Clinical trials: Prematurity; Extreme
Patent Ductus Arteriosus, Extreme Prematurity
Canadian National PDA Treatment Study
Patent ductus arteriosus (PDA) is the most common cardiovascular problem that develops in preterm infants. Persistent PDA may result in higher rates of death, chronic lung disease (CLD), pulmonary hemorrhage, necrotizing…
- Trial name
- CANRxPDA (NCT04347720)
- Testing
- Indomethacin, Ibuprofen, Acetaminophen
- Where
- 22 sites in Canada
- Volunteers
- 1,663 people
- Sponsor
- IWK Health Centre
Premature Infant, Extremely Low Birth Weight
Time to Accurate Heart Rate on Neonatal Outcomes
The goal of this trial is to compare the time to first heart rate displayed for iRes Warmer with ResusView and using iRes Warmer without ResusView when used in the resuscitation (e.g.
- Conditions
- Premature Infant, Extremely Low Birth Weight, Extreme Prematurity
- Trial name
- GE-EKG (NCT04587934)
- Testing
- iRes Warmer with ResusView, iRes Warmer without ResusView
- Where
- United States
- Volunteers
- 42 people
- Sponsor
- Sharp HealthCare
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
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
Abnormal Renal Function, Malnutrition
Effects of High vs. Standard Protein Intake in Newborn Extreme Premature
Introduction: The preterm newborn of extremely low birth weight (PNELW), endures adverse nutritional conditions to mimic intrauterine growth.
- Trial name
- experimental (NCT02478086)
- Testing
- use amine acids parenteral 3.5g, use amine acids parenteral 4g
- Where
- Mexico
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- Coordinación de Investigación en Salud, Mexico
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
Bronchopulmonary Dysplasia
Preservation of Blood in Extremely Preterm Infants
Current clinical protocols for blood sampling and analyses in extremely preterm infants rely on an infrastructure adapted to and developed for adult medicine.
- Trial name
- LIM (NCT04239690)
- Testing
- Micromethods for blood sample analysis
- Where
- Sweden
- Volunteers
- 201 people
- Sponsor
- David Ley
Pulmonary Hypertension, Bronchopulmonary Dysplasia
Inhaled Nitric Oxide for Pulmonary Hypertension and Bronchopulmonary Dysplasia
Inhaled nitric oxide (iNO) is an effective treatment for pulmonary hypertension (PH) in term and near-term infants. Preterm infants are at risk for early PH that is associated with high risk for bronchopulmonary dysplasia or…
- Trial name
- NCT03576885
- Testing
- inhaled nitric oxide
- Where
- United States
- Volunteers
- 32 people
- Sponsor
- AdventHealth
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
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
Extreme Prematurity, Respiratory Distress Syndrome
LISA in the Delivery Room for Extremely Preterm Infants
The purpose of this study is to evaluate the effect of LISA used in the delivery room (DR) in decreasing the intubation rates in preterm infants at 22-25 weeks gestational age (GA), during first 72 hours compared to the standard…
- Trial name
- DRLISA (NCT04715373)
- Testing
- LISA
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- University of Texas Southwestern Medical Center
Necrotizing Enterocolitis, Time to Full Enteral Nutrition
Intestinal Lavage to Promote Enteral Feeding and Prevent Necrotizing Enterocolitis in Extremely Preterm Infants
Optimizing enteral nutrition (EN) is challenging in extremely preterm infants due to feeding intolerance that relates to the functional gastrointestinal immaturity.
- Trial name
- NCT03631979
- Testing
- Intestinal lavage with normal saline
- Where
- Sweden
- Volunteers
- 200 people
- Sponsor
- Uppsala County Council, Sweden
Newborn Complication, Premature
Between Urgency and Efficiency: Assessing the Feasibility of Implementing a Protocol for the Care of Extremely Premature and Very Low Birth Weight Infants During the First Hour of Life: GOLD Study
Premature newborns are a particularly vulnerable population, especially during the first hours of life as they adapt to life outside the womb.
- Trial name
- GOLD (NCT07461623)
- Testing
- Golden Hour protocol
- Sponsor
- Centre Hospitalier Universitaire de Nice
Respiratory Distress Syndrome, Newborn, Respiratory Distress Syndrome in Premature Infant
Speed of Lung Inflation During Ventilation of Extremely Preterm Infants
Babies born extremely preterm (<28 weeks of pregnancy) require support to breathe. Some babies require help to breathe from a breathing machine (mechanical ventilator). While this keeps babies alive, it may damage their lungs.
- Trial name
- FLOW-VENT (NCT07101419)
- Testing
- Long PRT, Short PRT
- Where
- 3 sites in Australia
- Volunteers
- 68 people
- Sponsor
- Murdoch Childrens Research Institute
Retinopathy of Prematurity
umBilical Or Adult Donor Red Blood Cells in Extremely Low Gestational Age Neonates and Retinopathy of Prematurity (BORN)
Extremely low gestational age neonates (ELGAN, i.e., born before 28 gestation weeks) are among the most heavily transfused pediatric patients.
- Trial name
- BORN (NCT05100212)
- Testing
- cord blood-RBC concentrates, adult donor RBC concentrates
- Where
- 10 sites in Italy
- Volunteers
- 146 people
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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
Prematurity; Extreme, Cerebral Circulatory Failure
Sonographic QUantification of Venous Circulation In the Preterm Brain
The aim of the study is to develop an accessible, reproducible ultrasound tool for objective clinical measurement of brain circulation in preterm infants in order to identify infants being at risk for preterm brain injury at an…
- Conditions
- Prematurity; Extreme, Cerebral Circulatory Failure, Intraventricular Hemorrhage, Periventricular Leukomalacia
- Trial name
- SQUIB (NCT04535375)
- Testing
- Doppler Ultrasound of venous cerebral circulation
- Where
- Belgium
- Volunteers
- 47 people
- Sponsor
- Universitair Ziekenhuis Brussel
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
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
Late-Onset Neonatal Sepsis
Clinical Impact of Donor Milk Pasteurized by HTST Treatment in Preterm Infants
Randomized double-blind clinical trial to compare the incidence of microbiological proven late onset sepsis in extremely preterm infants (<1000 grams) that are supplemented with donor milk pasteurized by High Temperature Short…
- Trial name
- NCT04424667
- Testing
- donor milk
- Where
- 2 sites in Spain
- Volunteers
- 211 people
- Sponsor
- Carmen Rosa Pallas