Clinical trials: Birth Injuries
Bronchopulmonary Dysplasia
Efficacy and Safety Evaluation of Pneumostem® Versus a Control Group for Treatment of BPD in Premature Infants
The objective of this study is to evaluate the efficacy and safety of a single intratracheal administration of Pneumostem® for treatment of Bronchopulmonary Dysplasia (BPD) in high-risk premature infants by comparing…
- Trial name
- NCT01828957
- Testing
- Pneumostem®, Normal Saline
- Where
- 2 sites in South Korea
- Volunteers
- 69 people
- Sponsor
- Medipost Co Ltd.
Hypoxic Ischemic Encephalopathy of Newborn, Premature Birth
Metformin Treatment in Infants After Perinatal Brain Injury
A phase I study to test the feasibility and safety of treatment with metformin in infants affected by hypoxic ischemic encephalopathy (HIE) or prematurity-related brain injury
- Trial name
- NCT05590676
- Testing
- Metformin Hydrochloride
- Where
- Canada
- Volunteers
- 1 people
- Sponsor
- The Hospital for Sick Children
Bronchopulmonary Dysplasia, Preterm
Body Weight Growth After Birth and Bronchopulmonary Dysplasia
Bronchopulmonary dysplasia (BPD) is one of the most common, complex, and severe diseases in preterm infants. BPD was first described as chronic pulmonary disease in survivors of severe respiratory distress syndrome (RDS) in 1967…
- Trial name
- NCT05053269
- Testing
- good body weight growth, poor body weight growth
- Where
- China
- Sponsor
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Neonatal Brachial Plexus Palsy
NMES Efficacy on Patients With NBPP
Neonatal Brachial Plexus Palsy (NBPP), characterized by weakness and sensory loss in the affected arm, results from damage in the prenatal period to the nerves extending from the spine to the arm.
- Trial name
- NCT01999465
- Testing
- Standard NMES device
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- University of Michigan
Premature Infants, Very Premature Infants
Anakinra Pilot 2 - A Study to Optimise Dose and Route of Administration of Anakinra in Preterm Infants
A phase 2 randomised, three-arm, parallel-group, dose-ranging trial to determine safety, efficacy and optimal dosing of intravenous anakinra in premature neonates, with subcutaneous pharmacokinetic sub-study.
- Conditions
- Premature Infants, Very Premature Infants, Inflammation
- Trial name
- AP2 (NCT07254000)
- Testing
- Anakinra (Kineret®)
- Where
- 2 sites in Australia, New Zealand
- Volunteers
- 24 people
- Sponsor
- Monash Medical Centre
Perinatal Morbidity
Post Term Pregnancy - Induction of Labor or Monitoring of Pregnancy
Post term pregnancy is a risk pregnancy. Aim of the study was to investigate whether induction of labor at gestational age 289(41 weeks+2 days) reduces neonatal morbidity compared to expectant management.
- Trial name
- NCT00385229
- Testing
- induction of labor
- Where
- Norway
- Volunteers
- 508 people
- Sponsor
- St. Olavs Hospital
Abscess
The Effect of Wound Irrigation With Irrisept on Abscess Healing (Irrisept UF Study)
The purpose of this study was to evaluate the safety and effectiveness of Irrisept compared to standard of care treatment of skin and soft tissue infections in the form of abscesses.
- Trial name
- NCT04957732
- Testing
- Standard of Care (SoC), Irrisept Delivery System
- Where
- United States
- Volunteers
- 35 people
- Sponsor
- Irrimax Corporation
Preterm Birth, Premature Birth
Exposure to Plasticisers in the Neonatal Intensive Care Unit
Neonatal intensive care relies on indwelling plastic medical devices fundamental in respiratory support, intravenous catheterization, and nutrition.
- Conditions
- Preterm Birth, Premature Birth, Neurodevelopmental Disorders, Pulmonary Disease
- Trial name
- PLASTIC-NICU (NCT05404815)
- Where
- Belgium
- Volunteers
- 132 people, healthy volunteers welcome
- Sponsor
- University Hospital, Antwerp
Cesarean Section
Comparison Study of Wound Closure at Time of Cesarean Delivery: Dermabond Glue Versus Surgical Staples
Women who have a cesarean delivery have a surgical incision on their abdomen (belly). The usual way to close this opening is with metal surgical staples.
- Trial name
- NCT00524511
- Testing
- Surgical skin staples, Dermabond
- Where
- United States
- Volunteers
- 136 people
- Sponsor
- University of Massachusetts, Worcester
Patent Ductus Arteriosus, Infant, Premature
Ibuprofen vs Expectant Management for hsPDA in Preterm Infants: Retrospective Cohort
This retrospective cohort study compares ibuprofen treatment versus expectant management for hemodynamically significant patent ductus arteriosus (hsPDA) in preterm infants.
- Trial name
- IMPACT-PDA (NCT07533721)
- Testing
- Ibuprofen
- Where
- China
- Volunteers
- 541 people
- Sponsor
- Shengjing Hospital
Perineal Tear, Perineum; Rupture
Vocalization for the Second Stage of Labor (VOCAL)
A randomized open-label trial will be conducted to evaluate the effect of vocalization as a perineal protection maneuver during the second period of labor.
- Trial name
- VOCAL (NCT03605615)
- Testing
- vocalization
- Where
- Brazil
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Instituto Materno Infantil Prof. Fernando Figueira
Deficits, Neurologic, Extreme Prematurity
SafeBoosC III Two-year Follow-up
The SafeBoosC-III 2 year follow up study will follow up on all patients randomised in the SafeBoosC-III clinical trial (NCT03770741).
- Conditions
- Deficits, Neurologic, Extreme Prematurity, Brain Damage
- Trial name
- NCT05134116
- Testing
- Treatment as usual + cerebral oximetry monitoring the first 72 hours of life
- Where
- Denmark
- Volunteers
- 1,601 people
- Sponsor
- Gorm Greisen
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
Cerebral Visual Impairment, Refractive and Accommodative Disorders
Babies in Glasses; a Feasibility Study.
This is a feasibility study to begin investigating the possibility that early use of near vision glasses will improve vision in infants at risk of Cerebral Visual Impairment (CVI), leading to further improvement in other areas of…
- Conditions
- Cerebral Visual Impairment, Refractive and Accommodative Disorders, Hypoxic-Ischemic Encephalopathy, Premature Birth
- Trial name
- BiG (NCT05048550)
- Testing
- Near vision spectacles
- Where
- United Kingdom
- Volunteers
- 55 people
- Sponsor
- Great Ormond Street Hospital for Children NHS Foundation Trust
Maternal Death Affecting Fetus or Newborn, Delivery Complication
Impact of a Smartphone Intervention on Tanzanian Women's Childbirth Location
This study investigates whether training Community Health Workers (CHW) to use a smartphone-based prenatal counseling application as a "job aid" instead of the existing paper based standard is associated with increased women's…
- Conditions
- Maternal Death Affecting Fetus or Newborn, Delivery Complication, Obstetric Complication, Birth Injuries
- Trial name
- SUSTAIN1 (NCT03161184)
- Testing
- SUSTAIN Smartphone training of CHW (SP+), SUSTAIN Paperbased training of CHW (SOC)
- Volunteers
- 572 people, healthy volunteers welcome
- Sponsor
- University of Toronto
Apnea, Infant, Premature
Randomized Trial of Nasal Continuous Positive Airway Pressure or Synchronized Nasal Ventilation in Premature Infants.
Very premature infants uniformly do not have mature functioning lungs to breathe well nor mature regulation mechanisms to breathe regularly. Assistance with a mechanical respirator is common.
- Conditions
- Apnea, Infant, Premature, Bronchopulmonary Dysplasia
- Trial name
- NCT00188968
- Testing
- Nasal Continuous Positive Airway Pressure, Synchronized Nasal Positive Pressure Ventilation
- Where
- 2 sites in Canada
- Volunteers
- 48 people
- Sponsor
- University of Manitoba
Premature Birth, Ventilator Lung; Newborn
sNIPPV Versus NIV-NAVA in Extremely Premature Infants
The aim of this study is to demonstrate a significant decrease in asynchrony with NIV-NAVA using the Servo n ventilator (Getinge, Sweden), as compared to abdominal triggered (Graseby capsule) synchronized nasal intermittent…
- Trial name
- EASYNNEO (NCT04068558)
- Testing
- VNI-NAVA/sNIPPV, sNIPPV/VNI-NAVA
- Where
- France
- Volunteers
- 14 people
- Sponsor
- Centre Hospitalier Intercommunal Creteil
Premature Infant
Bonding Quality and Gene Expression in Fullterm Infants Compared to Late Preterm Infants and Preterm Infants With Early Skin to Skin or Visual Contact
Recent research has identified differences in the quality of mother-child interaction and gene expression of six key molecules involved in stress response and neurobehavioral development in preterm infants (born <32 weeks of…
- Trial name
- NCT03366285
- Testing
- Attachment story completion taks (ASCT)
- Where
- Germany
- Volunteers
- 80 people
- Sponsor
- University of Cologne
Premature Infant, Bronchopulmonary Dysplasia
The Effects of Position on the Oxygenation Instability of Premature Infants as Documented by SpO2 Histograms
SpO2 instability is in the nature of premature infants. Hypoxic episodes occur spontaneously in many of these infants, especially after the first week of life.
- Trial name
- NCT03546543
- Testing
- Position change
- Where
- Israel
- Volunteers
- 23 people
- Sponsor
- Rambam Health Care Campus
Birth Injuries
The Effect of Primary Delivery of the Anterior Compared With the Posterior Shoulder on Perineal Trauma: a Randomized Controlled Trial
It is unknown if primary delivery of the anterior or the posterior shoulder causes less perineal tear. The objective of this trial is to evaluate the incidence and degree of perineal trauma after primary delivery of the anterior…
- Trial name
- NCT01937546
- Testing
- Primary delivery of anterior shoulder, Primary delivery posterior shoulder
- Where
- Denmark
- Volunteers
- 650 people, healthy volunteers welcome
- Sponsor
- Holbaek Sygehus