Clinical trials: Preterm Neonates
Premature Birth
Use of Dynamic Elastometric Body in Preterm Newborns
The goal of this prospective pilot study is to test the use of dynamic elastomeric body in a population of preterm newborns with hyperexcitability syndrome.
- Trial name
- BODYNEO (NCT05835765)
- Testing
- Dynamic Elastometric Body in Preterm Newborns
- Where
- Italy
- Volunteers
- 24 people
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Prematurity, Low Birth Weight
Supplementation With Lactoferrin in Preterm Newborns
The main objective of the study is to evaluate the antioxidant effect of lactoferrin and its ability to reduce free radicals related diseases in the newborn.
- Trial name
- lactoprenew (NCT01172236)
- Testing
- Lactoferrin
- Volunteers
- 1,300 people
- Sponsor
- University of Siena
Hypophosphataemia, Osteopenia of Prematurity
Investigating a New Way of Giving Medicine to Newborn and Preterm Babies
There is a deficit in the number of 'age-appropriate' formulations available for the delivery of medicines to children. Liquid preparations are considered the 'gold standard' for delivering medicines to children however many of…
- Trial name
- NCT01676844
- Testing
- Oral thin film therapy (Potassium acid phosphate oral thin films), Standard therapy (Potassium acid phosphate oral solution)
- Where
- United Kingdom
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- University of Strathclyde
Neonatal İntensive Care, Nutrition With A Chronobiological Approach
The Effect of PIOMI and Chronobiological Nutrition on Readiness for Feeding, Full Transition to Oral Feeding and Body Weight
This is a randomized controlled experimental study evaluating the effects of oral motor intervention and chronobiological approach to feeding model applied to preterm infants on feeding readiness, transition to total oral feeding…
- Conditions
- Neonatal İntensive Care, Nutrition With A Chronobiological Approach, Readiness For Feding, Body Weight
- Trial name
- PIOMI (NCT07306793)
- Testing
- PIOMI study group, Nutrition Study Group with a Chronobiological Approach, Control group
- Where
- Turkey (Türkiye)
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Aydin Adnan Menderes University
Infant, Premature, Diseases
Novel Human Milk Based Human Milk Fortifier
The primary objective is to assess weight gain of VLBW infants fed human milk supplemented with a novel human milk-based fortifier, in comparison to use of other fortifiers (historic controls).
- Trial name
- MHMHMF (NCT04478487)
- Testing
- Medolac human milk based human milk fortifier (MHMHMF)
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Northwest Health
Ductus Arteriosus, Patent
Analysis of the Impact of Patent Ductus Arteriosus on Brain Function in Preterm Neonates: Multimodal Approach Integrating EEG-NIRS, Ultrasound and Clinical Data
This project corresponds to the main field of research of the investigators's laboratory concerning analysis of cerebral electrometabolic and haemodynamic activity in neonates.
- Trial name
- NNP-MULTIMODAL (NCT02803671)
- Testing
- TFU-NIRS, NIRS, EEG
- Where
- France
- Volunteers
- 51 people, healthy volunteers welcome
- Sponsor
- Centre Hospitalier Universitaire, Amiens
Neonatal Skin Conditions
Evaluation of the Effects on the Skin of Different Materials Used in Orogastric Tube Detection in Premature Babies
While medical adhesives provide fixation of devices and catheters in neonatal intensive care, they can cause disruption of skin integrity when removed.
- Trial name
- NCT06246864
- Testing
- Hydrocolloid dressing, Hypoallergenic Flexible
- Volunteers
- 60 people
- Sponsor
- Ondokuz Mayıs University
Premature Birth, Extremely Low Birth Weight
DCS Study in Extremely Premature Newborns
The researchers are attempting to improve the cerebral monitoring of extremely low gestational age (ELGA) infants, such that in the future, real-time monitoring will be possible, to aid clinicians in management of these infants.
- Conditions
- Premature Birth, Extremely Low Birth Weight, Infant, Small for Gestational Age, Intracerebral Hemorrhage
- Trial name
- NCT04367181
- Testing
- Diffuse Correlation Spectroscopy (DCS), Amplitude Integrated Electroencephalography (aEEG)
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Maria Angela Franceschini
Sleep, Cerebral Oxygenation
Respiratory Support and Brain Health in Preterm Infants
Premature babies often require breathing support during their neonatal intensive care unit stay. This is because their lungs are not fully developed to perform the work of breathing on their own.
- Trial name
- NCT05589831
- Testing
- Non-invasive Neurally Adjusted Ventilatory Assist
- Where
- Canada
- Volunteers
- 50 people
- Sponsor
- Mount Sinai Hospital, Canada
Neonatal Sepsis, Preterm Infants
Effect of Vitamin D as Adjuvant Therapy in Preterm Infants With Neonatal Sepsis
The goal of this clinical trial is to learn the effect of vitamin D as an adjunctive therapy for preterm neonates with sepsis measured by the outcomes, which are sepsis score and C-reactive protein after 7 days.
- Trial name
- NCT07245277
- Testing
- Vitamin D
- Where
- 2 sites in Indonesia
- Volunteers
- 78 people
- Sponsor
- Universitas Padjadjaran
Neonatal Respiratory Distress
Aerosolized Infasurf Treatment Protocol: Aerosolized Infasurf for Spontaneously Breathing Patients With Early RDS (AERO-03)
Surfactant replacement therapy can be life-saving for newborn infants born with symptomatic lung surfactant deficiency causing Respiratory Distress Syndrome (RDS).
- Trial name
- NCT03582930
- Testing
- Infasurf Aero
- Where
- 5 sites in United States
- Sponsor
- ONY
Cord Clamping
Timing of Umbilical Cord Clamping in Preterm Neonates
Umbilical cord clamping is an important intervention that routinely done for all neonates afterbirth. yet the optimal timing for this intervention remains controversial
- Trial name
- NCT06000800
- Testing
- Group B, Group C, Group D
- Where
- Egypt
- Volunteers
- 4 people, healthy volunteers welcome
- Sponsor
- Cairo University
Necrotizing Enterocolitis
Components of Metabolic Derangement and Paracentesis for Determination of Surgery in Preterm Neonates With Necrotizing Enterocolitis.
The aim of this clinical trial is to associate paracentesis with positive metabolic derangement components for surgical determination in preterm infants with necrotizing enterocolitis.
- Trial name
- NCT06035848
- Testing
- Association of the components of metabolic derangement and paracentesis., Bell's criteria: pneumoperitoneum
- Where
- Mexico
- Volunteers
- 117 people
- Sponsor
- Gerardo Fernández Ortega
Pain, Infant, Premature, Diseases
Continuous Infusion of Fentanyl in Preterm on MV
The objective of this randomized, double-blind trial is to compare the efficacy and safety of 2 therapeutic regimens of fentanyl administration in a population of preterm newborns of GA <= 32 weeks in MV: Group A) continuous…
- Conditions
- Pain, Infant, Premature, Diseases, Respiration; Insufficient or Poor, Newborn
- Trial name
- NCT00571636
- Testing
- Fentanyl, 5% glucose solution
- Where
- Italy
- Volunteers
- 128 people
- Sponsor
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
Newborn Morbidity, Respiratory Failure
Comparing Two Different Modes of Ventilation in Pretem Neonates Bilevel VG and PRVC
Intubated preterm infants between 800-1200 grams and under 32 weeks of gestational age will start with PRVC ventilation mode, basal blood gases and work of breathing will measured.
- Conditions
- Newborn Morbidity, Respiratory Failure, Bronchopulmonary Dysplasia, Mechanical Ventilation Complication
- Trial name
- NCT04191239
- Testing
- GE ventilator with two different modes
- Where
- Turkey (Türkiye)
- Volunteers
- 20 people
- Sponsor
- Ankara City Hospital Bilkent
Preterm Infant, Hypothermia Neonatal
Kangaroo Mother Care With Plastic Bag (Trials 2A & 2B)
The purpose of this study is to determine whether the combination of Kangaroo Mother Care (KMC) as continuously as possible together with the use of a plastic bag in combination with routine World Health Organization (WHO)…
- Trial name
- NCT03141723
- Testing
- KMC & WHO protocol (0-1 hour), KMC, WHO protocol & bag (0-1 hour), KMC & WHO protocol (1-24 hours)
- Where
- Zambia
- Volunteers
- 423 people
- Sponsor
- University of Alabama at Birmingham
Gastroenteritis
Rotavirus Vaccine in Premature Babies
This study will establish the duration of excretion of rotavirus vaccine in stool following vaccination of premature babies hospitalised in a neonatal unit at the time of vaccination.
- Trial name
- RotaNeo (NCT02252029)
- Where
- 2 sites in United Kingdom
- Volunteers
- 20 people
- Sponsor
- University of Oxford
Infant, Premature, Diseases, Infant, Newborn, Disease
Noninvasive High Frequency Oscillatory Ventilation as a Post-extubation Respiratory Support in Neonates
A randomized controlled trial comparing Noninvasive high frequency oscillatory ventilation (NHFOV) and Noninvasive positive pressure ventilation (NIPPV) as post-extubation respiratory support in preterm neonates with respiratory…
- Conditions
- Infant, Premature, Diseases, Infant, Newborn, Disease, Respiratory Tract Diseases, RDS
- Trial name
- NCT05493527
- Testing
- noninvasive high frequency oscillatory ventilation, noninvasive positive pressure ventilation
- Where
- Egypt
- Volunteers
- 60 people
- Sponsor
- Ain Shams University
Periodontitis, Premature Birth of Newborn
Feasibility and Acceptability of Use of Daily Oral Rinse in Pregnant Women in Rural Nepal
In Nepal, investigators are conducting a cohort study to estimate the relationship between signs of periodontal disease in pregnant women and preterm delivery.
- Trial name
- NCT02788786
- Testing
- Chlorhexidine, Cetylpyridinium chloride, Salt and Water
- Where
- Nepal
- Volunteers
- 175 people
- Sponsor
- Johns Hopkins Bloomberg School of Public Health
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
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