Clinical trials: Infant, open to volunteers
Very Preterm Infant, Necrotizing Enterocolitis (NEC)
Effects of Enteral Feeding Regimens on NEC, Mortality, and Neurodevelopment in Very Preterm Infants
The goal of this clinical trial is to evaluate whether supplementing with pasteurized donor human milk (pHDM) or preterm formula (PTF) when own mother's milk (OMM) is insufficient can improve outcomes in very preterm infants born…
- Trial name
- NCT07045844
- Testing
- Pasteurized Donor Milk for Insufficient Breastfeeding, Preterm Formula for Insufficient Breastfeeding, Routine fortification
- Where
- 24 sites in China
- Volunteers
- 2,324 people
- Sponsor
- The Children's Hospital of Zhejiang University School of Medicine
Preterm, Preterm Infant Development
Nutritional Maturity in Preterm Newborns (Premature Infant Oral Motor Intervention, PIOMI)
Premature Infant Oral Motor Intervention (PIOMI) has been found to improve short-term clinical outcomes in preterm infants and contribute to their feeding skills.
- Trial name
- PIOMI (NCT07894380)
- Testing
- The PIOMI initiative in maternal interaction, Control
- Where
- Turkey (Türkiye)
- Volunteers
- 66 people, healthy volunteers welcome
- Sponsor
- Ataturk University
Pediatric Feeding Disorder, Feeding Difficulties in Infants and Young Children
Validation of the D-TAP Parental Questionnaire for Early Screening of Pediatric Feeding Disorder in Hospitalized Children Aged 8 to 18 Months
This single-center observational study aims to evaluate the validity of the D-TAP parental questionnaire for early screening of pediatric feeding disorder (PFD) in hospitalized children aged 8 to 18 months.
- Trial name
- D-TAP (NCT07895914)
- Where
- France
- Volunteers
- 100 people
- Sponsor
- University Hospital, Strasbourg, France
Healthy Infants
Study on the Effects of Probiotic on Infant Gut Microbiota and Immune Regulation
This is a probiotic intervention study in healthy infants aged 0 - 6 months. The primary objective is to evaluate the effects of Lacticaseibacillus paracasei LPB27 (also known as Lacticaseibacillus paracasei 207-27)…
- Trial name
- NCT07896083
- Testing
- Probiotic, Maltodextrin
- Where
- China
- Volunteers
- 370 people, healthy volunteers welcome
- Sponsor
- BYHEALTH Co., LTD
Alpha 1 Antitrypsin Deficiency
A Study of AIR-001 in Adults With Alpha-1 Antitrypsin Deficiency (AATD)
This is a Phase 1, open-label, single ascending dose (SAD) and multiple dose (MD) study of AIR-001 in participants with alpha-1 antitrypsin deficiency (AATD) due to PiZZ genotype.
- Trial name
- RepAIR1 (NCT07431112)
- Testing
- AIR-001 SAD dose level 1, AIR-001 SAD dose level 2, AIR-001 SAD dose level 3
- Where
- 13 sites in Australia, Georgia and 7 more
- Volunteers
- 54 people
- Sponsor
- AIRNA Corporation
Inflammation, Depression Disorder
Inflammatory Pathways Modulated by Prenatal Mindfulness: A Route to Improve Maternal Child Emotional Well Being and Whole Person Health
The goal of this study is to investigate inflammation as the biological mechanism by which mindfulness based cognitive therapy for perinatal depression (MBCT-PD) administered during pregnancy improves women's emotional well-being…
- Conditions
- Inflammation, Depression Disorder, Mindfulness, Emotional Well-being
- Trial name
- NCT07892326
- Testing
- Mindfulness-based cognitive therapy for perinatal depression, Pregnancy Health Group
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- Oregon Health and Science University
Infant Development, Language Development
The Impact of Music Medicine on Preterm Brain Development and Behavior
The investigators are conducting a two-site randomized control trial with the aim of defining the impact of music (M) without or with parent voice (MPV) on very preterm infants' acute and cumulative stress, intranetwork…
- Conditions
- Infant Development, Language Development, Prematurity, Stress
- Trial name
- NCT06536296
- Testing
- Music, Music and parent voice, Standard Care
- Where
- 2 sites in United States
- Volunteers
- 243 people
- Sponsor
- Brigham and Women's Hospital
Development Delay, Motor Skills Disorders
Effect of a Telerehabilitation-Supported, Family-Centered Early Intervention Program on Neurodevelopmental and Parental Outcomes in Infants at Mild-to-Moderate Risk
The goal of this pilot randomized controlled trial is to learn whether a family-centered early intervention program, delivered remotely to parents and carried out at home, can support the development of infants who were treated…
- Conditions
- Development Delay, Motor Skills Disorders, Neurodevelomental Disorders, High Risk Infant
- Trial name
- NCT07878819
- Testing
- Remote Family-Centered Early Intervention Program, Standard Information and Routine Follow-up
- Where
- Turkey (Türkiye)
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Bengisu Boz Gürboğa
Postpartum Depression (PPD), Breastfeeding
Methyl Donor-Rich Diet in the Postpartum Period
This study aims to evaluate the effects of a methyl-donor-rich diet during the postpartum period on maternal depression, breastfeeding success, and infant weight.
- Conditions
- Postpartum Depression (PPD), Breastfeeding, Maternal Nutrition, Infant Development
- Trial name
- NCT07887178
- Testing
- Methyl Donor-Rich Dietary Intervention
- Where
- Turkey (Türkiye)
- Volunteers
- 100 people
- Sponsor
- Istanbul University - Cerrahpasa
Neonatal Disease
Cerebral Monitoring Using Pulsatile Near Infrared Spectroscopy in Neonates
The transition from fetus to newborn is a complex physiological process. Monitoring this process to detect potential disruptions is critical but remains a challenge.
- Trial name
- pNIRS (NCT05896306)
- Testing
- No intervention
- Where
- Austria
- Volunteers
- 40 people
- Sponsor
- Medical University of Graz
Retinopathy of Prematurity, Preterm Infants
An Observational Study to Collect Data on How Aflibercept (Eylea) Given Using a Paediatric Dosing Device is Used in Preterm Babies With Retinopathy of Prematurity in the United Kingdom (UK)
This is an observational study in which only data from babies with retinopathy of prematurity (ROP) who are being treated with aflibercept (Eylea) in prefilled syringe (PFS) using a paediatric dosing device (PDD) are collected…
- Trial name
- NCT06315556
- Testing
- Aflibercept (Eylea)
- Where
- United Kingdom
- Volunteers
- 200 people
- Sponsor
- Bayer
Healthy Term Infants
Evaluation of the Nutritional Value of a New Hydrolysed Rice Protein-based Formula
The goal of this interventional clinical trial is to compare the growth parameters of healthy term infants fed either a new experimental rice hydrolyzed rice protein-based formula or a control formula (standard cow's milk…
- Trial name
- RIGA (NCT07686224)
- Testing
- Rice formula (New formula based on hydrolysed rice proteins), Control formula (Standard cow's milk proteins-based formula)
- Where
- 10 sites in France
- Volunteers
- 156 people, healthy volunteers welcome
- Sponsor
- Health and Happiness Research Limited
Malnutrition, Infant, Malnutrition
Hospital-Based Prospective Cohort of Malnutrition Under 6-Month Study (HOSPIC-6-Study)
This study is a hospital-based, prospective, multicentre cohort study (the HOSPIC-6 Study) that will follow infants under 6 months of age who are admitted to pediatric or perinatology wards with acute malnutrition, diagnosed…
- Trial name
- HOSPIC-6 (NCT07831343)
- Testing
- Not applicable- observational study
- Where
- 10 sites in Indonesia
- Volunteers
- 1,780 people
- Sponsor
- Universitas Indonesia
Premature Birth, Infant, Premature
Parent-Facilitated Early Oral-Sensory Experience in the NICU for Feeding Outcomes
The purpose of this study is to evaluate the feasibility, acceptability, and preliminary effects of the Parent-Facilitated Early Oral-Sensory Experience (PEOE) program for very preterm infants in the Neonatal Intensive Care Unit…
- Conditions
- Premature Birth, Infant, Premature, Infant, Very Premature
- Trial name
- NCT07883707
- Testing
- Parent-Facilitated Early Oral-Sensory Experience (PEOE)
- Volunteers
- 60 people
- Sponsor
- Boston College
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
Postpartum Complication, Postpartum
Postpartum Care in the NICU Multi-Site Breastfeeding
Parents of infants in the neonatal intensive care unit (NICU) face unique barriers to long-term breastfeeding and lactation. The physical and emotional demands of having a critically ill or premature newborn combined with the…
- Conditions
- Postpartum Complication, Postpartum, PTSD, PTSD (Childbirth-Related)
- Trial name
- PeliCaN (NCT07881731)
- Testing
- NICU-informed postpartum doula support
- Where
- 11 sites in United States
- Volunteers
- 640 people
- Sponsor
- Children's Hospital of Philadelphia
Breastfeeding, Mother-Infant Bonding
Effects of Maternal and Infant Massage on Breastfeeding and Mother-Infant Bonding
This study aims to evaluate the effects of different massage techniques applied to mothers and infants on breastfeeding parameters and mother-infant bonding during the postpartum period.
- Conditions
- Breastfeeding, Mother-Infant Bonding, Lactation
- Trial name
- MIM-BOND (NCT07867054)
- Testing
- Infant Massage, Oxytocin Massage, Infant Massage and Oxytocin Massage
- Volunteers
- 136 people
- Sponsor
- Istanbul University - Cerrahpasa
Respiratory Distress Syndrome, Pre-term Infants
Safety and Efficacy of APC-0101 in Preterm Infants With Respiratory Distress Syndrome
This is a 2-part, prospective, randomized, blinded, sham-controlled, multi-center study comparing preterm subjects with RDS who are treated with APC-0101 and nCPAP/NIV to subjects treated with nCPAP/NIV alone (Sham).
- Trial name
- NCT06776783
- Testing
- APC-0101 (SF-RI 1 surfactant for inhalation combined with a dedicated delivery system), Control
- Where
- 31 sites in United States, Canada and 1 more
- Volunteers
- 520 people
- Sponsor
- Aerogen Pharma Limited
Muscular Dystrophies, Muscular Dystrophies (Duchenne, Becker, Myotonic Dystrophy)
A Phase 3 Study to Evaluate the Safety and Efficacy of AOC 1044 (Also Referred to as Delpacibart Zotadirsen) in Participants With DMD With Gene Mutations Amenable to Exon 44 Skipping
A Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Intravenous AOC 1044 for the treatment of Duchenne Muscular Dystrophy (DMD) with Gene Mutations Amenable to Exon 44 Skipping
- Conditions
- Muscular Dystrophies, Muscular Dystrophies (Duchenne, Becker, Myotonic Dystrophy), Muscular Disorders, Atrophic, Muscular Disease
- Trial name
- SAFARI44 (NCT07587242)
- Testing
- AOC 1044
- Where
- 18 sites in Australia, Belgium and 6 more
- Volunteers
- 70 people
- Sponsor
- Avidity Biosciences, Inc.
Healthy, Newborn Infant
Smart Sock Heart Rate Monitoring in Hospitalized Newborns
The goal of this observational study is to evaluate a commercially available smart sock for heart rate monitoring in hospitalized newborn infants without known heart disease.
- Trial name
- NCT07838402
- Where
- Finland
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Tampere University Hospital