Clinical trials: Birth Injuries
Neonatal Respiratory Distress Syndrome, Extremely Low Birth Weight Infant (ELBW)
Effective Approaches & Strategies to Ease Off Nasal CPAP In Preterm Infants
Though Nasal Continuous Positive Airway Pressure (NCPAP) is a commonly used form of non-invasive neonatal respiratory support, the optimal method of weaning off NCPAP is not well established.
- Conditions
- Neonatal Respiratory Distress Syndrome, Extremely Low Birth Weight Infant (ELBW), BronchoPulmonary Dysplasia
- Trial name
- EASEOFFNCPAP (NCT02819050)
- Testing
- NCPAP
- Volunteers
- 80 people
- Sponsor
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Hypoxic-Ischemic Encephalopathy
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of RLS-0071 in Newborns With Moderate or Severe Hypoxic-Ischemic Encephalopathy Undergoing Therapeutic Hypothermia
Hypoxic-ischemic encephalopathy (HIE) affects approximately 4,000 to 12,000 persons annually in the United States. Mortality from HIE has been reported up to 60%, with at least 25% of survivors left with significant…
- Trial name
- STAR (NCT05778188)
- Testing
- RLS-0071
- Where
- 22 sites in United States
- Volunteers
- 173 people
- Sponsor
- ReAlta Life Sciences, Inc.
Premature Birth, Respiratory Disease
Towards Life-Long Healthy Lungs: A Multidisciplinary Follow-up Framework for Preterm Infants
Approximately 8% of all births occur between 30-36 weeks of gestation ('moderate-late' prematurity). Respiratory tract infections (RTI) and wheezing illnesses disproportionally affect preterm infants resulting in a 1.5-2 fold…
- Conditions
- Premature Birth, Respiratory Disease, Respiratory Tract Infections, Preterm Birth
- Trial name
- LONG LOVE (NCT05618769)
- Testing
- LONG LOVE Framework
- Where
- Netherlands
- Volunteers
- 330 people
- Sponsor
- Franciscus Gasthuis
Intraventricular Hemorrhage, Premature Birth
Intranasal Fresh Mother's Own Milk to Prevent Intraventricular Hemorrhage in Extremely Preterm Infants
Babies born very prematurely are at risk of intraventricular hemorrhage (IVH), which is bleeding in or around the fluid-filled spaces of the brain. Most IVH occurs during the first week after birth.
- Trial name
- iF-MOM-IVH (NCT07812922)
- Testing
- Intranasal Fresh Mother's Own Milk (iF-MOM)
- Volunteers
- 67 people
- Sponsor
- University of Manitoba
Extreme Prematurity,Extremely Low Birthweight, BPD - Bronchopulmonary Dysplasia
Impact of Higher Zinc Supplementation on Neonatal Weight Velocity
Preterm infants born prematurely are more likely to have low zinc levels because they have less time to build up zinc before birth.
- Conditions
- Extreme Prematurity,Extremely Low Birthweight, BPD - Bronchopulmonary Dysplasia, Growth
- Trial name
- NCT07896070
- Testing
- 1 mg/day Zinc Supplementation, 3 mg/day Zinc Supplementation
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Augusta University
Bronchopulmonary Dysplasia (BPD), Mortality Prediction
Chloride Imbalance in Preterm Infants
In adults and children low or high blood chloride levels are linked to the risk of death. The aim of this observational study is to determine whether there is a relationship between low or high blood chloride levels and the risk…
- Conditions
- Bronchopulmonary Dysplasia (BPD), Mortality Prediction, Chloride Disorder
- Trial name
- NCT06940856
- Testing
- Incomplete response, Complete response, Bad response
- Where
- Turkey (Türkiye)
- Volunteers
- 500 people
- Sponsor
- Kanuni Sultan Suleyman Training and Research Hospital
Posttraumatic Stress Disorder (PTSD)
DElivery of Self Training and Education for Stressful Situations-Primary Care Version
This study will compare a cognitive-behavioral online self-management intervention designed for primary care treatment of war-related PTSD to a control intervention, "optimized usual primary care PTSD treatment".
- Trial name
- DESTRESS-PC (NCT01474057)
- Testing
- DESTRESS-PC, Optimized Usual Primary Care PTSD treatment
- Where
- 4 sites in United States
- Volunteers
- 133 people
- Sponsor
- Henry M. Jackson Foundation for the Advancement of Military Medicine
Transfusion, Feeding During Transfusion
Withholding Feeds During Red Blood Cell Transfusion and TRAGI
Necrotising enterocolitis (NEC) is a devastating picture that all the neonatologists are afraid of facing during the follow up of newborns.
- Conditions
- Transfusion, Feeding During Transfusion, Transfusion Related Acute Gut Injury, Necrotising Enterocolitis
- Trial name
- Tx-TRAGI (NCT02132819)
- Testing
- Withholding feeds, feeding during transfusion
- Where
- Turkey (Türkiye)
- Volunteers
- 150 people
- Sponsor
- Zekai Tahir Burak Women's Health Research and Education Hospital
Lung Injury, Preterm Birth
Positive End-Expiratory Pressure (PEEP) Levels During Resuscitation of Preterm Infants at Birth (The POLAR Trial).
Premature babies often need help immediately after birth to open their lungs to air, start breathing and keep their hearts beating.
- Trial name
- POLAR (NCT04372953)
- Testing
- Positive End-Expiratory Pressure (PEEP)
- Where
- 27 sites in United States, Australia and 5 more
- Volunteers
- 906 people
- Sponsor
- Murdoch Childrens Research Institute
Chronic Lung Disease of Prematurity, Bronchopulmonary Dysplasia
Continuous Versus Intermittent Bolus Feeding in Very Preterm Infants - Effect on Respiratory Morbidity
Chronic Lung Disease (CLD) of Prematurity is a common yet challenging co-morbidity affecting extremely premature newborns. Multifactorial influences leading to this co-morbidity is known and targeted in various research studies.
- Trial name
- CONFER (NCT03961139)
- Testing
- Method of feeding; continuous feeding OR bolus feeding
- Where
- 2 sites in Malaysia, Singapore
- Volunteers
- 150 people
- Sponsor
- National University Hospital, Singapore
Sphincter (Anal); Perineal Rupture, Obstetric
Development and Validation of a Logistic Regression Algorithm to Predict the Risk of Obstetric Anal Sphincter Injury.
An obstetric anal sphincter injury (OASI) occurs during the final stage of a vaginal delivery. This tissue laceration, even if adequately sutured, poses a substantial threat to bowel continence in women.1,2 In a recent…
- Trial name
- NCT05218837
- Testing
- Vaginal birth
- Where
- Sweden
- Volunteers
- 800,000 people
- Sponsor
- Maria Gyhagen
Preterm Birth, Bronchopulmonary Dysplasia
Improving Prematurity-Related Respiratory Outcomes at Vanderbilt
The goal of IMPROV is to identify molecular mechanisms that contribute to lung injury and long-term breathing problems in preterm infants by investigating two interrelated biochemical pathways: the urea cycle-nitric oxide pathway…
- Conditions
- Preterm Birth, Bronchopulmonary Dysplasia, Chronic Lung Disease of Prematurity
- Trial name
- IMPROV (NCT01460576)
- Where
- 2 sites in United States
- Volunteers
- 253 people
- Sponsor
- Vanderbilt University Medical Center
Acute Kidney Injury, Fluid Overload
Assessment of Worldwide Acute Kidney Injury Epidemiology in Neonates 2.0
There is a growing focus on short- and long-term kidney health in neonates, including those with acute kidney injury (AKI). AKI occurs commonly in the Neonatal Intensive Care Unit (NICU) and is associated with adverse outcomes.
- Conditions
- Acute Kidney Injury, Fluid Overload, Prematurity Complications, Risk Factors
- Trial name
- AWAKEN 2 (NCT06823115)
- Where
- 125 sites in United States, Argentina and 31 more
- Volunteers
- 8,000 people
- Sponsor
- Indiana University
Bronchopulmonary Dysplasia
TINN2: Treat Infection in NeoNates 2
The aim of the TINN2 study is to evaluate the efficacy of azithromycin in prevention of bronchopulmonary dysplasia in preterm neonates.
- Trial name
- TINN2 (NCT02282176)
- Testing
- Azithromycin
- Where
- 16 sites in Belgium, France and 7 more
- Sponsor
- Institut National de la Santé Et de la Recherche Médicale, France
Bronchopulmonary Dysplasia
Ventilation-perfusion (V/Q) Ratio and Alveolar Surface Area in Preterm Infants
To non-invasively estimate the alveolar surface area of the lungs of prematurely born infants by taking measurements of oxygen and carbon dioxide and utilizing functional morphometry.
- Trial name
- NCT04936477
- Testing
- Calculation of ventilation-perfusion ratio
- Where
- United Kingdom
- Volunteers
- 30 people
- Sponsor
- King's College London
Prematurity, Respiratory Distress Syndrome
Trial of Non Invasive Ventilation for Respiratoy Distress Syndrome
The purpose of this study is to evaluate the hypothesis that nasal intermittent positive pressure(NIPP), used as a primary mode of ventilation in preterm infants with RDS, will decrease the need for conventional endotracheal…
- Trial name
- NCT00821119
- Testing
- nasal intermittent positive pressure ventilation
- Where
- 2 sites in Brazil
- Volunteers
- 200 people
- Sponsor
- Instituto Materno Infantil Prof. Fernando Figueira
Infant, Newborn, Infant, Low Birth Weight
Physiologic Definition of Bronchopulmonary Dysplasia
This observational study was conducted to design and test a physiologic definition for bronchopulmonary dysplasia at 36 weeks of life.
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- PhysiologicDef (NCT01223287)
- Where
- 21 sites in United States
- Volunteers
- 410 people
- Sponsor
- NICHD Neonatal Research Network
Brachial Plexus Birth Palsy, Physical Therapy
Virtual Reality and Dual-Task Training for Cortical Plasticity in Children With Brachial Plexus Injury
Brachial plexus birth injury (BPBI) is a condition that occurs when the nerves controlling the arm are injured during birth, leading to weakness, limited movement, and sensory problems.
- Trial name
- NCT07291310
- Testing
- Conventional Physiotherapy Program, Virtual Reality, Dual Task
- Where
- Turkey (Türkiye)
- Volunteers
- 14 people
- Sponsor
- Istanbul Aydın University
Premature, Tracheostomy Complication
Follow-up Results of Newborns With Tracheostomy
The chances of survival in premature babies, especially in babies born under 28 weeks, have increased in recent years, and comorbidities also increase.
- Conditions
- Premature, Tracheostomy Complication, Bronchopulmonary Dysplasia
- Trial name
- FRONWT (NCT04497740)
- Where
- Turkey (Türkiye)
- Volunteers
- 80 people
- Sponsor
- Hacettepe University