Clinical trials: Infant, Newborn
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
Cystic Fibrosis, Bronchiectasis Adult
Bacille Calmette-Guerin (BCG) Vaccine for Immune Protection Against Infections
This is pilot study of the immunologic effects of intradermal Bacille Calmette-Guerin (BCG) vaccination of adults with cystic fibrosis (CF), non-CF bronchiectasis (NCFB), and healthy volunteers.
- Conditions
- Cystic Fibrosis, Bronchiectasis Adult, Non-Tuberculous Mycobacteria
- Trial name
- NCT04884308
- Testing
- BCG TICE Vaccine
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins University
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
Cystic Fibrosis
The Impact of Insulin Therapy on Protein Turnover in Pre-Diabetic Cystic Fibrosis Patients
Insulin replacement therapy may be effective in breaking the cycle of protein catabolism, undernutrition and overall clinical deterioration in pre-diabetic, insulin insufficient CF youth because of its potent anabolic effect.
- Trial name
- NCT02496780
- Testing
- novolog insulin, levemir insulin
- Where
- 2 sites in United States
- Volunteers
- 65 people, healthy volunteers welcome
- Sponsor
- University of Minnesota
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 Colic
Effects of Acupuncture in the Treatment of Infant Colic
Standardized acupuncture treatment for infant colic is a common treatment in general practice for doctors educated in medical acupuncture.
- Trial name
- NCT00907621
- Testing
- Acupuncture with Seirin 020x15 mm sterile acupuncture needle
- Where
- Norway
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- University of Oslo
Plagiocephaly, Nonsynostotic
Observe the Effects of the Serkel Cranial Remolding Orthosis on Infants With Deformational Plagiocephaly
The purpose of this study is to determine the safety and effectiveness of a specific brand of cranial remolding orthosis (a custom made helmet), which is new to the United States market
- Trial name
- NCT06831513
- Testing
- Serkel 3D CRO
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- University of Texas Southwestern Medical Center
Asthma, COPD
The Natural History of Small Airways Physiology in Diseased and Healthy States
Spirometry is a useful clinical tool for the assessment and monitoring of lung disease, however, it does not provide information on peripheral airways resistance.
- Conditions
- Asthma, COPD, Interstitial Lung Disease, Cystic Fibrosis
- Trial name
- NCT00677560
- Where
- United Kingdom
- Volunteers
- 126 people, healthy volunteers welcome
- Sponsor
- Imperial College London
Stillbirth, Neonatal Death
Intermittent Auscultation Using Handheld Doppler: a Randomized Controlled Trial Comparing Perinatal Outcomes in Uganda
A novel handheld Doppler has been developed which is rugged and is powered only by a hand crank. This study aims to test the use of this Doppler versus the Pinard horn to monitor the fetal heart rate in labour in a hospital…
- Trial name
- NCT02273037
- Testing
- Fetal heart rate Doppler, Partograph
- Where
- 2 sites in Canada, Uganda
- Volunteers
- 1,987 people, healthy volunteers welcome
- Sponsor
- The Hospital for Sick Children
Obstetric Pain
Effect of Preemptive Epidural Analgesia in Labor on Cytokine Production
During labor there is an increased production of inflammatory mediators called cytokines. Higher concentration of certain cytokines has been linked to adverse neonatal and maternal outcomes.
- Trial name
- NCT00361712
- Testing
- Preemptive epidural analgesia, Standard of care
- Where
- Israel
- Volunteers
- 41 people, healthy volunteers welcome
- Sponsor
- Rabin Medical Center
Corona Virus Infection, Pregnancy Related
Understanding COVID-19 Infection in Pregnant Women and Their Babies
This national study will recruit expectant mothers with and without positive nasopharyngeal swabs for SARS-CoV-2, and aims to determine the seroepidemiology of SARS-CoV-2 amongst expectant mothers and their infants in the U.K.
- Conditions
- Corona Virus Infection, Pregnancy Related, Neonatal Infection, Breastfeeding
- Trial name
- periCOVID (NCT04703270)
- Where
- United Kingdom
- Volunteers
- 881 people, healthy volunteers welcome
- Sponsor
- St George's, University of London
Plagiocephaly
Premie Pouch to Manage Deformational Plagiocephaly in Very Low Birth Weight Infants
This pilot project proposes to develop and test a new device to manage (defined as resolving, prohibiting, inhibiting or preventing) the development of Deformational Plagiocephaly (DP) in prematurely born infants weighing < 1…
- Trial name
- NCT03184441
- Testing
- Premie Pouch
- Where
- 3 sites in United States
- Volunteers
- 11 people, healthy volunteers welcome
- Sponsor
- Boston Children's Hospital
Mental Health Issue (E.G., Depression, Psychosis, Personality Disorder, Substance Abuse), Infant Development
Maternal Adversity, Vulnerability and Neurodevelopment
Maternal Adversity Vulnerability and Neurodevelopment (MAVAN) project is a prospective community-based, pregnancy and birth cohort of Canadian mother-child dyads.
- Conditions
- Mental Health Issue (E.G., Depression, Psychosis, Personality Disorder, Substance Abuse), Infant Development, Infant Behavior
- Trial name
- MAVAN (NCT03434457)
- Where
- Canada
- Volunteers
- 630 people, healthy volunteers welcome
- Sponsor
- Douglas Mental Health University Institute
Metabolism, Inborn Errors, Hearing Loss
North Carolina Newborn Exome Sequencing for Universal Screening
The NC NEXUS research study is exploring the utility of next generation sequencing in newborn screening and parental decision making.
- Conditions
- Metabolism, Inborn Errors, Hearing Loss, Hereditary Disease
- Trial name
- NC_NEXUS (NCT02826694)
- Testing
- Well infant, whole exome sequencing, Diagnosed, whole exome sequencing
- Where
- United States
- Volunteers
- 106 people, healthy volunteers welcome
- Sponsor
- University of North Carolina, Chapel Hill
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
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
Staphylococcal Sepsis
Safety and Efficacy of Pagibaximab Injection in Very Low Birth Weight Neonates for Prevention of Staphylococcal Sepsis
Evaluate the safety, PK and efficacy comparing Pagibaximab Injection to placebo in preventing staphylococcal sepsis in very low birth weight infants.
- Trial name
- NCT00646399
- Testing
- Pagibaximab 50 mg/mL
- Where
- United States
- Volunteers
- 1,579 people, healthy volunteers welcome
- Sponsor
- Biosynexus Incorporated
Induction of Labor Affected Fetus / Newborn
A Trial of Cervidil for Outpatient Pre-induction of Cervical Ripening
Induction of labor is a frequently planned obstetric procedure. Induction for women with an unfavorable cervix (bishop score <6) increases the risk of cesarean section.
- Trial name
- NCT03806231
- Testing
- Outpatient Dinoprostone 10mg, Inpatient Dinoprostone 10 mg
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Intermountain Health Care, Inc.