Clinical trials: Neonates and Preterm Infants
Premature Birth of Newborn, Enterocolitis, Necrotizing
A Randomized Controlled Trial Investigating if Antibiotic Use in the First 48 Hours of Life Adversely Impacts the Preterm Infant Microbiome
The purpose of this study is to determine whether antibiotics given immediately after birth alter the development of the developing preterm infant's microbiome, which may further alter overall clinical outcomes.
- Trial name
- NCT02477423
- Testing
- Ampicillin, Gentamicins
- Where
- United States
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- University of Chicago
Infant, Newborn, Infant, Low Birth Weight
Multi-dose Pharmacokinetics and Dose Ranging of Inositol in Premature Infants (INS-2)
This pilot study is a randomized, placebo-controlled, clinical trial to measure changes in blood and urine levels of inositol in premature infants at high risk for retinopathy of prematurity (ROP) following repeated doses of…
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- INS-2 (NCT01030575)
- Testing
- Inositol lower volume, Inositol mid-level volume, Inositol high volume
- Where
- 17 sites in United States
- Volunteers
- 125 people, healthy volunteers welcome
- Sponsor
- NICHD Neonatal Research Network
Retinopathy of Prematurity, Retinal Detachment
Efficient Study of ACULAR in Inhibiting Proliferative Retinopathy in Prematurity
The purpose of this study is to test whether ACULAR, a nonsteroidal anti-inflammatory eye drop medication, can prevent the development of retinopathy of prematurity (ROP) and/ or decrease its severity.In this study ACULAR will be…
- Conditions
- Retinopathy of Prematurity, Retinal Detachment, Blindness
- Trial name
- ROP (NCT00634972)
- Testing
- ACULAR, REFRESH TEARS
- Where
- United States
- Volunteers
- 83 people, healthy volunteers welcome
- Sponsor
- University of South Alabama
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
Infant, Premature, Diseases, Infant, Newborn, Diseases
Pulmonary Function Using Non-invasive Forced Oscillometry
The purpose of this observational study is to measure pulmonary function in term and preterm infants with and without pulmonary disease including respiratory distress syndrome, bronchopulmonary dysplasia, transient tachypnea of…
- Conditions
- Infant, Premature, Diseases, Infant, Newborn, Diseases, Bronchopulmonary Dysplasia, Respiratory Distress Syndrome, Newborn
- Trial name
- PUFFOR (NCT03346343)
- Testing
- Non-invasive forced airway oscillometry
- Where
- United States
- Volunteers
- 600 people, healthy volunteers welcome
- Sponsor
- University of Alabama at Birmingham
Neonatal Infection
Experience of Mutaflor Suspension Use in Preterm Infants for Immunity Improvement
EcN has been registered as a medical drug under the brand name Mutaflor® SUSPENSION in Ukraine in 2010. Indications for its clinical use are acute diarrhea in infants and toddlers including those on tube feeding tube, diarrhea in…
- Trial name
- EMSUP (NCT01540162)
- Where
- Ukraine
- Volunteers
- 62 people, healthy volunteers welcome
- Sponsor
- Odessa National Medical University
Cerebral Palsy, Perinatal Stroke
Single-session tDCS in Cerebral Palsy
The goal of this study is to characterize individual responses to a single application of transcranial direct current stimulation (tDCS) in children with unilateral cerebral palsy (UCP), and to test which electrode configuration…
- Conditions
- Cerebral Palsy, Perinatal Stroke, Periventricular Leukomalacia
- Trial name
- NCT03635775
- Testing
- Active tDCS
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- University of Minnesota
Premature, Extremely Low Birth Weight Infants, Polyunsaturated Fatty Acid Levels
PUFA Supplementation in Premature Infants
The purpose of this study is to determine if buccal administration of a concentrated formulation of long-chain polyunsaturated fatty acids (LCPUFA) can help to maintain docosahexaenoic acid (DHA) levels in extremely low birth…
- Trial name
- NCT01955044
- Testing
- LCPUFA supplement
- Where
- 3 sites in United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Endeavor Health
Idiopathic Hyperbilirubinemia, Neonatal Hyperbilirubinemia
Glycerin Suppositories to Reduce Jaundice in Premature Infants
The purpose of this study is to find out if giving glycerin suppositories will help decrease the length of time premature infants need phototherapy.
- Conditions
- Idiopathic Hyperbilirubinemia, Neonatal Hyperbilirubinemia, Prematurity
- Trial name
- NCT01746511
- Testing
- Phototherapy, glycerin suppository
- Where
- United States
- Volunteers
- 79 people, healthy volunteers welcome
- Sponsor
- University of Rochester
Extremely Low Gestational Age Newborn, Premature Infant
Oropharyngeal Administration of Colostrum to Extremely Low Gestational Age Newborns
Colostrum is rich in cytokines and other immune agents that may provide immunomodulatory protection against nosocomial infection in extremely premature infants.
- Trial name
- NCT01536093
- Testing
- oropharyngeal administration of own mother's colostrum, oropharyngeal administration of sterile water
- Where
- South Korea
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Seoul National University Hospital
Premature Infant Disease, Family Research
PREEMIE PROGRESS: A Family Management Program for Parents of Preterm Infants
The purpose of this study is to refine and pilot test a mobile health (mHealth), video-based family management program for parents of preterm infants hospitalized in the Neonatal Intensive Care Unit (NICU).
- Conditions
- Premature Infant Disease, Family Research, Parent-Child Relations, Self Efficacy
- Trial name
- NCT04638127
- Testing
- PREEMIE PROGRESS, Attention Control
- Where
- United States
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- University of Cincinnati
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
Prematurity, Necrotizing Enterocolitis
Neutrophil Extracellular Trap Formation in Newborn Infants at Risk for Inflammatory Syndromes
The purpose of this study is to characterize the time to maturation of neutrophil extracellular trap(NET) formation capability in polymorphonuclear leukocytes(PMNs) isolated from newborn premature and term infants.
- Trial name
- NCT01106209
- Where
- 2 sites in United States
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- University of Utah
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
Upper Extremity Dysfunction
Movement Enhancing Device for Children
The purpose of this study is to assess: 1) how infants move their bodies to explore, play, and solve problems, 2) if this is different in a high-risk group of infants, and 3) if these abilities can be advanced in a high-risk…
- Trial name
- NCT01959581
- Testing
- Movement Enhancing Device
- Where
- 3 sites in United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- University of Delaware
Healthy, Cystic Fibrosis (CF)
MRI for Non-Invasive Imaging in Neonates and Children
The purpose of this study is to develop rapid MRI techniques for imaging the lung with hyperpolarized helium-3 gas as an inhaled contrast agent.
- Conditions
- Healthy, Cystic Fibrosis (CF), Asthma, Bronchopulmonary Dysplasia (BPD)
- Trial name
- NCT02163681
- Testing
- Hyperpolarized Helium-3 MRI of the chest
- Where
- United States
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- University of Virginia