Clinical trials: Infant Term Birth
Retinopathy of Prematurity (ROP)
Long-term Safety and Efficacy Outcome Study Comparing Children Previously Enrolled in Study ROPP-2008-01 for the Prevention of Retinopathy of Prematurity (ROP)
The main purpose of this study is to evaluate the long-term efficacy and safety outcomes following short-term exposure to rhIGF-1/rhIGFBP-3 versus standard neonatal care in Study ROPP-2008-01 (NCT01096784).
- Trial name
- PEDAL (NCT02386839)
- Testing
- rhIGF-1/rhIGFBP-3
- Where
- 16 sites in United States, Italy and 4 more
- Volunteers
- 76 people
- Sponsor
- Shire
Atopic Dermatitis (AD)
A Long-term Trial of OPA-15406 in Infants With Atopic Dermatitis
To investigate the efficacy of 0.3% OPA-15406 ointment when administered twice daily for 4 weeks in infants younger than 2 years of age with Atopic Dermatitis
- Trial name
- NCT05372653
- Testing
- OPA-15406
- Where
- Japan
- Volunteers
- 41 people
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
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
Transient Tachypnea of the Newborn
nHFOV Versus nCPAP in Transient Tachypnea of the Newborn
In this prospective, randomised clinical trial the investigators aim to assess if nasal high frequency oscillatory ventilation (nHFOV) could be used as the primary modality of respiratory support in late preterm and term infants…
- Trial name
- NCT03006354
- Testing
- nHFOV, nCPAP
- Where
- Turkey (Türkiye)
- Volunteers
- 60 people
- Sponsor
- The Hospital for Sick Children
Digestive System Disease, Sleepiness
Investigate Effects of A2 Milk on Breastmilk Composition and Subsequent Infant Gut Health, Crying and Sleep Patterns in Healthy, Full-term Infants
The goal of this interventional study is to investigate effects of a2 Full Cream Milk on Breastmilk composition and subsequent Infant gut health, crying frequency and sleep patterns in Healthy Full-term Infants.
- Conditions
- Digestive System Disease, Sleepiness, Crying
- Trial name
- NCT05829720
- Testing
- a2 Full Cream Milk, Conventional Milk (Weidendorf)
- Where
- 2 sites in China
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- a2 Milk Company Ltd.
Respiratory Syncytial Virus Infections
A Study to Assess Safety, Pharmacokinetics Anti-Drug Antibody and Anti-RSV Antibody After 2 Doses of Nirsevimab
The purpose of this study is to measure the safety, PK, occurrence of ADA to nirsevimab, and anti-RSV neutralizing Ab in Japanese children with certain health conditions or pre-term infants aged ≤12 months.
- Trial name
- JUBILUS (NCT06042049)
- Testing
- Nirsevimab
- Where
- 9 sites in Japan
- Volunteers
- 33 people
- Sponsor
- AstraZeneca
Omphalocele
Omphaloceles and Associated Malformations
Major birth defects like omphalocele are diagnosed in 3-8% of all newborns in Germany each year. Prevention and treatment quality of congenital malformations are key concerns for child health.
- Trial name
- NCT04126863
- Where
- Germany
- Volunteers
- 118 people
- Sponsor
- University Hospital Tuebingen
Infant ALL, Skin
Skin Condition of Term Newborns During Diaper Care for Meconium Removal
The aim of this study was to determine the effect of two different skin cleansing cotton wipes on skin condition during meconium removal diaper care in term newborns.
- Trial name
- NCT07072130
- Testing
- Control group (wet cotton), Experimental group (baby oil-impregnated cotton)
- Where
- Turkey (Türkiye)
- Volunteers
- 96 people, healthy volunteers welcome
- Sponsor
- Acibadem University
Healthy
New Infant Formula Trial in Healthy Term Subjects on Growth, Body Composition, Tolerance and Safety
This study is initiated to investigate the effect of a new infant formula in healthy term subjects on growth, body composition, tolerance and safety.
- Trial name
- Venus (NCT01609634)
- Testing
- Test Product, Control Product 1, Control Product 2
- Where
- 2 sites in Singapore
- Volunteers
- 541 people, healthy volunteers welcome
- Sponsor
- Danone Asia Pacific Holdings Pte, Ltd.
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.
Influenza
Study of Live, Attenuated Influenza Vaccination in Preterm and Full-Term Infants
Severe influenza respiratory disease is increasingly recognized in children. Influenza hospitalization rates in high-risk infants, such as premature infants, are increased some five-fold over rates in other children.
- Trial name
- NCT01194297
- Testing
- Live attenuated influenza vaccine, Inactivated influenza vaccine
- Volunteers
- 3 people, healthy volunteers welcome
- Sponsor
- University of Rochester
Congenital Diaphragmatic Hernia, Pulmonary Hypoplasia
Safety and Efficacy of FETO in CDH: A Phase III Trial
Congenital diaphragmatic hernia (CDH) is a birth defect characterized by the development of a hole in the diaphragm, the breathing muscle that separates the chest from the abdomen.
- Trial name
- CHOP FETO (NCT06884423)
- Testing
- FETO with GoldBAL2 Balloon and BALTACCIBDPE100 Catheter
- Where
- United States
- Volunteers
- 80 people
- Sponsor
- Holly L Hedrick, MD
Tolerance
Healthy Term Infants Fed Milk-Based Infant Formula
This is a randomized, controlled, double-blind, parallel, feeding study with the purpose to evaluate the tolerance of healthy term infants fed partially hydrolyzed whey protein infant formulas.
- Trial name
- NCT04529759
- Testing
- Control Infant Formula, Experimental Infant Formula
- Where
- 6 sites in United States
- Volunteers
- 108 people, healthy volunteers welcome
- Sponsor
- Abbott Nutrition
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
Microbial Colonization
Comparing Impacts of Donor Human Milk to Formula Supplementation on the Gut Microbiome of Full-term Infants
The goal of this pilot randomized controlled trial (RCT) is to examine donor human milk (DHM) as a clinical intervention targeted at achieving beneficial microbiome signatures in full-term infants who are exposed to intrapartum…
- Trial name
- PPDHM (NCT05815433)
- Testing
- Donor Human Milk - Nutritional Replacement
- Where
- Canada
- Volunteers
- 105 people, healthy volunteers welcome
- Sponsor
- University of Calgary
Gestational Diabetes Mellitus, Preeclampsia
User Testing and Feedback for a Mobile Health Program for Postpartum Women: A Pilot Study
Refine content and delivery of the mHealth delivered lifestyle intervention program through iterative testing with small groups of users who provide feedback through on-line asynchronous focus groups.
- Conditions
- Gestational Diabetes Mellitus, Preeclampsia, Gestational Hypertension, Pre-term Delivery
- Trial name
- NCT02384226
- Where
- United States
- Volunteers
- 26 people
- Sponsor
- University of Colorado, Denver