Clinical trials: Neonatal Disorder
Feeding Disorder Neonatal
Feasibility of Aerodigestive Stimulation Therapy Trial
The goal of this study is to demonstrate safety, feasibility, and efficacy of a novel pharyngo-esophageal stimulation technique in restoring aerodigestive and swallowing functions in select infants at-risk for chronic gavage tube…
- Trial name
- FAST (NCT06118697)
- Testing
- Esophageal stimulation with high resolution esophageal manometry and nutritive oral feeding therapy
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Sudarshan Jadcherla
Congenital Disorders, Cerebral Desaturation
International Study of Cerebral Oxygenation and Electrical Activity During Major Neonatal Surgery
The goal of this observational study is to determine the incidence of perioperative cerebral desaturation in neonates undergoing surgery for congenital malformations. The main questions it aims to answer are: 1.
- Conditions
- Congenital Disorders, Cerebral Desaturation, Neonatal Surgery
- Trial name
- NCT05673499
- Testing
- NIRS/EEG monitoring
- Where
- 15 sites in United States, Australia and 5 more
- Volunteers
- 900 people
- Sponsor
- Children's Hospital of Philadelphia
Pre-eclampsia, Oocyte Donation
PRIOR Study (Pre-eclampsia Risk In Oocyte Recipients)
The aim of this prospective observational cohort study is to investigate the pathophysiological mechanisms behind and risk of pre-eclampsia in women pregnant after fertility treatment with oocyte donation.
- Conditions
- Pre-eclampsia, Oocyte Donation, Pre-Eclampsia; Complicating Pregnancy, Pre-Eclampsia; Mild
- Trial name
- PRIOR (NCT07263490)
- Where
- 6 sites in Denmark
- Volunteers
- 462 people
- Sponsor
- Copenhagen University Hospital, Hvidovre
Necrotising Enterocolitis Neonatal, Nutrition Disorder, Child
Long-term Nutritional Impact of Necrotizing Enterocolitis in Premature Newborns.
With premature newborn increase survival, the risk of serious neonatal morbidity, such as necrotizing enterocolitis (NEC), also increased.
- Conditions
- Necrotising Enterocolitis Neonatal, Nutrition Disorder, Child, Oral Disorders
- Trial name
- PremGrowth (NCT07490834)
- Testing
- Observation of related perinatal and postnatal factors
- Where
- France
- Volunteers
- 200 people
- Sponsor
- Central Hospital, Nancy, France
BPD - Bronchopulmonary Dysplasia, VLBW - Very Low Birth Weight Infant
Duodenal Feeds in Very Low Birth Weight Infants
Premature infants have high rates of bronchopulmonary dysplasia (BPD) due to prematurity of the participants' lungs and the need for prolonged respiratory support.
- Conditions
- BPD - Bronchopulmonary Dysplasia, VLBW - Very Low Birth Weight Infant, Feeding Disorder Neonatal, Feeding; Difficult, Newborn
- Trial name
- NCT04246333
- Testing
- Mode of Delivery of Feeds
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins All Children's Hospital
Opioid-Related Disorders, Drug Addiction
Medication Treatment for Opioid Use Disorder in Expectant Mothers: Conceptual Model Assessments Sub-study
This is a sub-study of NIDA CTN Protocol 0080: Medication Treatment for Opioid Use Disorder in Expectant Mothers (MOMs; Unique protocol ID: 2019-0429-1).
- Conditions
- Opioid-Related Disorders, Drug Addiction, Pregnancy Related, Substance Abuse
- Trial name
- MOMs-CMA (NCT03911466)
- Testing
- Buprenorphine Injection, Buprenorphine Sublingual Product
- Where
- 12 sites in United States
- Volunteers
- 97 people
- Sponsor
- T. John Winhusen, PhD
Opioid-Related Disorders, Drug Addiction
Medication Treatment for Opioid Use Disorder in Expectant Mothers: Infant Neurodevelopmental Outcomes Sub-study
This is a sub-study of NIDA CTN Protocol 0080: Medication Treatment for Opioid Use Disorder in Expectant Mothers (MOMs; Unique protocol ID: 2019-0429-1).
- Conditions
- Opioid-Related Disorders, Drug Addiction, Pregnancy Related, Substance Abuse
- Trial name
- MOMs-INO (NCT03911739)
- Testing
- Buprenorphine Injection, Buprenorphine Sublingual Product
- Where
- 10 sites in United States
- Volunteers
- 71 people
- Sponsor
- T. John Winhusen, PhD
Respiratory Distress Syndrome, Newborn, Neonatal Respiratory Disorders
Non-Inferiority Test of Mixsafe® Compared to Neopuff® in Providing Respiratory Support to Neonates
The aim of the study is to compare the non-inferiority of the Mix-safe T-piece resuscitator (intervention group) to the Neopuff T-piece resuscitator (control group) in providing respiratory assistance during the resuscitation of…
- Trial name
- NCT07422116
- Testing
- Mixsafe T piece resucitator, Standardized T Piece resuscitator
- Where
- Indonesia
- Volunteers
- 107 people
- Sponsor
- Dr Cipto Mangunkusumo General Hospital
Blood and Blood Disorders, Anemia, Neonatal
Randomized Controlled Trial Comparing a Conservative Management and Laser Surgery
The objective of this trial is to compare both strategies (Expectative Vs Fetoscopic laser surgery) for patients with stage 1 TTTS and favorable obstetrical parameters in an international randomized controlled trial.
- Conditions
- Blood and Blood Disorders, Anemia, Neonatal, Hematologic Disease, Infant, Newborn, Diseases
- Trial name
- TTTS1 (NCT01220011)
- Testing
- Fetoscopic laser surgery
- Where
- 11 sites in United States, Canada and 1 more
- Volunteers
- 179 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Neonatal Abstinence Syndrome, Opioid-use Disorder
Effective Caregiving for Neonatal Abstinence Syndrome: Testing an Instructional Mobile Technology Platform for High-Risk Pregnant Women
Most newborns experiencing Neonatal Abstinence Syndrome (NAS) require non-pharmacologic care, which entails, most importantly, maternal involvement with her newborn.
- Trial name
- NCT04783558
- Testing
- Mobile-based NAS Caregiving Tool
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Washington State University
Lactation, Mindfulness
Mindfulness and Meditation Based Lactation Education on Maternal Breastmilk in the Neonatal ICU
The purpose of this research is to investigate associations between mindfulness and meditation techniques and changes in maternal breastmilk in the mother pumping for her NICU infant.
- Conditions
- Lactation, Mindfulness, NICU, Breastmilk
- Trial name
- NCT07351799
- Testing
- Standard of Care, Mindfulness-based Intervention
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Mayo Clinic
Mucopolysaccharidosis Disorders, Hurler Syndrome
MT2013-31: Allo HCT for Metabolic Disorders and Severe Osteopetrosis
This single-institution, phase II study is designed to test the ability to achieve donor hematopoietic engraftment while maintaining low rates of transplant-related mortality (TRM) using busulfan- and fludarabine-based…
- Conditions
- Mucopolysaccharidosis Disorders, Hurler Syndrome, Hunter Syndrome, Maroteaux Lamy Syndrome
- Trial name
- NCT02171104
- Testing
- Stem Cell Transplantation, IMD Preparative Regimen, Osteopetrosis Only Preparative Regimen
- Where
- United States
- Volunteers
- 149 people
- Sponsor
- Masonic Cancer Center, University of Minnesota
Neonatal Convulsions, Newborn Seizure Disorders
Clinical Profile And Outcomes Of Neonatal Convulsions In The Neonatal Intensive Care Unit At Assiut University Children's Hospital
Neonatal convulsions are seizures that occur during the first 28 days of a newborn's life. They are considered a medical emergency and often indicate an underlying problem in the brain, such as lack of oxygen at birth…
- Conditions
- Neonatal Convulsions, Newborn Seizure Disorders, Seizures
- Trial name
- NCT07274410
- Testing
- Management of Neonatal Convulsions
- Volunteers
- 139 people
- Sponsor
- Assiut University
Preterm Less Than 32wks With IVH, WMI/PVL, Late Preterm or Term (37-42wks) With Neonatal Encephalopathy Treated With Hypothermia for HIE
Cerebral/ Cortical Visual Impairment: Screening, Identification and Outcome Prediction in Neonates
Cerebral/Cortical Visual Impairment (CVI) is the leading cause of childhood visual impairment in the United States and other industrialized countries.
- Trial name
- CVI (NCT07275021)
- Testing
- Prospective Clinical and Neurodevelopmental Data Collection
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Brigham and Women's Hospital
Low Birth Weight Baby, Small for Gestational Age (SGA)
Biological Impacts of Rising Temperatures on Maternal, Fetal, and Newborn Health: A Cohort Study (BIRTH Cohort)
The goal of this study is to learn how being exposed to high environmental temperatures during pregnancy affects the health of pregnant women and their babies.
- Conditions
- Low Birth Weight Baby, Small for Gestational Age (SGA), Preterm Birth, Pregnancy Complications
- Trial name
- BIRTH (NCT06957769)
- Testing
- heat stress
- Where
- 3 sites in Pakistan
- Volunteers
- 6,000 people, healthy volunteers welcome
- Sponsor
- Aga Khan University
Neonatal Hypoglycemia, Neurodevelopmental Disorders
Neurodevelopment of Hypoglycemic Neonates
The investigators propose to prospectively conduct a neurodevelopmental evaluation of SGA and late preterm neonates who underwent risk-based screening for hypoglycemia at newborn nursery during the first 24 hours of life based on…
- Trial name
- NCT04875624
- Testing
- Bayley Scales of Infant and Toddler Development, Fourth Edition (Bayley-4)
- Where
- United States
- Volunteers
- 126 people
- Sponsor
- Montefiore Medical Center
Pediatric Disorder, Neonatal Disease
Neonatal Intensive Care Unit Virtual Family-Centered Rounds
The aim of this study is to evaluate the impact of virtual family-centered rounds in the neonatal intensive care unit on parental and neonatal outcomes.
- Trial name
- NCT05762835
- Testing
- Virtual family-centered rounds (FCR)
- Where
- United States
- Volunteers
- 514 people
- Sponsor
- University of California, Davis
Pregnancy, Neonatal Mortality
Scalable Public Health Empowerment, Research, and Education Sites (SPHERES)
SPHERES is a health service research trial in the Indonesian primary care system designed to improve health system performance using a structured data-driven action model.
- Conditions
- Pregnancy, Neonatal Mortality, Tuberculosis, Hepatitis B
- Trial name
- SPHERES (NCT07126041)
- Testing
- Prescription for Action (SPHERES Model)
- Where
- 2 sites in Indonesia
- Volunteers
- 1,750,000 people, healthy volunteers welcome
- Sponsor
- Oxford University Clinical Research Unit Indonesia
Maternal Health Services, Infant, Newborn
Comparing Integrative Midwife-led vs. Fragmented Inpatient Postpartum Care: Impact on Satisfaction and Transition to Motherhood
The goal of this clinical trial is to compare two different forms of postnatal care to find out which is most beneficial for mothers and their children after birth and with which they are most satisfied.
- Conditions
- Maternal Health Services, Infant, Newborn, Postnatal Care, Breast Feeding
- Trial name
- SMILE (NCT07077941)
- Testing
- Integrative care
- Where
- Austria
- Volunteers
- 784 people
- Sponsor
- Medical University of Vienna
Cystic Fibrosis, Lung Inflammation
TAAI Erasmus Research Initiative to Fight CF: Monitoring Inflammation in CF Lung Disease Into a New Era
Progressive destruction of the lungs is the main cause of shortened life expectancy in people with cystic fibrosis (pwCF). Inflammation and respiratory infections play a key role in CF lung disease.
- Conditions
- Cystic Fibrosis, Lung Inflammation, Lung Infection, Lung Disease; Cystic
- Trial name
- TERRIFIC-MILE (NCT05752019)
- Where
- Netherlands
- Volunteers
- 103 people
- Sponsor
- Erasmus Medical Center