Clinical trials: Newborn Infant
Infant, Newborn, Infant, Premature
Effect of a Vibratory Stimulus on Mitigating Nociception-specific Responses to Skin Puncture in Neonates
The assessment and treatment of pain in neonates remains a challenge. In an effort to improve the quality of care while limiting opioid-related adverse effects, this study aims to determine the efficacy of a non-pharmacological…
- Conditions
- Infant, Newborn, Infant, Premature, Pain Perception, Pain Measurement
- Trial name
- NCT04050384
- Testing
- Baby GentleStick
- Where
- United States
- Volunteers
- 134 people, healthy volunteers welcome
- Sponsor
- Lance M Relland, MD, PhD
Cystic Fibrosis
Glycerol Phenylbutyrate Corrector Therapy For CF (Cystic Fibrosis)
We propose to test the effectiveness of the combination of CF pancreatic enzyme replacement therapy (PERT) on absorption of Ravicti® and subsequent restoration of nasal epithelial cystic fibrosis transmembrane conductance…
- Trial name
- GPBA (NCT02323100)
- Testing
- Ravicti low dose
- Where
- 3 sites in United States
- Volunteers
- 16 people
- Sponsor
- National Jewish Health
Cystic Fibrosis
Study of VX-809 Alone and in Combination With VX-770 in Cystic Fibrosis (CF) Patients Homozygous or Heterozygous for the F508del-CFTR Mutation
The purpose of this study is to evaluate of the safety, efficacy, pharmacokinetics (PK) and pharmacodynamic (PD) effects of lumacaftor (VX-809) alone and when coadministered with ivacaftor (VX-770) in participants with cystic…
- Trial name
- NCT01225211
- Testing
- Lumacaftor, Ivacaftor
- Where
- 55 sites in United States, Australia and 5 more
- Volunteers
- 312 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Cystic Fibrosis, Burkholderia Cepacia Infection
Tobramycin Inhalation Powder (TIP) in Cystic Fibrosis Patients Infected With Burkholderia Cepacia Complex
The objective of this study is to determine if tobramycin inhalation powder (TIP) can reduce the amount of Burkholderia Cepacia Complex (BCC) species - type of bacteria, in the sputum of cystic fibrosis patient.
- Trial name
- NCT02212587
- Testing
- TOBI
- Where
- 2 sites in Canada
- Volunteers
- 10 people
- Sponsor
- Unity Health Toronto
Cerebral Palsy, Hypoxic-Ischemic Encephalopathy
Therapeutic Intervention Supporting Development From NICU to 6 Months for Infants Post Hypoxic-Ischemic Encephalopathy
The purpose of this study is to evaluate the feasibility and begin to evaluate the effect of a sensorimotor intervention (SMI) provided in the first 6 months of life for infants with hypoxic-ischemic encephalopathy.
- Trial name
- NCT05130528
- Testing
- Sensorimotor Intervention
- Where
- 2 sites in United States
- Volunteers
- 11 people
- Sponsor
- University of Southern California
Bronchopulmonary Dysplasia
Inhaled Nitric Oxide (INO) for the Prevention of Bronchopulmonary Dysplasia (BPD) in Preterm Infants
This phase 3, multi-center, double blind, placebo-controlled, randomized clinical trial will attempt to demonstrate if preterm infants who require mechanical ventilation and/or positive pressure support at any point during days 5…
- Trial name
- NCT00931632
- Testing
- Inhaled Nitric Oxide
- Where
- 33 sites in United States, Canada
- Volunteers
- 451 people
- Sponsor
- Mallinckrodt
Prematurity, Respiratory Distress Syndrome
Curosurf and Survanta Treatment(CAST)of RDS in Very Premature Infants
Approval of surfactant by the FDA in 1989 for the treatment of Respiratory Distress Syndrome (RDS) in premature infants greatly improved survival rates.
- Conditions
- Prematurity, Respiratory Distress Syndrome, Patent Ductus Arteriosus
- Trial name
- CAST (NCT00767039)
- Testing
- Survanta (beractant), Curosurf (poractant)
- Where
- United States
- Volunteers
- 52 people
- Sponsor
- Alan Fujii
Cystic Fibrosis
A Study to Assess the Effect of ELX/TEZ/IVA on Glucose Tolerance in Participants With Cystic Fibrosis (CF)
This study was evaluate the effect of elexacaftor (ELX)/tezacaftor (TEZ)/ivacaftor (IVA) on glucose tolerance in CF participants, 12 years of age and older who are heterozygous for the F508del mutation and a minimal function…
- Trial name
- NCT04599465
- Testing
- ELX/TEZ/IVA, IVA
- Where
- 41 sites in Australia, Belgium and 5 more
- Volunteers
- 69 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Neurocognitive, Neuroprotective
Darbepoetin Trial to Improve Red Cell Mass and Neuroprotection in Preterm Infants
Study Hypothesis: Preterm infants administered weekly Darbe during the neonatal period will have improved neurocognitive outcome at 22-26 months compared to placebo
- Conditions
- Neurocognitive, Neuroprotective, Neonatal, Neurodevelopmental Impairment
- Trial name
- Darbe (NCT03169881)
- Testing
- Darbepoetin
- Where
- 16 sites in United States
- Volunteers
- 650 people
- Sponsor
- NICHD Neonatal Research Network
Cystic Fibrosis
Short Term Effects of Ivacaftor in Non-G551D Cystic Fibrosis Patients
This is a study of the short-term effects of ivacaftor on sweat chloride concentration and lung function in cystic fibrosis (CF) patients who fall outside current FDA approval.
- Trial name
- NCT01784419
- Testing
- ivacaftor
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- University of California, San Francisco
Fabry Disease, Alpha Galactosidase A Deficiency
Study of the Effects of Fabrazyme Treatment on Lactation and Infants
The study was planned for up to 2 years (24 months). Planned full participation for both mother and infant was 24 months, planned full participation of mother and development of infant was 24 months, while planned full…
- Trial name
- NCT00230607
- Testing
- agalsidase beta
- Where
- 5 sites in United States, Austria and 1 more
- Volunteers
- 7 people
- Sponsor
- Genzyme, a Sanofi Company
Prematurity
A Clinical Trial of A Pacifier-Activated Music Player
Neonatal intensive care unit infants are at high risk for oromotor difficulties including poor coordination of sucking swallowing and breathing.
- Trial name
- NCT01600586
- Testing
- Pacifier-Activated-Lullaby system (PAL).
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Vanderbilt University Medical Center
Neonatal Anemia
Milking Versus Delayed Cord Clamping in Full Term Neonates
To compare the short term risks and benefits of cord milking 5 times toward the neonate with delayed cord clamping for 120 seconds in the full term neonate delivered by cesarean section.
- Trial name
- MDCCT (NCT02454101)
- Testing
- cord milking, delayed cord clamping
- Where
- Egypt
- Volunteers
- 300 people
- Sponsor
- Ahmed Mohamed El Kotb Abdel Fattah
Intraventricular Hemorrhage, Periventricular Leukomalacia
Effects of Delayed Cord Clamp and/or Indomethacin on Preterm Infant Brain Injury
Intraventricular hemorrhage (IVH) and periventricular leukomalacia (PVL) are brain lesions that commonly occur in preterm infants and are well-recognized major contributors to long-term brain injury and related disabilities later…
- Conditions
- Intraventricular Hemorrhage, Periventricular Leukomalacia, Brain Injury, Renal Injury
- Trial name
- NCT02221219
- Testing
- Indomethacin, delay in umbilical cord clamp at birth, immediate cord clamp at birth
- Where
- United States
- Volunteers
- 256 people
- Sponsor
- Hong Huang
Preterm Infants
NHFOV vs. NCPAP as a Primary Treatment to Neonatal Respiratory Distress Syndrome(NRDS)
The investigators compared advantages and disadvantages of two forms of noninvasive respiratory support -noninvasive high-frequency oscillatory ventilation (nHFOV) or nasal continuous positive airway pressure (nCPAP) -as a…
- Trial name
- NCT03099694
- Testing
- noninvasive high-frequency ventilation (nHFOV), nasal continuous positive airway pressure (nCPAP)
- Where
- China
- Volunteers
- 340 people
- Sponsor
- Xingwang Zhu
Cystic Fibrosis Related Bone Disease
Cystic Fibrosis Related Bone Disease: the Role of CFTR
The purpose of this study is to determine whether ivacaftor, a recently FDA-approved CFTR potentiator, improves bone micro-architecture and strength in patients with cystic fibrosis with at least one G551D CFTR mutation.
- Trial name
- NCT01549314
- Where
- United States
- Volunteers
- 79 people, healthy volunteers welcome
- Sponsor
- Massachusetts General Hospital
Cystic Fibrosis
Persistent Methicillin Resistant Staphylococcus Aureus Eradication Protocol (PMEP)
The prevalence of methicillin resistant Staphylococcus aureus (MRSA) respiratory infection in Cystic Fibrosis (CF) has increased dramatically over the last decade.
- Trial name
- PMEP (NCT01594827)
- Testing
- Inhaled Vancomycin, Rifampin, Trimethoprim/Sulfamethoxazole (TMP/SMX)
- Where
- 2 sites in United States
- Volunteers
- 29 people
- Sponsor
- Johns Hopkins University
Prematurity, Necrotizing Enterocolitis
Collaborative Research Group for Necrotizing Enterocolitis
This proposal will test the hypothesis that synthesis and catabolism of epidermal growth factor (EGF), the genotype of the EGF gene, and the microbiome interact to influence EGF expression in infants at risk for necrotizing…
- Trial name
- NCT00828451
- Testing
- [5,5,5-2H3]leucine (stable isotope labeled leucine)
- Where
- United States
- Volunteers
- 29 people
- Sponsor
- Washington University School of Medicine
Cystic Fibrosis
To Assess the Safety, Tolerability and Pharmacokinetics of AZD5634 Following Inhaled and Intravenous (IV)Dose Administration
This is a Phase 1, first-in-human (FIH) single ascending dose study being conducted to better understand the safety, tolerability and pharmacokinetics of AZD5634 in healthy subjects
- Trial name
- NCT02679729
- Testing
- AZD5634 for inhalation, AZD5634 for infusion
- Where
- 2 sites in United States
- Volunteers
- 63 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
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