Clinical trials: Very Preterm Infants
Infant, Premature
Brain Volumes of Very Low Birth Weight Infants Measured by Cranial Ultrasonography
Neonatal cranial ultrasound (US) remains the method of choice to detect brain injury in high risk preterm infants on neonatal intensive care units (NICU).
- Trial name
- NCT02848755
- Testing
- Cranial ultrasonography
- Where
- Turkey (Türkiye)
- Volunteers
- 341 people
- Sponsor
- Zekai Tahir Burak Women's Health Research and Education Hospital
Emotional Stress, Parents
VOICE Study in China 'Towards a Partnership Between Parents of Very Premature Infants and Healthcare Professionals'
Background: Admission to a Neonatal Intensive Care Unit (NICU) is associated with significant levels of parental stress and anxiety.
- Conditions
- Emotional Stress, Parents, Family Separation, Neonatal Intensive Care
- Trial name
- VOICE (NCT05385198)
- Testing
- VOICE care
- Volunteers
- 60 people
- Sponsor
- Hunan Children's Hospital
Infant, Very Low Birth Weight
Randomized Study of Human-Milk Based Nutrition Versus Formula in Premature Infants
The purpose of this study is to determine whether very low birth weight infants (less than or equal to 1250g or about 2 3/4 pounds) born prematurely fed a diet of only human milk and human milk-derived nutrition have better…
- Trial name
- NCT00506584
- Testing
- Pasteurized human milk and pasteurized human milk fortifier, Human milk fortifier (bovine-based), pre-term formula, Pre-term/term formula
- Where
- 13 sites in United States, Austria
- Volunteers
- 260 people
- Sponsor
- Prolacta Bioscience
Anti-infecting Agents, Local
Efficacy Study Comparing 2% Chlorhexidine in 70% Isopropyl Alcohol Versus 2% Aqueous Chlorhexidine
The purpose of this study is to compare the efficacy of two different antiseptic solutions (2%chlorhexidine in 70% alcohol with 2% aqueous chlorhexidine)when used in a standardized controlled manner in cleansing the skin of…
- Trial name
- NCT01270776
- Testing
- 2% aqueous chlorhexidine, 2% Chlorhexidine 70% isopropyl alcohol
- Where
- Canada
- Volunteers
- 462 people
- Sponsor
- Mount Sinai Hospital, Canada
Very Preterm Maturity of Infant, Very Low Birth Weight Infant
Individualized Nutrition to Optimize Preterm Infant Growth and Neurodevelopment
Human milk has several well-established benefits but does not adequately meet the increased nutritional demands of the growing preterm infant, necessitating additional nutrient supplementation in a process known as fortification.
- Trial name
- THRIVE (NCT06266455)
- Testing
- Standardized Fortification, Adjustable Fortification
- Where
- United States
- Volunteers
- 150 people
- Sponsor
- Children's National Research Institute
Liver Disease
Half-life of Plasma Phytosterols in Very Low Birth Weight Preterm Infants With Parenteral Nutrition-associated Cholestasis
Parenteral nutrition-associated cholestasis (PNAC) is one of the most common complications resulting from administration of parenteral nutrition in neonates.
- Trial name
- NCT02947594
- Volunteers
- 37 people
- Sponsor
- Università Politecnica delle Marche
Bronchopulmonary Dysplasia, Very Low Birth Weight Infant
Work of Breathing in Premature Infants at Discharge
The purpose of this study is to compare how premature infants who required oxygen for at least 28 days during their time in the NICU (Neonatal Intensive Care Unit) breathe at discharge compared to premature infants who did not…
- Conditions
- Bronchopulmonary Dysplasia, Very Low Birth Weight Infant, Prematurity
- Trial name
- NCT03682575
- Testing
- Enrollment
- Where
- United States
- Volunteers
- 78 people, healthy volunteers welcome
- Sponsor
- Christiana Care Health Services
Premature Baby 26 to 32 Weeks, Bronchopulmonary Dysplasia
Respiratory Outcome at Adolescence of Very Low Birthweight Infants
EPIPAGEADO is an observational study. Respiratory symptoms and lung function will be evaluated in very low birth weight and term infants, born in 1997 and included in the French EPIPAGE cohort.
- Trial name
- EPIPAGEADO (NCT01424553)
- Testing
- Prevention and follow-up of the patients pulmonary parameters
- Where
- France
- Volunteers
- 355 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Infant, Newborn, Infant, Low Birth Weight
Multi-dose Pharmacokinetics and Dose Ranging of Inositol in Premature Infants (INS-2)
This pilot study is 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 repeated doses of…
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- INS-2 (NCT01030575)
- Testing
- Inositol lower volume, Inositol mid-level volume, Inositol high volume
- Where
- 17 sites in United States
- Volunteers
- 125 people, healthy volunteers welcome
- Sponsor
- NICHD Neonatal Research Network
Prematurity; Extreme
High Flow Nasal Cannula in Preterm Infants
The HIFLO study evaluates the impact of HFNC oxygen therapy on duration of nCPAP therapy, oxygen therapy and hospitalization. The cost of use of CPAP and two HFNC devices are also evaluated.
- Trial name
- HIFLO (NCT03007056)
- Testing
- High flow nasal cannula
- Where
- France
- Volunteers
- 207 people
- Sponsor
- Hôpital de la Croix-Rousse
Preterm Infant, Effect of Drugs
Zinc Supplementation In Very Low Birth Weight Infants-A Randomised Controlled Trial
Zinc (Zn) is a structural component of human body and is a crucial element for a wide variety of cascades that take place in almost all organ systems.
- Conditions
- Preterm Infant, Effect of Drugs, Zinc Deficiency Disease
- Trial name
- NCT05311540
- Testing
- Zinc Sulfate
- Where
- Turkey (Türkiye)
- Volunteers
- 195 people
- Sponsor
- Zekai Tahir Burak Women's Health Research and Education Hospital
Very Low Birth Weight Infant, Very Preterm Maturity of Infant
Swiss Neonatal Network & Follow-up Group
The chief aim of the Swiss Neonatal Network \& Follow-Up Group (SwissNeoNet) is to maintain and / or improve the quality and safety of medical care for high-risk newborn infants and their families in Switzerland through a…
- Conditions
- Very Low Birth Weight Infant, Very Preterm Maturity of Infant, Asphyxia Neonatorum
- Trial name
- SwissNeoNet (NCT04239508)
- Where
- Switzerland
- Volunteers
- 1,000 people
- Sponsor
- Swiss Neonatal Network
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
Theory of Mind in Preschool Children, School Children, Youths and Adults Born Preterm or Full-term
This study tests preschoolers, school children, youths and young adults, who were born preterm or full-term, in their theory of mind abilities.
- Trial name
- NCT02628015
- Where
- Germany
- Volunteers
- 480 people, healthy volunteers welcome
- Sponsor
- University of Bonn
Children Born Extremely Premature, Disturbance of Visuo-spatial Working Memory
Long-term Effects of Visual Spatial Working Memory Training Program Performed at Preschool Age in Very Preterm Infants With Visual Spatial Working Memory Deficit. A Randomized Controlled Trial
Prematurity tends to increase in France in recent years and more children born extremely premature infants survive. If severe impairments have stabilized, the majority of former extremely premature children have…
- Trial name
- EPIREMED (NCT02757794)
- Testing
- computerized cognitive remediation program, standard remediation
- Where
- 18 sites in France
- Volunteers
- 166 people
- Sponsor
- Assistance Publique Hopitaux De Marseille
Children Born Very Prematurely in Relation to Structural Brain Abnormalities
Magnetic Resonance Spectroscopy at Term-equivalent Age and Executive Functions at 5 Years of Age Corrected in Very Preterm Infants
EPIRMEX is a complementary study to the national cohort EPIPAGE 2 the INSERM Unit 953 is responsible. The objective of this study is to evaluate at the age of 5 years corrected executive functions in children born very…
- Trial name
- EPIRMEX (NCT02851537)
- Testing
- an advanced technique as magnetic resonance spectroscopy (MRS)
- Volunteers
- 100 people
- Sponsor
- Assistance Publique Hopitaux De Marseille
Intestinal Blood Flow
Packed Red Blood Cell Transfusion and Intestinal Blood Flow in Preterm Neonates
The purpose of the study is to determine whether packed red blood cell (PRBC) transfusion affects intestinal blood flow of premature infants during feedings and if so, whether return of normal intestinal blood flow pattern occurs…
- Trial name
- NCT01628133
- Testing
- ultrasound
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- St. Louis University
Cerebral Autoregulation, Preterm Birth
Transitional Cerebrovascular Reactivity in Very Preterm Infants
The transitional period, defined as the first 72 hours after preterm birth, is often characterized by a significant hemodynamic instability and may also be associated with an impairment of cerebral autoregulation, with relevant…
- Conditions
- Cerebral Autoregulation, Preterm Birth, Premature Infant Disease
- Trial name
- NCT04423016
- Testing
- Near Infrared Spectroscopy monitoring, Electrical velocimetry and pulse oximetry
- Where
- Italy
- Volunteers
- 72 people
- Sponsor
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
Extubation Failure
Bubble Continuous Positive Airway Pressure (CPAP) With Conventional CPAP for Extubation in Preterm Infants
The objective of this study is to evaluate whether CPAP delivered by bubble CPAP resulted in a greater proportion of infants being successfully extubated when compared with management with ventilator derived CPAP.
- Trial name
- NCT00979433
- Testing
- Bubble CPAP, Conventional CPAP
- Where
- India
- Volunteers
- 32 people
- Sponsor
- All India Institute of Medical Sciences
Growth, Body Composition
Effect of Target Fortified Human Milk on the Growth Quality of Very Preterm Infants (TargetFort)
It is reported that the standard method for fortification of human milk (HM) overestimates the energy and protein densities of HM (Macedo MHNP 2018), thus originating infant undernutrition (Macedo AJP 2018).
- Conditions
- Growth, Body Composition, Prematurity, Breast Milk Collection
- Trial name
- TargetFort (NCT04400396)
- Testing
- standard HM fortification, target HM fortification
- Where
- Portugal
- Volunteers
- 80 people
- Sponsor
- Centro Hospitalar de Lisboa Central