Clinical trials: PreTerm Neonate, open to volunteers
Hypoxic-Ischemic Encephalopathy, Neonatal Encephalopathy
Nephroprotection Following Perinatal Asphyxia: Randomized Controlled Trial
The aim of this study is to determine the value of Pentoxifylline for nephroprotection in these neonates with perinatal asphyxia, using cystatin C, regional oxygenation measured near infrared spectroscopy and renal Doppler…
- Conditions
- Hypoxic-Ischemic Encephalopathy, Neonatal Encephalopathy, Pentoxifylline Adverse Reaction
- Trial name
- NCT07088328
- Testing
- Pentoxifylline
- Volunteers
- 30 people
- Sponsor
- Alexandria University
Bronchopulmonary Dysplasia (BPD)
Continued Pressure for Alveolar Protection (CPAP Trial)
The objective of the CPAP Trial is to test whether extending CPAP until 34 weeks' PMA or for at least 2 additional weeks compared to weaning to a nasal canula will decrease the likelihood of bronchopulmonary dysplasia or death at…
- Trial name
- CPAP (NCT07417111)
- Testing
- CPAP, Nasal Cannula
- Where
- 15 sites in United States
- Volunteers
- 860 people
- Sponsor
- NICHD Neonatal Research Network
Bronchopulmonary Dysplasia
Lung Ultrasound Score for Early Prediction of Bronchopulmonary Dysplasia in Preterm Newborns
Bronchopulmonary dysplasia (BPD) is one of the most common and severe complications of extreme prematurity, affecting approximately 40% of infants born before 28 weeks of gestation.
- Trial name
- LUS_BPD (NCT07633184)
- Testing
- Lung ultrasound at 7 (±1) days of life, Lung ultrasound at 14 (±2) days of life
- Where
- 4 sites in Italy
- Volunteers
- 40 people
- Sponsor
- Azienda USL Reggio Emilia - IRCCS
Respiratory Distress Syndrome, Newborn, Neonatal Respiratory Distress
Chest Ultrasound as Diagnostic and Prognostic Tool in Neonatal RDS
This cross-sectional study aims to evaluate the diagnostic accuracy of chest ultrasound in neonatal respiratory distress syndrome and to assess its potential prognostic value compared with chest X-ray.
- Trial name
- NCT07857304
- Volunteers
- 82 people
- Sponsor
- Assiut University
Intraventricular Hemorrhage Neonatal, Post-hemorrhagic Hydrocephalus
Advanced MRI in IVH
55,000 babies are born prematurely in the UK annually. Bleeding in the fluid spaces of the brain (ventricles) is common after prematurity; in England around 450 babies suffer from severe bleeds every year.
- Trial name
- NCT07412886
- Testing
- Advanced MRI
- Where
- 2 sites in United Kingdom
- Volunteers
- 30 people
- Sponsor
- Great Ormond Street Hospital for Children NHS Foundation Trust
Preterm Infant, Body Temperature
Air vs. Cutaneous Control Mode for Preterm Infants ≤ 32 WG in Incubators: Impact on Body Growth and Morbidity
Previous studies have shown that mortality and morbidity in preterm neonates are correlated with the fall in body temperature on admission. Hypothermia can be decreased by reducing body heat losses to the environment.
- Trial name
- ThermoKPreterm (NCT03919188)
- Testing
- air temperature control (ATC), skin servocontrol (SSC)
- Where
- France
- Volunteers
- 164 people
- Sponsor
- Centre Hospitalier Universitaire, Amiens
Respiratory Distress Syndrome RDS, Preterm Birth
Early Prediction of Lung Injury in Preterm Infants Score
The main hypothesis is that even preterm infants considered "stable" receiving non-invasive ventilation may be at risk of developing BPD due to an inhomogeneous distribution of ventilation.
- Trial name
- EPLIPS (NCT07265583)
- Where
- Italy
- Volunteers
- 104 people
- Sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
Newborn; Vitality, Nursing Caries
Effect of Intranasal Breast Milk Administration in Preterm Infants
The aim of the study was to investigate the effect of intranasal breast milk administration on cerebral oxygenation level, vital signs and time to full oral feeding in preterm infants.
- Conditions
- Newborn; Vitality, Nursing Caries, Breast Feeding
- Trial name
- NCT06706115
- Testing
- Intranasal human breast milk
- Where
- Turkey (Türkiye)
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Selcuk University
Preterm Premature Rupture of Membrane, Pregnancy, High Risk
Improvement of PPROM Management With Prophylactic Antimicrobial Therapy (iPROMPT)
To conduct an unblinded pragmatic randomized controlled trial (pRCT) "Improvement of PPROM Management with Prophylactic Antimicrobial Therapy (iPROMPT)" of a seven-day course of ceftriaxone, clarithromycin, and metronidazole…
- Conditions
- Preterm Premature Rupture of Membrane, Pregnancy, High Risk, Preterm Birth
- Trial name
- NCT06396078
- Testing
- Ceftriaxone 1000 MG, Clarithromycin 500mg, Metronidazole 500 mg
- Where
- 2 sites in United States
- Volunteers
- 56 people
- Sponsor
- Ohio State University
Stress
Swaddy, a Neonatal Positioning Device.
The objective of this clinical trial is to evaluate the effect of positional restraint on the stress level of preterm newborns, resting in the incubator.
- Trial name
- Swaddy (NCT07270055)
- Testing
- Swaddy day 1, 2, 3, Swaddy day 4, 5, 6
- Volunteers
- 56 people
- Sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Pre-eclampsia, Oocyte Donation
PRIOR Study (Pre-eclampsia Risk In Oocyte Recipients)
The aim of this prospective observational cohort study is to investigate the pathophysiological mechanisms behind and risk of pre-eclampsia in women pregnant after fertility treatment with oocyte donation.
- Conditions
- Pre-eclampsia, Oocyte Donation, Pre-Eclampsia; Complicating Pregnancy, Pre-Eclampsia; Mild
- Trial name
- PRIOR (NCT07263490)
- Where
- 6 sites in Denmark
- Volunteers
- 462 people
- Sponsor
- Copenhagen University Hospital, Hvidovre
Premature Infant Disease, Newborn Morbidity
Effects of Confortable Environment, Kangaroo Care and Music Therapy in Newborns in Neonatal Intensive Care Unit
Creating a comfortable environment, implementing kangaroo care, and incorporating music therapy are crucial interventions for newborns hospitalized in the Neonatal Intensive Care Unit (NICU).
- Trial name
- PRE-CARE (NCT06256406)
- Testing
- in the field of rehabilitation and neonatal care: the combination of Kangaroo care method and music therapy
- Where
- Italy
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Policlinico Universitario, Catania
Healthy Participants
Assessment of Neurofilaments Levels in Premature Newborns: Study of Their Early Development
This is a prospective observational study aiming to establish reference values of neurofilaments in late preterm newborns (34-37 weeks of gestation) and to evaluate their early postnatal evolution.
- Trial name
- NCT07159555
- Testing
- Blood sampling for neurofilament analysis
- Where
- Belgium
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Centre Hospitalier Universitaire de Liege
Newborn Care, Pain Management
The Effect of Breast Milk, 10% and 20% Dextrose on Pain and Physiological Variables During Heel Puncture in Infants
Pain, defined by the International Association for the Study of Pain as a subjective, sensory, and emotional experience, differs from nociception, which is merely a neural activity.
- Conditions
- Newborn Care, Pain Management, Physiological Parameters During Newborn Care İn Newborn's, Breast Milk
- Trial name
- NCT07716813
- Testing
- Administering oral breast milk in a supportive position, Administering oral 10% dextrose in a supportive position, Administering oral 20% dextrose in a supportive position
- Where
- Turkey (Türkiye)
- Volunteers
- 96 people
- Sponsor
- Mersin University
Apnea of Prematurity
MICropsampling for CAffeine in PREMature Newborns
Caffeine is one of the top five most prescribed drugs in neonatology. Caffeine has many beneficial impacts on preterm infants (cardiac, neurologic and pulmonary). One of these beneficial impacts is to prevent apnea.
- Trial name
- MICCAPREM (NCT07779915)
- Testing
- collection of an extra drop of capillary blood
- Where
- 2 sites in France
- Volunteers
- 40 people
- Sponsor
- University Hospital, Limoges
Procedural Pain
Intranasal Versus Intravenous Fentanyl For Procedural Analgesia in Preterm Neonates
Pain in neonatal life has profound long-term developmental impacts, so pain control is crucial. The intranasal (IN) route is a minimally invasive method for rapidly delivering fentanyl to provide short-term analgesia and sedation…
- Trial name
- NCT07190625
- Testing
- fentanyl intravenous, Fentanyl intranasal using atomizer, fentanyl intranasal direct
- Where
- Egypt
- Volunteers
- 75 people
- Sponsor
- Ain Shams University
PreTerm Neonate, Respiratory Distress Syndrome (RDS)
Neonatologist-Performed Lung Ultrasound (NPLUS) to Guide Respiratory Therapy
The goal of this cross-over clinical trial is to evaluate whether Neonatologist-Performed Lung Ultrasound (NPLUS) can be used in preterm babies on non-invasive breathing support to reduce the amount of oxygen they need.
- Trial name
- NCT06901206
- Testing
- Neonatologist performed lung ultrasound
- Where
- Australia
- Volunteers
- 20 people
- Sponsor
- Royal Hospital For Women
Pregnancy Related, Remote Monitoring
Feasibility of Remote eCTG Monitoring Home@Hospital in Complicated Pregnancies
The objective of this single center, interventional cohort study is to evaluate the feasibility of remote electrophysiological cardiotocography (eCTG) monitoring in complicated pregnancies in a home@hospital setting.
- Conditions
- Pregnancy Related, Remote Monitoring, Feasibility
- Trial name
- HASTA (NCT06859177)
- Testing
- Remote eCTG
- Where
- Netherlands
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Maxima Medical Center
Infant, Newborn, Diseases, Prematurity
Prophylactic Surfactant by Thin Endotracheal Catheter for Preterm Infants At Birth: the ProTeCt Trial
The goal of this clinical trial is to learn whether giving surfactant through a thin endotracheal catheter to extremely premature babies shortly after birth reduces the number of them who are ventilated in the first 3 days of…
- Conditions
- Infant, Newborn, Diseases, Prematurity, Prematurity; Extreme, Respiratory Distress Syndrome in Premature Infant
- Trial name
- proTeCt (NCT06557551)
- Testing
- Thin catheter surfactant
- Where
- Ireland
- Volunteers
- 164 people
- Sponsor
- University College Dublin
PreTerm Neonate, nCPAP
The Effect of Massage on Preterm Babies
This study was planned as a randomized controlled experimental study with pre-test post-test design in order to examine the effect of massage on pain, comfort and nutritional status in infants undergoing NCPAP in the NICU…
- Conditions
- PreTerm Neonate, nCPAP, Massage
- Trial name
- NCT06799572
- Testing
- massage
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Özlem BOZBUĞA