Clinical trials: Prematurity; Extreme
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
Extremely Premature Infant, Anemia Neonatal
Heterologous Cord Blood-Derived Red Blood Cell for Transfusion in Extremely Preterm Infants
Anemia is a condition in which there are not enough red blood cells to carry oxygen throughout the body. It is very common in extremely preterm infants (born before 28 weeks of pregnancy), and many of these babies require red…
- Conditions
- Extremely Premature Infant, Anemia Neonatal, Blood Transfusion, Umbilical Cord Blood
- Trial name
- NCT07502781
- Testing
- Cord Blood Red Blood Cells, Standard Adult Donor Red Blood Cells
- Where
- Spain
- Volunteers
- 176 people
- Sponsor
- Hospital Clinic of Barcelona
Neonatology
A Stylet Use May be Beneficial for Elective and Rescue Intubation of Prematurely Born Infants
Contrary to recent findings suggesting that stylets offer no advantage in general infant intubations, this study focuses on their potential benefits for premature infants undergoing elective or rescue intubation in the delivery…
- Trial name
- NCT06316765
- Testing
- Intubation with stylet
- Volunteers
- 70 people
- Sponsor
- Charles University, Czech Republic
Endothelial Dysfunction, Sublingual Capillary Glycocalyx and Density
Prematurity as Predictor of Children's Cardiovascular-renal Health
Extreme preterm birth interferes with the development of the cardiovascular system. Both macro- as well as microvasculature undergoes extensive, organ specific maturation.
- Conditions
- Endothelial Dysfunction, Sublingual Capillary Glycocalyx and Density, Visual Disturbances and Blindness, Ventricular Dysfunction, Left
- Trial name
- PREMATCH (NCT02147457)
- Where
- Belgium
- Volunteers
- 180 people, healthy volunteers welcome
- Sponsor
- Universitaire Ziekenhuizen KU Leuven
Prematurity; Extreme
Exercise Intervention to Rescue the Adverse Effect of Preterm Birth on Cardiovascular and Pulmonary Health.
In spite of advances in neonatal intensive care allowing the first generation survivors of extreme prematurity to now reach young adulthood, these individuals present with reduced exercise capacity; a strong predictor of later…
- Trial name
- NCT03504215
- Testing
- Exercise Intervention
- Where
- Canada
- Volunteers
- 68 people, healthy volunteers welcome
- Sponsor
- St. Justine's Hospital
Brain Injuries, Congenital Heart Disease
Protecting Brains and Saving Futures - the PBSF Protocol
Background: Multiple neonatal disorders are associated with risks of neurological injury. Thus, management of these infants should involve a coordinated approach to permit early diagnosis with improved clinical care.
- Conditions
- Brain Injuries, Congenital Heart Disease, Newborn Morbidity, Intraventricular Hemorrhage
- Trial name
- PBSF (NCT03786497)
- Where
- 2 sites in Brazil
- Volunteers
- 2,268 people
- Sponsor
- Protecting Brains Saving Futures
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
Bronchopulmonary Dysplasia
Early Predictors of Bronchopulmonary Dysplasia in Extremely Preterm Infants
Bronchopulmonary dysplasia (BPD) remains one of the most common complications in extremely preterm infants despite advances in neonatal intensive care.
- Trial name
- EPIRESP (NCT07771387)
- Where
- Austria
- Volunteers
- 140 people, healthy volunteers welcome
- Sponsor
- Medical University of Vienna
Infant, Extremely Low Birth Weight, Feeding Behavior
Somatosensory Modulation of Salivary Gene Expression and Oral Feeding in Preterm Infants
Two innovative approaches, pulsatile orocutaneous entrainment of non-nutritive suck via orosensory entrainment (NTrainer) device technology and serial salivary gene expression analyses, will be merged to examine the relation…
- Trial name
- NCT02696343
- Testing
- NTrainer
- Where
- 4 sites in United States
- Volunteers
- 121 people
- Sponsor
- University of Nebraska Lincoln
Infant,Premature
Effects of Closed-loop Automatic Control of FiO2 in Extremely Preterm Infants
Extremely low gestational age neonates (ELGANs), i.e. those born at <28 weeks, frequently experience intermittent hypoxemic/hyperoxemic episodes.
- Trial name
- FiO2-C (NCT03168516)
- Testing
- closed-loop automatic control of the inspiratory fraction of oxygen (FiO2-C)
- Where
- 32 sites in China, Germany and 2 more
- Volunteers
- 1,065 people
- Sponsor
- University Hospital Tuebingen
Prediction of Extubation Readiness
Prediction of Extubation Readiness in Extreme Preterm Infants by the Automated Analysis of CardioRespiratory Behavior
The investigators hypothesize that machine learning methods using a combination of novel, quantitative measures of cardio-respiratory variability can accurately predict the optimal time to extubate extreme preterm infants.
- Trial name
- NCT01909947
- Testing
- Cardiorespiratory signal acquisition
- Where
- 5 sites in United States, Canada
- Volunteers
- 266 people
- Sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
Prematurity; Extreme
Assessment of Renal Function in Adults Born Preterm: The HAPI-Kidney Study
Every year in Canada, 1500 babies are born ≤29 weeks' gestational age (GA) and the majority survive to adulthood. Preterm birth occurs during a critical period of nephrogenesis.
- Trial name
- NCT04735315
- Testing
- Preterm birth
- Where
- Canada
- Volunteers
- 157 people, healthy volunteers welcome
- Sponsor
- St. Justine's Hospital
Prematurity; Extreme, Growth Retardation
Nutritional Care and Head Growth in Preterm Infants
As extremely low birth weight infants are high-risk patients, the study aimed to compare neonatal care, nutritional strategy and postnatal growth of these infants in two European neonatal units.
- Trial name
- KARLY (NCT03635944)
- Where
- France
- Volunteers
- 71 people
- Sponsor
- Hôpital de la Croix-Rousse
Oxidative Stress
Prenatal Corticosteroids and Antioxidants in Preterm Infants
Premature infants are highly susceptible to oxidative stress because of the immaturity of their antioxidant defense system. The use of prenatal glucocorticosteroids administered to the mother improves respiratory function and…
- Trial name
- RESOX (NCT00791687)
- Where
- Spain
- Volunteers
- 57 people
- Sponsor
- Fundacion Para La Investigacion Hospital La Fe
Extremely Premature Infants, PDA
Comparison of Oral and Intravenous Ibuprofen for PDA Treatment in Premature Infants
Background: Patent ductus arteriosus (PDA) continues to be one of the most common problems in premature infants. Pharmacological closure of PDA with intravenous (IV) indomethacin was first reported in 1976, however, concern…
- Conditions
- Extremely Premature Infants, PDA, Oral Ibuprofen, IV Ibuprofen
- Trial name
- NCT01149564
- Testing
- iv ibuprofen, oral ibuprofen
- Where
- Taiwan
- Volunteers
- 70 people
- Sponsor
- China Medical University Hospital
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
Respiratory Distress Syndrome (RDS), Bronchopulmonary Dysplasia (BPD)
Can Betamethasone Given After Birth Help Extremely Premature Babies Come Off Breathing Support Safely and Effectively?
The goal of this study is to determine if giving a steroid medication (specifically, betamethasone) after birth can help extremely premature babies (born before 28 weeks) come off breathing machines safely and reduce their risk…
- Trial name
- NCT07447739
- Testing
- Betamethasone
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Khang Nguyen
Prematurity; Extreme
Respiratory Outcomes After Early Vitamin D Supplementation in Infants Born Extremely Preterm
This is a masked randomized clinical trial in which extremely preterm infants fed human milk will be randomly assigned to receive either the highest (intervention group) or lowest (control group) vitamin D dose recommended during…
- Trial name
- NCT05615311
- Testing
- Vitamin D supplementation, No additional vitamin D supplementation
- Where
- United States
- Volunteers
- 126 people
- Sponsor
- University of Alabama at Birmingham
ELGAN (22-28SA), Extremely Low Gestational Age Newborns
Cardiovascular Immaturity in Extremely Low Gestational Age Newborns: a Fundamental Prospective Study
Birth is a major turning point in the life of the newborn, as it moves from intrauterine life to extrauterine life. This sudden transition forces the newborn to adapt quickly.
- Conditions
- ELGAN (22-28SA), Extremely Low Gestational Age Newborns, Cardiovascular Immaturity
- Trial name
- ELGAN AMINES (NCT06737965)
- Testing
- Medical abortion, Foetopathology exam, Outcomes mesurement
- Where
- France
- Volunteers
- 15 people
- Sponsor
- University Hospital, Montpellier
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