Clinical trials: Neonatal and Perinatal Conditions
Hypoxic-Ischaemic Encephalopathy, Neonatal Encephalopathy
Intranasal Breast Milk Therapy in HIE
This is an open-label prospective single-center randomized controlled trial to evaluate the effect of intranasal breast milk in hypoxic-ischemic encephalopathic neonates receiving therapeutic hypothermia on long term…
- Conditions
- Hypoxic-Ischaemic Encephalopathy, Neonatal Encephalopathy, Perinatal Asphyxia, Neonatal Hypoxic Ischemic Encephalopathy
- Trial name
- NEO-BRIGHT (NCT06746532)
- Testing
- Intranasal breast milk
- Where
- Hungary
- Volunteers
- 80 people
- Sponsor
- Semmelweis University
Hypoxic Ischemic Brain Injury, Neonatal Encephalopathy
Perinatal Brain Injury: Potential of Innovative NIRS to Optimize Hypothermia
The purpose of this study is to improve the ability of the investigators to monitor brain health in newborn babies at risk of brain injuries.
- Trial name
- NCT02793999
- Testing
- Near-Infrared Spectroscopy (NIRS)
- Where
- 3 sites in United States
- Volunteers
- 125 people
- Sponsor
- Boston Children's Hospital
Neonate, Asphyxia
Multimodal Analysis of Early Biomarkers of the Impacts of Perinatal Asphyxia
Current diagnostic methods rely primarily on clinical symptoms, supplemented by brain imaging and physiological tests. However, these signs of injury only become apparent once significant damage has occurred, thus delaying…
- Conditions
- Neonate, Asphyxia, EEG, Eye Tracking
- Trial name
- Neurobiom (NCT07702500)
- Testing
- EEG
- Where
- France
- Volunteers
- 280 people, healthy volunteers welcome
- Sponsor
- Centre Hospitalier Universitaire, Amiens
Rare Disorders, Undiagnosed Disorders
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
The Coordination of Rare Diseases at Sanford (CoRDS) is an international patient registry that serves as a centralized resource for rare disease research.
- Conditions
- Rare Disorders, Undiagnosed Disorders, Disorders of Unknown Prevalence, Cornelia De Lange Syndrome
- Trial name
- CoRDS (NCT01793168)
- Where
- United States
- Volunteers
- 20,000 people
- Sponsor
- Sanford Health
Perinatal Mortality, Cause of Neonatal Death
Verbal Autopsy to Assess Early Neonatal Death and Stillbirth
The NICHD Global Network (GN) for Women's and Children's Health Research, a multi-site, international research network, provides a unique infrastructure to implement an expanded perinatal verbal autopsy study using the FIRST…
- Conditions
- Perinatal Mortality, Cause of Neonatal Death, Cause of Stilbirth
- Trial name
- VA (NCT00640055)
- Testing
- Coordinator, Physician-assigned cause of death
- Where
- 4 sites in Guatemala, Pakistan and 2 more
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- NICHD Global Network for Women's and Children's Health
Infant, Newborn, Hypoxia, Brain
Late Hypothermia for Hypoxic-Ischemic Encephalopathy
This study is a randomized, placebo-controlled, clinical trial to evaluate whether induced whole-body hypothermia initiated between 6-24 hours of age and continued for 96 hours in infants ≥ 36 weeks gestational age with…
- Conditions
- Infant, Newborn, Hypoxia, Brain, Hypoxia-Ischemia, Brain, Encephalopathy, Hypoxic-Ischemic
- Trial name
- NCT00614744
- Testing
- Hypothermia, Normothermic Control
- Where
- 22 sites in United States
- Volunteers
- 168 people
- Sponsor
- NICHD Neonatal Research Network
Fetal Membranes, Premature Rupture
Perinatal Outcome After Premature Rupture of Membranes
Premature rupture of membranes is an important cause of neonatal morbidity and mortality, mainly because of the complications associated with this pathology (oligohydramnios, cord compression or prolapse, infection).
- Trial name
- NCT01538030
- Where
- Panama
- Volunteers
- 80 people
- Sponsor
- Saint Thomas Hospital, Panama
Stillbirths, Sudden Infant Death
Magnetic Resonance Imaging Autopsy Study
The aim of this project is to establish whether magnetic resonance (MR) imaging can provide a minimally invasive approach for post-mortem assessment of the fetus, infant and child, with similar detection rates for anomalies and…
- Trial name
- MARIAS (NCT01417962)
- Where
- 2 sites in United Kingdom
- Volunteers
- 400 people
- Sponsor
- Thayyil, Sudhin
Abnormalities, Blood Coagulation Disorder
Study of Abnormal Blood Clotting in Children With Stroke
Effective treatment and prevention strategies for childhood stroke and porencephaly can only be developed once the causes are understood.
- Conditions
- Abnormalities, Blood Coagulation Disorder, Brain Disease, Cerebrovascular Accident
- Trial name
- NCT00001927
- Where
- United States
- Volunteers
- 130 people
- Sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)
External Causes of Morbidity and Mortality, Stillbirth
Linking Facility-based Mortality Audits With Community Engagement in Gilgit-Baltistan, Pakistan
Pakistan is one of the countries in South Asia where neonatal mortality rates remain stagnant. Babies born in Pakistan encounter the highest risk of dying; of every 1,000 babies born, 46 die before the end of their first month…
- Conditions
- External Causes of Morbidity and Mortality, Stillbirth, Neonatal Death
- Trial name
- NCT03904706
- Testing
- Audits only, Audits with community feedback
- Where
- Pakistan
- Volunteers
- 1,871 people, healthy volunteers welcome
- Sponsor
- Aga Khan University
Respiratory Distress Syndrome in Premature Infant, Patent Ductus Arteriosus After Premature Birth
Combined Lung Ultrasounds and Transthoracic Electrical Bioimpedance in Preterm Infants With Respiratory Distress.
Respiratory distress syndrome (RDS) is among the most common complications of preterm birth, and typically becomes manifested soon after birth.
- Conditions
- Respiratory Distress Syndrome in Premature Infant, Patent Ductus Arteriosus After Premature Birth, Perinatal Morbidity
- Trial name
- NCT04359134
- Where
- 2 sites in Italy
- Volunteers
- 60 people
- Sponsor
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
Hypoxic-Ischemic Encephalopathy, Cell Damage
Use of Melatonin for Neuroprotection in Asphyxiated Newborns
Protection of brain development is a major aim in the Neonatal Intensive Care Unit. Hypoxic-Ischemic Encephalopathy (HIE) occurs in 3-5 per 1000 births. Only 47% of neonates have normal outcomes.
- Conditions
- Hypoxic-Ischemic Encephalopathy, Cell Damage, Asphyxia Perinatal
- Trial name
- MELPRO (NCT03806816)
- Testing
- Melatonin
- Where
- 6 sites in Holy See, Italy
- Volunteers
- 100 people
- Sponsor
- University Hospital of Ferrara
Hypoxic Ischemic Encephalopathy
Topiramate in Neonates Receiving Whole Body Cooling for Hypoxic Ischemic Encephalopathy
The goal is to see whether topiramate (an anti-epileptic agent) improves the outcome of babies with neonatal hypoxic encephalopathy who are receiving whole body cooling.
- Trial name
- NCT01765218
- Testing
- Topiramate
- Where
- United States
- Volunteers
- 34 people
- Sponsor
- Kristin R Hoffman
Infection
Determination of Gentamicin Dosing in Neonatal Patients
The purpose of this study is to determine what dosage of gentamicin for use in one-time administration device (Uniject) is appropriate.
- Trial name
- NCT00198601
- Testing
- Gentamicin in Uniject Pre-filled syringe
- Where
- 3 sites in Bangladesh, India and 1 more
- Sponsor
- Johns Hopkins Bloomberg School of Public Health
Neonatal Death, Mental Competency
Survive and Thrive Boa Vista Early Childhood Program
The proposed project will tackle the two most salient problems for children under 5 in Brazil: the continued high rates of neonatal mortality, and the large disparities in early childhood development.
- Trial name
- STBV (NCT03386747)
- Testing
- Home visits to improve parenting behaviors, Center based parenting groups
- Where
- Brazil
- Volunteers
- 15,000 people, healthy volunteers welcome
- Sponsor
- University of Sao Paulo
Death; Neonatal, Morbidity;Newborn
The TELENEO Trial: A Multicenter Trial of Telemedicine for Advanced Neonatal Resuscitations in Community Hospitals
The purpose of this study is to evaluate the impact of real-time audio-video telemedicine consults with a neonatologist (termed teleneonatology) on the early health outcomes of at-risk neonates delivered in community hospitals.
- Trial name
- NCT06087224
- Testing
- Teleneonatology
- Where
- 36 sites in United States, Canada
- Volunteers
- 947 people
- Sponsor
- Mayo Clinic
Swallowing Disorder, Perinatal Asphyxia
Effect of Non-nutritive Sucking on Transition to Oral Feeding in Infants With Asphyxia
The transition period to full oral feeding in infants with perinatal asphyxia is important in predicting long-term outcomes. The transition to independent oral feeding is accepted as a discharge criterion by the American Academy…
- Conditions
- Swallowing Disorder, Perinatal Asphyxia, Feeding; Difficult, Newborn, Feeding Disorder of Infancy or Early Childhood
- Trial name
- NCT05687708
- Testing
- Non-Nutritive Sucking
- Where
- Turkey (Türkiye)
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Medipol University
Perinatal Stroke, Hemiparesis
Perinatal Arterial Stroke: A Multi-site RCT of Intensive Infant Rehabilitation (I-ACQUIRE)
This is a Phase III clinical trial to compare the efficacy of two dosages of a new infant rehabilitation protocol - I-ACQUIRE - to usual and customary forms of infant rehabilitation in infants who experienced Perinatal Arterial…
- Trial name
- I-ACQUIRE (NCT03910075)
- Testing
- I-ACQUIRE - High Dosage, I-ACQUIRE - Moderate Dosage, Usual & Customary Treatment (U&CT)
- Where
- 15 sites in United States
- Volunteers
- 216 people
- Sponsor
- Virginia Polytechnic Institute and State University
Hypoxic-Ischemic Encephalopathy
Study of Cerebrolysin for Treatment of Infants With History of Neonatal Hypoxic Ischemic Encephalopathy
The purpose of this study is to determine whether nerve growth factor (cerebrolysin®) therapy will improve the psychomotor outcome in infants with moderate and severe hypoxic ischemic encephalopathy after hospital discharge.
- Trial name
- CerebroHIE (NCT01059461)
- Testing
- Cerebrolysin®
- Where
- 2 sites in Egypt
- Volunteers
- 40 people
- Sponsor
- Sahar M.A. Hassanein, MD
Stillbirth and Fetal Death, Termination of Pregnancy
A Feasibility Study of Virtopsy With Tissue Sampling in Besancon University Hospital
The aim of this project is to assess the feasibility of a new local post mortem procedure at Besançon University Hospital : Virtopsy+, magnetic resonance (MR) imaging with tissue sampling of the fetus and newborns.
- Conditions
- Stillbirth and Fetal Death, Termination of Pregnancy, Neonatal Death
- Trial name
- VIRTOPSY+ (NCT03877900)
- Where
- France
- Volunteers
- 26 people
- Sponsor
- Centre Hospitalier Universitaire de Besancon