Clinical trials: Newborn Infant
Neonatal Encephalopathy, Cell Damage
Inflammation and Metabolic Acidosis at Birth (AGAIN: AutophaGy AcIdosis Newborn)
Protection of brain development is a major aim in the Neonatal Intensive Care Unit. Neonatal encephalopathy (NE) occurs in 1.8 to 7.7 infants per 1000 births.
- Conditions
- Neonatal Encephalopathy, Cell Damage, Metabolic Acidosis, Inflammation
- Trial name
- AGAIN (NCT03897101)
- Where
- 2 sites in Italy
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- University Hospital of Ferrara
Newborn; Vitality, Iron Deficiency Anemia
The Importance of Delayed Cord Clamping
After birth, the umbilical cord is usually clamped and separated from the placenta within the first 30 seconds. Although the exact time to clamp the umbilical cord is unknown, allowing placental transfusion after birth has many…
- Trial name
- NCT06405867
- Testing
- delayed cord clamping (> 60 sec)
- Where
- Turkey (Türkiye)
- Volunteers
- 316 people, healthy volunteers welcome
- Sponsor
- Goztepe Prof Dr Suleyman Yalcın City Hospital
Functional Gastrointestinal Disorders, Infant, Newborn, Diseases
Quantification of Fecal Calprotectin Concentration Difference Between Infants Aged Under 4 Months Old Suffering From Functional Gastrointestinal Disorders (FGID) and Infants Aged Under 4 Months Old Free From Disorders : a Transversal Case-control Monocentric Study
There is a high prevalence of FGID among infants : 30 % for regurgitations, 20 % for colitis , 15 % for functional constipation.This represents a frequent motive for pediatrics consultation : 23 to 28 % of medical consultations…
- Trial name
- Cal-IBS (NCT05936112)
- Testing
- Fecal calprotectin dosage, Questionnaire and interview with parents
- Volunteers
- 100 people
- Sponsor
- Centre Hospitalier Universitaire de Besancon
Cystic Fibrosis
Antibiotic Treatment Of Staphylococcus Aureus In Stable People With CF
This is a randomized, double-blinded study that aims to assess the effect of an oral antibiotic called Cephalexin (150 mg/kg/day) compared to placebo in clinically stable children with cystic fibrosis who have grown a bacteria…
- Trial name
- ASAP-CF (NCT04553419)
- Testing
- Cephalexin
- Where
- 2 sites in Canada
- Volunteers
- 86 people
- Sponsor
- University of British Columbia
Adrenal Insufficiency
Extension Study for Patients Entered Into Study Infacort 003
A Phase 3, open-label, single-group, non-randomised, observational study of the safety and biochemical disease control of Infacort® in neonates, infants and children with adrenal insufficiency and congenital adrenal hyperplasia…
- Trial name
- NCT02733367
- Testing
- Infacort®
- Where
- Germany
- Volunteers
- 18 people
- Sponsor
- Neurocrine UK Limited
Hypoxic Ischaemic Encephalopathy
Xenon and Cooling Therapy in Babies at High Risk of Brain Injury Following Poor Condition at Birth
This study examines the effect of inhaled xenon gas in the treatment of newborn infants with hypoxic-ischemic encephalopathy (HIE) in combination with cooling, which is the standard treatment for this condition.
- Trial name
- CoolXenon2 (NCT01545271)
- Testing
- xenon gas, Whole body cooling
- Where
- United Kingdom
- Volunteers
- 32 people
- Sponsor
- University Hospitals Bristol and Weston NHS Foundation Trust
Methamphetamine Abuse, Newborn Complication | Patient | Neonatalology
Cardiovascular Effects of Prenatal Methamphetamine Exposure
Methamphetamine (MA) is one of the commonly used drugs during pregnancy. Cardiovascular effects of MA include elevated blood pressure, acute vasospasm, atherosclerotic disease, structural and electrical remodeling of cardiac…
- Trial name
- NCT04616625
- Where
- 2 sites in United States
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- University of California, Davis
Newborn Screening
Genetic Newborn Screening for Rare Diseases Within the Screen4Care Project
The main objective of the genetic newborn screening part of the Screen4Care-project is to shorten the path to rare disease diagnosis and to facilitate early intervention.
- Trial name
- SCREEN4CARE (NCT06549218)
- Testing
- newborn genetic screening and whole genome sequencing
- Where
- 8 sites in France, Germany and 1 more
- Volunteers
- 20,000 people, healthy volunteers welcome
- Sponsor
- University Hospital Freiburg
Congenital Heart Disease
Inhaled NO as an Anti-inflammatory and Anti-reperfusion Agent in Infants and Children Undergoing Cardiopulmonary Bypass
Each year, there are over 400,000 cardiac surgical operations performed in the United States; of which 10,000 are performed on children.
- Trial name
- NCT00585013
- Testing
- Nitric Oxide
- Where
- United States
- Volunteers
- 17 people
- Sponsor
- Washington University School of Medicine
Infants With Positive GBS Bacteremia
Clinical Outcome of Neonates With GBS Positive Culture-12 Year Retrospective Study
Streptococci group B (GBS) is a the major reason for morbidity and mortality in neonates. It can present as pneumonia ,meningitis or sepsis.The mortality today is 5-20% and even more in preterm babies.
- Trial name
- NCT00326313
- Volunteers
- 74 people
- Sponsor
- Sheba Medical Center
Congenital Cytomegalovirus Infection
Diagnosis of Congenital CMV Infection in Neonates Who Failed Newborn Hearing Screening
Universal hearing screening at birth by use of otoacoustic emission (OAE) is now offered in most maternities in France to detect symptomatic hearing impairment at birth but screening of cCMV infection is not coupled with this…
- Trial name
- CYMEAUDIT (NCT02139423)
- Testing
- CMV PCR
- Where
- France
- Volunteers
- 235 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Acute Respiratory Tract Infections, Diarrhea
Home Based Child Care to Reduce Mortality and Malnutrition in Tribal Children of Melghat, India: CRCT
Melghat is poorly developed tribal area in India with very high child mortality \& malnutrition prevalence (grossly inadequate medical facilities). Important health problems.
- Conditions
- Acute Respiratory Tract Infections, Diarrhea, Malaria, Neonatal Sepsis
- Trial name
- HBCC (NCT02473796)
- Testing
- Home based child care
- Where
- India
- Volunteers
- 7,594 people
- Sponsor
- MAHAN Trust
Periventricular Leukomalacia, White Matter Disease
Cell-Based Therapy for White Matter Repair in Periventricular Leukomalacia
The goal of this study is to explore a new treatment that may help repair brain damage in individuals with periventricular leukomalacia (PVL), a condition that affects white matter in the brain.
- Conditions
- Periventricular Leukomalacia, White Matter Disease, Hypoxic-Ischemic Encephalopathy, Demyelinating Diseases
- Trial name
- NCT06985303
- Testing
- Investigational Combination Product
- Sponsor
- MGAM LLC
Staphylococcal Sepsis
Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity Study in VLBW Neonates of BSYX-A110
The purpose of this study is to evaluate the safety (including tolerability), pharmacokinetics, pharmacodynamics and clinical activity of BSYX-A110 administered in a 3-dose regimen on Study Days 0, 7, and 14.
- Trial name
- N003 (NCT00631800)
- Testing
- Pagibaximab (formerly BSYX-A110)
- Where
- United States
- Volunteers
- 88 people, healthy volunteers welcome
- Sponsor
- Biosynexus Incorporated
Respiratory Distress Syndrome in Premature Infant, Bronchopulmonary Dysplasia
Efficacy of Recombinant Human Clara Cell 10 Protein (rhCC10) Administered to Premature Neonates With Respiratory Distress Syndrome
Bronchopulmonary Dysplasia (BPD) is a multi-factorial disease process that is the end result of an immature, surfactant deficient lung that has been exposed to hyperoxia, mechanical ventilation and infection.
- Trial name
- NCT01941745
- Testing
- Half normal saline, Low Dose rhCC10, High dose rhCC10
- Where
- 3 sites in United States
- Volunteers
- 88 people
- Sponsor
- Tufts Medical Center
Cystic Fibrosis
CHaractErizing CFTR Modulated Changes in Sweat Chloride and Their Association With Clinical Outcomes
This is a multicenter, cross-sectional, cohort study which will collect contemporary sweat chloride (SC) values from approximately 5000 Cystic Fibrosis (CF) patients prescribed and currently receiving commercially approved Cystic…
- Trial name
- CHEC-SC (NCT03350828)
- Where
- 52 sites in United States
- Volunteers
- 5,000 people
- Sponsor
- Nicole Hamblett
Vacuum Extraction
Development of a Risk Score to Predict the Vacuum Extraction Failure
Safe operative vaginal delivery requires a careful assessment of the clinical situation. During the pushing efforts, the complexity of the delivery can lead to choose between an operative vaginal delivery attempt and a caesarean…
- Trial name
- FADS (NCT03853499)
- Testing
- No intervention (observational study)
- Where
- France
- Volunteers
- 1,743 people, healthy volunteers welcome
- Sponsor
- Centre Hospitalier Universitaire de Besancon
Infants Admitted to Neonatal Units, NICU
Effects of Early Physiotherapy Program on the Infants in NICU
High-risk of Infants are defined as one with a history of negative environmental and biological factors that could lead to neuromotor developmental problems.
- Conditions
- Infants Admitted to Neonatal Units, NICU, NICU Infants, Family Centered Care
- Trial name
- NCT07201792
- Testing
- Early Physiotherapy
- Where
- Turkey (Türkiye)
- Volunteers
- 100 people
- Sponsor
- Kahramanmaras Sutcu Imam University
Pregnancy Complications, Maternal Death
Nutrition Optimalization Among Pregnant Women to Improve Maternal and Neonatal Outcome in DKI Jakarta
The goal of this MONAS Study is to learn about comprehensive monitoring and nutritional intervention among pregnant women in order to improve maternal and neonatal outcomes. The main questions it aims to answer are: 1.
- Conditions
- Pregnancy Complications, Maternal Death, Preeclampsia, Intrauterine Infection
- Trial name
- MONAS (NCT06268509)
- Testing
- Nutritional panel laboratory examination, Pregnancy supplements (other than provided by Ministry of Health), Fetomaternal ultrasound
- Where
- Indonesia
- Volunteers
- 245 people
- Sponsor
- Dr Cipto Mangunkusumo General Hospital
Pregnancy Outcome Trends in Low-resource Geographic Areas
Maternal Newborn Health Registry
The primary purpose of this population-based study is to quantify and understand the trends in pregnancy outcomes in defined low-resource geographic areas over time, in order to provide population-based data on stillbirths…
- Trial name
- MNH (NCT01073475)
- Testing
- There is no intervention associated with the parent MNHR study. For the MNHR COVID sub-study, participants will be asked to provide a blood specimen at or near delivery.
- Where
- 15 sites in United States, Bangladesh and 5 more
- Volunteers
- 950,000 people, healthy volunteers welcome
- Sponsor
- NICHD Global Network for Women's and Children's Health
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