Clinical trials: Low Birthweight, open to volunteers
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
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
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
Non-Alcoholic Fatty Liver Disease, Low Birth Weight
Increased Risk of Non-alcoholic Fatty Liver Disease in Low Birth Weight Individuals
The investigators recently demonstrated a increase in liver fat in early middle-aged LBW compared to normal birth weight (NBW) men, and 20% of the LBW - but none of the normal birth weight (NBW) - men had previously unknown…
- Trial name
- NCT05890365
- Where
- Denmark
- Volunteers
- 300 people
- Sponsor
- Steno Diabetes Center Copenhagen
Preterm Birth, Premature Lungs
Effect of Nasal CPAP Versus NIPPV On Diaphragm Electrical Activity (Edi) In VLBW Preterm Infants
Background: In premature babies, many organ systems are not fully grown and developed, including the lungs and respiratory muscles, so they will need breathing support to help them to breathe by preventing their tiny air sacs to…
- Conditions
- Preterm Birth, Premature Lungs, Respiratory Distress Syndrome in Premature Infant
- Trial name
- NCT06295484
- Testing
- Alternating traditional CPAP, NIPPV, and high CPAP
- Where
- Canada
- Volunteers
- 24 people
- Sponsor
- Sunnybrook Health Sciences Centre
Respiratory Distress Syndrome RDS, Preterm Birth
Early Prediction of Lung Injury in Preterm Infants Score
The main hypothesis is that even preterm infants considered "stable" receiving non-invasive ventilation may be at risk of developing BPD due to an inhomogeneous distribution of ventilation.
- Trial name
- EPLIPS (NCT07265583)
- Where
- Italy
- Volunteers
- 104 people
- Sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
Adverse Pregnancy Outcome
Using Placental Pathology to Prevent Recurrent Adverse Pregnancy Outcomes: A Pilot Project
The goal of this randomized clinical trial is to evaluate if we can use placental pathology in a prior pregnancy which had an adverse outcome, such as early delivery, stillbirth, a baby born smaller than expected, or severe forms…
- Trial name
- NCT06004674
- Testing
- Lovenox 40mg
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Endeavor Health
Preterm Birth, Low Birth Weight
Periodontal Disease and Small Vulnerable Newborns in Rural Nepal: A Community-based Trial
Periodontal disease in pregnant women has been implicated as a potential risk factor for adverse pregnancy outcomes, including being born preterm, small-for-gestational age, and/or low birth weight.
- Conditions
- Preterm Birth, Low Birth Weight, Small Vulnerable Newborn, Small-for-gestational Age
- Trial name
- NCT07553286
- Testing
- A package of oral health interventions, including a daily antiseptic oral rinse (alcohol-free cetylpyridinium chloride (0.075%))
- Volunteers
- 2,280 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins Bloomberg School of Public Health
Respiratory Distress Syndrome in Premature Infant
Surfactant Therapy Via Supraglottic Airway to Preterm Neonates With RDS in Vietnam
Preterm babies often have trouble breathing because their lungs are not fully developed. This condition is called respiratory distress syndrome (RDS). A medicine called surfactant helps their lungs open up and work better.
- Trial name
- NEOSURF (NCT07098910)
- Testing
- Surfactant Administration Through Laryngeal or Supraglottic Airways (SALSA), Intubation - Surfactant administration - Extubation (INSURE)
- Where
- Vietnam
- Volunteers
- 440 people
- Sponsor
- Karolinska Institutet
Preterm Birth, Low Birthweight Neonate
Xylitol and the Prevention of Periodontal Disease and Preterm Birth Trial
The ground-breaking Prevention of Prematurity and Xylitol (PPaX) cluster randomized controlled clinical trial was conducted in Lilongwe, Malawi and enrolled approximately 10,069 pregnant individuals seeking to evaluate the impact…
- Conditions
- Preterm Birth, Low Birthweight Neonate, Periodontitis, Gingivitis
- Trial name
- XaPPP (NCT07424846)
- Testing
- Xylitol Chewing gum, Sorbitol chewing gum
- Where
- Malawi
- Volunteers
- 6,000 people
- Sponsor
- University of Washington
Family Involvement/Empowerment, Family-centered Care
Effectiveness of Family-Integrated Newborn Care to Improve Outcomes for Preterm and Low-birth-weight Neonates
The goal of this quasi-experimental study is to learn if integrating family in newborn care units as a key partner can improve the outcomes of preterm and low-birth-weight neonates.
- Conditions
- Family Involvement/Empowerment, Family-centered Care, Intensive Care Units, Neonatal, Family Integrated Newborn Care
- Trial name
- FINC (NCT07364903)
- Testing
- Family Integrated Newborn Care, an intervention to integrate family in the care targeted their preterm and Low-birth weight neonates, Standard medical treatment
- Where
- 2 sites in Ethiopia
- Volunteers
- 1,020 people
- Sponsor
- Laerdal Foundation
Very Low Birth Weight Baby, Early Nutrition and the Preterm Infant
Optimizing Nutrition and Milk (Opti-NuM) Project
Early nutrition critically influences growth, neurodevelopment and morbidity among infants born of very low birth weight (VLBW), but current one-size-fits-all feeding regimes do not optimally support these vulnerable infants.
- Conditions
- Very Low Birth Weight Baby, Early Nutrition and the Preterm Infant, Nutritional Requirements, Human Milk Fortification
- Trial name
- Opti-NuM (NCT06870981)
- Testing
- Opti-NuM is an observational secondary use of data/samples study, the investigators will analyze information and specimens from the MaxiMoM platform RCTs. No interventions form part of this study.
- Where
- 6 sites in United States, Canada
- Volunteers
- 1,100 people
- Sponsor
- The Hospital for Sick Children
Neonatal Death, Infectious Disease
Vitality in Infants Via Azithromycin for Neonates Trial
Nearly half of child deaths occur during the neonatal period, and 80% of those occur in babies with low birthweight. Although tremendous progress has been made towards reducing under-five mortality globally, declines in neonatal…
- Conditions
- Neonatal Death, Infectious Disease, Nutritional Deficiency
- Trial name
- VIVANT (NCT05763693)
- Testing
- Azithromycin at Baseline, Azithromycin at Day 21
- Where
- Burkina Faso
- Volunteers
- 4,000 people
- Sponsor
- University of California, San Francisco
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
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
Premature Birth, Growth Failure
Predictors of Postnatal Growth Failure in Preterm Infants
This prospective observational study aims to identify the clinical and nutritional predictors of postnatal growth failure among preterm infants admitted to the Neonatal Intensive Care Unit of Assiut University Children's Hospital.
- Conditions
- Premature Birth, Growth Failure, Very Low Birth Weight Infant
- Trial name
- NCT07818681
- Volunteers
- 120 people
- Sponsor
- Assiut University
Preeclampsia
Comparison of High- Versus Low-Dose Aspirin for Pregnancy Outcomes in Women at High Risk of Preeclampsia
The goal of this randomized clinical trial is to compare the effects of two doses of aspirin, 75 mg and 150 mg, in pregnant women who are at high risk of developing preeclampsia. The main question the study aims to answer is: 1.
- Trial name
- NCT07779057
- Testing
- Aspirin
- Where
- Pakistan
- Volunteers
- 60 people
- Sponsor
- Medicare Hospital (Pvt) Limited
Neonatology
Vermont Oxford Network Very Low Birth Weight Database
Vermont Oxford Network maintains a database for live born infants <=1500 grams or <=29 weeks gestational age who are born at participating hospitals or admitted to them within 28 days of birth, regardless of where in the hospital…
- Trial name
- VON VLBW (NCT01825499)
- Testing
- Registry
- Where
- United States
- Volunteers
- 60,000 people
- Sponsor
- Vermont Oxford Network
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