Clinical trials: Extremely Low Birth Weight
Extremely Low Birthweight Infant, Continuous Tracheal Gas Insufflation
Ventilation of the Extremely Premature Infants Optimized by Dead Space Washout
The Continuous Tracheal Gas Insufflation (CTGI) is a ventilation option of conventional mechanical ventilation that is used to reduce or even eliminate the dead space caused by respiratory prostheses.
- Conditions
- Extremely Low Birthweight Infant, Continuous Tracheal Gas Insufflation, Medical Device, Lung Protection
- Trial name
- Volem (NCT06334523)
- Testing
- Ventilation with Dead Space Washout via Continuous Tracheal Gas Insufflation (CTGI)
- Where
- 4 sites in France
- Volunteers
- 144 people
- Sponsor
- Centre Hospitalier Intercommunal Creteil
Pneumococcal Infections, Streptococcus Pneumoniae
Immunogenicity of PCV-7 Vaccine in VLBW Infants
Premature infants are at a high risk for pneumonia. The PCV-7 vaccine effectively prevents the invasive disease from Streptococcus pneumoniae in full-term infants, but was not thoroughly studied in premature infants.
- Conditions
- Pneumococcal Infections, Streptococcus Pneumoniae, Infant, Newborn, Infant, Low Birth Weight
- Trial name
- PCV-7 (NCT00273325)
- Where
- 10 sites in United States
- Volunteers
- 368 people, healthy volunteers welcome
- Sponsor
- NICHD Neonatal Research Network
Growth in Premature Infants
Early Protein Supplementation of Human Milk in Extremely Low Birth Weight Infants
We hypothesize that premature infants who receive their mothers' expressed breast milk supplemented with liquid protein early in their hospitalization will have a growth velocity in the first 28 days of life that is 20% greater…
- Trial name
- NCT01991613
- Testing
- liquid protein supplement
- Where
- United States
- Volunteers
- 43 people
- Sponsor
- Icahn School of Medicine at Mount Sinai
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
Extreme Prematurity,Extremely Low Birthweight, Extremely Low Birth Weight
Comparison of the Shukla and UN-1 Formulae in the Placement of the Umbilical Venous Catheter Among Neonates
Umbilical vein catheters (UVC) are commonly inserted in newborns especially neonates admitted to the Neonatal Intensive Care Unit (NICU).These catheters are used since 1959.
- Conditions
- Extreme Prematurity,Extremely Low Birthweight, Extremely Low Birth Weight, Very Low Birth Weight Infant, Neonatal Hypoglycemia
- Trial name
- NCT05022433
- Testing
- UVC insertion
- Where
- Singapore
- Volunteers
- 170 people
- Sponsor
- Singapore General Hospital
Infant, Newborn, Infant, Low Birth Weight
Follow-up Visit of High Risk Infants
The NICHD Neonatal Research Network's Follow-Up study is a multi-center cohort in which surviving extremely low birth-weight infants born in participating network centers receive neurodevelopmental, neurosensory and functional…
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- FU (NCT00009633)
- Testing
- No Intervention
- Where
- 31 sites in United States
- Volunteers
- 68,000 people
- Sponsor
- NICHD Neonatal Research Network
BPD - Bronchopulmonary Dysplasia
Randomized Control Trial: Synchronized Non-invasive Positive Pressure Ventilation Versus Non Synchronized Non Invasive Positive Pressure Ventilation in Extremely Low Birth Weight Infants
Infants delivered weighing less than 1 kg at birth (ELBW) are at high risk for the development of bronchopulmonary dysplasia (BPD) and Ventilator-Induced Lung Injury (VILI), in part because of the need for mechanical ventilation…
- Trial name
- NCT03613987
- Testing
- NAVA technology to synchronize NIPPV
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- New York Medical College
Infant, Newborn, Infant, Small for Gestational Age
Hydrocortisone for BPD
The Hydrocortisone and Extubation study will test the safety and efficacy of a 10 day course of hydrocortisone for infants who are less than 30 weeks estimated gestational age and who are intubated at 14-28 days of life.
- Conditions
- Infant, Newborn, Infant, Small for Gestational Age, Infant, Very Low Birth Weight, Infant, Premature
- Trial name
- NCT01353313
- Testing
- Hydrocortisone
- Where
- 20 sites in United States
- Volunteers
- 800 people
- Sponsor
- NICHD Neonatal Research Network
Infant, Newborn, Infant, Low Birth Weight
Inflammatory Cytokines Associated With Perinatal Brain Injury
This observational study assessed whether measurements of certain pro-inflammatory and anti-inflammatory cytokines in the blood (either singly or in combination) at birth and/or up to day of life 21 can predict cerebral palsy at…
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- Cytokines (NCT01035697)
- Where
- 18 sites in United States
- Volunteers
- 1,067 people, healthy volunteers welcome
- Sponsor
- NICHD Neonatal Research Network
Prematurity; Extreme
A Study of Factors Associated With Failure of the Golden Hour Protocol in the Initial Care of Extremely Preterm and Very Low Birth Weight Newborns
Preterm infants are a particularly vulnerable population, especially during the first hours of life as they adapt to life outside the womb.
- Trial name
- PREM-GH (NCT07829562)
- Testing
- Golden hour
- Where
- France
- Volunteers
- 50 people
- Sponsor
- Centre Hospitalier Universitaire de Nice
Bronchopulmonary Dysplasia, Death
Systemic Management in Extremely Preterm and Extremely Low Birth Weight Infants
to estimate incidences of major complications, such as bronchopulmonary dysplasia, death, and delivery room resuscitation among extremely preterm and extremely low birth weight infants in Northern China
- Trial name
- NCT06082414
- Testing
- no interventions
- Where
- China
- Volunteers
- 1,200 people, healthy volunteers welcome
- Sponsor
- Peking University
Respiratory Distress Syndrome, Preterm Birth
LISA vs INSURE in Extremely Low Birth Weight Infants. A Manikin Study
This is an unblinded, randomized, controlled, crossover (AB/BA) trial of surfactant treatment with LISA vs. INSURE in a manikin simulating an extremely low birth weight infant.
- Conditions
- Respiratory Distress Syndrome, Preterm Birth, Surfactant Deficiency Syndrome Neonatal
- Trial name
- NCT04944108
- Testing
- LISA approach, Insure approach
- Where
- 2 sites in Italy
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- University Hospital Padova
Infant, Newborn, Infant, Low Birth Weight
Early Blood Pressure Management in Extremely Premature Infants
This trial tests the feasibility of enrolling 60 extremely preterm infants in a randomized, double-blinded study of blood pressure management within 12 months.
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- ELGAN BP (NCT00874393)
- Testing
- Dopamine, Hydrocortisone
- Where
- 17 sites in United States
- Volunteers
- 10 people
- Sponsor
- NICHD Neonatal Research Network
Preterm Infants, Post Traumatic Stress Disorder
Developmental Outcomes of Extreme Prematurity, 5-15 Years Postpartum
The purpose of this study is to assess the emotional well being of mothers to preterm infants with ELBW 5-15 years after the birth. Post-traumatic symptoms and parental stress levels will be taken into consideration.
- Conditions
- Preterm Infants, Post Traumatic Stress Disorder, Emotional Stress, Infant, Very Low Birth Weight
- Trial name
- NCT01430832
- Where
- Israel
- Volunteers
- 95 people
- Sponsor
- Sheba Medical Center
Premature Birth, Extremely Low Birth Weight
DCS Study in Extremely Premature Newborns
The researchers are attempting to improve the cerebral monitoring of extremely low gestational age (ELGA) infants, such that in the future, real-time monitoring will be possible, to aid clinicians in management of these infants.
- Conditions
- Premature Birth, Extremely Low Birth Weight, Infant, Small for Gestational Age, Intracerebral Hemorrhage
- Trial name
- NCT04367181
- Testing
- Diffuse Correlation Spectroscopy (DCS), Amplitude Integrated Electroencephalography (aEEG)
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Maria Angela Franceschini
Bronchopulmonary Dysplasia, Apnea of Prematurity
Early Versus Late Caffeine for ELBW Newborns
Caffeine is routinely used in the management of apnea of prematurity. Extremely low birth weight (ELBW) infants are at higher risk of mortality and various neonatal morbidities such as bronchopulmonary dysplasia (BPD) for which…
- Trial name
- NCT02524249
- Testing
- Caffeine
- Where
- United States
- Volunteers
- 110 people
- Sponsor
- Wayne State University
Infant, Newborn, Infant, Low Birth Weight
Generic Database of Very Low Birth Weight Infants
The Generic Database (GDB) is a registry of very low birth weight infants born alive in NICHD Neonatal Research Network (NRN) centers.
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- GDB (NCT00063063)
- Testing
- No Intervention
- Where
- 31 sites in United States
- Volunteers
- 80,000 people
- Sponsor
- NICHD Neonatal Research Network
Preterm Birth, Low; Birthweight, Extremely (999 Grams or Less)
Clinical Evaluation of the "NICU Clinical Decision Support Dashboard" - MHSB
This study evaluates the use of a NICU clinical integration system (Dashboard and accessories) in improving the quality of care delivered, patient health outcomes, and parent and clinician satisfaction.
- Conditions
- Preterm Birth, Low; Birthweight, Extremely (999 Grams or Less), Neonatal Infection, Satisfaction
- Trial name
- NCT03673579
- Testing
- NICU Dashboard
- Where
- United States
- Sponsor
- Philips Healthcare
Infant, Newborn, Infant, Low Birth Weight
Benchmarking Initiative to Reduce Bronchopulmonary Dysplasia
This study tested whether Neonatal Intensive Care Unit (NICU) teams trained in benchmarking -- comparing care practices between different NICUs to see which practices prevent bronchopulmonary dysplasia (BPD) -- and quality…
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- Benchmarking (NCT00067613)
- Testing
- Benchmarking Management Practices, Standard Management Practices
- Where
- 17 sites in United States
- Volunteers
- 4,095 people, healthy volunteers welcome
- Sponsor
- NICHD Neonatal Research Network
Infant, Newborn, Infant, Low Birth Weight
Growth Observational Study
This study was a multicenter, prospective cohort study to define postnatal longitudinal growth for very low birth weight (VLBW) infants.
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- Growth (NCT01203475)
- Where
- 13 sites in United States
- Volunteers
- 1,660 people, healthy volunteers welcome
- Sponsor
- NICHD Neonatal Research Network