Clinical trials: Child Birth
Chronic Toxic Stress, Developmental/ Behavioral Regression in Young Children
(YMP) Young Moms Program
Young Moms Program (YMP) is designed to address systemic barriers to the health and stability of young moms and their children such as the lack of coordination of service delivery or logistical barriers within the health system.
- Trial name
- YMP (NCT05082857)
- Testing
- "traditional" Parents as Teachers (PAT), "hybrid" PAT model
- Where
- United States
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Wake Forest University Health Sciences
ADHD
Proton Magnetic Spectroscopy in Children and Adolescents With ADHD Before and After Treatment With OROS Methylphenidate
This will be an open label study using daily does of up to 126mg/day of Concerta in the treatment of children and adolescents, ages 12-17, who meet DSM-IV criteria for ADHD.
- Trial name
- NCT00593112
- Testing
- OROS methylphenidate, No intervention
- Where
- United States
- Volunteers
- 39 people, healthy volunteers welcome
- Sponsor
- Massachusetts General Hospital
Acute Pain
A Study to Look at Tapentadol Oral Solution in Children and Adolescents in Pain
The purpose of the study was to evaluate the efficacy of tapentadol oral solution, based on the total amount of supplemental opioid analgesic used over 12 hours or 24 hours after initiation of investigational medicinal product…
- Trial name
- NCT02081391
- Testing
- Tapentadol oral solution 4 mg/mL, Tapentadol oral solution 20 mg/mL
- Where
- 43 sites in United States, Bulgaria and 8 more
- Volunteers
- 216 people
- Sponsor
- Grünenthal GmbH
Child Externalizing Behavior
Technology-Enhanced Helping the Noncompliant Child
This study aimed to examine if technology could enhance the treatment engagement and outcomes of low income parents of 3 to 8 children with externalizing problems.
- Trial name
- TE-HNC (NCT01367847)
- Testing
- Helping the Noncompliant Child (HNC), Technology-Enhanced Helping the Noncompliant Child (TE-HNC)
- Where
- United States
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- University of North Carolina, Chapel Hill
Short Children Born Small for Gestational Age (SGA)
Long-term Safety Follow-up After Growth Hormone Treatment of Short Children Born Small for Gestational Age
This study is performed as part of the Marketing Authorisation Holder's post-marketing pharmacovigilance plan to investigate the long-term safety, in particular the diabetogenic potential and immunogenicity of rhGH therapy in…
- Trial name
- SGA (NCT01491854)
- Testing
- Bloodsampling
- Where
- 23 sites in Czechia, Georgia and 4 more
- Volunteers
- 130 people
- Sponsor
- Sandoz
Growth Hormone Therapy, Infant, Very Low Birth Weight
Somatropin Therapy In Children Born Preterm But Appropriate For Gestational Age
Safety and efficacy of Somatropin will be evaluated in short children born with a list weight below 1500 g and that did not catch up to normal height at the age of 4.
- Trial name
- AGA (NCT00174460)
- Testing
- Somatropin, Control Arm
- Where
- 8 sites in Germany
- Volunteers
- 33 people
- Sponsor
- Pfizer
Asthma
Drug Delivery Via Pressurized Metered-dose Inhaler and Valved Holding Chamber in Asthmatic Children: Determination of Delivered Dose Following Coordinated and Uncoordinated Use
The primary objective of this study is to determine ex vivo the amount of fluticasone deposited onto a filter (delivered dose) interposed between the OptiChamber Diamond Valved Holding Chamber (VHC) mouthpiece and the subject's…
- Trial name
- NCT01714063
- Testing
- Pressurized Metered-Dose Inhaler
- Where
- United States
- Volunteers
- 34 people
- Sponsor
- Philips Respironics
Intraocular Pressure, Delivery, Obstetric
Effect of Child Delivery on Intraocular Pressure
The purpose of this study is to evaluate the effect of child delivery on the intraocular pressure in healthy women.
- Trial name
- NCT01174342
- Where
- Israel
- Volunteers
- 30 people
- Sponsor
- Meir Medical Center
Malaria, Human Immunodeficiency Virus
Reducing the Burden of Malaria in HIV-Infected Pregnant Women and Their HIV-Exposed Children (PROMOTE-BC2)
This is a double-blinded, randomized controlled trial of 200 HIV-infected pregnant women living in Tororo, Uganda, an area of high malaria transmission.
- Trial name
- NCT02282293
- Testing
- Monthly dihydroartemisinin-piperaquine (DP) + daily trimethoprim/sulfamethoxazole (TS)
- Where
- Uganda
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- University of California, San Francisco
Diabetes Mellitus, Type 1
Omnipod® 5 With Libre 2 vs. MDI for Type 1 Diabetes in Children and Adults
This study is a randomized, controlled trial to evaluate the efficacy and safety of the Omnipod® 5 System with the FreeStyle Libre 2 continuous glucose monitor compared to Multiple Daily Injections (MDI) along with the FreeStyle…
- Trial name
- RADIANT (NCT05923827)
- Testing
- Omnipod 5 System
- Where
- 19 sites in Belgium, France and 1 more
- Volunteers
- 189 people
- Sponsor
- Insulet Corporation
Venous Thromboembolism
Open Label Study Comparing Efficacy and Safety of Dabigatran Etexilate to Standard of Care in Paediatric Patients With Venous Thromboembolism (VTE)
The main objectives of this large phase IIb/III paediatric study are to assess the efficacy and safety of dabigatran etexilate relative to standard of care and to document the appropriateness of the proposed dabigatran etexilate…
- Trial name
- NCT01895777
- Testing
- dabigatran etexilate, standard of care
- Where
- 65 sites in United States, Argentina and 24 more
- Volunteers
- 267 people
- Sponsor
- Boehringer Ingelheim
Short Stature Born Small for Gestational Age (SGA)
Long Term Study of Genotropin (Somatropin) for Short Children Born Small for Gestational Age (SGA)
To assess the long-term safety of Genotropin(somatropin) on Small for Gestational Age (SGA) without epiphyseal closing.
- Trial name
- NCT01859949
- Testing
- Genotropin (somatropin)
- Where
- 19 sites in Japan
- Volunteers
- 62 people
- Sponsor
- Pfizer
Small Gestational Age (SGA)
Optimization of the Dosage Regimen of Growth Hormone Therapy in Children Born Small for Gestational Age
Multicentric, open-label, randomized, pilot comparative study in parallel groups comparing 1 group of subjects receiving 0.057 milligram/kilogram/day (mg/kg/day) or 0.40 mg/kg/week of Saizen® during 1 year to 1 group receiving…
- Trial name
- SGA OPTIMIS (NCT00249821)
- Testing
- Saizen®
- Volunteers
- 22 people
- Sponsor
- Merck KGaA, Darmstadt, Germany
Infant Apnea, Neonatal Abstinence Syndrome
Interventions to Help Infants Recover in the Hospital
This pilot project will evaluate independently two non-pharmacological interventions, 1) Neurosensory, Environmental Adaptive Technology (NEATCAP) and 2) Stochastic Vibrotactile Stimulation (SVS), as adjuvant non-pharmacological…
- Conditions
- Infant Apnea, Neonatal Abstinence Syndrome, Sleep
- Trial name
- NCT03881553
- Testing
- NEATCAP, SVS mattress
- Where
- United States
- Volunteers
- 17 people
- Sponsor
- Elisabeth Salisbury, PhD
Children Born With Serious Intra-uterine Growth Retardation
Saizen in Intra-uterine Growth Retardation
Study of safety of Saizen® in children born with serious intra-uterine growth retardation (IUGR) treated to final height. An open, phase III study involving 17 centers in France.
- Trial name
- NCT01400698
- Testing
- Saizen® A, Saizen® B, Observation only
- Volunteers
- 91 people
- Sponsor
- Merck KGaA, Darmstadt, Germany
Asthma
Redesigning Ambulatory Care Delivery to Enhance Asthma Control in Children
The investigators have developed a tool to facilitate asthma self-management in children, the electronic-AsthmaTracker (e-AT). The e-AT changes ambulatory asthma care delivery to a new model that is continuous and proactive…
- Trial name
- NCT02409277
- Testing
- Experimental: Standard vs Intensive e-AT Intervention
- Where
- United States
- Volunteers
- 926 people, healthy volunteers welcome
- Sponsor
- University of Utah
Infections, Streptococcal, Streptococcus Pneumoniae Vaccines
Evaluate Safety and Immunogenicity of a Booster Dose of Pneumococcal Conjugate Vaccine in Preterm Born Infants.
The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of a booster dose of GlaxoSmithKline (GSK) Biologicals´ pneumococcal conjugate vaccine co-administered with a booster dose of DTPa-IPV/Hib…
- Trial name
- NCT00609492
- Testing
- GSK Biologicals´ Pneumococcal Conjugate Vaccine (GSK1024850A), Infanrix™-IPV/Hib
- Where
- 7 sites in Greece, Spain
- Volunteers
- 245 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
A. Longitudinal Cohort n=400, B. Lower Risk (n=45) and Higher Risk (n=105) Randomized 2:1 to PERCCS Intervention
Study to Understand Risk and Resilience Opportunity for Newborns After Delivery
Childhood Maltreatment (CM) has highly deleterious effects on human development and is a preventable known cause of enduring psychopathology in the United States.
- Trial name
- SURROuND (NCT04438161)
- Testing
- PERCCS: Personalized Education Regarding Clinical and Community Supports
- Where
- United States
- Volunteers
- 399 people, healthy volunteers welcome
- Sponsor
- Washington University School of Medicine
HIV Infections
Reducing the Incidence of Nevirapine Resistance Mutations in Pregnant HIV Infected Women Who Receive Anti-HIV Drugs Prior to and After Giving Birth
The purpose of this study is to determine which of 3 different anti-HIV drug regimens given to HIV infected pregnant women during and after their pregnancies is most effective in reducing the incidence of nevirapine (NVP)…
- Trial name
- NCT00109590
- Testing
- Didanosine, enteric-coated, Lopinavir/ritonavir, Nevirapine
- Where
- 7 sites in Thailand
- Volunteers
- 175 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Metachromatic Leukodystrophy (MLD)
Multicenter Study of HGT-1110 Administered Intrathecally in Children With Metachromatic Leukodystrophy (MLD)
The purpose of this study is to determine the safety of ascending doses of HGT-1110 administered by intrathecal (IT) injection for 38 weeks (20 injections) in children with metachromatic leukodystrophy (MLD).
- Trial name
- IDEAMLD (NCT01510028)
- Testing
- Recombinant human arylsulfatase A
- Where
- 5 sites in Australia, Denmark and 3 more
- Volunteers
- 24 people
- Sponsor
- Shire