Clinical trials: Neonates and Preterm Infants
Bronchopulmonary Dysplasia (BPD)
Enteral Lipid Supplementation and Bronchoplumonary Dysplasia of Premature Infants
The Impact of Omega-3 (DHA - Docosahexaenoic Acid) and Omega-6 (ARA - Arachidonic Acid) Supplementation on the Development of Bronchopulmonary Dysplasia in Extremely and Very Preterm Infants (24-29 weeks of gestational age).
- Trial name
- PRELUDE (NCT07652684)
- Testing
- Enteral supplementation with ARA and DHA (in a 2:1 ratio) in addition to standard care and feeding, Standard care and feeding
- Where
- Greece
- Volunteers
- 74 people
- Sponsor
- Aristotle University Of Thessaloniki
Sepsis, Pre-Term
Olive Oil Massage Effect for Reduction of Preterm Sepsis (OMEPS)
The OMEPS trial is a randomized clinical trial in the western region of Saudi Arabia. Conducted to assess the safety and feasibility of olive oil as massage for preterm infants and if associated with reduced risk of Late-Onset…
- Conditions
- Sepsis, Pre-Term, Late-Onset Neonatal Sepsis
- Trial name
- OMEPS (NCT04717037)
- Testing
- Olive Oil Massage
- Where
- 2 sites in Saudi Arabia
- Volunteers
- 300 people
- Sponsor
- King Abdullah International Medical Research Center
Maternal Depression
Problem Solving Education and Neonatal Intensive Care Unit (NICU) Mothers
Premature infants are born at substantial risk for poor health and developmental outcomes, which commonly include hearing and vision problems, developmental delays, and poor school performance.
- Trial name
- Project Solve (NCT01214967)
- Testing
- Problem Solving Education
- Where
- 2 sites in United States
- Volunteers
- 50 people
- Sponsor
- Boston Medical Center
Prematurity; Extreme
High Flow Nasal Cannula in Preterm Infants
The HIFLO study evaluates the impact of HFNC oxygen therapy on duration of nCPAP therapy, oxygen therapy and hospitalization. The cost of use of CPAP and two HFNC devices are also evaluated.
- Trial name
- HIFLO (NCT03007056)
- Testing
- High flow nasal cannula
- Where
- France
- Volunteers
- 207 people
- Sponsor
- Hôpital de la Croix-Rousse
Ventilator Lung; Newborn, Hemodynamic Instability
Cardiorespiratory Effects of Nasal High Frequency Ventilation in Neonates
The aim of the present work is to study the cardio-respiratory effects of non-invasive ventilation (nasal high-frequency ventilation and nasal CPAP) as an initial therapy of respiratory distress in moderate and late preterm…
- Conditions
- Ventilator Lung; Newborn, Hemodynamic Instability, Echocardiography
- Trial name
- NCT05706428
- Testing
- NHFOV, NCPAP
- Where
- Egypt
- Volunteers
- 100 people
- Sponsor
- Alexandria University
Premature Birth of Newborn
The Effect of Perinatal Stress on the Development of Preterm Infants
In this project, the investigators will study a cohort of preterm infants, together with their parents, during NICU hospitalization and follow their developmental trajectory until the age of two.
- Trial name
- RESILIENCE (NCT02623400)
- Where
- Belgium
- Volunteers
- 174 people
- Sponsor
- Universitaire Ziekenhuizen KU Leuven
Premature Birth of Newborn, Enterocolitis, Necrotizing
A Randomized Controlled Trial Investigating if Antibiotic Use in the First 48 Hours of Life Adversely Impacts the Preterm Infant Microbiome
The purpose of this study is to determine whether antibiotics given immediately after birth alter the development of the developing preterm infant's microbiome, which may further alter overall clinical outcomes.
- Trial name
- NCT02477423
- Testing
- Ampicillin, Gentamicins
- Where
- United States
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- University of Chicago
Infant, Newborn, Diseases, Infant Development
Probiotics and the Neurodevelopment in the Premature Infant <32 Weeks Gestational Age and <1500g
Unicentric, quasi-experimental, cohort study to evaluate the effect of combining two probiotics (Bifidobacterium bifidum NCDO 2203 and Lactobacillus acidophilus NCDO 1748) in the neurodevelopment of preterm neonates below 32…
- Trial name
- NCT05945017
- Testing
- Infloran® -Berne, Switzerland- (Bifidobacterium bifidum NCDO 2203 and Lactobacillus acidophilus NCDO 1748
- Where
- Spain
- Volunteers
- 233 people
- Sponsor
- Fundacion Clinic per a la Recerca Biomédica
Respiratory Distress Syndrome, Newborn
Antepartum Betamethasone Treatment for Prevention of Respiratory Distress in Infants Born by Elective Cesarean Section
This is a randomized, multicenter, double blind, placebo controlled trial of betamethasone versus a placebo given prior to the mothers at term and near term gestation (>34 and <40 weeks of gestation) who are scheduled to undergo…
- Trial name
- NCT00139256
- Testing
- Betamethasone
- Where
- United States
- Volunteers
- 67 people, healthy volunteers welcome
- Sponsor
- Emory University
Infant, Newborn, Infant, Low Birth Weight
Dexamethasone Therapy in VLBW Infants at Risk of CLD
Infants who are on breathing support are often treated with steroids (dexamethasone); however, the best timing of therapy is not known.
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- Dexamethasone (NCT00011362)
- Testing
- Dexamethasone Early, Dexamethasone Late
- Where
- 13 sites in United States
- Volunteers
- 371 people
- Sponsor
- NICHD Neonatal Research Network
Premature; Infant, Light-for-dates, Breastfeeding
Probiotics and Early Microbial Contact in Preterm Neonates
Probiotics are live microbes which, when administered in sufficient amounts, confer a health benefit to the host. According to recent clinical trials, administration of probiotics to very low birth weight infants significantly…
- Trial name
- ProPre (NCT01454661)
- Testing
- LGG, LGG+Bb-12
- Where
- Finland
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Turku University Hospital
Persistent Ductus Arteriosus
Betamethasone and Closure of Ductus Arteriosus
The ductus arteriosus (DA) normally closes after birth as a result of exposure to oxygen. Its persistence of DA (PDA) occurs in 20 to 50% of very preterm infants and is associated with significant morbidity and mortality…
- Trial name
- CELESTE (NCT05987202)
- Testing
- DA closure in a population of premature infants
- Where
- France
- Volunteers
- 51 people
- Sponsor
- Hospices Civils de Lyon
Prematurity, Oxidative Injury
Comparison of Different Oxygen Delivery Strategies During Resuscitation of Babies
Preterm infants are born with immature lungs and often require help with breathing shortly after birth. This currently involves administering 100% oxygen.
- Conditions
- Prematurity, Oxidative Injury, Respiratory Distress
- Trial name
- NCT00356902
- Testing
- titration of oxygen during resuscitation
- Where
- Canada
- Volunteers
- 215 people
- Sponsor
- University of Calgary
Feeding; Difficult, Newborn, Premature
A New Intervention Method to Enhance Oral Feeding Ability in Premature Infants: A Randomized Controlled Trial
Indonesia is the fifth country with the highest number of premature infants in the world. Research has shown that as many as 40% to 70% of premature infants exhibit both immature and atypical feeding skills and those requiring…
- Trial name
- NCT04945967
- Testing
- New Method, Conventional Method
- Where
- Indonesia
- Volunteers
- 70 people
- Sponsor
- Universitas Indonesia
Intrahepatic Cholestasis of Pregnancy, Respiratory Distress Syndrome, Newborn
Impact of Intrahepatic Cholestasis of Pregnancy on Neonatal Respiratory Outcomes
Intrahepatic cholestasis of pregnancy is a liver condition in late pregnancy, causing itching and high bile acid levels that return to normal after birth.
- Trial name
- CHOLE-RESP (NCT06679972)
- Where
- Romania
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Carol Davila University of Medicine and Pharmacy
Malaria
Congenital and Neonatal Malaria in Mali
This study will look at blood samples taken from 300 preterm babies and newborns admitted for inpatient care at Hopital Gabriel Toure in Bamako, Mali, and to gather information that will help the investigators verify the role of…
- Trial name
- NCT00384267
- Where
- Mali
- Volunteers
- 44 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Bronchopulmonary Dysplasia (BPD)
Metformin for Premature Infants With Bronchopulmonary Dysplasia
The overall objective of this study is to investigate the role of metformin in decreasing lung injury and promoting lung growth in premature infants. There are two phases to this pilot study.
- Trial name
- NCT07120971
- Testing
- Metformin (open-label)
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Medical College of Wisconsin
Psychomotor Impairment
Correlation Between Cerebral Oxygenation and Neurodevelopment in VLBW Preterm Infants.
The recent improvements in neonatal intensive care have led to a substantial increase in the survival rate of preterm infants; nevertheless, this population is still at high risk for long-term neurodevelopmental disabilities.
- Trial name
- NCT03104296
- Testing
- Griffiths Mental Development Scales
- Where
- Italy
- Volunteers
- 63 people
- Sponsor
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
Early-Onset Neonatal Sepsis, Antibiotic Stewardship
Efficacy And Safety Of Short Course Antibiotic Therapy In Preterm Neonates With Early Onset Sepsis
Objective of the study is to compare the efficacy and safety of 'Short duration antibiotic' (72hrs) and 'Standard duration antibiotic'(5 - 7days) in preterm neonates ( >28weeks and >1000grams ) with culture negative early onset…
- Trial name
- NCT06197269
- Testing
- Short duration antibiotics, Standard duration antibiotics
- Where
- India
- Volunteers
- 75 people
- Sponsor
- Lady Hardinge Medical College
Preterm Birth, Ventilator Lung; Newborn
Cerebral Oxygenation in Preterm Neonates with Respiratory Support During Skin-to-skin Care on the First Day After Birth
This is a prospective observational pilot study investigating if skin-to-skin care (SSC) has an influence on cerebral oxygenation and perfusion measured with near-infrared spectroscopy (NIRS) compared to incubator care in…
- Trial name
- Kangaroo (NCT04865302)
- Testing
- SSC
- Where
- Austria
- Volunteers
- 43 people
- Sponsor
- Medical University of Graz
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