Clinical trials: Development, Infant
Infant, Premature, Diseases, Brain White Matter Disease Periventricular
Initial Efficacy Study of Supporting Play, Exploration, & Early Development Intervention
The primary aims of this randomized controlled trial are to evaluate efficacy potential of SPEEDI at enhancing reaching and play based problem solving compared to infants receiving usual care.
- Trial name
- SPEEDI (NCT02153736)
- Testing
- SPEEDI Intervention
- Where
- United States
- Volunteers
- 14 people
- Sponsor
- Virginia Commonwealth University
Congenital Hypothyroidism
Targeted Levothyroxine Dosing in Infants With Congenital Hypothyroidism
This is a clinical study comparing targeted levothyroxine dosing based on thyroid anatomy as visualized on ultrasound (normal vs. ectopic/sublingual vs.
- Trial name
- NCT02374593
- Testing
- Levothyroxine, Ultrasound
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- Erica Eugster
Healthy
Study of Stool Patterns to Collect a Panel of Stool Images for the Development of a Software
Collection of a panel of stool images from healthy infants/toddlers for the development of a software
- Trial name
- Poobao (NCT03402555)
- Testing
- Stool pattern
- Where
- 2 sites in United States, Singapore
- Volunteers
- 96 people, healthy volunteers welcome
- Sponsor
- Danone Asia Pacific Holdings Pte, Ltd.
Maternal Depression and Parent Practices, Postpartum, Infant Development
Reducing Maternal Depression and Promoting Infant Social-Emotional Health & Development
A mobile remote coaching program study to improve maternal mood and increase parenting practices that lead to better infant social-emotional and communication outcomes
- Trial name
- MBN (NCT03464630)
- Testing
- Mom & Baby Net, Depression & Developmental Awareness System
- Where
- United States
- Volunteers
- 368 people, healthy volunteers welcome
- Sponsor
- Georgia State University
Infants With or at Risk/Concern for Developmental Delay
Otteroo Case Series
Rationale. The Otteroo is a floatie which supports an infant or young child with their head above and their body in water. Researchers are proposing that the Otteroo may be a good "tool" to facilitate exploring the ability to…
- Trial name
- NCT03502265
- Testing
- Otteroo
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- University of Southern California
Congenital Heart Disease, Periventricular Leucomalacia
Randomized Trial of Maternal Progesterone Therapy
Neurodevelopmental disability is now recognized as the most common long-term complication after cardiac surgery in neonates. Research studies have shown that progesterone is critical to the development of the brain and in a…
- Conditions
- Congenital Heart Disease, Periventricular Leucomalacia, Brain Development, Cardiac Surgery
- Trial name
- NCT02133573
- Testing
- Progesterone, Vaginal lubricant
- Where
- United States
- Volunteers
- 102 people
- Sponsor
- Children's Hospital of Philadelphia
Autism, Autism Spectrum Disorder
Intensive Intervention for Toddlers With Autism (EARLY STEPS)
Goals of the current project: (1) Does the Early Start Denver Model experimental intervention for toddlers with autism reduce disability associated with autism significantly more than standard community interventions?; and (2)…
- Trial name
- NCT00698997
- Testing
- Early Start Denver Model, Standard community care
- Where
- United States
- Volunteers
- 118 people
- Sponsor
- University of California, Davis
Seizure in Participants With Tuberous Sclerosis Complex, Seizure in Participants With Dravet Syndrome
Assessment of Adjunctive Cannabidiol Oral Solution (GWP42003-P) in Children With Tuberous Sclerosis Complex (TSC), Dravet Syndrome (DS), or Lennox-Gastaut Syndrome (LGS) Who Experience Inadequately-controlled Seizures
This study will be conducted to evaluate the safety, pharmacokinetics (PK), and efficacy of adjunctive GWP42003-P in participants < 2 years of age with tuberous sclerosis complex (TSC), Lennox-Gastaut syndrome (LGS), or Dravet…
- Conditions
- Seizure in Participants With Tuberous Sclerosis Complex, Seizure in Participants With Dravet Syndrome, Seizure in Participants With Lennox-Gastaut Syndrome
- Trial name
- NCT04485104
- Testing
- GWP42003-P
- Where
- 11 sites in United States, Italy and 1 more
- Volunteers
- 3 people
- Sponsor
- Jazz Pharmaceuticals
Poor Feeding, Infant Development
taVNS Paired With Bottle Feeding in Infants Failing Oral Feeds
Oromotor dysfunction and poor feeding is common after premature birth and hypoxic ischemic encephalopathy (HIE). Pairing vagus nerve stimulation (VNS) with motor activity accelerates functional improvements after stroke.
- Conditions
- Poor Feeding, Infant Development, Vagus Nerve Stimulation
- Trial name
- NCT04643808
- Testing
- transcutaneous auricular vagus nerve stimulation
- Where
- United States
- Volunteers
- 35 people
- Sponsor
- Medical University of South Carolina
Hypovolemia, Craniosynostoses
Bedside Resources to Gauge Intravascular Volume Status
The goal if this study is to employ the CardioQ-Esophageal Aortic Doppler probe to define fluid responders from non-responders among infants undergoing cranial vault reconstruction for craniosynostosis.
- Trial name
- NCT03915587
- Testing
- CardioQ-EDM and CipherOx-CRI
- Where
- United States
- Volunteers
- 23 people
- Sponsor
- University of Colorado, Denver
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
Craniosynostosis, Bleeding
Tranexamic Acid for Craniofacial Surgery
This is a randomized, blinded, prospective study that will investigate the potential benefit of tranexamic acid to reduce the intraoperative bleeding and blood transfusions in pediatric patients undergoing craniofacial surgeries.
- Trial name
- NCT00722436
- Testing
- Tranexamic acid, saline
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- University of Pittsburgh
Lung Disease
Safety and Efficacy Study of Nitric Oxide for Inhalation on Chronic Lung Disease in Premature Babies
The purpose of this study is to assess the safety and efficacy of inhaled nitric oxide to reduce the risk of chronic lung disease in pre-term infants with respiratory distress, and to assess the long-term effects of the therapy…
- Trial name
- NCT00551642
- Testing
- Nitric oxide
- Where
- 35 sites in Belgium, Finland and 7 more
- Volunteers
- 800 people
- Sponsor
- Mallinckrodt
Obesity, Infant, Language Development
Music and Child Health and Development
The goal of this clinical trial is to learn about the effects of a music enrichment program on the quality of parent child interactions, a child's motivation to eat, and a child's language environment in 9 to 24 month-old…
- Conditions
- Obesity, Infant, Language Development, Parent-Child Relations
- Trial name
- NCT05868811
- Testing
- Music Together, Play Group
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Children's Mercy Hospital Kansas City
Klinefelter Syndrome
Body Composition in Infants With Klinefelter Syndrome and Effects of Testosterone Treatment
This research study in infant males with Klinefelter syndrome (47,XXY) will learn more about body composition (muscle and fat) and male hormones and look at the effect of testosterone shots on body composition.
- Trial name
- NCT02408445
- Testing
- testosterone cypionate 200mg/ml
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- University of Colorado, Denver
Infant Development, Gut Microbiome
INF108F in Infants With Food Protein Induced Proctocolitis
Single-center, randomized, double-blind, placebo-controlled trail evaluating INF108F in breastfed infants with FPIAP
- Conditions
- Infant Development, Gut Microbiome, Food Protein Induced Allergic Proctocolitis
- Trial name
- RESTORE (NCT05793112)
- Testing
- INF108F probiotic
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Massachusetts General Hospital
Infant Development, Motivation
Infant Environment Study
This study evaluates the effect of a music enhancement program to strengthen the motivation to engage in music related behaviors rather than eating in infants who are high in motivation to eat.
- Trial name
- NCT02936284
- Testing
- Music Enhancement, Play Date
- Where
- United States
- Volunteers
- 94 people, healthy volunteers welcome
- Sponsor
- State University of New York at Buffalo
Premature Birth of Newborn
Supporting and Enhancing NICU Sensory Experiences (SENSE)
Seventy preterm infants born less than or equal to 32 weeks gestation were put into either the sensory-based intervention (experiment) group or traditional care (control) group. Consecutive admissions at St.
- Trial name
- SENSE (NCT03316547)
- Testing
- SENSE Program
- Where
- United States
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Washington University School of Medicine
Tuberous Sclerosis Complex, Epilepsy
Stopping TSC Onset and Progression 2: Epilepsy Prevention in TSC Infants
This phase I/II clinical trial is an open-label clinical trial design to verify safety and dosing for TAVT-18 (sirolimus) powder for oral solution in TSC infants (N=5).
- Trial name
- STOP2 (NCT04595513)
- Testing
- TAVT-18 (sirolimus)
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- Children's Hospital Medical Center, Cincinnati
Cerebral Palsy, Developmental Delay
Efficacy of the START-Play Program for Infants With Neuromotor Disorders
The purpose of this project is to evaluate the efficacy of Sitting Together And Reaching To Play (START-Play), an intervention designed to target sitting, reaching, and motor-based problem solving to improve development and…
- Conditions
- Cerebral Palsy, Developmental Delay, Infant Development
- Trial name
- START-Play (NCT02593825)
- Testing
- START-Play intervention, Business as usual
- Where
- United States
- Volunteers
- 134 people
- Sponsor
- Duquesne University