Clinical trials: Development, Infant
Digestion, Gut Microbiota
Feeding Tolerance and Gut Maturation of Infants Consuming a Formula Rich in Glycoprotein
This is a non-randomized, single-arm, open-label, prospective interventional study using a commercially available starter infant formula in healthy term formula-fed infants with a parallel group of healthy term breast-fed infants…
- Trial name
- NCT04880083
- Testing
- Commercially Available Starter Infant Formula
- Where
- China
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)
Congenital Hypothyroidism
Use of Tirosint®-SOL or Tablet Formulations of Levothyroxine in Pediatric Patients With Congenital Hypothyroidism (CH)
This is a multi-center, prospective, parallel-group, open-label, randomized clinical study in one hundred and twenty-six (126) neonates and infants diagnosed with CH.
- Trial name
- NCT05228184
- Testing
- Tirosint®-SOL, Levothyroxine Sodium
- Where
- 10 sites in United States
- Volunteers
- 34 people
- Sponsor
- IBSA Institut Biochimique SA
Infant Development
Phase II Growth and Safety Study of an Infant Formula for Healthy Term Infants
A goal of infant formula development is to mimic human milk (HM) both in nutrient composition as well as physiologic outcomes. investigators have developed an infant formula for term infants that more closely resembles the…
- Trial name
- NCT04593147
- Testing
- BBN, Brand
- Where
- United States
- Volunteers
- 131 people, healthy volunteers welcome
- Sponsor
- Building Block Nutritionals, LLC
Dravet Syndrome
A Clinical Study to Evaluate the Safety and Efficacy of ETX101 in Infants and Children With SCN1A-Positive Dravet Syndrome
ENDEAVOR is a Phase 1/2, 2-part, multicenter study to evaluate the safety and efficacy of ETX101 in participants with SCN1A-positive Dravet syndrome aged ≥6 to <36 months (Part 1A), aged ≥48 months to <18 years (Part 1B), and…
- Trial name
- ENDEAVOR (NCT05419492)
- Testing
- ETX101
- Where
- 14 sites in United States, Australia and 1 more
- Volunteers
- 113 people
- Sponsor
- Encoded Therapeutics
Pulmonary Hypertension, Familial Persistent, of the Newborn
A Study To Evaluate Safety And Efficacy Of IV Sildenafil In The Treatment Of Neonates With Persistent Pulmonary Hypertension Of The Newborn
This study will evaluate whether IV sildenafil can reduce the time on inhaled nitric oxide treatment and reduce the failure rate of available treatments for persistent pulmonary hypertension of the newborn.
- Trial name
- NCT01720524
- Testing
- iv sildenafil
- Where
- 42 sites in United States, Belgium and 10 more
- Volunteers
- 59 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Infant Development
A Neurocognitive and Immunological Study of a New Formula for Healthy Infants
To compare the neurocognitive and immunological development in infants fed a new infant formula with functional specific nutrients to infants consuming a standard infant formula.
- Trial name
- COGNIS (NCT02094547)
- Testing
- New infant formula, Standard infant formula, Breastfeeding
- Where
- Spain
- Volunteers
- 220 people, healthy volunteers welcome
- Sponsor
- Laboratorios Ordesa
Preterm Birth
Oral Entrainment on Suck Development of Preterm Infants Born 23 to 34 Weeks Gestational Age (GA)
The development of sucking behaviors in preterm infants is thought to reflect neurobehavioral maturation and organization. From a clinical perspective, the ability to feed depends upon a coordinated sucking, swallowing and…
- Trial name
- NCT01069744
- Where
- United States
- Volunteers
- 71 people
- Sponsor
- KC BioMediX, Inc
Infant Development
Acceptability and Tolerance Study of an Amino Acid Formula with HMOs
To evaluate the acceptability (including gastrointestinal tolerance and compliance) of a hypoallergenic amino acid infant formula with HMOs for the dietary management of cows' milk allergy in infants less than 12 months of age.
- Trial name
- NCT04575298
- Testing
- Acceptability, tolerance study for an infant formula with human milk oligosaccharides
- Where
- United Kingdom
- Volunteers
- 10 people
- Sponsor
- Société des Produits Nestlé (SPN)
Achondroplasia
Interventional Study of Infigratinib in Children < 3 Years Old With Achondroplasia (ACH)
This is a Phase 2, multicenter, randomized, placebo-controlled study to evaluate the safety and efficacy of infigratinib in participants < 3 years old with ACH.
- Trial name
- NCT07169279
- Testing
- Infigratinib is provided as a single dose of minitablets for oral administration, Infigratinib is provided as sprinkle capsules for daily oral administration
- Where
- 12 sites in United States, Australia and 5 more
- Volunteers
- 77 people
- Sponsor
- QED Therapeutics, a BridgeBio company
Infant Developmental Assessment
A Study to Evaluate Infants With Potential Exposure to Tanezumab Before Birth
This study will examine post-natal neurologic and cognitive development of infants who may have been exposed to tanezumab or comparator in-utero during the tanezumab clinical program (whether the exposure is through maternal or…
- Trial name
- NCT01362660
- Testing
- Unintentional exposure in utero
- Where
- 8 sites in United States
- Volunteers
- 7 people
- Sponsor
- Pfizer
Chronic Idiopathic Constipation (CIC)
A Study of Prucalopride in Breastfeeding Women With Constipation
Prucalopride is a medicine used to treat constipation. The main aim of the study is to measure prucalopride concentrations in breast milk.
- Trial name
- NCT04838522
- Testing
- No Intervention
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Takeda
Infant Development
Infants Fed Extensively Hydrolyzed Casein-Based Infant Formulas
This is a randomized, controlled, double-blind, multicenter parallel study to evaluate the growth, tolerance and compliance of healthy infants fed infant formulas with extensively hydrolyzed casein protein.
- Trial name
- NCT04006236
- Testing
- Experimental Infant Formula, Control Infant Formula
- Where
- 17 sites in United States
- Volunteers
- 245 people, healthy volunteers welcome
- Sponsor
- Abbott Nutrition
Osteoarthritis, Cancer Pain
Protocol to Monitor the Neurological Development of Infants With Exposure in Utero From Birth to 15 Months in Tanezumab Clinical Studies
A4091065 is a multicenter, prospective, cohort study with enhance physical an neurodevelopmental surveillance to characterize the outcomes related to the development of infants up to the age of 15 months who were potentially…
- Conditions
- Osteoarthritis, Cancer Pain, Recurrent Low Back Pain
- Trial name
- NCT03031938
- Testing
- Investigational medical product (IMP) administered in parent study
- Where
- 6 sites in United States
- Volunteers
- 4 people
- Sponsor
- Pfizer
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
Diarrhea, Acute Respiratory Infection
Oral Supplement for Pregnant and Lactating Mothers
To assess protection against early life infections through supplementation of mothers during pregnancy to the newborns' growth, morbidity, immune status intra and extra-uterine.
- Trial name
- NCT01073033
- Testing
- milk supplement 1, milk supplement 2
- Where
- Philippines
- Volunteers
- 234 people, healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)
Infant, Small for Gestational Age
Follow-up to Adult Height of a Cohort of Subjects Born Small for the Gestational Age and Treated With Growth Hormone
This non-interventional study for prospective follow up of a cohort of 220 subjects born small for gestational age (SGA) is planned for the purpose of finding out if normalisation of adult height is associated or not with…
- Trial name
- SGA (NCT01196156)
- Where
- 28 sites in Spain
- Volunteers
- 443 people
- Sponsor
- Merck KGaA, Darmstadt, Germany
Short Stature, Idiopathic, Infant, Small for Gestational Age
Evaluation of the Ease of Use, Preference, and Safety of EutropinPen Inj.
The purpose of this study is to assess the ease of use, preference, and safety after 8 weeks subcutaneous administration of EutropinPen Inj. in patients pretreated with recombinant human growth hormone by reusable device.
- Conditions
- Short Stature, Idiopathic, Infant, Small for Gestational Age, Growth Hormone Deficiency, Chronic Renal Failure
- Trial name
- NCT03015909
- Testing
- Somatropin
- Where
- South Korea
- Volunteers
- 116 people
- Sponsor
- LG Life Sciences
Healthy
Study of Stool Patterns to Collect a Panel of Stool Images for the Development of a Software
Collection of a panel of stool images from healthy infants/toddlers for the development of a software
- Trial name
- Poobao (NCT03402555)
- Testing
- Stool pattern
- Where
- 2 sites in United States, Singapore
- Volunteers
- 96 people, healthy volunteers welcome
- Sponsor
- Danone Asia Pacific Holdings Pte, Ltd.
Dysbiosis, Prophylaxis
Lactobacillus Reuteri DSM 17938 in Gut Microbiota Development in Infant Born by Caesarean Section
The aim of this study is to assess influence of probiotic Lactobacillus reuteri DSM 17938 on formation of gut microbiota in infant born by Caesarean section.
- Trial name
- NCT03675048
- Testing
- BioGaia Protectis drops
- Where
- Russia
- Volunteers
- 97 people
- Sponsor
- BioGaia AB
Health Behavior, Disorder of Growth and Development
The Effects of Dietary Palmitic Acid Triacylglyceride Position on Intestinal Parameters in Infants (InFat_005)
The purpose of this study is to determine the effect of high sn-2 palmitic acid based infant formula on intestinal parameters in term formula fed infants.
- Trial name
- NCT01116115
- Testing
- InFat™ based infant formula, Standard vegetable oil based infant formula
- Where
- Israel
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Enzymotec