Clinical trials: Infant
Mucopolysaccharidosis II
A Study to Determine the Efficacy and Safety of Tividenofusp Alfa (DNL310) vs Idursulfase in Pediatric and Young Adult Participants With Neuronopathic (nMPS II) or Non-Neuronopathic Mucopolysaccharidosis Type II (nnMPS II)
This is a Phase 2/3, multiregional, two-arm, double-blind, randomized, active (standard-of-care)-controlled study of the efficacy and safety of tividenofusp alfa (DNL310), an investigational central nervous system (CNS)-penetrant…
- Trial name
- COMPASS (NCT05371613)
- Testing
- tividenofusp alfa, idursulfase
- Where
- 30 sites in United States, Argentina and 12 more
- Volunteers
- 65 people
- Sponsor
- Denali Therapeutics Inc.
Obesity, Pregnancy
Maternal Obesity, Breast Milk Composition, and Infant Growth
Today the majority of pregnant women in the United States are either overweight or obese at conception with their offspring having greater adiposity at birth, a 2-fold greater risk of later obesity, and neonatal insulin…
- Conditions
- Obesity, Pregnancy, Breastmilk Collection, Infant Overnutrition
- Trial name
- (MILK) (NCT03301753)
- Where
- 2 sites in United States
- Volunteers
- 2,050 people, healthy volunteers welcome
- Sponsor
- University of Minnesota
Infant Vitamin K Status, Vitamin K Deficiency Bleeding
The OK Daily Study
The OK Daily Study is a multi-centred, part-randomised, part blinded, four cohort study. We are exploring daily dietary supplementation with vitamin K2, specifically menaquinone-7 (MK-7), given to breastfed infants or…
- Trial name
- NCT07620236
- Testing
- Combined MK-7 + vitamin D3 drops, Vitamin D3 Drops, MK-7 capsules
- Volunteers
- 134 people, healthy volunteers welcome
- Sponsor
- Norfolk and Norwich University Hospitals NHS Foundation Trust
Infant Development, Cerebral Palsy
Families Filming Infants Learning Movement
The study objective is to improve accuracy in the early detection of neurodevelopmental impairment, especially CP, by evaluating the timepoint (in weeks post term age) that the Prechtl GMA is most useful for prediction of…
- Conditions
- Infant Development, Cerebral Palsy, Motor Disorders, Neurological Disorder
- Trial name
- FILM (NCT06278961)
- Testing
- Observational
- Where
- United States
- Volunteers
- 350 people, healthy volunteers welcome
- Sponsor
- Ann & Robert H Lurie Children's Hospital of Chicago
Healthy Infants
Efficacy of a New Infant Formula Composition on Gut Health in Infants
The aim of this study is to investigate potential health benefits of the experimental formula. The main objective is whether the experimental formula elevates the relative abundance of Bifidobacterium in stool samples after 10…
- Trial name
- NCT07242508
- Testing
- Infant Formula, Infant Formula with bioactive ingredients
- Where
- Bulgaria
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- FrieslandCampina
Premature Infants
Using the Babble Boot Camp© Speech Therapy Approach With Babies Born Prematurely
Babble Boot Camp focuses on early speech and language development, environmental enrichment and supporting parent-infant interaction with the aim of improving communication outcomes and parental well-being in at risk children.
- Trial name
- BBCPrem (NCT07738224)
- Testing
- Babble Boot Camp
- Where
- 2 sites in Australia
- Volunteers
- 86 people
- Sponsor
- Murdoch Childrens Research Institute
Feeding Intolerance in Preterm Infants
The Effect of Lactase-Treated Feeds on Feeding Intolerance in Preterm Infants
The purpose of this study is to evaluate whether adding lactase enzyme to milk feeds can improve feeding tolerance in preterm neonates.
- Trial name
- NCT07784062
- Testing
- Lactase enzyme, Distilled water
- Where
- Egypt
- Volunteers
- 70 people
- Sponsor
- Ain Shams University
Child Malnutrition
Growth and Nutritional Impact of Small Fish Powder Supplementation in Infants
This randomized controlled trial evaluated the effectiveness of supplementing the diets of infants aged 6-7 months with small fish powder on growth outcomes in the Garoua 1st Health District, Northern Cameroon.
- Trial name
- NCT07794085
- Testing
- Small Fish Powder, Millet Flour
- Where
- Cameroon
- Volunteers
- 240 people, healthy volunteers welcome
- Sponsor
- Centre for Food and Nutrition Research, Yaounde
Deglutition Disorders in Infants, Chronic Tube Feeding in Hospitalized Infants
Parent Implemented Oral Nutrition, Eating, and Esophageal Reflexes Reintegration Protocol: RCT
Feeding dysfunction remains a major unmet challenge among neonatal ICU survivors, frequently leading to prolonged tube feeding or gastrostomy at discharge, increased healthcare utilization, substantial socioeconomic burden, and…
- Trial name
- PIONEER (NCT07035912)
- Testing
- PIONEER Protocol
- Volunteers
- 130 people
- Sponsor
- Nationwide Children's Hospital
Formula Milk, Infants
Infant Formula Study With Pre- And Postbiotics
This prospective, single-arm study evaluates the gastrointestinal tolerance, safety, and growth, quality of life and gut microbiome development of healthy term infants fed a commercially available palm oil free infant formula…
- Trial name
- NCT07734532
- Testing
- Infant Formula
- Where
- Ireland
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Nutricia UK Ltd
Dermatitis, Atopic, Eczema, Infantile
Goat Infant Formula Feeding and Eczema (the GIraFFE Study)
To determine the relative risk of developing atopic dermatitis in infants fed a study formula based on whole goat milk compared to infants a study formula based on cow milk protein.
- Conditions
- Dermatitis, Atopic, Eczema, Infantile, Infant Development, Child Development
- Trial name
- GIraFFE (NCT04599946)
- Testing
- Infant formula and follow-on formula made from whole goat milk, Infant formula and follow-on formula made from cow's milk ingredients
- Where
- 12 sites in Germany, Poland and 1 more
- Volunteers
- 2,132 people, healthy volunteers welcome
- Sponsor
- Dairy Goat Co-operative (N.Z.) Limited
Healthy Infants
The Trial of a New Infant Formula in Healthy Term Chinese Infants
The aim of this randomized, controlled, multi-center, double-blind study of healthy term infants is to test the safety and efficacy of a new infant formula with a specific blend of six human milk oligosaccharides.
- Trial name
- HexaHMO (NCT06053112)
- Testing
- New infant formula with 6 HMOs blend, Standard infant formula without 6 HMOs blend
- Where
- 5 sites in China
- Volunteers
- 326 people, healthy volunteers welcome
- Sponsor
- Junlebao Dairy Group Co., Ltd.
Infant, Very Low Birth Weight, Infant Development
Cue-Based Vs. Clinician-Driven Feeding in Very Low Birthweight Infants
In this parallel-group randomized controlled trial, very low birthweight infants will be randomly assigned in a 1:1 ratio to either cue-based (intervention group) or clinician-driven feeding (control group).
- Conditions
- Infant, Very Low Birth Weight, Infant Development, Feeding Patterns
- Trial name
- NCT06569186
- Testing
- Cue-based feedings
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- University of Alabama at Birmingham
Healthy Term Infant
The Impact of a Novel Infant Formula on Immunity, Gut Health and Growth
The goal of this multicenter, double-blind, randomized, controlled trial is to assess the safety and efficacy of a new infant formula on healthy term infants from enrollment to the age of 6 months.
- Trial name
- NCT06686433
- Testing
- Novel infant formula, Standard infant formula
- Where
- 5 sites in China
- Volunteers
- 342 people, healthy volunteers welcome
- Sponsor
- Biostime (Guangzhou) Health Products Limited
Infant Admitted to Neonatal Intensive Care Unit (NICU)
The Effects of a Caregiver-initiated Reading Intervention to Their Infant in the Neonatal Intensive Care Unit
The purpose of this study is to investigate the impact of a caregiver-initiated reading intervention to their infant, in the Neonatal Intensive Care Unit (NICU), on the caregiver-infant dyad, both during hospitalization and…
- Trial name
- NCT07789145
- Testing
- Reading Intervention
- Volunteers
- 120 people
- Sponsor
- University of Texas Southwestern Medical Center
Breastfeeding, SUID
Social Media and Risk Reduction Teaching-Enhanced Reach
This study aims to improve adherence to American Academy of Pediatrics safe sleep (SS) recommendations and improve rates of initiation and duration of partial and exclusive breastfeeding (BF) through direct education of mothers…
- Conditions
- Breastfeeding, SUID, SIDS
- Trial name
- SMARTER (NCT04387552)
- Testing
- Prenatal Safe Sleep Mobile Health (mHealth) Messaging, Prenatal Breastfeeding Mobile Health (mHealth) Messaging, Postnatal Safe Sleep Mobile Health (mHealth) Messaging
- Where
- United States
- Volunteers
- 2,093 people
- Sponsor
- Boston University
Respiratory Distress Syndrome, Newborn, Respiratory Distress Syndrome in Premature Infant
Optimising Breathing Support at Extubation in Very Preterm Infants: A Clinical Study
Many babies born very preterm (<32 weeks of pregnancy) require support to breathe from a breathing machine (mechanical ventilator) via a breathing tube. Although this keeps babies alive, it can damage their lungs.
- Trial name
- PrePAP (NCT07251790)
- Testing
- Pre-extubation continuous positive airway pressure
- Where
- 3 sites in Australia
- Volunteers
- 134 people
- Sponsor
- Murdoch Childrens Research Institute
Invasive Ventilation, Infant Pain
Dexmedetomidine for Invasive Ventilation In the NEOnate
Despite the increasing use of non-invasive ventilation, a large majority of premature neonates still receive invasive ventilation during their NICU (neonatal intensive care unit) stay.
- Conditions
- Invasive Ventilation, Infant Pain, Infant Discomfort, Infant Neurodevelopment
- Trial name
- NCT07493785
- Testing
- Dexmedetomidine Injectable Solution, Glucose 5% Injectable Solution
- Where
- 12 sites in France
- Volunteers
- 246 people
- Sponsor
- Centre Hospitalier Intercommunal Creteil
Gastrointestinal Tolerance of Probiotics in Infants
Evaluating the Impact of Synbiotic Supplementation on Infants and Toddlers
Background and Significance: Bifidobacterium longum subspecies infantis (B. infantis) and other infant associated Bifidobacterium (such as Bifidobacterium longum subspecies longum and Bifidobacterium breve) are known to be…
- Trial name
- NCT06746285
- Testing
- Synbiotic Supplement
- Where
- United States
- Volunteers
- 110 people, healthy volunteers welcome
- Sponsor
- Persephone Biosciences
Hydrocephalus in Infants, Hydrocephalus in Children
Ultrasound and Photoacoustic Imaging of Hydrocephalus in Pediatric Patients
The goal of this study is to out find out the capabilities and limitations of the combined photoacoustic and ultrasound (PAUS) imaging device for diagnosing hydrocephalus in children.
- Trial name
- NCT07784179
- Testing
- PAUS imaging
- Volunteers
- 250 people
- Sponsor
- Michael McDowell