Clinical trials: Term Infant
Diphtheria, Tetanus
Safety, Long Term Immunogenicity and Lot Consistency Study of Liquid Pentavalent Combination Vaccine
A randomized phase IV study of the liquid pentavalent combination vaccine to evaluate the safety, immunogenicity (short term and long term) and clinical consistency of three production lots of the vaccine.
- Conditions
- Diphtheria, Tetanus, Pertussis, Hepatitis B
- Trial name
- NCT00877357
- Testing
- Shan 5
- Where
- India
- Volunteers
- 3,000 people, healthy volunteers welcome
- Sponsor
- Shantha Biotechnics Limited
Safety Issues, Infant Nutrition Disorders
Clinical Evaluation of a Low Protein Content Formula in the First Months of Life: a RCT
This study aimed to evaluate the tolerance and safety of a low-protein formula in healthy full-term infants by investigating effects on growth and gastrointestinal tolerance and by identifying any adverse effects.
- Trial name
- NCT03035721
- Testing
- Low protein formula, Standard protein formula
- Where
- Italy
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Healthy Term Infants
Growth and Tolerance of Healthy Term Infants to a New Infant Formula
The objective of this study is to evaluate the effect of two experimental milk-based infant formulas on the growth and gastrointestinal (GI) tolerance of term infants.
- Trial name
- NCT01137877
- Testing
- Milk based infant formula powder, Investigational Infant Formula #1, Investigational Infant Formula #2
- Where
- 20 sites in United States
- Volunteers
- 399 people, healthy volunteers welcome
- Sponsor
- Abbott Nutrition
Premature Birth
Neuroendocrine Mechanisms of Growth and Body Composition in Preterm and Term Infants
The purpose of this study is to test the feasibility of measuring body composition by air displacement plethysmography (ADP) in rapidly growing, medically stable late gestation [32-35 weeks post-menstrual age (PMA)] premature…
- Trial name
- PREMA (NCT00833222)
- Where
- United States
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- University of Utah
Neonatal Hypothermia, Brown Adipose Tissue
Investigation of the Mechanisms of the Tendency to Hypothermia in Newborns and Premature Neonates
Newborns have thermoregulatory mechanisms that differ from those of adults. Instead of producing heat through shivering, newborns primarily rely on non-shivering thermogenesis by the brown adipose tissue.
- Conditions
- Neonatal Hypothermia, Brown Adipose Tissue, Preterm and Term Infants, Neonate
- Trial name
- NCT06803069
- Where
- 2 sites in Hungary
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- University of Pecs
Infant Formula Intolerance, Well-being
Efficacy of JINLINGGUAN and TOFER Formula in Formula-fed Chinese Term Infants
Objective：The present trial aimed to assess efficacy and safety of Jin Ling Guan and Tofer infant formula on body growth, intestinal tolerance, gut microbiota and fecal residual nutrients as compared to breast-milk in term…
- Trial name
- NCT03178474
- Testing
- JINLINGGUAN Infant formula,PRO-KIDO™ I-PROTECH®, TOFER Infant formula,TOFER®, Breast milk
- Where
- 3 sites in China
- Volunteers
- 180 people, healthy volunteers welcome
- Sponsor
- Sun Yat-sen University
Growth
The Effects on Growth of a Non-Routine Infant Formula
A study to evaluate the growth and development of term infants fed either an extensively hydrolyzed formula with probiotics, a partially hydrolyzed formula with probiotics, or an extensively hydrolyzed formula without probiotics
- Trial name
- NCT00655720
- Testing
- infant formula
- Volunteers
- 293 people, healthy volunteers welcome
- Sponsor
- Mead Johnson Nutrition
Analgesia
Newborn Cortical Response to Pain and Non Pharmacological Analgesia
Minor painful procedures are frequently performed on newborn infants and non-pharmacological analgesia is commonly used. As more than one analgesic method may be applied simultaneously in clinical practice, the relative…
- Trial name
- NCT03389789
- Testing
- Oral glucose solution + maternal holding, Breastfeeding, Oral glucose solution
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- IRCCS Burlo Garofolo
Healthy Infant and Mother Pairs
Ex Vivo Exploratory Analysis in Healthy Full-term Infants
Exploratory analyses of the immune response in a ex vivo culture system Characterization of the composition of maternal milk and infant urine
- Trial name
- NCT01573884
- Where
- 2 sites in United States
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Abbott Nutrition
Infant Nutrition
Study Evaluating Growth and Tolerance of Infant Formula Containing HMOs
The primary objective of this clinical study is to investigate the suitability of an infant formula containing five different human milk oligosaccharides to support normal physical growth (evaluated per weight gain), in…
- Trial name
- NCT03513744
- Testing
- human milk oligosaccharides
- Where
- 9 sites in Germany, Italy and 1 more
- Volunteers
- 340 people, healthy volunteers welcome
- Sponsor
- Jennewein Biotechnologie GmbH
Healthy Volunteers
Early Environmental and Maternal Determinants of Airway Inflammation in Wheezing Disorders in Infants
This study collects data on microbiological, genetic and environmental factors, as well as lung function parameters (e.g. spirometry, body plethysmography, lung-MRI) to assess the complex interaction of predisposing risk factors…
- Trial name
- NCT04286464
- Testing
- No intervention
- Where
- Switzerland
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- Insel Gruppe AG, University Hospital Bern
Infant Development, Gut Microbiome
Characterisation of the Gut Microbiota in Term Infants After Maternal Supplementation of Probiotics
A monocenter, open label pilot study in pregnant women and their offspring with at least four weeks prenatal and four weeks postnatal maternal intervention with a study product consisting of four different food constituents.
- Trial name
- NCT04987593
- Testing
- Probiotics
- Where
- Denmark
- Volunteers
- 23 people, healthy volunteers welcome
- Sponsor
- Chr Hansen
Infant, Small for Gestational Age
SURF, Neurodevelopment, Growth Study in SGA Infants
The purpose of this study is to determine whether term SGA infants who are fed a nutrient-enriched pre-term formula will have a higher cognitive score, a more appropriate length-for-age Z-score (leading to a lower prevalence of…
- Trial name
- NCT04360967
- Testing
- Standard Formula, Nutrient-enriched Formula
- Volunteers
- healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)
Respiratory Distress, Transient Tachypnea of the Newborn
Effect of Supine or Prone Position After Caesarean Birth
Respiratory Distress is a frequent clinical diagnosis of babies delivered by elective Caesarean birth. There has been no study comparing the efficacy of immediately positioning a newly born infant prone vs.
- Conditions
- Respiratory Distress, Transient Tachypnea of the Newborn, Delayed Transition of the Newborn, Persistent Pulmonary Hypertension
- Trial name
- NCT01310153
- Testing
- prone positioning, Supine
- Where
- United States
- Volunteers
- 65 people, healthy volunteers welcome
- Sponsor
- Montefiore Medical Center
Gastrointestinal Tolerance
Tolerance of Healthy Term Infants Fed Infant Formulas #3
The primary objective of this study is to assess the comparative gastrointestinal (GI) tolerance of normal term infants to six experimental milk protein-based powdered infant formulas.
- Trial name
- NCT00977964
- Testing
- Experimental milk protein infant formula Process A, Experimental milk protein infant formula Process B, Experimental milk protein infant formula Process C
- Where
- 15 sites in United States
- Volunteers
- 270 people, healthy volunteers welcome
- Sponsor
- Abbott Nutrition
Preterm and Term Infants
Relationship of Gestational Age and Urine Concentration of S100B in Preterm and Term Infants in the First Week of Life
S100B, a calcium-binding protein, is found predominantly in the central nervous system (CNS) and is increased in CSF and blood after CNS injury. There are two objectives to this study.
- Trial name
- NCT00747864
- Volunteers
- 106 people, healthy volunteers welcome
- Sponsor
- University of Utah
Microbial Colonization
Milk Oriented Microbiota
The purpose of this study is to determine if supplementing healthy term infants delivered vaginally who consume breast milk, formula, or both with a probiotic for 21 consecutive days increases levels of bacteria in infants' stool.
- Trial name
- MOM (NCT03222804)
- Testing
- Bifidobacterium
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- University of California, Davis
Microbial Colonization
DOnor Milk to REpair the Full-term Infant MIcrobiome in Infants Born Via Cesarean Section.
The objective of this novel study is to establish proof of concept using a pilot randomized controlled trial to determine the effect of DHM compared to formula supplementation on the microbiome in full-term infants who are born…
- Trial name
- DO-RE-MI C-S (NCT06177184)
- Testing
- Donor Human Milk - Nutritional Replacement
- Where
- Canada
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- University of Calgary
Bottle Feeding
Effect of Infant Formulas Containing a New Fat Blend or the New Fat Blend Plus Fiber in Healthy Term Infants
The primary objective of the study was to compare stool composition (stool soap and non-soap fatty acids, total fatty acids, minerals, and other stool constituents) of infants randomized to receive either standard formula, or 1…
- Trial name
- 9055A1-2000 (NCT02031003)
- Testing
- Infant formula
- Where
- 4 sites in Taiwan
- Volunteers
- 220 people, healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)
Sleep Problem, Neurobehavioral Manifestations
NapBiome: Targeting Gut Microbiota and Sleep Rhythm to Improve Developmental and Behavioral Outcomes in Early Childhood
The gut-brain axis plays a crucial role in the regulation and development of psychological and physical processes. The first year of life is a critical period for the development of the gut microbiome, which parallels important…
- Trial name
- NapBiome (NCT06396689)
- Testing
- Synbiotic
- Where
- 2 sites in Switzerland
- Volunteers
- 380 people, healthy volunteers welcome
- Sponsor
- Petra Zimmermann