outcomes in Very Preterm Infants.
The investigators hypothesise that intact umbilical cord milking (I-UCM) will reduce neonatal morbidity and improve long term neurodevelopmental outcome in very preterm infants.
- Trial name
- Cord-milking (NCT03200301)
- Testing
- Intact Umbilical Cord Milking
- Where
- India
- Volunteers
- 250 people, healthy volunteers welcome
- Sponsor
- Jubilee Mission Medical College and Research Institute
Infant Development, Sensory Disorder
The Prechtl's General Movement Assessment, Hammersmith Infant Neurological Examination and Sensory Profile-2
In the Neonatal Intensive Care Unit (NICU), infants encounter many sensory stimuli (excessive noise, bright lights, painful medical applications, etc.) that are not present in the uterus.
- Conditions
- Infant Development, Sensory Disorder, Sensory Processing Disorder, Motor Delay
- Trial name
- highrisk (NCT05217199)
- Testing
- Measurements
- Where
- Turkey (Türkiye)
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Kahramanmaras Sutcu Imam University
Premature Infants, Stool Bacterial Composition
Effects of Probiotic and Prebiotic Combinations on Premature Infants
The purpose of this study is to see how oral preparations containing both probiotics and prebiotics impact the growth, bacterial colonization of the intestines, and fecal short chain fatty acid content in premature infants.
- Conditions
- Premature Infants, Stool Bacterial Composition, Growth
- Trial name
- NCT00282113
- Testing
- ProBioPlus, Culturelle
- Where
- United States
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- University of California, Davis
Premature Birth of Newborn, Enterocolitis, Necrotizing
A Randomized Controlled Trial Investigating if Antibiotic Use in the First 48 Hours of Life Adversely Impacts the Preterm Infant Microbiome
The purpose of this study is to determine whether antibiotics given immediately after birth alter the development of the developing preterm infant's microbiome, which may further alter overall clinical outcomes.
- Trial name
- NCT02477423
- Testing
- Ampicillin, Gentamicins
- Where
- United States
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- University of Chicago
Music Therapy
Premature Family Music Therapy Intervention (PFMI)
The music therapy intervention it is dedicated to premature baby and their family at the Neonatal Intensive Care Unit (NICU)of the Woman-Child department "Hospital Del Ponte".
- Trial name
- PFMI (NCT04335240)
- Testing
- Premature family music therapy intervention to support parenting, attachment bond and preterm development
- Where
- Italy
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- Ospedale di Circolo - Fondazione Macchi
Respiratory Distress Syndrome, Newborn
Antepartum Betamethasone Treatment for Prevention of Respiratory Distress in Infants Born by Elective Cesarean Section
This is a randomized, multicenter, double blind, placebo controlled trial of betamethasone versus a placebo given prior to the mothers at term and near term gestation (>34 and <40 weeks of gestation) who are scheduled to undergo…
- Trial name
- NCT00139256
- Testing
- Betamethasone
- Where
- United States
- Volunteers
- 67 people, healthy volunteers welcome
- Sponsor
- Emory University
Pre-Term, Breast Milk Expression
Preemie Milk Analyser Validation Study
This study aims to test and validate the Preemie Ecosystem- a new device and associated software package for measuring the nutrient (fat, protein and carbohydrate) content of the breast milk of the mothers of premature babies.
- Conditions
- Pre-Term, Breast Milk Expression, Nutrition Disorder, Infant
- Trial name
- NCT06486194
- Testing
- Targeted breast milk fortification using preemie device, Standard Breast milk fortification
- Where
- United Kingdom
- Volunteers
- 180 people, healthy volunteers welcome
- Sponsor
- University Hospital Southampton NHS Foundation Trust
Premature; Infant, Light-for-dates, Breastfeeding
Probiotics and Early Microbial Contact in Preterm Neonates
Probiotics are live microbes which, when administered in sufficient amounts, confer a health benefit to the host. According to recent clinical trials, administration of probiotics to very low birth weight infants significantly…
- Trial name
- ProPre (NCT01454661)
- Testing
- LGG, LGG+Bb-12
- Where
- Finland
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Turku University Hospital
Intrahepatic Cholestasis of Pregnancy, Respiratory Distress Syndrome, Newborn
Impact of Intrahepatic Cholestasis of Pregnancy on Neonatal Respiratory Outcomes
Intrahepatic cholestasis of pregnancy is a liver condition in late pregnancy, causing itching and high bile acid levels that return to normal after birth.
- Trial name
- CHOLE-RESP (NCT06679972)
- Where
- Romania
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Carol Davila University of Medicine and Pharmacy
Preterm
Co-regulation and Interaction in the NICU
Preterm infants are exposed to multiple stressors each day, posing a risk of toxic stress that can impact their developing brains during a critical period of sensitivity.
- Trial name
- CORI (NCT06753435)
- Where
- Sweden
- Volunteers
- 105 people, healthy volunteers welcome
- Sponsor
- Linkoeping University
Malaria, Sexually Transmitted Diseases
Gestational Sulfadoxine-pyrimethamine and Azithromycin Treatment to Prevent Preterm Birth
The purpose of this study is to examine whether treatment of pregnant Malawian women with repeated doses of sulfadoxine-pyrimethamine and azithromycin antibiotics will prevent preterm deliveries and result in other health…
- Conditions
- Malaria, Sexually Transmitted Diseases, Preterm Birth, Pregnancy
- Trial name
- NCT00131235
- Testing
- Sulfadoxine-pyrimethamine treatment twice during pregnancy, Sulfadoxine-pyrimethamine at 4-week intervals, Sulfadoxine-pyrimethamine every 4 weeks + azithromycin twice
- Where
- Malawi
- Volunteers
- 1,320 people, healthy volunteers welcome
- Sponsor
- Tampere University
Language Development
Language Development in Preterm Children
This research investigates the ways in which preterm birth affects how very young children learn to speak and understand language, and how older children gain efficiency in language processing.
- Trial name
- NCT01599780
- Where
- United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Stanford University
Biochemical Cobalamin Status, Motor Neurodevelopment
B Vitamin Status in Premature and Small for Gestational Age(SGA) Infants
Premature birth and low birth weight implies insufficient intrauterine growth and fetal malnutrition. During the first months of life where the infant is breastfed, the low stores aquired during fetal life, may cause specific B…
- Trial name
- NCT01201005
- Testing
- Hydroxycobalamin
- Where
- Norway
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Haukeland University Hospital