Clinical trials: Preterm Delivery
Respiration; Insufficient or Poor, Newborn, Infant,Premature
Comparison of Leakage With Nasal Prongs and Nasal Mask Interface in Newborns Receiving CPAP Treatment
The study is a two-armed randomized cross-over comparison of leakage with nasal prongs and nasal mask interface in newborn infants treated with CPAP, born after 28 weeks of gestational age.
- Trial name
- ToNIL (NCT03586856)
- Testing
- Nasal mask interface, Nasal prongs interface
- Where
- 2 sites in Sweden
- Volunteers
- 50 people
- Sponsor
- Baldvin Jonsson
Echocardiography
Normal Reference Range for Neonatal Echocardiography
Echocardiography is the main method of bedside examination of neonatal cardiac morphology, which can timely diagnose congenital heart disease and quantitatively assess its severity, but the diagnosis and evaluation process…
- Trial name
- NORRNE (NCT05462301)
- Where
- China
- Volunteers
- 1,500 people, healthy volunteers welcome
- Sponsor
- Children's Hospital of Chongqing Medical University
Respiratory Distress Syndrome, Newborn, Noninvasive Ventilation
RAM Cannula VS Short Nasal Prongs for Delivering NIPPV in Preterm Infants
Randomized control trial, Ram cannula VS short nasal prongs for delivering Non Invasive Positive Pressure Ventilation (NIPPV) for preterm infants
- Conditions
- Respiratory Distress Syndrome, Newborn, Noninvasive Ventilation, Infant, Premature, Intubation, Intratracheal
- Trial name
- RAMCAN (NCT03081611)
- Testing
- Ram cannula, Short nasal prongs
- Where
- Israel
- Volunteers
- 166 people
- Sponsor
- Rambam Health Care Campus
Healthy Volunteers
Early Environmental and Maternal Determinants of Airway Inflammation in Wheezing Disorders in Infants
This study collects data on microbiological, genetic and environmental factors, as well as lung function parameters (e.g. spirometry, body plethysmography, lung-MRI) to assess the complex interaction of predisposing risk factors…
- Trial name
- NCT04286464
- Testing
- No intervention
- Where
- Switzerland
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- Insel Gruppe AG, University Hospital Bern
Premature Birth
Development of a Developmental Prognostic Tool for the Premature Child Based on Automated Spontaneous Motor Analysis
Prematurity is a major risk factor for poor neurodevelopmental outcomes. The clinical and neuroradiological evaluations proposed during the neonatal period to assess the developmental prognosis of children born prematurely are…
- Trial name
- AGMA (NCT04770844)
- Testing
- Acquisitions
- Where
- France
- Volunteers
- 129 people
- Sponsor
- Centre Hospitalier Universitaire de Saint Etienne
Anemia of Prematurity
Autologous Cord Blood Transfusion in Preterm Infants
The purpose of this study is to investigate the efficacy and safety of autologous cord blood transfusions in very-low-birth-weight premature infants, and to evaluate the developmental outcomes of the infants who received…
- Trial name
- NCT02101086
- Testing
- Blood transfusion
- Where
- Turkey (Türkiye)
- Volunteers
- 39 people
- Sponsor
- Ankara University
Enterostomy
Efficacy and Safety of Refeeding in Preterm Infants With Enterostomy
Refeeding is an extracorporeal stool transport from the proximal stoma end to the distal end of stoma. Refeeding may be beneficial in preventing malabsorption, electrolyte imbalance, cholestasis and atrophy of the distal…
- Trial name
- NCT02812095
- Testing
- Refeeding
- Where
- South Korea
- Volunteers
- 20 people
- Sponsor
- Seoul National University Hospital
Bronchopulmonary Dysplasia
Efficacy and Safety of Zelpultide Alfa in Preterm Neonates at High Risk of Developing Bronchopulmonary Dysplasia (BPD)
This is a randomized, parallel-group, double-blind, placebo-controlled multicenter phase 2b/3 study with an adaptive seamless design.
- Trial name
- ZELA (NCT06897839)
- Testing
- Zelpultide alfa
- Where
- 49 sites in Argentina, Belgium and 6 more
- Volunteers
- 366 people
- Sponsor
- Airway Therapeutics, Inc.
Preterm Infants, Respiratory Distress Syndrome
Diaphragm Electrical Activity of Preterm Infants on nCPAP With Binasal Prongs Versus RAM Cannula
Preterm babies have immature lungs and frequent pauses in their breathing which often necessitates breathing support. Nasal Continuous Positive Airway Pressure (nCPAP) is one of the most commonly used tools, but the standard…
- Conditions
- Preterm Infants, Respiratory Distress Syndrome, CPAP, RAM Cannula
- Trial name
- NCT03121781
- Testing
- respiratory support- interface
- Where
- Canada
- Volunteers
- 20 people
- Sponsor
- Sunnybrook Health Sciences Centre
Pulmonary Hypertension of Newborn
Registry to Evaluate INOmax in Newborn Babies With Pulmonary Hypertension
Pulmonary hypertension is high blood pressure in the arteries to the lungs. It is a serious condition. It causes the blood vessels that carry blood from the heart to the lungs to become hard and narrow.
- Trial name
- PaTTerN (NCT03132428)
- Testing
- INOmax
- Where
- 30 sites in United States
- Volunteers
- 140 people
- Sponsor
- Mallinckrodt
Visual Impairment, Cerebral Visual Impairment
VIPPSTAR-G1 Digital Early Intervention for Visual Impairment
Visual impairment in infancy is associated with significant risks for neurodevelopmental impairment. Early intervention based on enriched visual and multisensory experiences may promote neuroplasticity and improve developmental…
- Conditions
- Visual Impairment, Cerebral Visual Impairment, Neurodevelopmental Disorders, Prematurity
- Trial name
- VIPPSTAR-G1 (NCT07717671)
- Testing
- VIPPSTAR Digital Early Intervention, Standard Clinical Care
- Where
- 5 sites in Belgium, Italy and 1 more
- Volunteers
- 150 people
- Sponsor
- Università degli Studi di Brescia
Neurodevelopmental Disorders
NeuroN-QI: An Intervention to Promote Preterm Infants' Neurodevelopment
NeuroN-QI aims to evaluate the effects of an intervention consisting of periods of: 1) parents/preterm infants skin-to-skin contact and auditory stimulation by the parents's voice and 2) calm without manipulation with olfactory…
- Trial name
- NCT06087744
- Testing
- NeuroN-QI, SSC alone
- Where
- 2 sites in Canada
- Volunteers
- 124 people
- Sponsor
- St. Justine's Hospital
Preterm Newborn
Radiofrequency Fields in Neonatology: Exposure and Impact on the Nervous System
Previously, the investigators showed that preterm newborns are exposed chronically to very low radiofrequency levels in average while hospitalized in NICUs.
- Trial name
- CHARLINE (NCT06281093)
- Testing
- questionary, Daily continuous recording of radiofrequency exposure levels, Follow-up of daily infants clinical parameters
- Where
- France
- Volunteers
- 200 people
- Sponsor
- Centre Hospitalier Universitaire, Amiens
Hypoxic Ischaemic Encephalopathy (HIE), Premature Birth
Healing Tiny Minds: Rural Recovery Through Virtual and Lived Experience Care
The goal of this behavioral-interventional study is to learn if the Abecedarian Approach implemented virtually for children ages 0-5 with a history of Hypoxic Ischaemic Encephalopathy (HIE) and/or premature birth produces the…
- Conditions
- Hypoxic Ischaemic Encephalopathy (HIE), Premature Birth, Cerebral Palsy, Neurological Disorder
- Trial name
- NCT06643598
- Testing
- Abecedarian Approach
- Where
- United States
- Volunteers
- 225 people
- Sponsor
- University of Wisconsin, Madison
Complications, Pregnancy
Repeat Antenatal Steroids Trial
A course of steroids given to a mother who is in labor with a premature fetus will reduce the risk of the premature infant dying or having serious complications.
- Trial name
- BEARS (NCT00015002)
- Testing
- Betamethasone
- Where
- 19 sites in United States
- Volunteers
- 486 people, healthy volunteers welcome
- Sponsor
- The George Washington University Biostatistics Center
Apnea of Prematurity, Intermittent Hypoxemia
Strap To Reduce Apnea in Preterm Infants: A Randomized Crossover Trial
The goal of this clinical trial is to learn if a chin strap helps reduce low oxygen episodes in premature babies receiving CPAP or NIPPV (breathing support through the nose).
- Conditions
- Apnea of Prematurity, Intermittent Hypoxemia, Bronchopulmonary Dysplasia of Newborn
- Trial name
- STRAP (NCT07895654)
- Testing
- Chinstrap
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- University of Alabama at Birmingham
Pre-Term, Breast Milk Expression
Preemie Milk Analyser Validation Study
This study aims to test and validate the Preemie Ecosystem- a new device and associated software package for measuring the nutrient (fat, protein and carbohydrate) content of the breast milk of the mothers of premature babies.
- Conditions
- Pre-Term, Breast Milk Expression, Nutrition Disorder, Infant
- Trial name
- NCT06486194
- Testing
- Targeted breast milk fortification using preemie device, Standard Breast milk fortification
- Where
- United Kingdom
- Volunteers
- 180 people, healthy volunteers welcome
- Sponsor
- University Hospital Southampton NHS Foundation Trust
Nutrition Disorder, Infant, Music
Lullaby and Classic Music's Effect on Vital Findings and Comfort
In the study, lullabies and classical music played to preterm babies during orogastric tube feeding; It will be tried to determine the effect on cerebral oxygenation level, vital signs and comfort levels.
- Conditions
- Nutrition Disorder, Infant, Music, Preterm, Vital Signs
- Trial name
- NCT05333575
- Testing
- Lullaby, Classic music
- Where
- 2 sites in Turkey (Türkiye)
- Volunteers
- 51 people, healthy volunteers welcome
- Sponsor
- Selcuk University
Premature Birth, Electrical Impedance Tomography (EIT)
Lung Volume Changes in Stable Preterm Infants Positioned in Car Seats
Premature infants (infants born <37 weeks' gestational age) are discharged from the hospital and transported home in car seats designed for term babies. The safe transport of these premature infants is an important concern.
- Conditions
- Premature Birth, Electrical Impedance Tomography (EIT), Lung Volume, Car Seat Transition for At-risk Infants
- Trial name
- CarSeat (NCT06724601)
- Testing
- Electrical Impedance Tomography
- Where
- Switzerland
- Volunteers
- 51 people
- Sponsor
- University of Zurich
Cerebral Disorders Congenital, Premature Birth
Italian Survey on Paediatric and Neonatal MRI
Paediatric anaesthesia care in the Magnetic Resonance Imaging is a challenge for clinicians. The recent debate about the role of anaesthetic agent on neural development, encouraged an evaluation of their actual activity in this…
- Trial name
- NCT04775641
- Testing
- questionnaire
- Where
- Italy
- Volunteers
- 876 people
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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