Clinical trials: Infant Term Birth
Cystic Fibrosis
Evaluation of Long-term Safety and Efficacy of ELX/TEZ/IVA in Cystic Fibrosis Participants 12 Months of Age and Older
The purpose of the study is to evaluate the long-term safety, tolerability, efficacy, and pharmacodynamics (PD) of elexacaftor (ELX)/tezacaftor (TEZ)/ivacaftor (IVA).
- Trial name
- NCT06460506
- Testing
- ELX/TEZ/IVA, IVA
- Where
- 18 sites in Australia, Canada and 5 more
- Volunteers
- 50 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Preterm Birth, Premature Birth
Exposure to Plasticisers in the Neonatal Intensive Care Unit
Neonatal intensive care relies on indwelling plastic medical devices fundamental in respiratory support, intravenous catheterization, and nutrition.
- Conditions
- Preterm Birth, Premature Birth, Neurodevelopmental Disorders, Pulmonary Disease
- Trial name
- PLASTIC-NICU (NCT05404815)
- Where
- Belgium
- Volunteers
- 132 people, healthy volunteers welcome
- Sponsor
- University Hospital, Antwerp
Cystic Fibrosis
Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Lumacaftor in Combination With Ivacaftor
Study 110 is a Phase 3, multicenter study in subjects aged 6 years and older with cystic fibrosis (CF) who are homozygous for the F508del-CF transmembrane conductance regulator (CFTR) mutation and who participated in Study 109…
- Trial name
- NCT02544451
- Testing
- LUM/IVA
- Where
- 60 sites in United States, Australia and 7 more
- Volunteers
- 246 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Healthy
Influence of Improved Formula on Fatty Acids and Mineral Metabolism in Infants
The purpose of this study is to determine whether different content of β-palmitate will cause significant differences on Fatty Acids and Mineral Metabolism in Infants
- Trial name
- NCT02587702
- Testing
- β-Palmitate Content, β-Palmitate Content Naturely in Human Milk
- Where
- China
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- Beingmate Baby & Child Food Co Ltd .
Infant Formula Intolerance
The Impact of a Prebiotics and Lactoferrin Containing Infant Formula on Stool Characteristics in Healthy Term Infants
Human milk (HM) is considered the gold standard nutrient for infants, which contains a lot of beneficial nutrients such as prebiotics and lactoferrin.
- Trial name
- NCT02363582
- Testing
- formula
- Where
- China
- Volunteers
- 65 people
- Sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Preterm Less Than 32wks With IVH, WMI/PVL, Late Preterm or Term (37-42wks) With Neonatal Encephalopathy Treated With Hypothermia for HIE
Cerebral/ Cortical Visual Impairment: Screening, Identification and Outcome Prediction in Neonates
Cerebral/Cortical Visual Impairment (CVI) is the leading cause of childhood visual impairment in the United States and other industrialized countries.
- Trial name
- CVI (NCT07275021)
- Testing
- Prospective Clinical and Neurodevelopmental Data Collection
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Brigham and Women's Hospital
Breast Feeding
Clinical Trial of Immediate Skin to Skin Contact at Birth Early vs. Immediate (CPPITLH)
SUMMARY: Human lactation is a simple, cost-effective strategy contributing to infant and maternal mortality control. Skin to skin contact (SSC), is an immediate postpartum period strategy that has proven to benefit the initiation…
- Trial name
- CPPITLH (NCT02687685)
- Testing
- Skin to skin contact immediate, skin to skin contact early
- Where
- Colombia
- Volunteers
- 300 people
- Sponsor
- Universidad de la Sabana
Neurodevelopmental Abnormality
Umbilical Cord Milking in Non-Vigorous Infants Developmental Followup (MINVIFU)
A sub-study to evaluate longer-term developmental outcomes in non-vigorous term and near-term newborns who receive umbilical cord milking in comparison to those who undergo early cord clamping at delivery.
- Trial name
- MINVIFU (NCT03621943)
- Testing
- Umbilical Cord Milking, Early Cord Clamping
- Where
- 10 sites in United States, Canada and 1 more
- Volunteers
- 1,207 people
- Sponsor
- Sharp HealthCare
Growth of Term Infants
The Effects on Growth and Tolerance of an Infant Formula Fed to Term Infants
This clinical trial will evaluate an investigational infant formula with a probiotic to determine if it provides normal growth and if it is well tolerated by term infants compared to a marketed routine infant formula.
- Trial name
- NCT01897922
- Testing
- An investigational infant formula containing a probiotic source, Control: Marketed routine infant formula
- Where
- 22 sites in United States
- Volunteers
- 348 people, healthy volunteers welcome
- Sponsor
- Mead Johnson Nutrition
Preterm Milk, Term Milk
Pre/Term Milk Profiling
This study aims for an in-depth characterization of human milk of mothers who delivered prematurely to decipher differences with milk of mothers who delivered at the expected term, with a particular focus on milk proteins
- Trial name
- NCT02052245
- Where
- Switzerland
- Volunteers
- 61 people, healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)
Bronchopulmonary Dysplasia
Follow-Up Study of Safety and Efficacy of Pneumostem® in Premature Infants With Bronchopulmonary Dysplasia
This is a long term follow-up study of the open label, single-center, phase I clinical trial to evaluate the safety of Pneumostem® in premature infants with BPD.
- Trial name
- NCT01632475
- Testing
- Pneumostem®
- Where
- 2 sites in South Korea
- Volunteers
- 9 people
- Sponsor
- Samsung Medical Center
Cystic Fibrosis
A Short-term Comparative Study of Aerosure for Airway Clearance in Patients With Cystic Fibrosis
This is a double-blind randomised controlled crossover study to investigate whether high frequency airflow oscillation (HFAO), delivered using Aerosure, improves sputum clearance in patients admitted to hospital with infective…
- Trial name
- NCT01923753
- Testing
- Aerosure at 15 Hz, Aerosure at 25 Hz
- Where
- United Kingdom
- Volunteers
- 6 people
- Sponsor
- Actegy Ltd.
Pregnancy, Hyperlipidemias
Bempedoic Acid Pregnancy Surveillance Program
Bempedoic acid pregnancy surveillance program
- Trial name
- NCT05103254
- Testing
- Bempedoic Acid, Bempedoic Acid / Ezetimibe
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Esperion Therapeutics, Inc.
Cesarean Sections
Delayed Umbilical Cord Clamping - C-section Pilot
This is a pilot study of delayed cord clamping (DCC) at progressively longer intervals (90 to 120 seconds) during elective cesarean deliveries of term infants.
- Trial name
- NCT02229162
- Where
- United States
- Volunteers
- 41 people
- Sponsor
- University of California, Davis
Healthy
Tolerance of Healthy, Term Infants to Infant Formulas
To assess the gastrointestinal tolerance of healthy full-term infants fed either experimental formula or a control formula
- Trial name
- NCT00543673
- Testing
- Milk based formula A, #2 Standard formula, #3 Human Milk
- Where
- 10 sites in United States
- Volunteers
- 180 people, healthy volunteers welcome
- Sponsor
- Abbott Nutrition
Pain Management
Comparing Breastmilk, Massage, and no Intervention for Pain Management During Vaccination of Term Infants
The goal of this clinical trial is to learn if breastmilk, massage or no intervention works for pain management during vaccination of term infants. It will also learn about the safety of these 3 approaches.
- Trial name
- NCT06879613
- Testing
- Breastmilk, Massage
- Where
- Cameroon
- Volunteers
- 102 people
- Sponsor
- University of Bamenda
Intrauterine Growth Restriction (IUGR)
Determination of Clinical Phenotypes of Intrauterine Growth Restriction in Term Infants Based on Body Composition
Intrauterine growth restriction (IUGR) is defined as the inability of the fetus to fulfill its genetic growth potential. "Small for gestational age" (SGA) is the most commonly used indicator for diagnosing IUGR.
- Trial name
- Restrigrowth (NCT07483424)
- Testing
- Small for gestational age (SGA) infants, Adequate for gestational age (AGA) infants
- Where
- Portugal
- Volunteers
- 290 people, healthy volunteers welcome
- Sponsor
- Centro Hospitalar de Lisboa Central
Full Term Infants, Environmental Exposures
Epigenetic and Developmental Effects of In Utero Exposure to Environmental Toxicants
Metabolic diseases such as obesity and diabetes are modern day epidemics. Early life exposure to an adverse developmental environment, including environmental toxins, are linked to increased susceptibility to obesity, metabolic…
- Conditions
- Full Term Infants, Environmental Exposures, Adiposity
- Trial name
- NCT01815385
- Where
- United States
- Volunteers
- 110 people, healthy volunteers welcome
- Sponsor
- Montefiore Medical Center
Cystic Fibrosis
Long-term Safety of Lumacaftor/Ivacaftor in Participants With Cystic Fibrosis Who Are Homozygous for F508del and 12 to <24 Months of Age at Treatment Initiation
This is a Phase 3, multicenter, open-label and roll-over study in participants who are 12 to <24 months of age at initiation of Lumacaftor/Ivacaftor (LUM/IVA) treatment.
- Trial name
- NCT04235140
- Testing
- LUM/IVA
- Where
- 23 sites in United States, Canada
- Volunteers
- 52 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Preterm
Added Value of Supersonic Shear Imaging in the Diagnosis of White Matter Damage in Preterm Infants
Preterm birth and perinatal events related can interrupt microscopic maturation of the developing white matter leading to diffuse injury and subsequent neurocognitive impairments.
- Trial name
- BELUGA (NCT02042716)
- Testing
- diagnosis of white matter damage in preterm infants
- Where
- France
- Volunteers
- 128 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris