Clinical trials: Infant, Extremely Premature
Bronchopulmonary Dysplasia (BPD)
Steroids and Surfactant in Extremely Low Gestation Age Infants Dose Escalation Trial
This is a phase I/II open-label study to determine the lowest, safe, effective dose of budesonide given with calfactant as the vehicle.
- Trial name
- SASSIE (NCT02907593)
- Testing
- Budesonide in Calfactant
- Where
- 5 sites in United States
- Volunteers
- 25 people
- Sponsor
- Cynthia McEvoy
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
Premature Birth, Infant, Extremely Low Birth Weight
Additional Protein Fortification in Extremely Low Birth Weight Infants
Postnatal growth is a crucial in premature infants as it could be correlated with the long-term cognitive development. Optimal nutritional care is required to reduce the initial weight loss and further growth deficit.
- Conditions
- Premature Birth, Infant, Extremely Low Birth Weight, Growth Failure
- Trial name
- PROTSUP (NCT02515266)
- Testing
- nutrition: protein intake
- Volunteers
- 152 people
- Sponsor
- Hôpital de la Croix-Rousse
Newborn, Extreme Prematurity
Improve the Survival Without Morbidity of Extremely Preterm Infants (PREMEX)
The intervention proposed is a new organization of care, based on the EXPRIM (EXtrem PRematurity Innovative Management) protocol, involving early, standardized, and multidisciplinary management of women hospitalized for a risk of…
- Conditions
- Newborn, Extreme Prematurity, Pretrm Infants
- Trial name
- PREMEX (NCT05248477)
- Testing
- Premex Protocol
- Where
- France
- Volunteers
- 2,377 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Intraventricular Hemorrhage
VentFirst: A Multicenter RCT of Assisted Ventilation During Delayed Cord Clamping for Extremely Preterm Infants
The purpose of this study is to determine whether providing ventilatory assistance prior to umbilical cord clamping influences the occurrence of intraventricular hemorrhage (IVH) in extremely preterm (EPT) infants, compared to…
- Trial name
- NCT02742454
- Testing
- Standard 30-60 Seconds Cord Clamping, VentFirst 120 Seconds Cord Clamping
- Where
- 12 sites in United States, Canada
- Volunteers
- 570 people, healthy volunteers welcome
- Sponsor
- University of Virginia
Prematurity; Extreme, Failure to Thrive in Newborn
Targeted Fortification of Donor Breast Milk in Preterm Infants
This study is a randomized controlled trial comparing standard fortification of donor breast milk to targeted fortification of donor breast milk in preterm infants.
- Conditions
- Prematurity; Extreme, Failure to Thrive in Newborn, Growth Retardation, Growth Failure
- Trial name
- NCT04294368
- Testing
- Similac Human Milk Fortifier Extensively Hydrolyzed Protein Concentrated Liquid, Similac Liquid Protein Fortifier, Nestle Microlipid
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Columbia University
Neonatal Respiratory Failure
Flow and Grow - The Ideal Time to Wean CPAP Off In Extremely Low Birth Weight Infants
Preterm neonates born at less than 30 weeks' gestation are commonly maintained on invasive or non-invasive respiratory support to facilitate gas exchange.
- Trial name
- Flow&Grow (NCT06123143)
- Testing
- Standardized/structured CPAP weaning protocol
- Where
- 5 sites in United States
- Volunteers
- 130 people
- Sponsor
- University of California, San Diego
Extreme Prematurity, Neurodevelopmental Abnormality
Osteopathic Manipulative Medicine to Reduce Developmental Delays
This randomized clinical trial seeks to determine if osteopathic manipulative medicine (OMM) increases the likelihood of improved neurodevelopmental outcomes as estimated by the Test of Infant Motor Performance (TIMP).
- Trial name
- NCT04652063
- Testing
- Osteopathic Manipulative Medicine
- Where
- 2 sites in United States
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- University of Rochester
Extremely Premature Infant
Vitamin A in Cord Blood and Preterm Outcomes
This single-center prospective cohort study aims to describe the distribution of umbilical-cord blood vitamin A concentrations in extremely preterm infants (<32 weeks' gestation) and to evaluate whether low cord blood vitamin A…
- Trial name
- NCT07296393
- Volunteers
- 155 people
- Sponsor
- The First Hospital of Jilin University
Premature, Extremely Low Birth Weight Infants, Polyunsaturated Fatty Acid Levels
PUFA Supplementation in Premature Infants
The purpose of this study is to determine if buccal administration of a concentrated formulation of long-chain polyunsaturated fatty acids (LCPUFA) can help to maintain docosahexaenoic acid (DHA) levels in extremely low birth…
- Trial name
- NCT01955044
- Testing
- LCPUFA supplement
- Where
- 3 sites in United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Endeavor Health
Necrotizing Enterocolitis, Death
Probiotic Supplementation in Extremely Preterm Infants in Scandinavia
The primary aim of this research is to determine whether supplementation with probiotics during the first weeks of life reduces the risk of necrotizing enterocolitis (NEC) and neonatal mortality and is safe to use among extremely…
- Conditions
- Necrotizing Enterocolitis, Death, Sepsis Newborn, Feeding Disorder Neonatal
- Trial name
- PEPS (NCT05604846)
- Testing
- ProPrems
- Where
- Sweden
- Volunteers
- 1,600 people
- Sponsor
- Region Stockholm
Bronchopulmonary Dysplasia, Pulmonary Hypertension Due to Lung Diseases and Hypoxia
Ventilator Pressure and Optimization of Compliance and Hemodynamics
In preterm infants < 34 weeks' gestation at birth receiving respiratory support with invasive positive pressure ventilation, the positive end-expiratory pressure (PEEP) of best compliance will increase the cardiac output and…
- Conditions
- Bronchopulmonary Dysplasia, Pulmonary Hypertension Due to Lung Diseases and Hypoxia, Extreme Prematurity, Ventilator Lung; Newborn
- Trial name
- VPOCH (NCT06512935)
- Testing
- Increase in the PEEP followed by decrease in the PEEP, Decrease in the PEEP followed by increase in the PEEP
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- University of Alabama at Birmingham
Neonatal Respiratory Distress Syndrome, Extremely Low Birth Weight Infant (ELBW)
Effective Approaches & Strategies to Ease Off Nasal CPAP In Preterm Infants
Though Nasal Continuous Positive Airway Pressure (NCPAP) is a commonly used form of non-invasive neonatal respiratory support, the optimal method of weaning off NCPAP is not well established.
- Conditions
- Neonatal Respiratory Distress Syndrome, Extremely Low Birth Weight Infant (ELBW), BronchoPulmonary Dysplasia
- Trial name
- EASEOFFNCPAP (NCT02819050)
- Testing
- NCPAP
- Volunteers
- 80 people
- Sponsor
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Premature Birth, Ventilator Lung; Newborn
sNIPPV Versus NIV-NAVA in Extremely Premature Infants
The aim of this study is to demonstrate a significant decrease in asynchrony with NIV-NAVA using the Servo n ventilator (Getinge, Sweden), as compared to abdominal triggered (Graseby capsule) synchronized nasal intermittent…
- Trial name
- EASYNNEO (NCT04068558)
- Testing
- VNI-NAVA/sNIPPV, sNIPPV/VNI-NAVA
- Where
- France
- Volunteers
- 14 people
- Sponsor
- Centre Hospitalier Intercommunal Creteil
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
Intraventricular Hemorrhage, Periventricular Leukomalacia
Prediction of Brain Injury in Premature Infants
Extremely low birth weight (ELBW), birth weight less than or equal to 1000 g, infants are at high risk for developing brain injury in the first week of life.
- Conditions
- Intraventricular Hemorrhage, Periventricular Leukomalacia, Brain Injury, Extreme Prematurity
- Trial name
- NCT02814383
- Testing
- Brain Monitoring Platform
- Where
- 3 sites in United States
- Volunteers
- 70 people
- Sponsor
- Baylor College of Medicine
Understanding of Consent in Clinical Research, Implementation of Video-Consent in Clinical Research
Impact of Video-Enhanced Consent on Informed Decision-Making for Parents of Extremely Preterm Infants Eligible for the ViDES Study
This pilot randomized controlled trial evaluates the impact of video-enhanced consent compared to the usual approach. The investigators aim to assess if video-enhanced consent empowers decision-making and improves understanding…
- Trial name
- NCT06446492
- Testing
- ViDEO explaining study, Usual Care
- Where
- United States
- Volunteers
- 83 people, healthy volunteers welcome
- Sponsor
- The University of Texas Health Science Center, Houston
Infant, Newborn, Infant, Low Birth Weight
Early-Onset Sepsis Surveillance Study
In this observational study, the NICHD Neonatal Research Network (NRN) is conducting surveillance of all infants born at NRN centers to identify all newborns who are diagnosed with early-onset sepsis (EOS) and/or meningitis.
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- EOS (NCT00874367)
- Where
- 19 sites in United States
- Volunteers
- 615 people, healthy volunteers welcome
- Sponsor
- NICHD Neonatal Research Network
Respiratory Insufficiency of Prematurity
Nasal Intermittent Positive Pressure Ventilation in Premature Infants (NIPPV)
The machines and oxygen used to help very premature babies breathe can have side-effects, such as bronchopulmonary dysplasia (BPD).
- Trial name
- NIPPV (NCT00433212)
- Testing
- nCPAP, NIPPV
- Where
- 35 sites in United States, Austria and 8 more
- Volunteers
- 1,011 people
- Sponsor
- McMaster University
Vitamin D Deficiency, Preterm Infants
Vitamin D Supplementation for Extremely Preterm Infants
The study hypothesis states that giving early enteral Vitamin D supplementation to preterm infants will decrease respiratory morbidity in extremely preterm infants.
- Conditions
- Vitamin D Deficiency, Preterm Infants, Bronchopulmonary Dysplasia
- Trial name
- NCT01600430
- Testing
- Cholecalciferol
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- University of Alabama at Birmingham