Clinical trials: Extremely Low Birth Weight
Feeding; Difficult, Newborn, Growth Failure
Prophylactic Probiotics to Extremely Low Birth Weight Prematures
Mortality and incidence of severe complications is still high among extremely premature infants. Common causes of severe complications in this population are poor nutrition, necrotizing enterocolitis, and severe infections.
- Conditions
- Feeding; Difficult, Newborn, Growth Failure, Necrotizing Enterocolitis, Sepsis
- Trial name
- PROPEL (NCT01603368)
- Testing
- Lactobacillus reuteri
- Where
- 2 sites in Sweden
- Volunteers
- 134 people, healthy volunteers welcome
- Sponsor
- Ostergotland County Council, Sweden
Infant, Newborn, Infant, Low Birth Weight
Delayed Cord Clamping in VLBW Infants
This study tested the feasibility of conducting a randomized controlled trial to vary the timing that doctors clamp the umbilical cord after birth in extremely low birthweight infants.
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- NCT01222364
- Testing
- Standard Cord Clamping, Delayed Cord Clamping
- Where
- 4 sites in United States
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- NICHD Neonatal Research Network
Infant, Newborn, Infant, Low Birth Weight
The Effects of Erythropoietin (EPO) on the Transfusion Requirements of Very Low Birth Weight Infants
This study tested the safety and efficacy of transfusing erythropoietin (Epo) and iron in infants of <1,250g birth weight. For infants 401-1,000g birth weight, we tested whether early erythropoietin (Epo) and iron therapy would…
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- EPO (NCT01203514)
- Testing
- Erythropoietin
- Where
- 9 sites in United States
- Volunteers
- 318 people, healthy volunteers welcome
- Sponsor
- NICHD Neonatal Research Network
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
Chickenpox, Rubella
MMR and Varicella Vaccine in Premature Infants
This research is designed to address the question, "Does the relative deficit in vaccine immunogenicity in extremely premature infants persist beyond the first 6 months of life?" We propose to measure the immunogenicity of…
- Conditions
- Chickenpox, Rubella, Rubeola, Mumps
- Trial name
- NCT00156559
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- University of Rochester
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
Infant, Newborn, Infant, Low Birth Weight
Antenatal Phenobarbital to Prevent Neonatal Intracranial Hemorrhage
This large randomized trial tested whether phenobarbital given to a pregnant woman about to deliver a premature infant would prevent brain injuries in their newborns.
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- Phenobarbital (NCT00009620)
- Testing
- Phenobarbital, Saline
- Where
- 11 sites in United States
- Volunteers
- 610 people, healthy volunteers welcome
- Sponsor
- NICHD Neonatal Research Network
Qt Interval, Preterm Birth
QTc Intervals in Former Preterm/Extreme Low Birth Weight Infants: a Pooled Study Proposal
Pooling effort to collect previously reported data on QTc time in former preterm neonates, and compare these data to controls. At present and based on a recently conducted systematic search, there are conflicting data on the…
- Trial name
- NCT05243537
- Testing
- ECG (diagnostic)
- Where
- 2 sites in Belgium, Canada
- Volunteers
- 250 people, healthy volunteers welcome
- Sponsor
- Universitaire Ziekenhuizen KU Leuven
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
Extremely Low Birth Weight
The Effect of Schumann Resonance on Preterm Newborns
Body weight gain is crucial for preterm newborns, especially those with a low birth weight. Owing to their noninvasive, noncontact, and non-pharmaceutical properties, extremely low frequency electromagnetic fields (ELF-EMFs) are…
- Trial name
- NCT05146752
- Testing
- extremely low frequency electromagnetic fields, routine care
- Where
- Taiwan
- Volunteers
- 61 people, healthy volunteers welcome
- Sponsor
- Chung Shan Medical University
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
Infection, Candida
Early Diagnosis of Candidiasis in Premature Infants
This observational study evaluated the performance of new lab tests in detecting candida species fungal infections in extremely low birth weight (ELBW) infants quickly and accurately.
- Conditions
- Infection, Candida, Candidiasis, Infant, Newborn
- Trial name
- Candida (NCT00109525)
- Where
- 20 sites in United States
- Volunteers
- 1,500 people, healthy volunteers welcome
- Sponsor
- NICHD Neonatal Research Network
Infant, Newborn, Infant, Low Birth Weight
Development of Standards for the New Ballard Maturation Score
The primary purpose of this study was to evaluate the accuracy of gestational age (GA) estimates by using the New Ballard Score (NBS) in newborns 24 to 27 weeks GA with accurate obstetric estimates of GA.
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- Ballard (NCT01203449)
- Where
- 11 sites in United States
- Volunteers
- 1,090 people, healthy volunteers welcome
- Sponsor
- NICHD Neonatal Research Network
Preterm Infant, Infant, Newborn
Neonatal Wireless Monitoring System for Intensive Care
Babies who require intensive care need to have their heart rate, oxygen levels and temperature measured continuously using specially designed monitors.
- Conditions
- Preterm Infant, Infant, Newborn, Low; Birthweight, Extremely (999 Grams or Less)
- Trial name
- NCT04241263
- Testing
- Wireless vital sign monitoring - comparative, Wireless vital sign monitoring - usability
- Where
- United Kingdom
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Cambridge University Hospitals NHS Foundation Trust
Infant, Extremely Premature
Milking the Umbilical Cord for Extreme Preterm Infants
Milking the umbilical cord from the placental end toward the infant has been shown to benefit preterm infants when compared to either clamping the umbilical cord immediately or waiting delaying the clamping of the cord.
- Trial name
- NCT01666847
- Testing
- Milking the umbilical cord before cord clamping
- Where
- 2 sites in United States
- Volunteers
- 59 people, healthy volunteers welcome
- Sponsor
- St. Louis University
Thrombocytopenia, Neonatal
Neonatal Platelet Transfusion Threshold Trial
The objective of the NeoPlaTT trial is to test whether, among extremely preterm infants born at 23 0/7 to 26 6/7 weeks' gestation, a lower platelet transfusion threshold, compared to a higher threshold, improves survival without…
- Conditions
- Thrombocytopenia, Neonatal, Platelet Transfusion, Infant, Newborn, Diseases
- Trial name
- NeoPlaTT (NCT06676904)
- Testing
- Higher Platelet Transfusion Threshold, Lower Platelet Transfusion Threshold
- Where
- 20 sites in United States
- Volunteers
- 2,433 people, healthy volunteers welcome
- Sponsor
- NICHD Neonatal Research Network
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
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
Infant, Premature, Erythropoietin
High-Dose Erythropoietin in Extremely Premature Infants to Prevent/Attenuate Brain Injury: A Phase II Study
The highest risk for perinatal brain injury occurs among extremely premature infants who weigh less than 1250 grams at birth. Such perinatal brain injury is currently irreversible, associated with neurodevelopmental disability…
- Conditions
- Infant, Premature, Erythropoietin, Brain Injury, Intraventricular Hemorrhage
- Trial name
- NCT00589953
- Testing
- Erythropoietin
- Where
- United States
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Atlantic Health System
Premature Infants, Cerebral Palsy
Interrater Reliability of Infant Motor Profile
The aim of this study is to assess risky infants (or diagnosed infants) with Infant Motor Profile, and analyze interrater and intrarater reliability of this test.
- Conditions
- Premature Infants, Cerebral Palsy, Down Syndrome, Metabolic Disorders
- Trial name
- IMP (NCT03188107)
- Testing
- Video based assessment
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Abant Izzet Baysal University