Clinical trials: Preterm Neonates
Respiratory Distress Syndrome, Newborn
Aerosolized Surfactant in Neonatal RDS
Respiratory distress syndrome (RDS), caused by surfactant deficiency, is the leading cause of mortality and morbidity in preterm infants.
- Trial name
- AS-02 (NCT02294630)
- Testing
- Surfactant
- Where
- United States
- Volunteers
- 159 people
- Sponsor
- Sood, Beena G., MD, MS
Surfactant Deficiency Syndrome Neonatal, Respiratory Distress Syndrome in Premature Infant
Fast Assessment of Surfactant Deficiency in Preterm Infants to Speed up Treatment - Validation Study
The aim is to re-validate a FTIR spectroscopy test for measuring lung maturity/Respiratory Distress Syndrome (RDS) before conducting a RCT using this test to guide surfactant treatment of preterm infants.
- Trial name
- FAST2 (NCT05615428)
- Testing
- LS-ratio
- Where
- 3 sites in Denmark
- Volunteers
- 68 people
- Sponsor
- Copenhagen University Hospital, Rigshospitalet
Respiratory Failure
A Pilot Study of Synchronized and Non-invasive Ventilation ("NeuroPAP") in Preterm Newborns
There is currently a consensus that non-invasive ventilation (NIV) in preterm infants is preferred over intubation. There are two ways of delivering NIV in preterm infants, nasal continuous positive airway pressure (CPAP) or…
- Trial name
- NeuroPAP (NCT02480205)
- Testing
- NeuroBox to deliver the NeuroPAP
- Where
- Canada
- Volunteers
- 20 people
- Sponsor
- St. Justine's Hospital
Bronchopulmonary Dysplasia
Implementation of a Consensus-Based Discharge Protocol for Preterm Infants With Lung Disease
The researchers have worked to create consensus recommendations among national efforts to help with the transition and coordination of care for preterm infants with lung disease around discharge from the neonatal intensive care…
- Trial name
- NCT05285345
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Boston Children's Hospital
Preterm, Iron Metabolism
Iron Metabolism in Small Pre Term Newborns
Iron is an essential micronutrient that plays an important role in cellular functions of all microorganisms. Both iron deficiency and iron excess during the early weeks of life can have severe effects on neurodevelopment that may…
- Conditions
- Preterm, Iron Metabolism, Iron Overload
- Trial name
- NCT01443195
- Testing
- Iron preparation
- Where
- Israel
- Volunteers
- 50 people
- Sponsor
- HaEmek Medical Center, Israel
Preterm Neonate Analgesia
Melatonin As an Analgesic in Preterm Neonate
Melatonin (N-acetyl-5-methoxytryptamine) is a neurohormone secreted by the pineal gland with several important functions, including regulation of the circadian rhythms, antioxidant and anti-inflammatory effects, accumulating…
- Trial name
- NCT05971485
- Testing
- Melatonin 10 mg
- Where
- Egypt
- Volunteers
- 40 people
- Sponsor
- Ain Shams University
Premature Neonate
Assessment of Ketamine and Propofol Sedation During LISA Method (Less Invasive Surfactant Administration)
Respiratory distress syndrome (RDS) caused by surfactant deficiency remains one of the major reasons of morbi-mortality in preterm infants and affects 85% of preterm babies born less than 32 week gestational age (wGA).
- Trial name
- ANALISA (NCT03705468)
- Where
- France
- Volunteers
- 71 people
- Sponsor
- University Hospital, Montpellier
Bronchopulmonary Dysplasia
The Impact of Lung Recruitment Maneuver in 24-32 Weekers, and the Incidence of Bronchopulmonary Dysplasia
hypothesis : 1. The incident of dysplasia bronchopulmonary and/or death in 24-32 weekers babies on assist-control volume guarantee ventilation are lower in lung recruitment maneuver (LRM) group compare to control. 2.
- Trial name
- NCT04555889
- Testing
- lung recruitment maneuver (LRM) with DrageerVN500
- Volunteers
- 110 people
- Sponsor
- Dr. R. Adhi Teguh Perma Iskandar, Sp.A(K)
Bronchopulmonary Dysplasia
Intratracheal Umbilical Cord-derived Mesenchymal Stem Cell for the Treatment of Bronchopulmonary Dysplasia (BPD)
Umbilical Cord-derived Mesenchymal stem cell has been proven effective in the experimental bronchopulmonary dysplasia (BPD).A multi-center study was designed to evaluate the safety and efficacy of the cellular therapy in…
- Trial name
- IUMTB (NCT03645525)
- Testing
- Human Umbilical Cord-derived Mesenchymal stem cell
- Where
- 3 sites in China
- Sponsor
- Children's Hospital of Fudan University
Bronchopulmonary Dysplasia
Pulmonary MRI of Ex-preterm Children With and Without BPD To Understand Risk of Emphysematous Changes
Health Issue: Bronchopulmonary dysplasia (BPD), a chronic lung disease, is the most common complication of being born premature. Damage to the still developing lung stops the normal formation of the alveoli.
- Trial name
- PICTURE (NCT02921308)
- Where
- 4 sites in Canada
- Volunteers
- 45 people
- Sponsor
- Children's Hospital of Eastern Ontario
Chorioamnionitis, Pregnancy Complications, Infectious
Closure of Skin in ChorioAmnionitis Research Pilot Study
The purpose of the CSCAR pilot study is to improve the design of a full-scale trial by determining the patient recruitment rate and participation rate.
- Conditions
- Chorioamnionitis, Pregnancy Complications, Infectious, Complications; Cesarean Section, Postoperative Complications
- Trial name
- CSCAR (NCT01988168)
- Testing
- Suture closure, Staples closure
- Where
- Canada
- Volunteers
- 60 people
- Sponsor
- University of British Columbia
Breastfeeding, Quality of Life
The Effectiveness of Proactive Telephone Support Provided to Breastfeeding Mothers of Preterm Infants
Although breast milk has numerous benefits for infants' development, with heightened effects in those born preterm (at < 37 gestational weeks), mothers of preterm infants have shorter breastfeeding duration than mothers of term…
- Conditions
- Breastfeeding, Quality of Life, Parental Stress, Attachment
- Trial name
- NCT01806480
- Testing
- Person-centred proactive breastfeeding telephone support
- Where
- 6 sites in Sweden
- Volunteers
- 493 people, healthy volunteers welcome
- Sponsor
- Uppsala University
Respiratory Distress Syndrome, Newborn
Feasibility of Mid-frequency Ventilation in Newborns With RDS: Randomized Crossover Pilot Trial
Respiratory distress syndrome (RDS) is the most common respiratory disorder in preterm infants. Despite improved survival of extremely premature infants with RDS, complications related to mechanical ventilation still occur.
- Trial name
- NCT01242462
- Testing
- Conventional Pressure Controlled SIMV, Mid-frequency Ventilation
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- University of Alabama at Birmingham
Neonates
NICU-TECH RM9L-RS Probe ME Feasibility Study
Use of a new ultrasound device designed for babies to look at the catheters in veins and arteries as well as the blood vessel itself.
- Trial name
- NCT01181596
- Where
- United States
- Volunteers
- 31 people
- Sponsor
- GE Healthcare
Retinopathy of Prematurity (ROP), ROP Examination
Point-of-Care Ophthalmic Diagnostic Imaging of Retinopathy of Prematurity
The goal of this proposal is to develop novel HH-SECTR technology for visualizing and quantifying diagnostic disease features in prematurely born infant retinopathy of prematurity (ROP) patients that lead to more informed…
- Trial name
- ROP Imaging (NCT06612541)
- Where
- United States
- Volunteers
- 90 people
- Sponsor
- Vanderbilt University Medical Center
NEC - Necrotizing Enterocolitis
Multidimensional Dynamic Early Warning System for Neonatal Necrotizing Enterocolitis: A Multicenter Clinical Study
Necrotizing enterocolitis (NEC) is one of the most severe gastrointestinal emergencies in preterm infants, characterized by insidious onset, rapid progression, and high mortality.
- Trial name
- NCT07545993
- Testing
- No Intervention: Observational Cohort
- Volunteers
- 1,050 people
- Sponsor
- Guangzhou Women and Children's Medical Center
Infant Development, Premature
Development of a Scale for Evaluation of Neuromotor Development of Infants
Although the scales used so far provide information about the neuromotor progression of a single baby, it is thought that they are not sufficient to distinguish babies from each other, and it is thought that there is no…
- Conditions
- Infant Development, Premature, Neurodevelopmental Disorders, Neonatal Disease
- Trial name
- NCT05860166
- Testing
- Test Scale
- Where
- Turkey (Türkiye)
- Volunteers
- 68 people
- Sponsor
- Ondokuz Mayıs University
Vitamin D Deficiency, Osteopenia of Prematurity
The High Initial Dose of Monitored Vitamin D Supplementation in Preterm Infants.
The aim of this study will be to assess the effectiveness of monitored vit D supplementation in a population of preterm infants and to identify whether the proper vit D supplementation in preterm infants can reduce the incidence…
- Conditions
- Vitamin D Deficiency, Osteopenia of Prematurity, Nephrolithiasis, Metabolic Bone Disease
- Trial name
- HIDVID (NCT06199102)
- Testing
- cholecalciferol/ Devikap
- Where
- Poland
- Volunteers
- 130 people
- Sponsor
- Princess Anna Mazowiecka Hospital, Warsaw, Poland
Anemia of Prematurity
Premature Infants in Need of Transfusion (PINT)
Hypothesis: That a high hemoglobin threshold for transfusion in extremely low birth weight (ELBW) infants is associated with a lower rate of survival without severe morbidity (defined as one or more of retinopathy of prematurity…
- Trial name
- NCT00182390
- Testing
- Red blood cell transfusion
- Where
- 10 sites in United States, Australia and 1 more
- Volunteers
- 424 people
- Sponsor
- McMaster University
Respiratory Distress Syndrome of Newborn
Modified Intubation-surfactant-extubation (InSurE) Technique in Preterm Neonates With Respiratory Distress Syndrome
This study evaluates the less invasive surfactant administration (LISA) combined with synchronized nasal intermittent positive pressure ventilation (SNIPPV) technique in the treatment of respiratory distress syndrome (RDS) of…
- Trial name
- NCT03989960
- Testing
- LISA+SNIPPV, traditional InSurE
- Where
- China
- Volunteers
- 120 people
- Sponsor
- The First Affiliated Hospital with Nanjing Medical University
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