Clinical trials: Prematurity; Extreme
Bronchopulmonary Dysplasia, Neurodevelopmental Impairment
Lipid Infusions to Optimize Nutrition Trial
The purpose of this study is to identify survival free of bronchopulmonary dysplasia (BPD), fatty acid profiles, and early biochemical measures for oxidative stress comparing mixed oil lipid emulsion (MOLE) vs soybean oil-based…
- Trial name
- LION (NCT06915441)
- Testing
- SOLE, MOLE
- Where
- United States
- Volunteers
- 230 people
- Sponsor
- The University of Texas Health Science Center, Houston
Infant, Premature, Respiratory Disease
Extremely Preterm Respiratory Outcome Cohort
This study examines the respiratory outcomes of preterm infants born at gestational ages less than 29 weeks, spanning from birth to 24 months corrected age.
- Trial name
- NCT06726226
- Testing
- Standard care for preterm infants
- Where
- South Korea
- Volunteers
- 600 people, healthy volunteers welcome
- Sponsor
- Seoul National University Hospital
Microbial Colonization, Extreme Prematurity
NICU Antibiotics and Outcomes Trial
The goal of the NANO trial is to study the longstanding clinical practice of empirically administering intravenous antibiotics to extremely low birthweight (ELBW) infants in the first days of life.
- Conditions
- Microbial Colonization, Extreme Prematurity, Early-Onset Neonatal Sepsis, Late-Onset Neonatal Sepsis
- Trial name
- NANO (NCT03997266)
- Testing
- Ampicillin, Gentamycin, Normal saline
- Where
- 14 sites in United States
- Volunteers
- 359 people
- Sponsor
- Michael Morowitz
Extremely Low Birth Weight Infants, Respiratory Distress Syndrome, Newborn
LUS AT BIRTH IN INFANTS BORN BEFORE 26 WEEKS
All infants born before 26 weeks born in a hospital included in the registry will receive a LU at birth, before the first dose of surfactant. We will register as well the length of IMV, NIV or the need of IMV in the whole sample.
- Trial name
- MINI-LUS (NCT06394583)
- Testing
- Lung ultrasound
- Volunteers
- 150 people
- Sponsor
- Andaluz Health Service
Patent Ductus Arteriosus After Premature Birth
Selective Early Medical Treatment of Patent Ductus Arteriosus in Extremely Low Gestational Age Infants: A Pilot RCT
Background: Among preterm infants, those born at a gestational age less than 26 weeks are considered the most vulnerable with a high risk of short- and long-term health problems that include chronic lung disease, brain bleeds…
- Trial name
- SMART-PDA (NCT05011149)
- Testing
- Ibuprofen
- Where
- 9 sites in United States, Canada
- Volunteers
- 100 people
- Sponsor
- IWK Health Centre
Prematurity; Extreme
Risk of Chronic Diseases in Young Adults Born Preterm: Relationship With Inflammation and Oxidative Stress Biomarkers.
The purpose of the HAPI project is to study the overall health of preterm infants once they reach adulthood. The investigators would like to compare the health of adults born preterm with that of adults born full-term.
- Trial name
- NCT03261609
- Testing
- preterm birth
- Where
- Canada
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- St. Justine's Hospital
Infant, Premature, Diseases, Infant
The Alberta BLOOM Long Term Follow Up Study
This is a prospective, observational clinical cohort study involving children born very preterm at less than 31 weeks and six days gestation.
- Conditions
- Infant, Premature, Diseases, Infant, Asthma, Asthma in Children
- Trial name
- BLOOM-LTFU (NCT04641000)
- Where
- Canada
- Volunteers
- 15 people
- Sponsor
- University of Calgary
Infant, Premature, Diseases, Perinatal Morbidity
Prognosis of Extremely Premature Birth
Pregnant women at risk of giving birth before 28 weeks' gestational age will be enrolled. Fetal circulation will be studied and blood for inflammatory parameters will be collected.
- Conditions
- Infant, Premature, Diseases, Perinatal Morbidity, Development, Problem;Growth
- Trial name
- BabyPEP (NCT01150396)
- Where
- 2 sites in Norway
- Volunteers
- 160 people
- Sponsor
- University of Bergen
Infant, Newborn, Diseases, Other Preterm Infants
Surfactant Positive Airway Pressure and Pulse Oximetry Trial
This study compared the use of continuous positive airway pressure initiated at birth with the early administration of surfactant administered through a tube in the windpipe within 1 hour of birth for premature infants born at 24…
- Conditions
- Infant, Newborn, Diseases, Other Preterm Infants, Infant, Small for Gestational Age, Premature Birth
- Trial name
- SUPPORT (NCT00233324)
- Testing
- Surfactant, Continuous Positive Airway Pressure (CPAP), Supplemental oxygen with target saturation of 85 to 89%
- Where
- 22 sites in United States
- Volunteers
- 1,316 people
- Sponsor
- NICHD Neonatal Research Network
Very Preterm and Extremely Preterm Birth
Sodium and Milk Fortification Evaluation of Body Composition Among Very Preterm Infants
The goal of the trial is to learn if targeted sodium supplementation (including blood and urine sodium testing) versus standard milk fortification (including blood sodium testing) improves growth and body composition in very…
- Trial name
- SAFE (NCT07562997)
- Testing
- Urine sodium testing, Serum sodium testing, Milk fortification
- Where
- 3 sites in United States
- Volunteers
- 150 people
- Sponsor
- University of Washington
Cholestasis, Psychomotor Disorders, Developmental
Preventing Cholestasis Using SMOFLipid®
Preterm infants of extreme low birth weight (ELBW, < 1000 gram birth weight) cannot immediately be nourished with mother´s or formula milk and are typically dependent on parenteral nutrition (PN) for a prolonged period of time.
- Trial name
- NCT01585935
- Testing
- SMOFLIPID, INTRALIPID
- Where
- Austria
- Volunteers
- 230 people
- Sponsor
- Medical University of Vienna
IVH- Intraventricular Hemorrhage, Extreme Prematurity
Delayed Cord Clamping With Oxygen In Extremely Low Gestation Infants
This study is being conducted to compare the incidence of preterm infants (up to 28+6 weeks GA) who achieve a peripheral oxygen saturation of 80 percent by 5 minutes of life (MOL) given mask CPAP/PPV with an FiO2 of 1.0 during…
- Conditions
- IVH- Intraventricular Hemorrhage, Extreme Prematurity, Hypoxia Neonatal, Hyperoxia
- Trial name
- DOXIE (NCT04413097)
- Testing
- Delayed Cord Clamping with Low Oxygen concentration, Delayed Cord Clamping with High Oxygen concentration
- Where
- 3 sites in United States
- Volunteers
- 140 people
- Sponsor
- Sharp HealthCare
Premature Birth, Extremely Premature Infants
Prenatal Counseling in Extreme Prematurity: Professionals' View
This study is part of the PreCo study, evaluating Dutch care in (imminent) extreme preterm birth including current and preferred counseling, barriers and facilitators for preferred counseling from both obstetricians and…
- Trial name
- PreCo-profs (NCT02782650)
- Testing
- survey and interview
- Volunteers
- 122 people, healthy volunteers welcome
- Sponsor
- Radboud University Medical Center
Premature Infant, Extremely Low Birth Weight
Time to Accurate Heart Rate on Neonatal Outcomes
The goal of this trial is to compare the time to first heart rate displayed for iRes Warmer with ResusView and using iRes Warmer without ResusView when used in the resuscitation (e.g.
- Conditions
- Premature Infant, Extremely Low Birth Weight, Extreme Prematurity
- Trial name
- GE-EKG (NCT04587934)
- Testing
- iRes Warmer with ResusView, iRes Warmer without ResusView
- Where
- United States
- Volunteers
- 42 people
- Sponsor
- Sharp HealthCare
Infant, Extremely Low Birth Weight, Lung Diseases, Obstructive
Growth, Health and Development in Children Born Extremely Preterm
Background: In a national Norwegian cohort of children born before 28 weeks gestation or with a birth weight less than 1000 g born in 1999 and 2000, 372 survived.
- Conditions
- Infant, Extremely Low Birth Weight, Lung Diseases, Obstructive, Disorder of Bone Density and Structure, Unspecified, Cognition Disorders
- Trial name
- PEP11 (NCT01150071)
- Where
- 2 sites in Norway
- Volunteers
- 232 people
- Sponsor
- University of Bergen
Kangaroo Care, Premature Infant
Efficacy of Lateral Kangaroo Care in Hemodynamic Stabilization of Premature Infant.
The objetive of the study is to evaluate the non-inferiority or the equivalence of the kangaroo care position, in lateral versus traditional one in prone measuring the stability of several parameters in premature infants less…
- Conditions
- Kangaroo Care, Premature Infant, Body Temperature
- Trial name
- Cangulat (NCT03990116)
- Testing
- Lateral, Prone
- Where
- Spain
- Volunteers
- 70 people
- Sponsor
- Laura Collados Gomez
Preterm, Very Low Birth Weight Infant
Weight Gain in Extremely Premature Infant With Targeted Versus Adjusted Fortification
Investigation about the effect on weight gain in extremely low birth weight preterm with individualized fortification, according to human milk analysis versus fortification adjusted according to urea serum concentration.
- Conditions
- Preterm, Very Low Birth Weight Infant, Feeding, Breast, Food, Fortified
- Trial name
- FORTIN (NCT04982133)
- Testing
- Protein supplementation based on plasma urea concentration every other week or human milk analysis on experiment
- Where
- Spain
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- Hospital Universitario La Paz
Cholestasis
Cholestasis in Extreme Low Birth Weight Infants (ELBW)
Parenteral nutrition associated liver disease (PNALD) in preterm neonates is characterized by early occurrence of intrahepatic cholestasis (parenteral nutrition associated cholestasis (PNAC).
- Trial name
- NCT01164878
- Volunteers
- 122 people
- Sponsor
- Medical University of Vienna
Late-Onset Neonatal Sepsis
Clinical Impact of Donor Milk Pasteurized by HTST Treatment in Preterm Infants
Randomized double-blind clinical trial to compare the incidence of microbiological proven late onset sepsis in extremely preterm infants (<1000 grams) that are supplemented with donor milk pasteurized by High Temperature Short…
- Trial name
- NCT04424667
- Testing
- donor milk
- Where
- 2 sites in Spain
- Volunteers
- 211 people
- Sponsor
- Carmen Rosa Pallas
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