Clinical trials: Newborn Health
Fetal Alcohol Spectrum Disorders
Efficacy Trial of the FMF Connect Mobile Health Intervention
The purpose of this study is to test a new smartphone "app" for parents/caregivers of children with fetal alcohol spectrum disorder (FASD). The app is called Families Moving Forward (FMF) Connect.
- Trial name
- NCT05028517
- Testing
- FMF Connect, Coaching
- Where
- United States
- Volunteers
- 129 people, healthy volunteers welcome
- Sponsor
- University of Rochester
Neonatal Death, Perinatal Death
Mobile WACh NEO: Mobile Solutions for Neonatal Health and Maternal Support
To improve neonatal mortality, it is critical to engage families, especially mothers, in essential newborn care (ENC) and appropriate care-seeking for neonatal illness as well as to support maternal mental health and…
- Conditions
- Neonatal Death, Perinatal Death, Depression
- Trial name
- NCT04598165
- Testing
- Interactive two-way SMS dialogue
- Where
- 6 sites in Kenya
- Volunteers
- 5,020 people, healthy volunteers welcome
- Sponsor
- Women and Infants Hospital of Rhode Island
Severe Hereditary Factor VIII Deficiency Disease Without Inhibitor, Moderate Hereditary Factor VIII Deficiency Disease Without Inhibitor
An Observational Study to Evaluate Physical Activity, Bleeding Incidence and Health Related Quality of Life, in Participants With Haemophilia A Without Inhibitors Receiving Standard of Care Treatment
This multicenter, non-interventional, prospective study will collect information about activity status, bleeds, health-related quality of life (HRQoL), health status, and safety in participants with moderate or severe haemophilia…
- Conditions
- Severe Hereditary Factor VIII Deficiency Disease Without Inhibitor, Moderate Hereditary Factor VIII Deficiency Disease Without Inhibitor, Haemophilia A
- Trial name
- POWER (NCT04165135)
- Testing
- Standard of Care for Haemophilia A
- Where
- 17 sites in Italy
- Volunteers
- 103 people
- Sponsor
- Hoffmann-La Roche
Maternal Death, Maternal Morbidity
BetterBirth: A Trial of the WHO Safe Childbirth Checklist Program
The purpose of this study is to measure the impact of a checklist-based childbirth safety program (the WHO Safe Childbirth Checklist Program) on reduction of severe maternal, fetal, and newborn harm in institutional deliveries in…
- Conditions
- Maternal Death, Maternal Morbidity, Stillbirth, Neonatal Death
- Trial name
- BetterBirth (NCT02148952)
- Testing
- WHO Safe Childbirth Checklist Program
- Where
- India
- Volunteers
- 157,689 people, healthy volunteers welcome
- Sponsor
- Harvard School of Public Health (HSPH)
Sickle Cell Disease
Sickle Cell Anemia WE CARE
This mixed-methods study aims to understand the implementation of a previously tested, efficacious social determinants of health (SDoH) screening and referral intervention in the outpatient pediatric hematology setting…
- Trial name
- SCAWECARE (NCT03716726)
- Testing
- WE CARE SDoH Screening Survey, Family Resource Book, Standard of care
- Where
- United States
- Volunteers
- 112 people, healthy volunteers welcome
- Sponsor
- Boston Medical Center
Congenital Heart Defects
Congenital Heart Adolescents: Program of Transition Evaluation Research
The objective of this study is to evaluate the potential role of a cardiology clinic-based educational intervention for 15 to 17 year olds with congenital heart disease (CHD) and their parents, and to determine whether this…
- Trial name
- CHAPTER (NCT01286480)
- Testing
- Clinic-based Educational Intervention
- Where
- Canada
- Volunteers
- 66 people
- Sponsor
- University of Alberta
Hemophilia A, Hemophilia B
An 18-month Low-interventional Study to Assess Joint Health in Haemophilia A and B Patients on Prophylaxis With Efmoroctocog Alfa or Eftrenonacog Alfa
The goal of this low-interventional study is to describe the overall joint health in patients with haemophilia A or haemophilia B prophylactically treated with rFVIIIFc or rFIXFc.
- Trial name
- JOIN-us (NCT05856266)
- Testing
- Haemophilia Early Arthropathy Detection with Ultrasound (HEAD-US), Haemophilia Joint Health Score (HJHS)
- Where
- 56 sites in Bulgaria, Croatia and 9 more
- Volunteers
- 10 people
- Sponsor
- Swedish Orphan Biovitrum
Preterm Infants
Very Low Birth Weight Preterm Infant Bundled Care in the NICU
The purpose of this study is to explore the impact of bundling nursing care activities on the overall health of Very Low Birthweight (VLBW) preterm infants who receive bundled care in a Level IV Neonatal Intensive Care Unit…
- Trial name
- NCT03370757
- Testing
- 3-hour bundled care, 6-hour bundled care
- Where
- United States
- Volunteers
- 49 people
- Sponsor
- Duke University
Autism Spectrum Disorder, Cerebral Palsy
READYorNot[TM] Brain-Based Disabilities Trial
The purpose of this study is to find out if there is a benefit to using the MyREADY Transition[TM] BBD App for brain-based disabilities, compared to not using it.
- Conditions
- Autism Spectrum Disorder, Cerebral Palsy, Epilepsy, Fetal Alcohol Spectrum Disorders
- Trial name
- NCT03852550
- Testing
- e-health application
- Where
- 9 sites in Canada
- Volunteers
- 52 people
- Sponsor
- McMaster University
Dysphagia, Airway Aspiration
Mechanisms and Management of Infant Dysphagia
The purpose of the investigator's study is to evaluate the causes of feeding difficulty in infants. New treatments can be possible only if the cause is known.
- Conditions
- Dysphagia, Airway Aspiration, Airway Penetration
- Trial name
- NCT02583360
- Testing
- Combined testing (diagnostic VFSS + research HRM) + Parent Preferred Therapy
- Where
- United States
- Volunteers
- 109 people
- Sponsor
- Sudarshan Jadcherla
Maternal Sepsis, Neonatal Sepsis
Smart Discharges for Mom & Baby
This study aims to build a predictive algorithm that identifies mother-newborn dyads most at risk of death or complications in the 6 weeks after birth.
- Trial name
- NCT05730387
- Testing
- Observational only
- Where
- Canada
- Volunteers
- 7,182 people
- Sponsor
- University of British Columbia
Nurse Delivered Counseling, Emotional Distress
Listening Visits for Emotionally Distressed Mothers of Hospitalized Newborns
The proposed research has potential to dramatically improve care for emotionally distressed mothers of newborns hospitalized on the neonatal intensive care unit (NICU).
- Trial name
- NCT03704948
- Testing
- RCT Treatment -Listening Visits delivered by NICU nurse in person, RCT Control Usual mental health care delivered by NICU social workers, Open trial: Listening Visits delivered by a NICU nurse via zoom
- Where
- United States
- Volunteers
- 55 people
- Sponsor
- University of Iowa
Sickle Cell Disease
A Study of SHP655 (rADAMTS13) in Sickle Cell Disease
TAK-755 (previously known as SHP655) is a medicine used to treat sickle cell disease (SCD). The main aim of the study is to measure the safety and tolerability of TAK-755 in SCD participants.
- Trial name
- RAISE (NCT03997760)
- Testing
- TAK-755
- Where
- 14 sites in United States
- Volunteers
- 19 people
- Sponsor
- Shire
Fetal Alcohol Spectrum Disorders
Trial of the Families Moving Forward (FMF) Connect Mobile Health Intervention
The purpose of this study is to test a new smartphone "app" for parents/caregivers of children with fetal alcohol spectrum disorder (FASD). The app is called Families Moving Forward (FMF) Connect.
- Trial name
- NCT04194489
- Testing
- FMF Connect
- Where
- United States
- Volunteers
- 171 people, healthy volunteers welcome
- Sponsor
- University of Rochester
Infant Mortality, Preterm Birth
Antenatal Micronutrient Supplementation and Infant Survival
The purpose of this community-based randomized trial is to examine whether a daily antenatal and postnatal multiple micronutrient supplement given to women will enhance newborn and infant survival and health and other birth…
- Conditions
- Infant Mortality, Preterm Birth, Low Birth Weight, Neonatal Mortality
- Trial name
- JiVitA-3 (NCT00860470)
- Testing
- Iron (27 mg) - folic acid (600 ug), Multiple micronutrient
- Where
- 2 sites in United States, Bangladesh
- Volunteers
- 44,567 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins Bloomberg School of Public Health
Sickle Cell Trait
Increasing Documentation and Disclosure of Sickle Cell Trait Status: An Implementation Science Approach
The hemoglobinopathy newborn screen (NBS) performed on all neonates in the U.S. allows for early life-saving medical care for infants with sickle cell disease (SCD), an autosomal recessive genetic disorder.
- Trial name
- NCT05387564
- Testing
- SCT Documentation and Disclosure Toolkit (SCT-DD)
- Where
- United States
- Volunteers
- 114 people
- Sponsor
- Nemours Children's Clinic
Health Volunteers, Huntington Disease
A Study to Evaluate Sigma-1 and Dopamine-2 Receptor Occupancy by Pridopidine in the Human Brain of Healthy Volunteers and in Patients With Huntington's Disease
The purpose of this study is to demonstrate engagement of pridopidine with S1R and D2R (optional) in the living human brain. No formal statistical analysis will be conducted
- Trial name
- NCT03019289
- Testing
- pridopidine (90 mg)
- Where
- Germany
- Volunteers
- 23 people, healthy volunteers welcome
- Sponsor
- Prilenia
Mental Health Issue (E.G., Depression, Psychosis, Personality Disorder, Substance Abuse), Infant Development
Maternal Adversity, Vulnerability and Neurodevelopment
Maternal Adversity Vulnerability and Neurodevelopment (MAVAN) project is a prospective community-based, pregnancy and birth cohort of Canadian mother-child dyads.
- Conditions
- Mental Health Issue (E.G., Depression, Psychosis, Personality Disorder, Substance Abuse), Infant Development, Infant Behavior
- Trial name
- MAVAN (NCT03434457)
- Where
- Canada
- Volunteers
- 630 people, healthy volunteers welcome
- Sponsor
- Douglas Mental Health University Institute
Chronic Obstructive Pulmonary Disease, Pulmonary Fibrosis
Using Health-related Quality of Life (HRQL) in Routine Clinical Care
The objective of this study is to assess the effects of using HRQL measures in the clinical care of pre- and post-lung transplant patients.
- Conditions
- Chronic Obstructive Pulmonary Disease, Pulmonary Fibrosis, Pulmonary Hypertension, Cystic Fibrosis
- Trial name
- NCT00457301
- Testing
- HUI score card
- Where
- Canada
- Volunteers
- 213 people
- Sponsor
- University of Alberta
Down Syndrome
Promoting Health Through Parent Empowerment and the Activation of Routines (PrO-PEAR)
This study will examine the feasibility of the Promoting Health through Parent Empowerment and the Activation of Routines (Pro-PEAR) intervention using a open case-series for intervention optimization followed by a pilot RCT in…
- Trial name
- Pro-PEAR (NCT05020366)
- Testing
- Promoting Health through Parent Empowerment and the Activation of Routines, Enhanced Usual Care
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- University of Pittsburgh