Clinical trials: Preterm Neonates
Premature Birth, Respiratory Distress Syndrome
Non-invasive Ventilation in Preterm Infants
This is a prospective, observational cohort study. For the study part on noninvasive neurally adjusted ventilatory assist (NIV-NAVA) the design is interventional.
- Conditions
- Premature Birth, Respiratory Distress Syndrome, Ventilator Lung; Newborn
- Trial name
- NCT05987800
- Testing
- Titration procedure, Electrical impedance tomography, Lung and diaphragm ultrasound
- Where
- Belgium
- Volunteers
- 136 people
- Sponsor
- Universitair Ziekenhuis Brussel
Shock, Preterm Birth Complication
Early Hydrocortisone Versus Regular Treatment in Shock in Extremely Preterm Neonates - an Open Randomized Controlled Trial
The goal of this clinical trial is to determine the effectiveness of early use of hydrocortisone (since the diagnosis of shock) for its resolution within the first 72 hours in premature infants under 1,500 g.
- Conditions
- Shock, Preterm Birth Complication, Preterm Intraventricular Hemorrhage, Asphyxia Perinatal
- Trial name
- NCT07248761
- Testing
- Intravascular Hydrocortisone (stress dosage): 1 mg/k/dose each 8 hours for 5 days, Vasoactive drug therapies
- Where
- Mexico
- Volunteers
- 76 people
- Sponsor
- Coordinación de Investigación en Salud, Mexico
Premature Infants, Intracranial Hemorrhages
Effect of Erythropoietin in Premature Infants on White Matter Lesions and Neurodevelopmental Outcome
Preterm and very preterm infants are at risk of developing encephalopathy of prematurity and long-term neurodevelopmental delay.
- Conditions
- Premature Infants, Intracranial Hemorrhages, Periventricular Leukomalacia, Cerebral Palsy
- Trial name
- NCT03110341
- Testing
- Erythropoietin, Normal saline
- Where
- China
- Volunteers
- 400 people
- Sponsor
- First Affiliated Hospital Xi'an Jiaotong University
Infection Associated With Catheter, Bacteremia
Safety and Efficacy Study of Ethanol Locking to Prevent Central Line Infection in Premature Neonates
Appropriate delivery of adequate nutrition and medications in premature infants often requires central venous access in the form of a special IV called a PICC (peripherally inserted central catheter).
- Conditions
- Infection Associated With Catheter, Bacteremia, Sepsis
- Trial name
- NCT01365312
- Testing
- Ethanol lock, Heparinized saline
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- East Carolina University
Caffeine
Early Versus Routine Caffeine Administration in Extremely Preterm Neonates
Premature infants are at risk of having pauses in breathing, or apneas, due to their immaturity. Premature infants are routinely given caffeine, a respiratory stimulant, on the first day of life to prevent apneas.
- Trial name
- EARLYCAFFEINE (NCT01783561)
- Testing
- Caffeine
- Where
- United States
- Volunteers
- 21 people
- Sponsor
- Sharp HealthCare
Patent Ductus Arteriosus
Early Treatment Versus Expectative Management of PDA in Preterm Infants
Much controversy exists about the optimal management of a patent ductus arteriosus (PDA) in preterm infants, especially in those born at a gestational age <28 weeks and/or a birth weight ≦1000 grams due to a lack of evidence for…
- Trial name
- BeNeDuctus (NCT02884219)
- Testing
- Ibuprofen, Expectative Management, Indomethacin
- Where
- 13 sites in Belgium, Netherlands
- Volunteers
- 273 people
- Sponsor
- Radboud University Medical Center
Respiratory Distress Syndrome in Premature Infants
First In Human Study on Synthetic Surfactant CHF 5633 in Respiratory Distress Syndrome
The aim of this study is to investigate the safety and tolerability of intratracheal administration of two different single doses of CHF 5633 in preterm neonates with RDS in terms of adverse events, adverse drug reactions…
- Trial name
- NCT01651637
- Testing
- synthetic surfactant (CHF5633)
- Where
- United Kingdom
- Volunteers
- 40 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Respiratory Distress Syndrome, Newborn
Efficacy Evaluation of Surfactant Administration Via Laryngeal Mask Airway
With the development of the Intubation Surfactant Extubation technic, in which surfactant is administered during a brief intubation followed by immediate extubation, surfactant therapy can be given during nasal continuous…
- Trial name
- NCT01173237
- Testing
- Use tracheal intubation for surfactant therapy, Use of Proseal laryngeal mask airway for surfactant therapy
- Where
- 2 sites in Brazil
- Volunteers
- 60 people
- Sponsor
- Federal University of Minas Gerais
Cystic Fibrosis
Interest of Gentamicin-induced Readthrough in Cystic Fibrosis Patients
Suppression of stop mutations in the CFTR gene with parenteral gentamicin can be predicted in vitro and is associated with clinical benefit and significant modification of the CFTR-mediated chloride transport in nasal and sweat…
- Trial name
- NCT00376428
- Testing
- Gentamicin
- Where
- France
- Volunteers
- 20 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Pulmonary Hypertension, Bronchopulmonary Dysplasia
Neolifes Heart - Pulmonary Hypertension in Preterm Children
NeoLifeS is a cohort follow up study that prospectively collects data of regular care of children born preterm in the University Medical Center Groningen (UMCG) and aims to improve the quality of care for these children.
- Trial name
- NCT02729844
- Where
- Netherlands
- Volunteers
- 134 people, healthy volunteers welcome
- Sponsor
- University Medical Center Groningen
Preterm Birth, Low Birthweight Neonate
Xylitol and the Prevention of Periodontal Disease and Preterm Birth Trial
The ground-breaking Prevention of Prematurity and Xylitol (PPaX) cluster randomized controlled clinical trial was conducted in Lilongwe, Malawi and enrolled approximately 10,069 pregnant individuals seeking to evaluate the impact…
- Conditions
- Preterm Birth, Low Birthweight Neonate, Periodontitis, Gingivitis
- Trial name
- XaPPP (NCT07424846)
- Testing
- Xylitol Chewing gum, Sorbitol chewing gum
- Where
- Malawi
- Volunteers
- 6,000 people
- Sponsor
- University of Washington
Malondialdehyde, Melatonin
Oral Melatonin as Neuroprotectant in Preterm Infants
Preterm newborns survival rates are improved, but long-term disabilities are still common. Major destructive focal lesions became less common, the most predominant lesion at present is diffuse white matter (WM damage).
- Trial name
- NCT04235673
- Testing
- melatonin
- Where
- 4 sites in Italy
- Volunteers
- 60 people
- Sponsor
- Francesca Garofoli
PreTerm Neonate, Positive End Expiratory Pressure (PEEP)
PEEP FOR LUNG RECRUITMENT IN PRETERM INFANTS-EIT STUDY
Babies born early (under 32 weeks) are at risk of developing lung problems after birth. A major reason for this is that the lungs are not fully developed.
- Conditions
- PreTerm Neonate, Positive End Expiratory Pressure (PEEP), Lung Recruitment, Electrical Impedance Tomography (EIT)
- Trial name
- [PEOPLE] (NCT06705257)
- Testing
- Studying the effects of varying levels of PEEP using Electrical impedance tomography
- Where
- United Kingdom
- Volunteers
- 30 people
- Sponsor
- South Tees Hospitals NHS Foundation Trust
Premature Birth
Family Nurture Intervention in the CHoNJ NICU
The purpose of this proposal is to conduct a replication study of Family Nurture Intervention (FNI) at CHoNJ. FNI facilitates mother-infant interactions that are vital to early development.
- Trial name
- NCT02352142
- Testing
- Full Term EEG, Facilitated Infant Care
- Where
- 2 sites in United States
- Volunteers
- 54 people
- Sponsor
- Columbia University
Respiratory Failure
Low and High Flow Suctioning in Intubated Infants
Preterm and term intubuted infants in the NICU will undergo two sequential suctioning procedures: a new, FDA-approved suction device called EXSALTA (ED) and the standard conventional wall (SCW).
- Trial name
- NCT06443970
- Testing
- Exsalta Suction Device
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Columbia University
Respiratory Disease, Respiratory Insufficiency
Evaluation Of The Efficacy Of Four Different Non-invasive Ventilation Modes Performed In The Delivery Room
Evaluation Of The Efficacy Of Four Different Non-invasive Ventilation Modes Performed In The Delivery Room In Late Preterm And Term Infants Wıth Respiratory Distress
- Trial name
- NCT04282369
- Testing
- HHHFNC, NCPAP, NIPPV
- Where
- 2 sites in Turkey (Türkiye)
- Volunteers
- 100 people
- Sponsor
- Kanuni Sultan Suleyman Training and Research Hospital
Preterm Birth, Preterm Labor
The Biomarker Study
Preterm birth (PTB) is a leading contributor to perinatal morbidity and mortality. While patients with preterm labor (PTL) are at an increased risk for PTB, not all PTL patients will deliver preterm.
- Trial name
- NCT01148654
- Where
- United States
- Volunteers
- 1,076 people
- Sponsor
- University of Pennsylvania
PreTerm Birth
Linear Growth and Neurobehavioural Outcome in PT Neonates (<34 Wks) at 37 and 40 Wks of CGA
This study will evaluate the association of linear growth on neurobehavioural outcome in preterm neonates at 37 and 40 weeks of (CGA) corrected gestational age.
- Trial name
- NCT02970994
- Volunteers
- 70 people
- Sponsor
- Lady Hardinge Medical College
Intraventricular Brain Hemorrhage
Detection and Quantification of Neonatal Intraventricular Hemorrhage
Dense array EEG and EIT (electrical impedence tomography) are new technologies that can add to information needed to diagnose neurological problems in infants - both preterm and term.
- Trial name
- DQNIH (NCT01899651)
- Where
- United States
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Electrical Geodesics, Inc.
Intensive Care, Neonatal, Analgesia
Clonidine for Analgesia to Preterm Infants During Neonatal Intensive Care
A prospective pharmacokinetic (PK), pharmacodynamic (PD) and pharmacogenetic (PG) observation study, including the PK/PD/PG relationship, in clonidine administered for analgesia and sedation to preterm newborn infants receiving…
- Conditions
- Intensive Care, Neonatal, Analgesia, Hypnotics and Sedatives
- Trial name
- NCT04928651
- Testing
- Clonidine
- Where
- 2 sites in Sweden
- Volunteers
- 40 people
- Sponsor
- Region Skane
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