Clinical trials: High Risk Infant, active
Breast Cancer, Ductal Carcinoma
Randomized Double-Blind Phase II Trial of Baby Exemestane Versus Baby Tamoxifen in Post-Menopausal Women at High Risk for Breast Cancer
The goal of this research study is to evaluate the efficacy and safety of low-dose exemestane versus low-dose tamoxifen in post-menopausal women at high risk for breast cancer.
- Conditions
- Breast Cancer, Ductal Carcinoma, Estrogen-receptor-positive Breast Cancer, Atypical Lobular Hyperplasia
- Trial name
- BabyTEARS (NCT07499999)
- Testing
- Exemestane, Tamoxifen
- Where
- 2 sites in United States
- Volunteers
- 140 people
- Sponsor
- Dana-Farber Cancer Institute
Prematurity, Low Birth Weight
Paternal Involvement in Nursing Guidance and Breastfeeding Self-Efficacy in Mothers of High-Risk Newborns
This study aims to evaluate whether a structured nursing guidance program that increases fathers' participation in the care of hospitalized high-risk newborns improves maternal outcomes compared with routine nursing care.
- Conditions
- Prematurity, Low Birth Weight, Respiratory Distress Syndrome, Newborn, Neonatal Hyperbilirubinemia
- Trial name
- NCT07834008
- Testing
- step-by-step parent education, active father participation in breastfeeding support
- Where
- Taiwan
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Taipei Medical University Shuang Ho Hospital
Postpartum Depression, Postpartum Anxiety
Mother-infant Bonding in the Brain: a Mindfulness-based Intervention
The study investigates the effectiveness of the mindfulness-based intervention "Mindful with your Baby" in women with babies between 5-9 months postpartum who experience heightened levels of postpartum depression, anxiety and/or…
- Conditions
- Postpartum Depression, Postpartum Anxiety, Parental Stress
- Trial name
- NCT05830266
- Testing
- "Mindful with your Baby" group-based therapist-guided intervention, "Mindful with your baby" self-guided online intervention
- Where
- Netherlands
- Volunteers
- 64 people
- Sponsor
- Tilburg University
Eczema, Asthma
The PEBBLES Study - Testing a Strategy for Preventing Eczema and Food Allergy in High Risk Infants
This is a phase III, single blind (outcome assessor is blinded), randomised controlled multicentre trial of the effect of EpiCeram emollient for improving and maintaining skin barrier function and reducing incidence of eczema and…
- Conditions
- Eczema, Asthma, Allergy;Food
- Trial name
- PEBBLES (NCT03667651)
- Testing
- EpiCeram
- Where
- 4 sites in Australia
- Volunteers
- 760 people, healthy volunteers welcome
- Sponsor
- University of Melbourne
Mobile Health Apps, Lifestyle Intervention
Effectiveness of an AI-Enabled Mobile Intervention on Lifestyle Behaviors and Maternal-Infant Health
The goal of this pragmatic randomized controlled trial is to evaluate the effectiveness of an AI-enabled mobile health management application ("Better Pregnancy" app), grounded in the Theory of Planned Behavior, in preventing…
- Conditions
- Mobile Health Apps, Lifestyle Intervention, Prevention, Multi-component Based Behavioral Intervention
- Trial name
- NCT07582068
- Testing
- Multi-component lifestyle intervention
- Where
- China
- Volunteers
- 400 people, healthy volunteers welcome
- Sponsor
- Fangbiao Tao
Cerebral Palsy
GO-PLAY - Early Family-Centered Intervention for Infants With High-Risk of Cerebral Palsy
Background. Early diagnosis of cerebral palsy (CP) is important to enable appropriate intervention at a time when neuroplasticity is at its highest.
- Trial name
- GO-PLAY (NCT05883969)
- Testing
- GO-PLAY, Usual care
- Where
- 2 sites in Denmark
- Volunteers
- 60 people
- Sponsor
- Copenhagen University Hospital, Rigshospitalet
Pre-Exposure Prophylaxis (PrEP), Breast Feeding
Tshireletso: Safety, Efficacy and Feasibility of Cabotegravir-LA PrEP in a Breastfeeding Population in Botswana
The goal of this this hybrid safety/implementation study is to evaluate whether using long-acting cabotegravir (CAB-LA) for HIV prevention (PrEP) is acceptable, feasible and safe in post-partum people who are breastfeeding.
- Trial name
- Tshireletso (NCT05986084)
- Testing
- Cabotegravir Injection [Apretude]
- Where
- 2 sites in United States, Botswana
- Volunteers
- 500 people
- Sponsor
- Beth Israel Deaconess Medical Center
Premature Infant, Ventilation Therapy
High Flow Nasal Cannula for Stabilization of Extremely Premature Infants
A prospective observational study evaluates the safety and efficacy of using High-Flow Nasal Cannula to stabilize extremely preterm infants immediately after birth.
- Conditions
- Premature Infant, Ventilation Therapy, High Flow Nasal Canula
- Trial name
- SIMPLSAFE2 (NCT06683677)
- Testing
- High-Flow Nasal Cannula
- Where
- Czechia
- Volunteers
- 60 people
- Sponsor
- Charles University, Czech Republic
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
Pediatric and Young Adult Patientswith Hypodiploid or t(17;19) B-ALL, Infants With Very High Risk KMT2A B-ALL
Orphan Indications for CD19 Redirected Autologous T Cells
This is an open-label, four-cohort, phase 2 study to determine the efficacy of CART19 in pediatric and young adult patientswith hypodiploid (Cohort A) or t(17;19) B-ALL (Cohort B), infants with very high risk KMT2A B-ALL (Cohort…
- Conditions
- Pediatric and Young Adult Patientswith Hypodiploid or t(17;19) B-ALL, Infants With Very High Risk KMT2A B-ALL, Patients With Central Nervous System Relapse Who Did Not Receive Cranial Radiation or Bone Marrow Transplantation
- Trial name
- NCT04276870
- Testing
- Murine CART19
- Where
- United States
- Volunteers
- 133 people
- Sponsor
- Stephan Grupp MD PhD
Nutrition Disorder, Infant, Biliary Atresia
Nutritional Intervention for Biliary Atresia
Infants with biliary atresia (Biliary atresia, BA) have an increased risk of malnutrition due to insufficient dietary intake to maintain normal growth, impaired intestinal absorption, increased metabolic rate, and damage to some…
- Trial name
- NCT06764082
- Testing
- high MCT formula, normal oral intake of the traditional formula
- Where
- China
- Volunteers
- 120 people
- Sponsor
- Tongji Hospital
Leukodystrophy, White Matter Disease
The Myelin Disorders Biorepository Project
The Myelin Disorders Biorepository Project (MDBP) seeks to collect and analyze clinical data and biological samples from leukodystrophy patients worldwide to support ongoing and future research projects.
- Conditions
- Leukodystrophy, White Matter Disease, Leukoencephalopathies, 4H Syndrome
- Trial name
- MDBP (NCT03047369)
- Where
- 23 sites in United States
- Volunteers
- 12,000 people
- Sponsor
- Children's Hospital of Philadelphia
Infection, Bacterial, Infection Prevention
Optimising Kangaroo Care to Reduce Neonatal Severe Infection/Sepsis and Resistant Bacterial Colonisation Among High-risk Infants in NICU.
NeoDeco is a pragmatic, multicenter, parallel-group, cluster-randomised hybrid effectiveness-implementation trial designed to evaluate the impact of implementing optimised Kangaroo Care (KC) at the unit level compared to standard…
- Trial name
- NeoDeco (NCT05993442)
- Testing
- Optimised kangaroo care
- Where
- 24 sites in Greece, Italy and 3 more
- Volunteers
- 3,080 people
- Sponsor
- PENTA Foundation
High Fidelity Simulation Training
High Fidelity Simulation-based Learning Approach in Maternal and Infant Care
Study type: clinical trial - randomized control trial Primary purpose: to explore the effectiveness of high-fidelity simulation (HFS) interventions, specifically scenario-based training with pre-briefing and de-briefing on (1)…
- Trial name
- NCT06722248
- Testing
- high fidelity simulation-based training, conventional training
- Where
- Hong Kong
- Volunteers
- 158 people, healthy volunteers welcome
- Sponsor
- The University of Hong Kong
High Risk Pregnancy, Congenital Heart Disease
Fetal Electrophysiologic Abnormalities in High-Risk Pregnancies Associated With Fetal Demise
Each year world-wide, 2.5 million fetuses die unexpectedly in the last half of pregnancy, 25,000 in the United States, making fetal demise ten-times more common than Sudden Infant Death Syndrome.
- Conditions
- High Risk Pregnancy, Congenital Heart Disease, Fetal Hydrops, Twin Monochorionic Monoamniotic Placenta
- Trial name
- NCT03775954
- Testing
- Fetal Magnetocardiogram and Neonatal Electrocardiogram, Substudy only: Maternal/Infant Pharmacogenomic assessment postnatally
- Where
- 2 sites in United States
- Volunteers
- 30 people
- Sponsor
- Medical College of Wisconsin
Premature Birth, Cerebral Palsy
Neuro-biomechanical Determinants for Motor Behavior in High-risk Infants
This project focuses on motor development, muscle growth and muscle activity. Using advanced, instrumented tests such as , the link between muscles and the movement characteristics will be studied.
- Conditions
- Premature Birth, Cerebral Palsy, Neurodevelopmental Disorders, Brain Injuries
- Trial name
- BAMBI (NCT06111898)
- Testing
- No Intervention
- Where
- Switzerland
- Volunteers
- 348 people, healthy volunteers welcome
- Sponsor
- University Hospital, Geneva
Major Depressive Disorder, Postpartum Depression
Maternal Mental Health Trial
Perinatal depression affects 10-15% of women postpartum and has a recurrence rate of 40%. Women who develop perinatal depression might be particularly susceptible to the rapid and large changes in sex steroid hormones…
- Trial name
- MAMA (NCT04685148)
- Testing
- Transdermal patch estradiol
- Where
- Denmark
- Volunteers
- 220 people
- Sponsor
- Vibe G Frøkjær, MD, PhD
Development Delay, Motor Skills Disorders
Effect of a Telerehabilitation-Supported, Family-Centered Early Intervention Program on Neurodevelopmental and Parental Outcomes in Infants at Mild-to-Moderate Risk
The goal of this pilot randomized controlled trial is to learn whether a family-centered early intervention program, delivered remotely to parents and carried out at home, can support the development of infants who were treated…
- Conditions
- Development Delay, Motor Skills Disorders, Neurodevelomental Disorders, High Risk Infant
- Trial name
- NCT07878819
- Testing
- Remote Family-Centered Early Intervention Program, Standard Information and Routine Follow-up
- Where
- Turkey (Türkiye)
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Bengisu Boz Gürboğa
Obesity, Obesity, Childhood
A Novel Obesity Prevention Program for High-Risk Infants in Primary Care
The goal of this clinical trial is to test a responsive parenting obesity prevention program with infants and caregivers of color (e.g., non-White; Hispanic/Latinx) and/or who are economically marginalized (i.e., publicly…
- Conditions
- Obesity, Obesity, Childhood, Weight Gain, Weight Gain Trajectory
- Trial name
- THRIVE (NCT06028113)
- Testing
- THRIVE 2.0
- Where
- United States
- Volunteers
- 144 people, healthy volunteers welcome
- Sponsor
- Children's Hospital Medical Center, Cincinnati
Preterm Infants, Respiratory Distress Syndrome (Neonatal)
Pressure Targeting During High Flow Therapy in Premature Infants
The goal of this study is to see if a new approach to breathing support ('Pressure Targeted High Flow') is as effective as standard of care ('Continuous Positive Airway Pressure') in prematurely born infants.
- Conditions
- Preterm Infants, Respiratory Distress Syndrome (Neonatal), BPD - Bronchopulmonary Dysplasia
- Trial name
- NeoMATCH (NCT07418502)
- Testing
- Pressure Targeted High Flow, CPAP
- Where
- 2 sites in United States
- Volunteers
- 78 people
- Sponsor
- University of Texas at Austin