Clinical trials: Neonates and Preterm Infants
Very Low Birth Weight Infant, Very Preterm Maturity of Infant
Swiss Neonatal Network & Follow-up Group
The chief aim of the Swiss Neonatal Network \& Follow-Up Group (SwissNeoNet) is to maintain and / or improve the quality and safety of medical care for high-risk newborn infants and their families in Switzerland through a…
- Conditions
- Very Low Birth Weight Infant, Very Preterm Maturity of Infant, Asphyxia Neonatorum
- Trial name
- SwissNeoNet (NCT04239508)
- Where
- Switzerland
- Volunteers
- 1,000 people
- Sponsor
- Swiss Neonatal Network
PREMATURITY
Skin-to-skin Contact to Promote Bacterial Decolonization in Preterm Infants
BACKGROUND Decolonization with topical antibiotics is necessary to prevent and / or control outbreaks of multidrug-resistant bacterial infection in the NICU (Neonatal Intensive Care Unit), but can trigger bacterial resistance.
- Trial name
- NCT01498133
- Testing
- skin-to skin contact
- Where
- Brazil
- Volunteers
- 102 people, healthy volunteers welcome
- Sponsor
- Universidade Federal do Maranhão
Positive Pressure Ventilation, Preterm Infants
Applied Forces During Neonatal Face Mask Ventilation With Different Face-mask Air Cushion Volumes
Positive pressure ventilation (PPV) is the most important intervention in neonatal resuscitation. During PPV, it is important to hold the face-mask with care, as applying excessive pressure could cause injury to the infant, while…
- Conditions
- Positive Pressure Ventilation, Preterm Infants, Apnea
- Trial name
- ForVol (NCT06161389)
- Testing
- Partially inflated mask, Fully inflated mask
- Where
- Italy
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- University Hospital Padova
Total Parenteral Nutrition-induced Cholestasis, Cholestasis
Compassionate Use of Omegaven in Children
This is a single-assignment study to evaluate whether Omegaven (IV fish oil) is effective at treating liver disease in children on long-term IV nutrition.
- Conditions
- Total Parenteral Nutrition-induced Cholestasis, Cholestasis, Short Bowel Syndrome, Gastroschisis
- Trial name
- NCT02370251
- Testing
- Omegaven
- Where
- United States
- Volunteers
- 63 people
- Sponsor
- University of Oklahoma
Infant, Premature, Diseases, Bronchopulmonary Dysplasia
Forced Oscillometry in Infants With Bronchopulmonary Dysplasia
The purpose of this study is to use forced oscillometry technique (FOT) to measure pulmonary mechanics and function in in term infants and premature infants with bronchopulmonary dysplasia (BPD)
- Conditions
- Infant, Premature, Diseases, Bronchopulmonary Dysplasia, Respiratory Distress Syndrome
- Trial name
- NCT04270045
- Testing
- Non-invasive forced airway oscillometry
- Where
- United States
- Volunteers
- 80 people
- Sponsor
- Winston Manimtim
Newborn Morbidity, Respiratory Failure
Comparing Two Different Modes of Ventilation in Pretem Neonates Bilevel VG and PRVC
Intubated preterm infants between 800-1200 grams and under 32 weeks of gestational age will start with PRVC ventilation mode, basal blood gases and work of breathing will measured.
- Conditions
- Newborn Morbidity, Respiratory Failure, Bronchopulmonary Dysplasia, Mechanical Ventilation Complication
- Trial name
- NCT04191239
- Testing
- GE ventilator with two different modes
- Where
- Turkey (Türkiye)
- Volunteers
- 20 people
- Sponsor
- Ankara City Hospital Bilkent
Bronchopulmonary Dysplasia, Extremely Premature Infants
Intratracheal Umbilical Cord-derived Mesenchymal Stem Cells for Severe Bronchopulmonary Dysplasia
Mesenchymal stem cells (MSCs) have been reported to be effective to prevent alveolar growth arrest in experimental bronchopulmonary dysplasia (BPD).
- Conditions
- Bronchopulmonary Dysplasia, Extremely Premature Infants, Severe BPD That Conventional Therapies Has Failed, No Severe Congenital Anomalies
- Trial name
- NCT01207869
- Testing
- ucMSCs, Normal saline
- Where
- Taiwan
- Volunteers
- 10 people
- Sponsor
- China Medical University Hospital
Hyperbilirubinemia, Neonatal
Effectiveness of Phototherapy With and Without Probiotics
Raised serum bilirubin levels can cause kernicterus and premature infants are at increased risk due to metabolic immaturity. The standard treatment for neonatal jaundice is phototherapy but probiotics along with it can reduce the…
- Trial name
- NCT06173856
- Testing
- LED phototherapy
- Where
- Pakistan
- Volunteers
- 76 people
- Sponsor
- Fatima Jinnah Medical University
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
Infant,Premature, Bronchopulmonary Dysplasia
L-citrulline and Pulmonary Hypertension Associated With Bronchopulmonary Dysplasia
Bronchopulmonary dysplasia (BPD) is a chronic lung disease that affects up to 35% of very low birth weight infants (VLBW < 1500 g).
- Conditions
- Infant,Premature, Bronchopulmonary Dysplasia, Pulmonary Hypertension
- Trial name
- NCT03542812
- Testing
- L-Citrulline
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- University of Utah
Premature Birth of Newborn, Family
GPS (Giving Parents Support): Parent Navigation After NICU Discharge
BACKGROUND: Annually >400,000 US newborns require neonatal intensive care unit (NICU) care.1/3 will require ongoing or specialty care after discharge.
- Conditions
- Premature Birth of Newborn, Family, Immature Newborn, Newborn Morbidity
- Trial name
- GPS (NCT02643472)
- Testing
- Parent Navigator, Care Notebook
- Where
- United States
- Volunteers
- 300 people
- Sponsor
- Children's National Research Institute
Hemorrhage, Premature Infants
NIRS Monitoring in Premature Infants
This study uses frequency domain near-infrared spectroscopy coupled with diffuse correlation spectroscopy (FDNIRS-DCS) technology for monitoring cerebral blood flow (CBF) and cerebral oxygen metabolism (CMRO2) at the bedside for…
- Conditions
- Hemorrhage, Premature Infants, Newborn, Hydrocephalus
- Trial name
- NCT02601339
- Testing
- ETV/CPC
- Where
- 3 sites in United States
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Boston Children's Hospital
Bronchopulmonary Dysplasia
Follow-Up Study of Safety and Efficacy of Pneumostem® in Premature Infants With Bronchopulmonary Dysplasia
This is a long term follow-up study of the open label, single-center, phase I clinical trial to evaluate the safety of Pneumostem® in premature infants with BPD.
- Trial name
- NCT01632475
- Testing
- Pneumostem®
- Where
- 2 sites in South Korea
- Volunteers
- 9 people
- Sponsor
- Samsung Medical Center
Retinopathy of Prematurity (ROP)
Comparing Alternative Ranibizumab Dosages for Safety and Efficacy in Retinopathy of Prematurity
This study is designed as an exploratory study to assess safety and efficacy of two different doses of the anti-VEGF agent ranibizumab (0.12 mg vs. 0.20 mg) in the treatment of infants with retinopathy of prematurity.
- Trial name
- CARE-ROP (NCT02134457)
- Testing
- ranibizumab
- Where
- 9 sites in Germany
- Volunteers
- 19 people
- Sponsor
- University Hospital Freiburg
Retinopathy of Prematurity
Cost-effectiveness of Tele-expertise for Premature Infants for Retinopathy
The purpose of this study is to determine whether telemedicine would be as effective as having a pediatrics ophthalmologist on site for screening examination of retinopathy in premature infants and would be cost-effective.
- Trial name
- Dite-ROP (NCT02157727)
- Testing
- Infants hospitalized in health facilities performing Tele-expertise
- Where
- 2 sites in France
- Volunteers
- 843 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Nasal Continuous Positive Airway Pressure,, Preterm Infants,
Early NCPAP Before Surfactant Treatment in Very Preterm Infants With RDS
We hypothesis a period of early NCPAP before surfactant treatment is effective for treating RDS and preventing BPD in very premature infants.
- Conditions
- Nasal Continuous Positive Airway Pressure,, Preterm Infants,, Surfactant Treatment,, Respiratory Distress Syndrome,
- Trial name
- NCT01996670
- Volunteers
- 683 people
- Sponsor
- Xiangya Hospital of Central South University
Premature Infants, Pierre Robin Sequence
Comparison of Sucking in Premature Infants and Infants With Pierre Robin Sequence
The NUTROBIN study aims to analyze sucking in two populations of vulnerable children who require intensive and prolonged care, and whose treatment has an impact on the subsequent development of oral function.
- Conditions
- Premature Infants, Pierre Robin Sequence, Feeding Disorder
- Trial name
- NUTROBIN (NCT07604818)
- Testing
- Succiometry
- Where
- France
- Volunteers
- 26 people
- Sponsor
- Hospices Civils de Lyon
Intracranial Hemorrhages, Mesenchymal Stem Cells
Follow-Up Study of Safety of Pneumostem® in Premature Infants With Intraventricular Hemorrhage
This is a follow-up study of the open label, single-center, phase I clinical trial to evaluate the safety of Pneumostem® in premature infants with Intraventricular hemorrhage.
- Conditions
- Intracranial Hemorrhages, Mesenchymal Stem Cells, Newborn Infant
- Trial name
- NCT02673788
- Testing
- observation without intervention in this follow up study
- Where
- South Korea
- Volunteers
- 9 people
- Sponsor
- Samsung Medical Center
Newborn Complication, Premature
Between Urgency and Efficiency: Assessing the Feasibility of Implementing a Protocol for the Care of Extremely Premature and Very Low Birth Weight Infants During the First Hour of Life: GOLD Study
Premature newborns are a particularly vulnerable population, especially during the first hours of life as they adapt to life outside the womb.
- Trial name
- GOLD (NCT07461623)
- Testing
- Golden Hour protocol
- Sponsor
- Centre Hospitalier Universitaire de Nice
Early-Onset Sepses, Neonatal, Periventricular Haemorrhage Neonatal
Zinc Supplementation on Very Low Birth Weight Infant
Premature birth is a major cause of neonatal death in addition to neonatal asphyxia and infections. Early in life, premature babies must get aggressive nutrition so that there is no extrauterine growth restriction (EUGR) in the…
- Conditions
- Early-Onset Sepses, Neonatal, Periventricular Haemorrhage Neonatal, Bronchopulmonary Dysplasia, Retinopathy of Prematurity
- Trial name
- NCT04050488
- Testing
- Zinc Sulfate
- Volunteers
- 364 people, healthy volunteers welcome
- Sponsor
- Fakultas Kedokteran Universitas Indonesia