Clinical trials: Infants, Extremely Premature
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
Extremely Low Birth Weight Infants
Post-Extubation Assessment of Clinical Stability in ELBW Infants
This is an observational, proof-of-concept, feasibility study that aims to evaluate the feasibility of a monitoring system that integrates clinical data, high-resolution waveforms from the bedside monitor, regional oxygenation…
- Trial name
- PEACE (NCT06037083)
- Testing
- Oxygen saturation probe, Near infrared spectroscopy sensors, Electrical impedance tomography
- Where
- 2 sites in Canada
- Volunteers
- 20 people
- Sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
Fetal Hemoglobin
The Relevance Between the Level of Fetal Hemoglobin and Short-term Complications in Extremely Preterm Infants
A monocentric prospective study was conducted to find the relevance between the level of fetal hemoglobin and short-term complications in extremely preterm infants
- Trial name
- NCT05788562
- Where
- China
- Volunteers
- 92 people
- Sponsor
- The First Hospital of Jilin University
BPD
Effect of Autologous Cord Blood Mononuclear Cells for Prevention of Bronchopulmonary Dysplasia or Death in Extremely Preterm Neonates
This is the first and largest randomized, controlled, blinded trial that evaluates the efficacy of autologous cord blood mononuclear cells infusion as a prevention therapy for BPD or death.
- Trial name
- NCT04440670
- Testing
- autologous cord blood mononuclear cells, normal saline
- Where
- 2 sites in China
- Volunteers
- 140 people
- Sponsor
- Guangdong Women and Children Hospital
Extremely Low Gestational Age Newborn, Premature Infant
Oropharyngeal Administration of Colostrum to Extremely Low Gestational Age Newborns
Colostrum is rich in cytokines and other immune agents that may provide immunomodulatory protection against nosocomial infection in extremely premature infants.
- Trial name
- NCT01536093
- Testing
- oropharyngeal administration of own mother's colostrum, oropharyngeal administration of sterile water
- Where
- South Korea
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Seoul National University Hospital
Extreme Prematurity, Enteral Nutrition
High-energy Human Milk Diets in the First Two Weeks After Birth to Reduce BPD in Extremely Preterm Infants
This Phase II, parallel-group, masked, randomized clinical trial aims to evaluate whether a DHA/ARA-enriched, fortified human milk diet administered during the first 14 days of life reduces respiratory morbidity and improves lung…
- Conditions
- Extreme Prematurity, Enteral Nutrition, Bronchopulmonary Dysplasia
- Trial name
- MEND-BPD (NCT07307612)
- Testing
- High-energy group, Standard-energy group
- Where
- United States
- Volunteers
- 150 people
- Sponsor
- University of Alabama at Birmingham
Retinopathy of Prematurity
umBilical Or Adult Donor Red Blood Cells in Extremely Low Gestational Age Neonates and Retinopathy of Prematurity (BORN)
Extremely low gestational age neonates (ELGAN, i.e., born before 28 gestation weeks) are among the most heavily transfused pediatric patients.
- Trial name
- BORN (NCT05100212)
- Testing
- cord blood-RBC concentrates, adult donor RBC concentrates
- Where
- 10 sites in Italy
- Volunteers
- 146 people
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Infant, Newborn, Diseases, Infant, Extremely Low Birth Weight
Transfusion of Prematures Trial
The objective of the TOP trial is to determine whether higher hemoglobin thresholds for transfusing ELBW infants resulting in higher hemoglobin levels lead to improvement in the primary outcome of survival and rates of…
- Conditions
- Infant, Newborn, Diseases, Infant, Extremely Low Birth Weight, Infant, Small for Gestational Age, Bronchopulmonary Dysplasia (BPD)
- Trial name
- TOP (NCT01702805)
- Testing
- Liberal Cell Transfusion, Restricted red cell transfusion
- Where
- 20 sites in United States
- Volunteers
- 1,824 people
- Sponsor
- NICHD Neonatal Research Network
Poor Growth in Extremely Preterm Infants, Necrotizing Enterocolitis
Early Routine vs. Selective Human Milk Fortification in Extremely Preterm Infants
The aim of the project is to study the effects of fortification (using a Human Milk Donor Fortifier) of an exclusive preterm human milk diet on outcome of extremely preterm neonates, born at less or equal to 27 weeks.
- Trial name
- NCT04284280
- Testing
- Routine vs Selective use of Human Milk Donor Fortifier
- Where
- United States
- Volunteers
- 170 people
- Sponsor
- Crouse Hospital
Necrotizing Enterocolitis, Time to Full Enteral Nutrition
Intestinal Lavage to Promote Enteral Feeding and Prevent Necrotizing Enterocolitis in Extremely Preterm Infants
Optimizing enteral nutrition (EN) is challenging in extremely preterm infants due to feeding intolerance that relates to the functional gastrointestinal immaturity.
- Trial name
- NCT03631979
- Testing
- Intestinal lavage with normal saline
- Where
- Sweden
- Volunteers
- 200 people
- Sponsor
- Uppsala County Council, Sweden
Low Birth Weight
Probiotics-Supplemented Feeding in Extremely Low Birth Weight Infants
The overall purpose of this research is to test whether adding a supplement to the feeding of extremely low birth weight infant (infants weighing less than 2 pound 2 oz at birth) will help him/her achieve full feeding faster and…
- Trial name
- PAS (NCT01164124)
- Testing
- Probiotic supplementation (Lactobacillus rhamnosus GG and Bifidobacterium infantis)
- Where
- 3 sites in United States
- Volunteers
- 101 people
- Sponsor
- Vermont Oxford Network
Bronchopulmonary Dysplasia, Extreme Prematurity
Relationship Between Fungal Colonization and Severe Bronchopulmonary Dysplasia
The aim of this study is to determine if fungal colonization is associated to severe bronchopulmonary dysplasia in premature infants less than 29 weeks of gestation, and to determine if an association exists between fungal…
- Conditions
- Bronchopulmonary Dysplasia, Extreme Prematurity, Fungal Infection
- Trial name
- FunDyP (NCT05152875)
- Testing
- biological
- Where
- France
- Volunteers
- 153 people
- Sponsor
- Centre Hospitalier Sud Francilien
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
Infant, Newborn, Infant, Low Birth Weight
In Utero Magnesium Sulfate Exposure: Effects on Extremely-Low-Birth-Weight Infants
This study examined the effect of magnesium sulfate (MgSO4) exposure on adverse outcome in extremely low birth weight (ELBW) infants.
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- MgSO4 (NCT01203501)
- Where
- 15 sites in United States
- Volunteers
- 1,339 people, healthy volunteers welcome
- Sponsor
- NICHD Neonatal Research Network
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, Newborn, Infant, Low Birth Weight
Observational Study of Surgical Treatment of Necrotizing Enterocolotis
The purposes of this study were: 1) to compare mortality and postoperative morbidities in extremely low birth weight (ELBW) infants who underwent initial laparotomy or drainage for necrotizing enterocolitis (NEC) or isolated…
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- NEC Surgery (NCT01223261)
- Where
- 17 sites in United States
- Volunteers
- 156 people
- Sponsor
- NICHD Neonatal Research Network
Bilirubin Encephalopathy
Bilirubin Neurotoxicity (BN) and Neurodevelopmental Impairment (NDI) in Extremely Preterm (EP) Infants: Avoidable by Reducing the Usual Intravenous Lipid (UL) Administration
The purpose of this study is to evaluate the effect of usual versus reduced lipid intake on unbound bilirubin levels, brainstem auditory evoked responses, and neurodevelopmental outcome at 2 years in extremely preterm infants.
- Trial name
- NCT04584983
- Testing
- usual prescribed intralipid (UL) regimen, restricted prescribed intralipid (RL) regimen
- Where
- United States
- Volunteers
- 134 people
- Sponsor
- The University of Texas Health Science Center, Houston
Bronchopulmonary Dysplasia, Respiratory Distress Syndrome
Minimal Breathing Support and Early Steroids to Prevent Chronic Lung Disease in Extremely Premature Infants (SAVE)
This multicenter clinical trial tested whether minimal ventilation decreases death or BPD. Infants with birth weight 501g to 1000g and mechanically ventilated before 12 hours were randomly assigned to minimal ventilation (partial…
- Conditions
- Bronchopulmonary Dysplasia, Respiratory Distress Syndrome, Infant, Newborn, Infant, Low Birth Weight
- Trial name
- SAVE (NCT00005777)
- Testing
- Minimal mechanical ventilation management, Routine mechanical ventilation management, Dexamethasone
- Where
- 13 sites in United States
- Volunteers
- 220 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
Apnea of Prematurity, Preterm Infant
Detection of Respiratory Events Using Acoustic Monitoring in Extremely Preterm Infants
Extremely preterm infants, born before 29 weeks of pregnancy, often face breathing difficulties, also known as respiratory events, due to their undeveloped lungs and respiratory systems.
- Conditions
- Apnea of Prematurity, Preterm Infant, Periodic Breathing, Hypopnea
- Trial name
- DREAM 2 (NCT07552025)
- Testing
- Wireless acoustic sensor, Semi-structured interview, Nox T3s portable sleep monitoring device
- Where
- Canada
- Volunteers
- 50 people
- Sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre