Clinical trials: Pre-Term
Hypothermia
Warming Mattress Versus Polyethylene Wrapping to Prevent Hypothermia in Preterm Newborns.
Mean axillary temperatures, taken during NICU resuscitation upon admission to the NICU, will not differ between VLBW babies who are occlusively wrapped and very low birth weight (VLBW) babies who are placed on thermal warming…
- Trial name
- NCT00603837
- Testing
- NeoWrap, InfaTherm
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- University of Oklahoma
Sepsis, Infections
Bacillus Cereus Invasive Infections in Preterm Neonates Hospitalized in French Hospitals
Background. Bacillus cereus group (Bc) comprises twenty-six closely related species of spore-forming environmental bacteria. Recently, increased sepsis and septic shock caused by Bc were reported in preterm neonates (PN), and the…
- Trial name
- NCT06973174
- Testing
- Premature neonates with invasive infection caused by Bacillus cereus
- Where
- 13 sites in France
- Volunteers
- 40 people
- Sponsor
- Centre Hospitalier Universitaire de Nice
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
Respiratory Distress Syndrome
The Safety and Efficacy of Lucinactant for Inhalation in Premature Neonates 26 to 32 Weeks Gestational Age
The primary objective of this study is to evaluate the safety and efficacy of lucinactant for inhalation administered as an aerosolized dose in two doses to preterm neonates 26 - 32 weeks gestational age who are receiving nasal…
- Trial name
- NCT02636868
- Testing
- Lucinactant delivered via investigational delivery device, nCPAP
- Where
- 54 sites in United States, Canada and 6 more
- Volunteers
- 221 people
- Sponsor
- Windtree Therapeutics
Respiratory Distress Syndrome (& [Hyaline Membrane Disease]), Respiratory Distress Syndrome (Neonatal)
Surfactant Administration Methods in Preterm Infants With RDS: A Swedish Cohort Study
The goal of this observational study is to evaluate different methods of surfactant administration in preterm infants with respiratory distress syndrome (RDS).
- Conditions
- Respiratory Distress Syndrome (& [Hyaline Membrane Disease]), Respiratory Distress Syndrome (Neonatal), Respiratory Distress Syndrome (RDS), Respiratory Distress Syndrome of Newborn
- Trial name
- NCT07550218
- Where
- Sweden
- Volunteers
- 300 people
- Sponsor
- Vastra Gotaland Region
Prematurity, RSV
The Impact of a Short Intervention During RSV Prophylaxis on Influenza Vaccination Rate.
Premature infants (born before 34 wk) are routinely vaccinated against RSV but vaccination rate against influenza are low in spite of national programs.
- Conditions
- Prematurity, RSV, Influenza, Upper Respiratory Tract Infection
- Trial name
- NCT01985620
- Testing
- Educational intervention
- Where
- Israel
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Tel-Aviv Sourasky Medical Center
Respiratory Distress Syndrome (&Amp; [Hyaline Membrane Disease])
Early Surfactant Administration at FiO₂ >0.25 Under NIPPV for RDS in Very Preterm Infants
This multicenter randomized controlled trial investigates whether initiating pulmonary surfactant (PS) at a lower oxygen threshold (FiO₂ >0.25) during nasal intermittent positive pressure ventilation (NIPPV) for very preterm…
- Trial name
- NCT07100652
- Testing
- Threshold FiO₂
- Where
- China
- Volunteers
- 384 people
- Sponsor
- Jiulongpo No.1 People's Hospital
Ventricular Arrhythmia, Ventricular Tachycardia
IVTCC 2.0: A Prospective Multicenter Ventricular Tachycardia Catheter Ablation Registry
This is a prospective multi-center international registry. The objective of this registry is to collect prospective data on patients undergoing catheter ablation for Ventricular Tachycardia (VT) and Premature Ventricular…
- Conditions
- Ventricular Arrhythmia, Ventricular Tachycardia, Premature Ventricular Contraction (PVC), Cardiomyopathy
- Trial name
- IVTCC (NCT04520347)
- Where
- 41 sites in United States, Canada and 5 more
- Volunteers
- 10,000 people
- Sponsor
- University of California, Los Angeles
Ovarian Failure, Premature
Comparison of Transdermal and Oral Estrogens in Adolescent Girls With Ovarian Failure
To directly compare the safety (by laboratory evaluation) and efficacy (feminization and growth) of three commonly used estrogen preparations in adolescent patients with ovarian failure, either due to congenital causes (Turner…
- Trial name
- NCT01023178
- Testing
- 17beta Estradiol, Conjugated estrogens, 17Beta Estradiol - transdermal
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Stanford University
Intraventricular Hemorrhage
The PREMOD Trial: A Randomized Controlled Trial of Umbilical Cord Milking vs. Delayed Cord Clamping in Premature Infants
Premature babies can be very sick and have bleeding in the brain. Giving babies more blood before cutting the umbilical cord by delayed cord clamping or umbilical cord milking has been shown to reduce the risk of bleeding in the…
- Trial name
- PREMOD (NCT01866982)
- Testing
- Umbilical Cord Milking, Delayed Cord Clamping
- Where
- 3 sites in United States
- Volunteers
- 197 people
- Sponsor
- Sharp HealthCare
Retinopathy of Prematurity (ROP)
Aflibercept for Retinopathy of Prematurity - Intravitreal Injection Versus Laser Therapy
The purpose of this study is to demonstrate how well aflibercept works in babies with ROP, comparing it with laser therapy. The study also has the objective to demonstrate how safe aflibercept is when used in babies, and describe…
- Trial name
- FIREFLEYE (NCT04004208)
- Testing
- Eylea (Aflibercept, BAY86-5321), Laser photocoagulation
- Where
- 90 sites in Argentina, Austria and 25 more
- Volunteers
- 113 people
- Sponsor
- Bayer
Premature Birth
Perception of Temporal Regularity in Tactile Stimulation: a Diffuse Correlation Spectroscopy Study in Preterm Neonates
A key function of our brain is to identify temporal structures in the environment and use them to form expectations. These expectations allow us to plan and organize our behavior towards changes in the environment, and optimize…
- Trial name
- PREMATEMP (NCT02880696)
- Testing
- Regular stimulation sequence, Random stimulation sequence, DCS
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- University Hospital, Caen
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
Patent Ductus Arteriosus
Timing for the Medical Treatment of Patent Ductus Arteriosus in Preterm Infants
This is a retrospective chart review to look at the timing of using indomethacin and ibuprofen for PDA closure for infants admitted into the NICU of the University of Utah Hospital from 1/2007-8/2008.
- Trial name
- NCT00795990
- Where
- United States
- Volunteers
- 350 people
- Sponsor
- University of Utah
CHILDREN BORN VERY PRETERM AT SCHOOL-AGE
QUALITY OF LIFE OF CHILDREN BORN VERY PRETERM AT SCHOOL-AGE
AIMS The aims were 1) to describe the quality of life (QoL) of a cohort of children born very preterm (<28 weeks of gestation) aged 7 to 9 years; 2) to compare children's QoL to the QoL reported by a French general population of…
- Trial name
- NCT01675726
- Testing
- questionary on quality of life
- Where
- France
- Volunteers
- 350 people
- Sponsor
- Assistance Publique Hopitaux De Marseille
Bronchopulmonary Dysplasia
TINN2: Treat Infection in NeoNates 2
The aim of the TINN2 study is to evaluate the efficacy of azithromycin in prevention of bronchopulmonary dysplasia in preterm neonates.
- Trial name
- TINN2 (NCT02282176)
- Testing
- Azithromycin
- Where
- 16 sites in Belgium, France and 7 more
- Sponsor
- Institut National de la Santé Et de la Recherche Médicale, France
Intubation; Difficult or Failed, Preterm Infant
New Intubation Method to Achieve Circulatory Stability and to Reduce Number of Intubation Attempts in Neonates
This is a randomized controlled pilot study investigating a new intubation method in newborn infants. In contrast to the conventional intubation method, in the new method the respirator is connected to the tube prior to insertion…
- Conditions
- Intubation; Difficult or Failed, Preterm Infant, Term Infant
- Trial name
- NOONA (NCT04089540)
- Testing
- New intubation method, Conventional intubation method
- Where
- Austria
- Volunteers
- 16 people
- Sponsor
- Medical University of Graz
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
Patent Ductus Arteriosus
Paracetamol Versus Ibuprofen for PDA Closure
Comparison between the safety and efficacy of oral paracetamol and oral ibuprofen in treatment of Patent Ductus Arteriosus (PDA) in premature infants
- Trial name
- NCT03265782
- Testing
- ibuprofen, paracetamol
- Volunteers
- 30 people
- Sponsor
- Ain Shams University
Prematurity, Mechanical Ventilation
Circadian Feeding and Reciprocal Scent Intervention in NICU
Objective: This study evaluated the effects of circadian-aligned feeding and reciprocal scent intervention on premature infants receiving mechanical ventilation and on postpartum depression levels in their mothers.
- Trial name
- NCT07622459
- Testing
- Reciprocal Scent Intervention, Circadian-Aligned Feeding, Standard Care (in control arm)
- Where
- Turkey (Türkiye)
- Volunteers
- 150 people
- Sponsor
- Inonu University
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