Clinical trials: Neonatal Care
Preterm Infant, Hypothermia, Newborn
Early Kangaroo Mother Care in Gambian Hospitalised Unstable Neonates
The mortality effect of kangaroo mother care in stable newborns <2000g is well established but mortality effect in unstable newborns is not conclusively known.
- Conditions
- Preterm Infant, Hypothermia, Newborn, Death, Kangaroo Mother Care
- Trial name
- eKMC (NCT03555981)
- Testing
- Early Kangaroo Mother Care, Standard care
- Where
- The Gambia
- Volunteers
- 279 people
- Sponsor
- London School of Hygiene and Tropical Medicine
Sickle Cell Disease
Using Patient-Centered Guidelines in a Technology Platform to Improve Health Care in Adults With Sickle Cell Disease
SCD is an inherited disorder of hemoglobin that affects over 100,000 Americans, most of whom live in low-resourced neighborhoods.
- Trial name
- NCT03629678
- Testing
- mobile health application
- Where
- 2 sites in United States
- Volunteers
- 67 people
- Sponsor
- Vanderbilt University Medical Center
Vitamin D Deficiency, Thoracic Surgery
Prevention of Vitamin D Deficiency Following Pediatric CHD Surgery: a Phase II Dose Evaluation Randomized Controlled Trial Comparing Usual Care With a High Dose Pre-operative Supplementation Regimen Based on the Institute of Medicine Daily Upper Tolerable Intake Level
Our research group has shown that almost all children with congenital heart disease (CHD) are vitamin D deficient following heart surgery.
- Conditions
- Vitamin D Deficiency, Thoracic Surgery, Pediatric Disorders, Heart Defects, Congenital
- Trial name
- HICCUPS 2 (NCT01838447)
- Testing
- Cholecalciferol
- Where
- Canada
- Volunteers
- 46 people
- Sponsor
- Children's Hospital of Eastern Ontario
Metastatic Solid Tumors
Dose Escalation Study of TAK-117 (MLN1117) in Subjects With Advanced Cancer
The purpose of this study is to determine the maximum tolerated dose (MTD) and/or optimal biologic dose(OBD), safety and tolerability, dose-limiting toxicity (DLT) of TAK-117 when administered orally in subjects with advanced…
- Trial name
- NCT01449370
- Testing
- TAK-117
- Where
- 5 sites in United States, Spain and 1 more
- Volunteers
- 125 people
- Sponsor
- Millennium Pharmaceuticals, Inc.
Sickle Cell Disease
LCI-HEM-SCD-ST3P-UP-001: The Sickle Cell Trevor Thompson Transition Project (ST3P-UP Study)
This multi-center study will compare the effectiveness of adding virtual peer mentoring (PM) to a structured education-based (STE) transition program for emerging adults with sickle cell disease to determine its effect on…
- Trial name
- ST3P-UP (NCT03593395)
- Testing
- Peer Mentoring [PM], Structured Education Based Transition Program STE
- Where
- 14 sites in United States
- Volunteers
- 291 people
- Sponsor
- Wake Forest University Health Sciences
Cystic Fibrosis
A 4-week Study to Test Different Doses of BI 1265162 in Adolescents and Adults With Cystic Fibrosis Using the Respimat® Inhaler - BALANCE - CF™1
The primary objective of this trial is to assess the efficacy, safety and pharmacokinetics of twice daily inhaled doses of BI 1265162 delivered by Respimat® inhaler versus placebo in adolescents and adult patients with cystic…
- Trial name
- NCT04059094
- Testing
- BI 1265162
- Where
- 26 sites in United States, Belgium and 6 more
- Volunteers
- 52 people
- Sponsor
- Boehringer Ingelheim
Abdominal Surgery, Thoracic Surgery
Parent/Nurse Controlled Analgesia in the Neonatal Intensive Care Unit
The aim of this study is to examine the safety and effectiveness of 2 morphine delivery systems for post-surgical neonates. The investigators hypothesize that this study will be feasible to conduct, and that neonates receiving…
- Trial name
- PNCA (NCT01823497)
- Testing
- Morphine
- Where
- United States
- Volunteers
- 36 people
- Sponsor
- Medical College of Wisconsin
Retinopathy of Prematurity (ROP)
Long-term Safety and Efficacy Outcome Study Comparing Children Previously Enrolled in Study ROPP-2008-01 for the Prevention of Retinopathy of Prematurity (ROP)
The main purpose of this study is to evaluate the long-term efficacy and safety outcomes following short-term exposure to rhIGF-1/rhIGFBP-3 versus standard neonatal care in Study ROPP-2008-01 (NCT01096784).
- Trial name
- PEDAL (NCT02386839)
- Testing
- rhIGF-1/rhIGFBP-3
- Where
- 16 sites in United States, Italy and 4 more
- Volunteers
- 76 people
- Sponsor
- Shire
Gout
Gout Self-Monitoring Aiming to Reach Target
This study evaluates whether a supported self-management approach to gout is able to achieve target levels of serum urate, and better control of gout flares.
- Trial name
- Gout-SMART (NCT03274063)
- Testing
- Supported self-management, Usual care
- Where
- United Kingdom
- Volunteers
- 60 people
- Sponsor
- University of Edinburgh
Sickle Cell Disease
Patient-Provider Tools to Improve the Transition to Adult Care in Sickle Cell Disease
The purpose of the study is to develop patient-provider clinical support tools to improve clinical practice, patient self-management, and disease outcomes in sickle cell disease during transition to adult care.
- Trial name
- iTransition (NCT02200510)
- Testing
- Self-management intervention for Adolescents with SCD, Patient Portal Intervention for Adolescents with SCD
- Where
- United States
- Volunteers
- 78 people
- Sponsor
- Children's Hospital Medical Center, Cincinnati
Prematurity, Neurodevelopmental Disorder
Effect of Early L-Carnitine Supplementation on Neurodevelopmental Outcomes in Very Preterm Infants
Preterm infants are vulnerable to brain injury, nutritional deficiencies and poor early growth which places them at increased risk for developmental problems later in life.
- Conditions
- Prematurity, Neurodevelopmental Disorder, Carnitine Deficiency
- Trial name
- NCT01783041
- Testing
- L-carnitine, 5% Dextrose
- Where
- 2 sites in United States
- Volunteers
- 144 people
- Sponsor
- Montefiore Medical Center
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
Procedural Pain
Crochet Octopus in The Process of Heel Lance in Neonates
The main objective of the study was to determine the effect of using crochet octopus in order to reduce the acute pain developed during the process of heel lance in neonates.
- Trial name
- NCT04560374
- Testing
- crochet octopus
- Where
- Turkey (Türkiye)
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Marmara University
Congenital Heart Disease
Assessing and Promoting Resilience in Patients With Adult Congenital Heart Disease
The purpose of this study is to evaluate the feasibility and preliminary efficacy of the Promoting Resilience in Stress Management (PRISM) intervention in patients with adult congenital heart disease.
- Trial name
- PRISMACHD (NCT04738474)
- Testing
- Promoting Resilience in Stress Management (PRISM), Usual Care
- Where
- United States
- Volunteers
- 78 people
- Sponsor
- University of Washington
Gout
Combining Lesinurad With Allopurinol in Inadequate Responders
This study will compare the serum uric acid lowering effects, clinical benefits, and safety of lesinurad in combination with allopurinol to allopurinol alone in subjects with gout who have had an inadequate response to…
- Trial name
- CLEAR 2 (NCT01493531)
- Testing
- Lesinurad, Allopurinol
- Where
- 175 sites in United States, Australia and 9 more
- Volunteers
- 610 people
- Sponsor
- Ardea Biosciences, Inc.
Opioid Use Disorder, Maternal Drugs Affecting Fetus
Night Respite for Postpartum Mothers With SUD
This single arm pilot feasibility study will evaluate the implementation of overnight infant respite care and parenting skills to mothers with substance use disorders in the early postpartum period residing in residential…
- Conditions
- Opioid Use Disorder, Maternal Drugs Affecting Fetus, Postpartum Mood Disturbance, Sleep Disorder
- Trial name
- NCT05746507
- Testing
- Night Respite Care
- Where
- 2 sites in United States
- Volunteers
- 41 people
- Sponsor
- Massachusetts General Hospital
Pain
Caring for Babies During the Newborn Screening Blood Test
Newborn infants have blood work procedures in their first days of life that cause pain, distress and physiological changes. Breastfeeding (BF), skin to skin care (SSC), or giving sweet solutions (sucrose or glucose) has been…
- Trial name
- NCT02608892
- Testing
- BSweet2Babies video
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Children's Hospital of Eastern Ontario
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
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
Image Evaluation
Development of a MR Scanner Capable of Being Sited in a Neonatal Intensive Care Unit
This study investigates a novel magnetic resonance imaging (MRI) system designed by GEHC for imaging viable neonate and infant populations.
- Trial name
- Firefly (NCT02232009)
- Testing
- 3.0 T Neonatal MRI Scanner
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- GE Healthcare