Clinical trials: Extremely Low Birth Weight
Prematurity; Extreme, Low Birthweight, Extremely (999 Grams or Less)
Extremely Low Gestatonal Age Infants' Paracetamol Study
In the present trial, early, intravenous paracetamol is compared to placebo in extremely premature or low birth weight infants in order to evaluate the effect on ductal closure.
- Trial name
- Paras (NCT03641209)
- Testing
- Paracetamol 10mg/mL infusion solution
- Where
- Finland
- Volunteers
- 40 people
- Sponsor
- Outi Aikio
Preterm Birth, Low; Birthweight, Extremely (999 Grams or Less)
Effect of Support for Low-Income Mothers of Preterm Infants
Preterm birth is a leading cause of childhood mortality and developmental disabilities. Socioeconomic disparities in the incidence of preterm birth and morbidities, mortality, and quality of care for preterm infants persist.
- Trial name
- NCT06362798
- Testing
- Financial Transfers
- Where
- 4 sites in United States
- Volunteers
- 420 people
- Sponsor
- University of Massachusetts, Worcester
Infant, Newborn, Infant, Low Birth Weight
Multi-dose Pharmacokinetics and Dose Ranging of Inositol in Premature Infants (INS-2)
This pilot study is a randomized, placebo-controlled, clinical trial to measure changes in blood and urine levels of inositol in premature infants at high risk for retinopathy of prematurity (ROP) following repeated doses of…
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- INS-2 (NCT01030575)
- Testing
- Inositol lower volume, Inositol mid-level volume, Inositol high volume
- Where
- 17 sites in United States
- Volunteers
- 125 people, healthy volunteers welcome
- Sponsor
- NICHD Neonatal Research Network
Infant, Newborn, Infant, Small for Gestational Age
Donor Milk vs. Formula in Extremely Low Birth Weight (ELBW) Infants
The Milk Trial seeks to determine the effect on neurodevelopmental outcomes at age 22-26 months of donor human milk as compared to preterm infant formula as the in-hospital diet for infants whose mothers choose not to provide…
- Conditions
- Infant, Newborn, Infant, Small for Gestational Age, Infant, Extremely Low Birth Weight
- Trial name
- NCT01534481
- Testing
- Donor Milk, Preterm Formula
- Where
- 17 sites in United States
- Volunteers
- 483 people
- Sponsor
- NICHD Neonatal Research Network
Infant, Newborn, Infant, Low Birth Weight
Inhaled Nitric Oxide for Preterm Infants With Severe Respiratory Failure
This multicenter trial tested whether inhaled nitric oxide would reduce death or the need for oxygen in preterm infants (less than 34 weeks gestational age) with severe lung disease.
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- Preemie iNO (NCT00016523)
- Testing
- Inhaled nitric oxide
- Where
- 17 sites in United States
- Volunteers
- 420 people
- 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
Infant, Newborn, Infant, Low Birth Weight
Laparotomy vs. Drainage for Infants With Necrotizing Enterocolitis
This study will compare the effectiveness of two surgical procedures -laparotomy versus drainage - commonly used to treat necrotizing enterocolitis (NEC) or isolated intestinal perforations (IP) in extremely low birth weight…
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- NEST (NCT01029353)
- Testing
- Laparotomy, Drainage
- Where
- 22 sites in United States
- Volunteers
- 529 people
- Sponsor
- NICHD Neonatal Research Network
Hyperbilirubinemia, Premature Newborns
Cycled Phototherapy: A Safer Effective Treatment for Small Premature Infants?
Cycled (intermittent) phototherapy will be compared to continuous (uninterrupted) phototherapy in the treatment of hyperbilirubinemia (newborn jaundice) in extremely low birth weight newborns in a pilot randomized controlled…
- Conditions
- Hyperbilirubinemia, Premature Newborns, Extremely Low Birth Weight
- Trial name
- NCT01944696
- Testing
- phototherapy
- Where
- 6 sites in United States
- Volunteers
- 210 people
- Sponsor
- The University of Texas Health Science Center, Houston
Fluid Loss, Dehydration
The Application of Sterile Water to the Skin of Extremely Low Birth Weight (ELBW) Infants
Extremely low birth weight infants have significant water loss through their skin immediately after birth. This significant fluid loss is because they have large amounts of fluids, have immature skin and large surface area.
- Conditions
- Fluid Loss, Dehydration, Extreme Immaturity
- Trial name
- NCT02052284
- Testing
- Sterile water application
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- George Washington University
Necrotizing Enterocolitis
STP206 for the Prevention of Necrotizing Enterocolitis (NEC)
This study is a sequential dose escalation study to assess the safety, tolerability, and preliminary NEC-preventative efficacy of two doses of STP206 versus control in very low birth weight and extremely low birth weight neonates.
- Trial name
- NCT01954017
- Testing
- STP206, Control
- Where
- 13 sites in United States
- Volunteers
- 103 people
- Sponsor
- Leadiant Biosciences, Inc.
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
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
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
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
Hemodynamic Instability
Multimodal Monitoring of Hemodynamics in Extremely Low Birth Weight Preterm Infant in a Canadian Tertiary Level Unit
Low blood pressure is a common problem in the premature newborn and can affect over 30% of all Extremely Low Gestational Age Neonates (ELGAN) babies delivered less than 28 weeks completed.
- Trial name
- MUSE (NCT03841929)
- Testing
- Hemodynamic report
- Where
- Canada
- Volunteers
- 128 people
- Sponsor
- University of Alberta
Infant, Newborn, Infant, Low Birth Weight
Exosurf Neonatal and Survanta for Treatment of Respiratory Distress Syndrome
The purpose of this study is to compare the efficacy of two surfactants, Exosurf Neonatal (Burroughs Wellcome Co.) and Survanta (Ross Laboratories), for the treatment of neonatal respiratory distress syndrome.
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- Surfactant 1 (NCT01203358)
- Testing
- Exosurf, Survanta
- Where
- 13 sites in United States
- Volunteers
- 617 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
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
Anemia of Prematurity
Effects of Transfusion Thresholds on Neurocognitive Outcome of Extremely Low Birth Weight Infants
To compare the effect of restrictive versus liberal red blood cell transfusion thresholds on long-term neurodevelopmental outcome in extremely low birth weight infants.
- Trial name
- ETTNO (NCT01393496)
- Testing
- red blood cell transfusion
- Where
- 32 sites in Denmark, Germany
- Volunteers
- 1,013 people
- Sponsor
- University Hospital Tuebingen
Preterm Infant, Morbidity;Infant
To Research the Relation Between Neonatal Morbidities and Poor Outcome in Preterm Infants
From November 2014 to October 2015, a multi-centers retrospective study was conducted to collect compliance, and 8 three-level hospitals from China were included.
- Conditions
- Preterm Infant, Morbidity;Infant, Outcome, Fatal
- Trial name
- NCT03104946
- Testing
- Mental Development Index;Auditory Brainstem Response;okineticnystagmus
- Volunteers
- 834 people
- Sponsor
- yangjie