Clinical trials: Premature Neonates
Intrauterine Growth Retardation, Prematurity
Severe Intrauterine Growth Retardation: Developmental Newborn Intensive Care Unit (NICU) Care
The purpose of the study is to learn more about the development of small for gestational age (SGA) preterm infants and whether focusing on the infant's behavior has a positive effect on outcome.
- Trial name
- NCT00914108
- Testing
- Newborn Individualized Developmental Care
- Where
- 2 sites in United States
- Volunteers
- 30 people
- Sponsor
- Boston Children's Hospital
Patent Ductus Arteriosus
Patent Ductus Arteriosus and Splanchnic Oxygenation at First Feed
Patent ductus arteriosus (PDA) is common in preterm infants. In the presence of a large PDA, significant systemic to pulmonary shunting occurs, which may results in pulmonary hyperperfusion and systemic hypoperfusion.
- Trial name
- NCT03723889
- Volunteers
- 50 people
- Sponsor
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
Infant, Newborn, Infant, Small for Gestational Age
Hydrocortisone for BPD
The Hydrocortisone and Extubation study will test the safety and efficacy of a 10 day course of hydrocortisone for infants who are less than 30 weeks estimated gestational age and who are intubated at 14-28 days of life.
- Conditions
- Infant, Newborn, Infant, Small for Gestational Age, Infant, Very Low Birth Weight, Infant, Premature
- Trial name
- NCT01353313
- Testing
- Hydrocortisone
- Where
- 20 sites in United States
- Volunteers
- 800 people
- Sponsor
- NICHD Neonatal Research Network
Respiratory Distress Syndrome, Newborn, Respiratory Failure
Brain Oxygenation and Function of Preterm Newborns During Administration of Two Different Surfactant Preparations
The purpose of the study is to determine whether there are differences in bioelectrical function (measured by amplitude integrated electroencephalography) and brain oxygenation (measured by near infrared spectroscopy) while and…
- Trial name
- NCT01941524
- Testing
- Poractant alfa instillation, Beractant instillation
- Where
- Poland
- Volunteers
- 22 people
- Sponsor
- Poznan University of Medical Sciences
Premature Between 32 and 36 Weeks of Amenorrhoea
Place of Birth and Neonatal Health in Cases of Premature Birth Between 32 and 36 Weeks of Amenorrhoea
Moderate and late premature babies (32-36 weeks of amenorrhoea) account for around 6% of births, but 20% of neonatal deaths. These children also have an increased risk of neonatal morbidity and long-term neurodevelopmental…
- Trial name
- PREM3236 (NCT06078618)
- Where
- France
- Volunteers
- 240,000 people
- Sponsor
- Centre Hospitalier Universitaire Dijon
Acute Respiratory Distress Syndrome
Surfactant Versus Nasal Continuous Positive Airway Pressure (nCPAP) for Respiratory Distress Syndrome in the Newborn ≥ 35 Weeks of Gestation
Term and near term newborns can present acute respiratory distress syndrome (RDS). Surfactant treatment has been shown effective in reducing mechanical ventilation and oxygen treatment durations in the preterm newborn.
- Trial name
- ASPEN (NCT01306240)
- Testing
- Surfactant instillation, nCPAP
- Where
- France
- Volunteers
- 19 people
- Sponsor
- Centre Hospitalier Universitaire, Amiens
Ductus Arteriosus Patent, Respiratory Distress Syndrome
Paracetamol vs Ibuprofen for PDA Closure in Preterm Infants.
Current pharmacological options to treat an hemodynamically significant PDA (HsPDA) in preterm infants are limited to non-selective cyclo-oxygenase (COX) inhibitors, indomethacin or ibuprofen.
- Trial name
- PARIDA (NCT02056223)
- Testing
- Intravenous paracetamol, Intravenous ibuprofen
- Where
- Italy
- Volunteers
- 120 people
- Sponsor
- University of Padova
Bronchopulmonary Dysplasia, Gastroesophageal Reflux
Transpyloric Versus Gastric Feeding in Bronchopulmonary Dysplasia
The goal of this clinical trial is to learn if transpyloric tube feeding (feeding directly into the small intestine) versus gastric tube feeding tolerably and effectively reduces gastroesophageal reflux in infants born premature…
- Trial name
- NCT06534359
- Testing
- Transpyloric tube feeding, Gastric tube feeding
- Where
- 4 sites in United States
- Volunteers
- 60 people
- Sponsor
- Children's Hospital of Philadelphia
Neonatal Respiratory Distress Syndrome, Prematurity
Breathing Variability and NAVA in Neonates
The current study is a crossover trial, aiming at evaluating the effect of NAVA -NIV compared to Nasal Intermittent Positive Pressure Ventilation (PC-NIV) at the same level of peak inspiratory pressure, in terms of…
- Trial name
- BRAVe NANO (NCT04000568)
- Testing
- Respiratory support: NAVA -NIV and PC-NIV
- Where
- Italy
- Volunteers
- 25 people
- Sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Neonatal Late Onset Sepsis
Pentoxifylline and Late Onset Sepsis in Preterm Infants
Hypothesis: The investigators hypothesized that Pentoxifylline has potent anti-inflammatory effect which can augment the antimicrobial effect of antibiotics in treatment of Late onset sepsis (LOS) in preterm infants thus…
- Trial name
- NCT02163174
- Testing
- Pentoxifylline (PTX)
- Where
- Egypt
- Volunteers
- 120 people
- Sponsor
- Abd Elazeez Attala Shabaan
Ventilator-Associated Pneumonia (VAP), Neonatal, Bronchopulmonary Dysplasia (BPD)
National Surveillance and Prevention of Neonatal VAP
The goal of this observational study is to improve how hospital-acquired lung infections (called ventilator-associated pneumonia, or VAP) are diagnosed, treated and prevented in very low birth weight (VLBW) infants, babies born…
- Conditions
- Ventilator-Associated Pneumonia (VAP), Neonatal, Bronchopulmonary Dysplasia (BPD), Antibiotic-Resistant Organisms (AROs), Health-Care Associated Infection (HAI)
- Trial name
- NCT07109791
- Where
- Canada
- Volunteers
- 1,500 people
- Sponsor
- University of Alberta
Human Milk Fortification, Very Low Birth Weight Baby
Enrichment of Human Milk With Human and Bovine Milk-based Fortifiers for Very Preterm Infants: a Meta-analysis
Research has shown that provision of mother's milk is the optimal way to feed very low birthweight (VLBW) infants. Many infants will require a supplement to mother's milk, pasteurized donor human milk (PDHM) compared to preterm…
- Conditions
- Human Milk Fortification, Very Low Birth Weight Baby, Human Milk Nutrition, Human Milk Feeding
- Trial name
- NCT06870318
- Testing
- No intervention; Observational study
- Where
- 2 sites in Canada, Sweden
- Volunteers
- 355 people
- Sponsor
- The Hospital for Sick Children
Bronchopulmonary Dysplasia (BPD), Premature Births
PK, Safety and Preliminary Efficacy Study of Montelukast in Critically Ill Infants With Developing Bronchopulmonary Dysplasia
The purpose of the study is to learn how safe montelukast may be in premature infants at significant risk for Bronchopulmonary Dysplasia (BPD) and to determine how much and how quickly montelukast moves from the stomach into the…
- Conditions
- Bronchopulmonary Dysplasia (BPD), Premature Births, Critical Illness
- Trial name
- PRISM (NCT07101640)
- Testing
- montelukast 4 mg granule
- Where
- 5 sites in United States
- Volunteers
- 28 people
- Sponsor
- Duke University
Infant, Small for Gestational Age, Growth Hormone Treatment
Early hGH Treatment of SGA Infants to Prevent Irreversible Neurologic and Psychological Damage and Sequelae
SGA Infants who do not show a developmental catch-up growth within the first 6 months of life fall in the category of SGA children shown to have defects in the GH/IGF-I axis, resulting in partial hGH/IGF-I deficiency.
- Conditions
- Infant, Small for Gestational Age, Growth Hormone Treatment, Infant, Premature, Diseases
- Trial name
- hGH (NCT02326610)
- Testing
- Human growth hormone,ZOMACTON® (somatropin)
- Volunteers
- 20 people
- Sponsor
- Tel-Aviv Sourasky Medical Center
Bronchopulmonary Dysplasia, Infant,Premature
Efficacy of Adding Budesonide to Poractant Alfa to Prevent Bronchopulmonary Dysplasia.
This study evaluates the addition of budesonide to poractant alfa to prevent bronchopulmonary dysplasia in preterm infants with respiratory distress syndrome.
- Conditions
- Bronchopulmonary Dysplasia, Infant,Premature, Respiratory Distress Syndrome
- Trial name
- NCT03521063
- Testing
- Budesonide, Poractant Alfa, Saline
- Where
- Mexico
- Volunteers
- 108 people
- Sponsor
- Hospital Central "Dr. Ignacio Morones Prieto"
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
Respiratory Distress Syndrome, Newborn
Amniotic Fluid Optical Density Determination as a Test for Assessment of Fetal Lung Maturity.
To determine the relationship between the result of amniotic fluid optical density between 26 and 36 6/7 weeks of pregnancy and the risk of developing neonatal respiratory distress syndrome.
- Trial name
- NCT02332304
- Testing
- Preterm fetus
- Where
- Panama
- Volunteers
- 200 people
- Sponsor
- Saint Thomas Hospital, Panama
Infant, Very Low Birth Weight
Urine VEGF Levels in Very Low Birth Weight (VLBW) Infants
VLBW infants are at risk of developing retinopathy of prematurity (ROP). In the first phase of ROP there is a down-regulation of retinal VEGF-expression because of postnatal relative hyperoxia, followed by an upregulation of VEGF…
- Trial name
- NCT00799721
- Where
- Germany
- Volunteers
- 160 people
- Sponsor
- Charite University, Berlin, Germany
Preterm Birth, Intra-uterine Growth Restriction
Consequences of Antiangiogenic Factors Involved in Preeclampsia on Intra-uterine Growth Restricted Preterm Newborn
Preeclampsia complicates about 2-7% of pregnancies and is a major contributor to maternal and neonatal morbidity and mortality worldwide.
- Conditions
- Preterm Birth, Intra-uterine Growth Restriction, Maternal Preeclampsia, Bronchopulmonary Dysplasia
- Trial name
- ANGIODYS (NCT01648855)
- Testing
- Biological samples
- Where
- France
- Volunteers
- 33 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Bronchopulmonary Dysplasia
Stem Cells for Bronchopulmonary Dysplasia
Very preterm infants are at high risk to develop to bronchopulmonary dysplasia (BPD) for the lack of effective measures to prevent or ameliorate this common and serious disorder.
- Trial name
- NCT03378063
- Testing
- transplantation of mesenchymal stem cell, no transplantation of mesenchymal stem cell
- Where
- China
- Sponsor
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
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