Clinical trials: Term Infant
Pain
Topical Amethocaine Gel for Intramuscular Injection in Term Neonates
This study will examine the efficacy of topical amethocaine gel (Ametop) in decreasing the pain response in term neonates subjected to intramuscular injection for administration of vitamin K.
- Trial name
- NCT00267111
- Testing
- Eucerin plus, Amethocaine gel 4%
- Where
- Canada
- Volunteers
- 110 people
- Sponsor
- Mount Sinai Hospital, Canada
Hepatitis B, Pertussis
Long-term Persistence of Hepatitis B and Pertussis Antibody Responses in Healthy 4 to 5 Year Old Children Previously Vaccinated With Vaxelis® or INFANRIX® Hexa (V419-012)
This is a multicenter extension study of two European randomized, double-blind studies (V419-007 and V419-008). It describes long-term persistence of hepatitis B and pertussis antibody responses in healthy 4- to 5 year old…
- Trial name
- NCT02759354
- Testing
- Blood Sample
- Volunteers
- 754 people, healthy volunteers welcome
- Sponsor
- MCM Vaccines B.V.
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 .
Neonatal Hyperbilirubinemia
Reverse Phototherapy With Super Light-emitting Diode(Super-LED) for Hyperbilirubinemia in Term and Late Preterm Infants
The aim of this study is to compare the efficacy of super-LED reverse phototherapy with the fluorescent reverse phototherapy in term and late preterm newborns.
- Trial name
- NCT01340339
- Testing
- Phototherapy
- Where
- Brazil
- Volunteers
- 144 people
- Sponsor
- Professor Fernando Figueira Integral Medicine Institute
Cystic Fibrosis
Study to Evaluate Elexacaftor/Tezacaftor/Ivacaftor (ELX/TEZ/IVA) Long-term Safety and Efficacy in Subjects Without F508del
This study will evaluate the long-term safety, efficacy and pharmacodynamics of ELX/TEZ/IVA in participants with cystic fibrosis (CF) with at least 1 non-F508del ELX/TEZ/IVA-responsive CF transmembrane conductance regulator…
- Trial name
- NCT05331183
- Testing
- ELX/TEZ/IVA, IVA
- Where
- 81 sites in Austria, Belgium and 13 more
- Volunteers
- 297 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Small for Gestational Age at Delivery, Post-term Infant, Not Heavy-for-dates
Breast Milk Zinc Transfer to Appropriate- and Small-for-gestational-age Bangladeshi Infants
Data collected from this study will provide information on the breast milk zinc concentration, maternal and infant zinc status, and transfer of zinc from mothers breast milk to infants during first six months of life.
- Trial name
- NCT01728766
- Testing
- Small for gestational age at delivery, Post-term Infant, Not Heavy-for-dates
- Where
- Bangladesh
- Volunteers
- 76 people, healthy volunteers welcome
- Sponsor
- International Centre for Diarrhoeal Disease Research, Bangladesh
Gut Microbiota Modulation
STUDY OF THE EFFECTS OF L. CASEI DG® (ENTEROLACTIS BABY) IN HEALTHY PRETERM AND FULL-TERM INFANTS.
The goal of this clinical trial was to learn whether giving Enterolactis Baby®, a probiotic food supplement containing Lactobacillus casei DG® (under the new taxonomical denomination: Lacticaseibacillus paracasei DG, CNCM…
- Trial name
- NCT07882537
- Testing
- Enterolactis Baby® drops
- Where
- Italy
- Volunteers
- 61 people, healthy volunteers welcome
- Sponsor
- Alfasigma S.p.A.
Apnea
Management of Apnea in Late Preterm and Term Infants
Apnea is a common discharge-delaying diagnosis in the Newborn Intensive Care Unit. While it is relatively more common in extremely premature infants, it also occurs frequently in late preterm and even full term infants.
- Trial name
- NCT02408328
- Testing
- Caffeine citrate, Home monitor, Continued inpatient monitoring until apnea resolution
- Sponsor
- Boston Children's Hospital
Gastrointestinal Microbiome
Gastrointestinal Tract Microbiome in Healthy Term Infants Receiving Mother'S-own Breast Milk or Cow's Milk-based Infant Formulas
This clinical trial will compare stool and oral microbiome composition between infants fed breast milk or one of two infant formulas for a 60 day feeding period.
- Trial name
- NCT04059666
- Testing
- Investigational, Control
- Where
- 5 sites in United States
- Volunteers
- 57 people, healthy volunteers welcome
- Sponsor
- Mead Johnson Nutrition
Healthy Term Infants
Growth and Metabolic Biomarkers of Healthy Term Infants Fed Formulas With Staged Protein Concentrations Over the First Year of Life
Growth and metabolic biomarkers of healthy term infants fed formulas with staged protein concentrations over the first year of life
- Trial name
- NCT02646969
- Testing
- Formula regimen 1, Formula regimen 2
- Where
- 9 sites in France
- Volunteers
- 691 people, healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)
Healthy Participants, Infants
First Complementary Foods and the Infant Gastrointestinal Microbiota
This study evaluates the effect of different complementary foods on the gastrointestinal microbiota of exclusively human milk fed infants.
- Conditions
- Healthy Participants, Infants, Gastrointestinal Microbiota
- Trial name
- NCT05492253
- Testing
- Infant fruit, Infant vegetable, Infant meat
- Where
- United States
- Volunteers
- 43 people, healthy volunteers welcome
- Sponsor
- University of Delaware
Meconium Aspiration
Phase III Randomized Study of Lucinactant in Full Term Newborn Infants With Meconium Aspiration Syndrome
OBJECTIVES: Evaluate the safety and efficacy of lucinactant administered by bronchoalveolar lavage (BAL) in the treatment of meconium aspiration syndrome (MAS) in newborn infants.
- Trial name
- NCT00004500
- Testing
- Lucinactant, Standard Care
- Where
- United States
- Volunteers
- 69 people
- Sponsor
- Windtree Therapeutics
Preterm Infant Development, Preterm Infant Health
Neonatal Data and Biobank to Study Factors Influencing Development in Preterm Infants Born at <32 Weeks' Gestation and/or <1500 g Birth Weight
The Neo-Life project aims to establish a prospective neonatal data and biobank to investigate factors influencing the short- and long-term development of very preterm infants.
- Conditions
- Preterm Infant Development, Preterm Infant Health, Prematurity Complications, Premature Birth
- Trial name
- Neo-Life (NCT07490912)
- Where
- Germany
- Volunteers
- 1,300 people
- Sponsor
- University Hospital of Cologne
Younger Sibling of Child With Autism Spectrum Disorder, Signs of Developmental Delay
Effects of a Short-term Parent Mediated Social Training on Developmental Trajectories in Infants
This study is being done to examine the feasibility and impact of the Infant Achievements caregiver coaching treatment on caregiver child-engagement strategies used during play with their infant.
- Conditions
- Younger Sibling of Child With Autism Spectrum Disorder, Signs of Developmental Delay, Signs of Communication Delay, Signs of Social Delay
- Trial name
- IA (NCT03404505)
- Testing
- Infant Achievements, Caregiver Education (CE)
- Where
- United States
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Retinopathy of Prematurity (ROP)
Extension Study to Evaluate the Long-term Outcomes of Subjects in Study 20090
This is a follow-up study to evaluate the long term outcome of babies treated in the FIREFLEYE study.
- Trial name
- FIREFLEYE next (NCT04015180)
- Testing
- Eylea (Aflibercept, BAY86-5321), Laser photocoagulation
- Where
- 55 sites in Argentina, Belgium and 22 more
- Volunteers
- 100 people
- Sponsor
- Bayer
Healthy Infants
Probiotic for Infants
The BABIES II study is a single-center, randomized, double-blinded, placebo-controlled study in newborns with an 8½ months intervention period from 14 days of age to 9 months of age followed by a 3-months short-term follow-up…
- Trial name
- BABIES II (NCT07054216)
- Testing
- Probiotic
- Where
- 2 sites in Denmark
- Volunteers
- 378 people, healthy volunteers welcome
- Sponsor
- Hvidovre University Hospital
Infant, Very Low Birth Weight
Randomized Study of Human-Milk Based Nutrition Versus Formula in Premature Infants
The purpose of this study is to determine whether very low birth weight infants (less than or equal to 1250g or about 2 3/4 pounds) born prematurely fed a diet of only human milk and human milk-derived nutrition have better…
- Trial name
- NCT00506584
- Testing
- Pasteurized human milk and pasteurized human milk fortifier, Human milk fortifier (bovine-based), pre-term formula, Pre-term/term formula
- Where
- 13 sites in United States, Austria
- Volunteers
- 260 people
- Sponsor
- Prolacta Bioscience
Cystic Fibrosis
The Short Term Safety and Efficacy of Inhaled L-arginine in Patients With Cystic Fibrosis
The objective of this trial is to determine the safety and effect on pulmonary function of 14 days of inhaled L-arginine versus placebo administered over a period of 14 days in a cohort of CF patients.
- Trial name
- NCT00405665
- Testing
- L-arginine
- Where
- 2 sites in Canada
- Volunteers
- 20 people
- Sponsor
- The Hospital for Sick Children
Infant ALL
A Clinical Trial on the Effect of Infant Formula Consumption on Growth, Immune Parameters, and Gut Health in Healthy Term Infants
The goal of this clinical trial is to study growth (weight gain per day) in healthy full-term infants who consume the investigational infant formula containing beneficial ingredients against infants consuming a control infant…
- Trial name
- NCT07867509
- Testing
- Infant Formula, Breastfeeding
- Volunteers
- 387 people, healthy volunteers welcome
- Sponsor
- FrieslandCampina
Hypoxic-Ischemic Encephalopathy, Birth Asphyxia
Umbilical Cord Milking in Neonates Who Are Depressed at Birth-Developmental Follow Up (MIDAB-FU)
An extension of the MIDAB trial, the MIDAB-Follow-up trial will evaluate the neurodevelopmental outcomes at 22-26 months age of term/late preterm infants who were depressed at birth and received umbilical cord milking (UCM) or…
- Trial name
- MIDAB-FU (NCT03681314)
- Testing
- Umbilical Cord Milking
- Where
- 3 sites in India
- Sponsor
- Nemours Children's Clinic