Clinical trials: Very Premature Baby
Preterm Birth
Human Milk in Preterm Infants
Current NICU protocol introduces human milk fortifier at 8 days of feeding. This study will introduce human milk fortifier at day 1. The primary outcome is the effect on growth velocity at 28 days and 36 weeks post menstrual age.
- Trial name
- NCT05228535
- Testing
- Human milk fortifier
- Where
- United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Augusta University
Infant, Newborn, Infant, Low Birth Weight
Supplemental Therapeutic Oxygen for Prethreshold Retinopathy of Prematurity
The purpose of this trial was to determine the efficacy and safety of supplemental therapeutic oxygen for infants with prethreshold retinopathy of prematurity (ROP) to reduce the probability of progression to threshold ROP and…
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- STOP-ROP (NCT01203436)
- Testing
- Supplemental Oxygen Management, Conventional Oxygen Management
- Where
- 9 sites in United States
- Volunteers
- 649 people
- Sponsor
- NICHD Neonatal Research Network
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
Bronchopulmonary Dysplasia
Gastrointestinal Microbiome Influence on the Development of Bronchopulmonary Dysplasia
The purpose of this study is to advance our knowledge of the factors that contribute to the development of bronchopulmonary dysplasia (BPD), a chronic lung affecting premature infants.
- Trial name
- MiBPD (NCT03229967)
- Testing
- 16S rRNA stool microbiome sequencing.
- Where
- 2 sites in United States
- Volunteers
- 197 people
- Sponsor
- University of Tennessee
Bronchopulmonary Dysplasia, Premature
Autologous Cord Blood Mononuclear Cells for Bronchopulmonary Dysplasia in Very Preterm Neonates
Rationale: Pre-clinical animal studies provide robust evidence regarding the beneficial effect of cord blood-derived mononuclear cells (MNCs) for experimental bronchopulmonary dysplasia (BPD).
- Conditions
- Bronchopulmonary Dysplasia, Premature, Neonatal Death
- Trial name
- NCT02999373
- Testing
- Autologous Umbilical Cord Blood Mononuclear Cells Therapy
- Where
- China
- Volunteers
- 62 people
- Sponsor
- Guangdong Women and Children Hospital
Preterm Birth
Effect of Tactile and Kinesthetic Stimulation on Very Low Birth Weight Preterm Infants
Two groups of preterm infants with birth weight equal to or less than 1500 grams will be studied. One group will receive the standard care and the other will receive standard care plus maternal special tactile stimulation.
- Trial name
- NCT00128141
- Testing
- Tactile stimulus
- Where
- Brazil
- Volunteers
- 104 people
- Sponsor
- National Bioethics Commission of Brazil
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
Postnatal Growth Failure of Preterm Infants, Human Milk Fortification
Target Versus Standard Human Milk Fortification in Very Low Birth Weight Preterm Infants
The prevention of postnatal growth failure in very low birth weight (VLBW) preterm infants is of utmost importance. Standard fortification is the most commonly used supplementation practice but it does not consider the native…
- Trial name
- NCT02716337
- Testing
- Addition of human milk fortifiers according to human milk analysis
- Volunteers
- 10 people
- Sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Hypotension, Very Low Birth Weight Infants
N-Terminal Pro-B-Type Natriuretic Peptide and Troponin Levels as Markers of Hemodynamic Stability in Very Low Birth Weight Infants During the First Days of Life
The primary objective is to test the hypothesis that there is an association between the hemodynamic status and the serum levels of NT-proBNP and cTnT in prematurely born infants.
- Conditions
- Hypotension, Very Low Birth Weight Infants, Ventricular Dysfunction, Prematurity
- Trial name
- NCT00425581
- Volunteers
- 100 people
- Sponsor
- Sheba Medical Center
Practice Guideline of Erythrocyte Transfusion in Preterm Infant
Red Blood Cell Transfusion in Very Premature Infants and HAS 2014 Guideline
The indications that motivated the decision to transfuse (or not) were analyzed to verify compliance with HAS recommendations. Medical records from 57 premature infants < 32 weeks hospitalized between 2016 -2017 were…
- Trial name
- RBCPREM (NCT03599167)
- Where
- France
- Volunteers
- 57 people
- Sponsor
- Centre Hospitalier Universitaire, Amiens
Prematurity, Extreme Prematurity
Early Intervention Based on Neonatal Crawling in Very Premature Infants at Risk For Neurodevelopmental Disorder
Extreme prematurity is constantly increasing according to the World Health Organization. However, methods to train premature infants at risk of disability is sorely lacking. The goal of this project is to overcome this problem.
- Conditions
- Prematurity, Extreme Prematurity, Infant Development, Brain Damage
- Trial name
- Premalocom2 (NCT06027645)
- Testing
- Crawling stimulation with a mini-skateboard (i.e. the crawliskate)
- Where
- 3 sites in France
- Volunteers
- 50 people
- Sponsor
- Marianne Barbu-Roth
Nasal Continuous Positive Airway Pressure,, Preterm Infants,
Early NCPAP Before Surfactant Treatment in Very Preterm Infants With RDS
We hypothesis a period of early NCPAP before surfactant treatment is effective for treating RDS and preventing BPD in very premature infants.
- Conditions
- Nasal Continuous Positive Airway Pressure,, Preterm Infants,, Surfactant Treatment,, Respiratory Distress Syndrome,
- Trial name
- NCT01996670
- Volunteers
- 683 people
- Sponsor
- Xiangya Hospital of Central South University
Prematurity, Neurodevelopmental Disorder
Effect of Early L-Carnitine Supplementation on Neurodevelopmental Outcomes in Very Preterm Infants
Preterm infants are vulnerable to brain injury, nutritional deficiencies and poor early growth which places them at increased risk for developmental problems later in life.
- Conditions
- Prematurity, Neurodevelopmental Disorder, Carnitine Deficiency
- Trial name
- NCT01783041
- Testing
- L-carnitine, 5% Dextrose
- Where
- 2 sites in United States
- Volunteers
- 144 people
- Sponsor
- Montefiore Medical Center
Hyperbilirubinemia, Neonatal, Jaundice, Neonatal
Trial of Aggressive Versus Conservative Phototherapy in Infants <1,000 Grams Birth Weight
This multi-center, randomized clinical trial compared different bilirubin levels as thresholds for timing of phototherapy in extremely low birth weight infants.
- Conditions
- Hyperbilirubinemia, Neonatal, Jaundice, Neonatal, Infant, Newborn, Infant, Low Birth Weight
- Trial name
- Phototherapy (NCT00114543)
- Testing
- Aggressive Phototherapy 501-750g, Aggressive Phototherapy 751-1000g, Conservative Phototherapy 501-750g
- Where
- 17 sites in United States
- Volunteers
- 1,974 people
- Sponsor
- NICHD Neonatal Research 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
Weight Gain Preterm
Strategy to Minimize In-hospital Malnutrition in Premature Babies
Adequate nutrition is important for preventing malnutrition in the postnatal period and thus optimize growth and development of children born prematurely.
- Trial name
- SPN (NCT01217164)
- Testing
- no intervention
- Where
- Brazil
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Hospital Universitario Pedro Ernesto
Respiratory Distress Syndrome In Premature Infants
Safety and Efficacy Study of the Draeger Babylog VN500 Device in HFOV Mode in VLBW Neonates
The purpose of this study is to determine the safety and effectiveness of the Babylog VN500 in high frequency oscillatory ventilation (HFOV) mode as a method for treating very low birth weight (VLBW) neonates requiring invasive…
- Trial name
- NCT02445040
- Testing
- Babylog VN500 in HFOV Mode
- Where
- 14 sites in United States
- Volunteers
- 225 people
- Sponsor
- Draeger Medical Systems, Inc.
Necrotizing Enterocolitis, Sepsis
Probiotic Administartion to Mothers of Preterm Infants to Prevent Necrotizing Enterocolitis and Sepsis
We hypothesize that supplementing maternal diet with probiotics will decrease the incidence of feeding intolerance, necrotizing enterocolitis and sepsis in preterm infants fed breastmilk.
- Trial name
- NCT00835874
- Testing
- Probiotics
- Where
- Israel
- Volunteers
- 57 people
- Sponsor
- Tel-Aviv Sourasky Medical Center
Mechanical Ventilation, Retinal Disease
Cpap at Delivery Room for Preterm Infants
The objective of the study is to determine if CPAP applied within less than 15 min of life in the DR reduces the necessity of mechanical ventilation and surfactant during the first 5 days of life.
- Conditions
- Mechanical Ventilation, Retinal Disease, Death, Respiratory Tract Disease
- Trial name
- CPAP-DR (NCT01024361)
- Testing
- CPAP
- Volunteers
- 200 people
- Sponsor
- University of Sao Paulo
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