Clinical trials: Very Premature Infants
Bronchopulmonary Dysplasia
Mesenchymal Stem Cell Therapy for Bronchopulmonary Dysplasia in Preterm Babies
Bronchopulmonary Dysplasia (BPD) is the most frequent disease related to a premature birth, 15-50% of very low birth newborns (<1500 gr.) will develop BPD.
- Trial name
- NCT02443961
- Testing
- Mesenchymal Stem Cell (MSC) therapy
- Where
- 4 sites in Spain
- Volunteers
- 10 people
- Sponsor
- Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Preterm Infant, Very Low Birth Weight Infant
Lactoferrin Infant Feeding Trial - LIFT_Canada
This is a multicentre, phase III, 2-arm, masked randomized controlled trial. The primary hypothesis is that oral bovine lactoferrin (bLF), through its antimicrobial, antioxidant and anti-inflammatory properties, will reduce the…
- Conditions
- Preterm Infant, Very Low Birth Weight Infant, Morbidity;Newborn
- Trial name
- NCT03367013
- Testing
- Bovine Lactoferrin, No Bovine Lactoferrin added
- Where
- 9 sites in Canada
- Volunteers
- 453 people
- Sponsor
- Dr. Elizabeth Asztalos
Very Preterm Infants (<32 Weeks of Gestation)
Administration of Extracellular Vesicles From Donor Human Milk in Preterm Infants
The AdVEMPrem study is exploring whether tiny particles called extracellular vesicles (EVs), which are naturally found in human milk, can help protect very premature babies from serious gut problems such as necrotizing…
- Trial name
- AdVEMPrem (NCT07402083)
- Testing
- Donor human milk extracellular vesicles (DHM-EVs)
- Where
- Spain
- Volunteers
- 20 people
- Sponsor
- Instituto de Investigacion Sanitaria La Fe
Neonatal Respiratory Distress Syndrome, PreTerm Neonate
MINImising Total Radiation EXposure in Preterm Infants
Being born too early (preterm birth) is the leading cause of death in children world-wide. In Australia, 97% of very preterm babies who are admitted to Neonatal Intensive Care Units need breathing support after birth to survive.
- Trial name
- MINI T-Rex (NCT06975189)
- Testing
- Lung ultrasound group, Standard Care
- Where
- Australia
- Volunteers
- 180 people
- Sponsor
- Western Health, Australia
Body Composition
Growth and Body Composition in Preterm Infants
Growth is traditionally used as a prognostic measure after admission to a neonatal intensive care unit (NICU). Quality of neonatal intensive care is one of the factors determining the health and quality of life for those that…
- Trial name
- Crescer (NCT00875251)
- Testing
- body composition
- Where
- 2 sites in Brazil
- Volunteers
- 60 people
- Sponsor
- Oswaldo Cruz Foundation
Bronchopulmonary Dysplasia, Respiratory Distress Syndrome in Premature Infant
Intratracheal Budesonide With Surfactant to Prevent Bronchopulmmonary Dysplasia.
This study is designed to determine whether intratracheal administration of budesonide combined with surfactant, as compared to surfactant alone, will modify ecographic (lung ultrasound score) and biological markers (IL-6…
- Conditions
- Bronchopulmonary Dysplasia, Respiratory Distress Syndrome in Premature Infant, Prematurity
- Trial name
- BuS (NCT04862377)
- Testing
- Poractant Alfa Intratracheal Suspension [Curosurf], Budesonide 0.5 MG/ML
- Volunteers
- 50 people
- Sponsor
- Hospital Clinic of Barcelona
Respiratory Distress Syndrome, Pneumothorax/Pulmonary Intersticial Emphysema
Very Early Surfactant and NCPAP for Premature Infants With RDS
The present study will test the use of very early nasal continuous airway pressure(NCPAP)with and without surfactant in premature infants with clinical evidence or respiratory distress syndrome.
- Conditions
- Respiratory Distress Syndrome, Pneumothorax/Pulmonary Intersticial Emphysema, Chronic Lung Disease
- Trial name
- CNRNCPAP (NCT00563641)
- Testing
- Very early surfactant and bubble NCPAP, bubble NCPAP
- Where
- Colombia
- Volunteers
- 278 people
- Sponsor
- Colombian Neonatal Research Network
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
Respiratory Distress Syndrome in Premature Infants, Very Low Birth Weight Baby
Inhaled Nitric Oxide (iNO) as an Adjunct to Neonatal Resuscitation
This study hopes to determine whether nitric oxide along with oxygen during the first 20 minutes of life in infants needing help with breathing will reduce the percentage and total exposure to oxygen during that time frame.
- Trial name
- iNO (NCT01220687)
- Testing
- iNO, Nitrogen
- Where
- 2 sites in United States
- Volunteers
- 33 people
- Sponsor
- University of Oklahoma
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
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
Parenteral Nutrition-Associated Liver Disease
Low Dose Parenteral Fat for Prevention of Parenteral Nutrition Associated Cholestasis in Preterm Neonates
The goal of the study is to determine if parenteral nutrition-associated cholestasis (PNAC) is related to the amount of parenteral (intravenous) fat administered to premature babies until full enteral nutrition is achieved.
- Trial name
- NCT01050660
- Testing
- Intravenous fat emulsion, Restriction of intravenous fat emulsion to 1 gm/kg/d
- Where
- United States
- Volunteers
- 136 people
- Sponsor
- Yale University
Infant, Newborn, Infant, Low Birth Weight
Dexamethasone Therapy in VLBW Infants at Risk of CLD
Infants who are on breathing support are often treated with steroids (dexamethasone); however, the best timing of therapy is not known.
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- Dexamethasone (NCT00011362)
- Testing
- Dexamethasone Early, Dexamethasone Late
- Where
- 13 sites in United States
- Volunteers
- 371 people
- Sponsor
- NICHD Neonatal Research Network
Psychomotor Impairment
Correlation Between Cerebral Oxygenation and Neurodevelopment in VLBW Preterm Infants.
The recent improvements in neonatal intensive care have led to a substantial increase in the survival rate of preterm infants; nevertheless, this population is still at high risk for long-term neurodevelopmental disabilities.
- Trial name
- NCT03104296
- Testing
- Griffiths Mental Development Scales
- Where
- Italy
- Volunteers
- 63 people
- Sponsor
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
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
Infant, Very Low Birth Weight
L-arginine Concentrations and CPS Polymorphisms in VLBW Infants
Plasma L-arginine concentrations are decreased in premature infants with necrotizing enterocolitis (NEC). A carbamoyl-phosphate synthetase 1 (CPS1) polymorphism has been correlated with low plasma concentrations of L-arginine in…
- Trial name
- NCT00554866
- Testing
- blood sample and buccal swab sample
- Where
- 4 sites in Italy, Netherlands and 1 more
- Volunteers
- 477 people
- Sponsor
- Maastricht University Medical Center
Premature Infant, Breast Milk Expression
Growth and Nutritional Status of Very Low Birth Weight Infants Fed a High Protein Exclusive Human Milk Diet
The purpose of this two-arm investigation is to determine if growth patterns of very low birth weight infants (VLBW) (birth weight 750-1500 grams) fed human milk (maternal or donor) supplemented with a human milk-based fortifier…
- Trial name
- MedolacHMF (NCT03839173)
- Testing
- Human milk based human milk fortifier
- Where
- United States
- Volunteers
- 51 people
- Sponsor
- Augusta University
Growth Failure, CLABSI - Central Line Associated Bloodstream Infection
The Effect of Early Versus Standard Central Line Removal on Growth of Very Low Birth Weight Premature Infants
This study compares two different regimens of a central line removal in respect to weight at 36 weeks postmenstrual age in very low birth weight (VLBW) preterm infants.
- Trial name
- NCT03730883
- Testing
- Central line removal at 100ml/kg/day., Central line removal at 140ml/kg/day.
- Where
- 4 sites in Poland
- Volunteers
- 214 people
- Sponsor
- Princess Anna Mazowiecka Hospital, Warsaw, Poland
Preterm
Early Childhood (2-year) Outcomes Among Former VLBW From the ReDiMOM Trial
The goal of this study is to determine the long-term outcomes associated with an economic intervention that was provided to encourage mother's of very premature infants to provide mother's own milk.
- Trial name
- NCT07702318
- Where
- United States
- Volunteers
- 275 people
- Sponsor
- Rush University Medical Center
Prematurity
Preterm Donor Human Milk Supplementation of Mother's Own Milk in VLBW Infants
This prospective randomized controlled trial aims to investigate whether feeding very low birth weight (VLBW) infants with Mother's own milk (MOM) supplemented with either preterm (PDM) or term donor milk (TDM), when MOM is…
- Trial name
- NCT05675397
- Testing
- donor human milk
- Where
- 2 sites in Greece
- Volunteers
- 200 people
- Sponsor
- National and Kapodistrian University of Athens