Clinical trials: Premature Birth of Newborn
Retinopathy of Prematurity, Preterm Infants
An Observational Study to Collect Data on How Aflibercept (Eylea) Given Using a Paediatric Dosing Device is Used in Preterm Babies With Retinopathy of Prematurity in the United Kingdom (UK)
This is an observational study in which only data from babies with retinopathy of prematurity (ROP) who are being treated with aflibercept (Eylea) in prefilled syringe (PFS) using a paediatric dosing device (PDD) are collected…
- Trial name
- NCT06315556
- Testing
- Aflibercept (Eylea)
- Where
- United Kingdom
- Volunteers
- 200 people
- Sponsor
- Bayer
Retinopathy of Prematurity
The Effects of Light Reduction on Retinopathy of Prematurity (Light-ROP)
To evaluate the effect of ambient light reduction on the incidence of retinopathy of prematurity (ROP).
- Trial name
- NCT00000156
- Testing
- Goggles, Ambient Light Reduction
- Where
- 3 sites in United States
- Sponsor
- National Eye Institute (NEI)
PPROM, Preterm
Preterm Rupture of Membranes Optimising Antibiotics Trial
The goal of this clinical trial is to learn which antibiotic regimen works best to prevent infection in pregnant women whose waters break early (preterm, pre-labour rupture of membranes, or PPROM) and assess the health outcomes…
- Trial name
- PROMOAT (NCT06906757)
- Testing
- Erythromycin 250mg and Amoxicillin 500mg
- Volunteers
- 3,900 people
- Sponsor
- University of Melbourne
Retinopathy of Prematurity (ROP)
Long-term Safety and Efficacy Outcome Study Comparing Children Previously Enrolled in Study ROPP-2008-01 for the Prevention of Retinopathy of Prematurity (ROP)
The main purpose of this study is to evaluate the long-term efficacy and safety outcomes following short-term exposure to rhIGF-1/rhIGFBP-3 versus standard neonatal care in Study ROPP-2008-01 (NCT01096784).
- Trial name
- PEDAL (NCT02386839)
- Testing
- rhIGF-1/rhIGFBP-3
- Where
- 16 sites in United States, Italy and 4 more
- Volunteers
- 76 people
- Sponsor
- Shire
NEC, Gastroschisis
Neokare Safety and Tolerability Assessment in Neonates With GI Problems
With an increasing body of evidence to support a causal link between drinking milk that contain cow's milk protein (CMP) and the development of gastrointestinal disturbance in infants, many clinicians avoid the use of CMP…
- Conditions
- NEC, Gastroschisis, Intestinal Perforation, Atresia, Intestinal
- Trial name
- NCT05293353
- Testing
- NeoKare Breast Milk Fortifier
- Where
- United Kingdom
- Volunteers
- 50 people
- Sponsor
- University Hospital Southampton NHS Foundation Trust
Neonatal Morbidity and Mortality, Intrauterine Growth Disorders (IUGR and Macrosomia)
Analysis on the Health of Newborns in Three Hospitals, 2008-2024
The objective of this observational study is to analyze the factors associated with neonatal morbidity and mortality in three hospitals in Quito, Ecuador, from January 2008 to June 2024.
- Conditions
- Neonatal Morbidity and Mortality, Intrauterine Growth Disorders (IUGR and Macrosomia), Prematurity Complications, Neonatal Infections
- Trial name
- NCT06758622
- Where
- Ecuador
- Volunteers
- 40,000 people
- Sponsor
- HOSPITAL GINECO OBSTETRICO ISIDRO AYORA
Immune System Diseases, Premature Infant Disease
Oral Colostrum and Its Effect on Immune System
The purpose of this project is to increase the serum immunological defenses of premature infants less then 32 weeks of gestation by administrating colostrum in the oropharyngeal mucosa versus placebo
- Conditions
- Immune System Diseases, Premature Infant Disease, Immunoglobulin Deficiency
- Trial name
- NCT03578341
- Testing
- Orally Colostrum
- Where
- 2 sites in Mexico
- Volunteers
- 96 people
- Sponsor
- Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes
Pre-Term, Persistent Ductus Arteriosus
Evaluation of the Brain and Renal Regional Oxygenation Using NIRS in Preterm Infants
This study evaluates the brain and renal oxygenation using near infrared spectroscopy in preterm infants with persistent ductus arteriosus
- Trial name
- NCT04295395
- Testing
- NONIN SenSmart model X-100 near- infrared spectrometer
- Where
- Lithuania
- Volunteers
- 150 people
- Sponsor
- Vilnius University
Prematurity
Umbilical Cord Milking on the Reduction of Red Blood Cell Transfusion Rates in Infants
Delayed cord clamp of at least 30 seconds in neonates under 37 weeks has shown that these infants have higher circulating blood volume in the first 24 hours, less need for blood transfusions, and less incidence of…
- Trial name
- NCT01523769
- Testing
- Umbilical Cord Milking
- Where
- United States
- Volunteers
- 113 people, healthy volunteers welcome
- Sponsor
- Eastern Virginia Medical School
Previous; Cesarean Section, Cicatricial, Complicating Pregnancy or Childbirth, Affecting Fetus or Newborn, Prelabor Rupture of Membranes
Balloon Induction of Labor in PROM for TOLAC
A prospective randomized controlled trial to evaluate the safety and efficacy of labor induction with a double balloon catheter (Atad Ripener Device) in women desiring TOLAC (trial of labor after cesarean) with PROM (pre labor…
- Trial name
- BILROM-TOLAC (NCT03399266)
- Testing
- Double Balloon catheter for induction of labor
- Where
- Israel
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Soroka University Medical Center
Neonatal Respiratory Distress Related Conditions, Neonatal Respiratory Failure
Automated Versus Manual Control Of Oxygen For Preterm Infants On Continuous Positive Airway Pressure In Nigeria
One in ten babies are born preterm (<37 weeks gestation) globally. Complications of prematurity are the leading cause of death in children under 5 years, with the highest mortality rate in Sub-Saharan Africa (SSA).
- Conditions
- Neonatal Respiratory Distress Related Conditions, Neonatal Respiratory Failure, Prematurity, Oxygen Toxicity
- Trial name
- NCT05508308
- Testing
- OxyMate, Manual oxygen control
- Where
- 2 sites in Nigeria
- Volunteers
- 49 people
- Sponsor
- Murdoch Childrens Research Institute
Maternal; Chorioamnionitis, Affecting Fetus, Early-Onset Sepses, Neonatal
A Chart Review of Newborns With the Presence of Confirmed or Suspected Maternal Chorioamnionitis and Utilization of the Early Onset Sepsis Calculator
This study will review practices in relation to chorioamnionitis (CAM) before and after to the implementation of the Neonatal Early-Onset Sepsis (EOS) Risk Calculator to determine the effect in the nursery at Banner - University…
- Trial name
- NCT04513691
- Testing
- EOS Calculator
- Where
- United States
- Volunteers
- 236 people
- Sponsor
- Pediatrix
Respiratory Distress Syndrome, Newborn, Premature Birth
SURFAXIN® Treatment for Prevention of Bronchopulmonary Dysplasia (BPD) in Very Low Birth Weight (VLBW) Infants.
SURFAXIN® (lucinactant) treatment will be examined in very low birth weight infants to prevent development of chronic lung disease, commonly known as bronchopulmonary dysplasia (BPD), in premature infants who have required…
- Conditions
- Respiratory Distress Syndrome, Newborn, Premature Birth, Bronchopulmonary Dysplasia
- Trial name
- NCT00215540
- Testing
- Lucinactant 175 mg/kg, Lucinactant 90 mg/kg
- Where
- United States
- Volunteers
- 136 people
- Sponsor
- Windtree Therapeutics
Preterm Birth, Pediatric Cancer
eHealth as an Aid for Facilitating and Supporting Self-management in Families With Long-term Childhood Illness
The overall aim is twofold: 1) to stretch the borderline regarding the present knowledge of clinical and economic cost-effectiveness of eHealth as an aid for facilitating and supporting self-management in families with long-term…
- Conditions
- Preterm Birth, Pediatric Cancer, Hirschsprung Disease, Congenital Malformation
- Trial name
- eChildHealth (NCT04150120)
- Testing
- e-health device with application, Mobile phone text messaging, early detection of cerebral palsy using a mobile phone application
- Where
- 7 sites in Denmark, Ethiopia and 1 more
- Volunteers
- 720 people
- Sponsor
- Lund University
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
Respiratory Distress Syndrome, Newborn, Bronchopulmonary Dysplasia
Work of Breathing During Non-invasive Ventilation in Premature Neonates
Background: Non-invasive forms of respiratory support have been developed to manage respiratory distress and failure in premature newborns without exposing them to the risks associated with invasive mechanical ventilation.
- Trial name
- NCT02788110
- Testing
- Noninvasive neurally adjusted ventilatory assist (NIV NAVA), Nasal intermittent positive pressure ventilation (NIPPV)
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Arkansas Children's Hospital Research Institute
Bacteremia, Infant, Very Low Birth Weight
Preventing Catheter-related Bacteremia When Administering Injectable Medications in Premature Infants.
This study evaluates the potential interest of a new multi-lumen infusion access device (Edelvaiss® Multiline NEO) in the prevention of catheter-related bacteremia when administering injectable drugs in premature infants.
- Trial name
- MultilineNEO (NCT02633124)
- Testing
- Edelvaiss Multiline NEO, Standard Infusion Set
- Where
- 4 sites in France
- Volunteers
- 87 people, healthy volunteers welcome
- Sponsor
- University Hospital, Lille
Pain, Acute
Assessment of Pain in Newborns and Older Infants (Infant Pain Assessment Study =
Pain assessments in non-verbal, critically ill infants represent an important clinical challenge. Older children or adults can easily express their pain, but infants lack that capability.
- Trial name
- iPAS) (NCT03330496)
- Testing
- Pain Measurement
- Where
- United States
- Volunteers
- 43 people
- Sponsor
- Stanford University
Neonatal Oxygen Desaturation, Premature
Non-Invasive Neurally Adjusted Ventilatory Assist (NAVA) Prone vs Supine in Premature Infants
This research study is being done to investigate the effect of changing an infant's body position on how hard the baby works to breathe, the baby's oxygen level, the baby's carbon dioxide level, the baby's lung volume, the baby's…
- Conditions
- Neonatal Oxygen Desaturation, Premature, Ventilator Lung; Newborn, Apnea of Prematurity
- Trial name
- NCT05968586
- Testing
- Body positioning
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Milton S. Hershey Medical Center
Preterm Birth
Effects of Mother's Voice and Heartbeat Sounds on Preterm Newborns
The purpose of this RCT is to learn more about how sounds that we experience in the womb can affect early development in premature infants.
- Trial name
- NCT01913288
- Testing
- Biological Maternal Sounds
- Where
- United States
- Volunteers
- 150 people
- Sponsor
- Brigham and Women's Hospital
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