Clinical trials: Infant, Preterm
- Condition Infant, Preterm
- Funder type Industry (pharma, biotech, devices)
- Accepts healthy volunteers yes
Wheezing
A Phase 3 Trial of the Effect of Motavizumab Prophylaxis on Reduction of Serious Early Childhood Wheezing in Infants
The primary objective of this study is to assess the efficacy of motavizumab compared to placebo when administered monthly to preterm infants during their first RSV season for the reduction of the incidence of serious early…
- Trial name
- NCT00628303
- Testing
- Motavizumab
- Volunteers
- healthy volunteers welcome
- Sponsor
- MedImmune LLC
RSV Immunization, Healthy Volunteer
Study of a Single Intramuscular Dose of Nirsevimab in the Prevention of Hospitalizations Due to Respiratory Syncytial Virus (RSV) Infection in Healthy Term and Preterm Infants During the First Year of Life
The purpose of this study was to determine the efficacy and safety of a single intramuscular (IM) dose of nirsevimab, compared to no intervention, for the prevention of hospitalizations due to lower respiratory tract infection…
- Trial name
- NCT05437510
- Testing
- Nirsevimab
- Where
- 240 sites in France, Germany and 1 more
- Volunteers
- 8,057 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Prematurity
Dietary Protein in the Very-low-birth-weight Infant
In this randomized study The investigators aim to compare the growth of very-low-birth-weight (VLBW) infants fed either a high protein or a standard protein preterm infant formula.
- Trial name
- NCT01208493
- Testing
- preterm infant formula with high protein levels, preterm standard infant formula
- Where
- 4 sites in United States, Belgium and 2 more
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)
Infant, Extremely Premature, Length of Stay
Trial of Patterned Oral Somatosensory Entrainment for Shortening Time to Oral Feeding
The primary hypothesis is that the preterm infants (26 0/7 to 30 6/7 weeks gestational age) who undergo the NTrainer System® training will transition to full oral feeds faster than the control group (i.e.
- Conditions
- Infant, Extremely Premature, Length of Stay, Feeding
- Trial name
- NCT01158391
- Testing
- NTrainer® Intervention, Control Intervention
- Where
- 5 sites in United States
- Volunteers
- 210 people, healthy volunteers welcome
- Sponsor
- KC BioMediX, Inc
Preterm Birth, Healthy
A Study Evaluating Sleep, Stress and Infant Nutrition Using a Chatbot
20 parents with healthy preterm infants (born at <37 weeks of gestation), age 0-6 months and discharged from the hospital at time of enrollment and 20 parents with healthy full-term infants (born at ≥37 weeks of gestation), age…
- Trial name
- NCT03630679
- Where
- Singapore
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- Danone Asia Pacific Holdings Pte, Ltd.
Retinopathy of Prematurity
Prospective Evaluation of iCam-OCT
This is a prospective, non-significant-risk clinical study sponsored by Siloam Vision, Inc. to evaluate whether ophthalmologists can assess retinopathy of prematurity (ROP) using images from the iCam-OCT device as effectively as…
- Trial name
- NCT07839923
- Testing
- imaged with i-Cam OCT
- Where
- United States
- Volunteers
- 68 people, healthy volunteers welcome
- Sponsor
- Siloam Vision
Premature Infants
Feeding Study in Premature Infants
To evaluate weight gain of preterm infants fed fortified human milk.
- Trial name
- NCT00681018
- Testing
- Liquid human milk fortifier, Powder human milk fortifier
- Where
- 14 sites in United States
- Volunteers
- 143 people, healthy volunteers welcome
- Sponsor
- Mead Johnson Nutrition
Intraventricular Brain Hemorrhage
Detection and Quantification of Neonatal Intraventricular Hemorrhage
Dense array EEG and EIT (electrical impedence tomography) are new technologies that can add to information needed to diagnose neurological problems in infants - both preterm and term.
- Trial name
- DQNIH (NCT01899651)
- Where
- United States
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Electrical Geodesics, Inc.
Respiratory Syncytial Virus Infections
A Study of TNM001 in Chinese Healthy Preterm and Term Infants
The purpose of this clinical trial is to evaluate the safety, tolerability and pharmacokinetics (PK) profile of TNM001 injection in healthy preterm and term infants.
- Trial name
- NCT05630573
- Testing
- TNM001
- Where
- 6 sites in China
- Volunteers
- 31 people, healthy volunteers welcome
- Sponsor
- Zhuhai Trinomab Pharmaceutical Co., Ltd.
Retinopathy of Prematurity, ROP
Automated Screening Device to Detect MTMROP
The purpose of the study is to evaluate the i-ROP DL system for autonomous ROP screening. To demonstrate the sensitivity and specificity of the i-ROP DL system on images obtained by healthcare providers in the neonatal intensive…
- Trial name
- NCT06517836
- Testing
- iROP DL
- Where
- United States
- Volunteers
- 1,284 people, healthy volunteers welcome
- Sponsor
- Siloam Vision
Preterm Infant
Growth and Safety of a Two-stage Feeding System in Preterm Infants
This study evaluates the safety and suitability of the two-stage feeding system in preterm infants.
- Trial name
- NCT03728764
- Testing
- Preterm infant formula
- Where
- 4 sites in Czechia, Poland and 1 more
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)
Other Preterm Infants
Invictus Medical, Medical Cranial Support Device (CSD) is a Device Safety Study in Infants at Risk of Head Ulcers.
While using the device as a cushion, the passive distribution of pressure over bony skull prominences of infants will protect against formation of pressure ulcers.
- Trial name
- INV-CS-001 (NCT02224859)
- Testing
- HCP will place the Invictus Cranial Support Device (CSD) on the patient, human intervention
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- Invictus Medical, Inc.
Necrotizing Enterocolitis
Necrotizing Enterocolitis (Nec) and B. Lactis in Premature Babies
The purpose of the trial is to demonstrate the effect of B. lactis in reducing the incidence of Necrotizing Enterocolitis (NEC) compared to placebo in preterm infants.
- Trial name
- NCT00977912
- Testing
- Probiotic supplementation
- Where
- 3 sites in South Africa
- Volunteers
- 318 people, healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)
Preterm Milk, Term Milk
Pre/Term Milk Profiling
This study aims for an in-depth characterization of human milk of mothers who delivered prematurely to decipher differences with milk of mothers who delivered at the expected term, with a particular focus on milk proteins
- Trial name
- NCT02052245
- Where
- Switzerland
- Volunteers
- 61 people, healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)
Premature Birth
Development of a Therapeutic Device to Improve Speech Sound Differentiation in Preterm Infants
The goal of this clinical study is to test a new, novel medical device designed to improve speech sound differentiation among hospitalized preterm infants.
- Trial name
- NCT06063122
- Testing
- smallTalk NICU Active
- Where
- 2 sites in United States
- Volunteers
- 203 people, healthy volunteers welcome
- Sponsor
- Thrive Neuromedical, LLC
Infections, Streptococcal
Study to Evaluate the Safety and Immunogenicity of a 10-valent Pneumococcal Conjugate Vaccine in Preterm Infants
This study aims to evaluate the safety, reactogenicity and immunogenicity of GlaxoSmithKline (GSK) Biologicals´ 10-valent pneumococcal conjugate vaccine when co-administered with diphtheria, tetanus, acellular pertussis-hepatitis…
- Trial name
- NCT00390910
- Testing
- Pneumococcal conjugate vaccine GSK1024850A, Infanrix hexa
- Where
- 8 sites in Greece, Spain
- Volunteers
- 286 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Pre-term Infant
Growth and Safety of Two Partially-hydrolyzed Feeding Systems for Preterm Infants
This is an open-label trial consisting of two sub-studies to be conducted sequentially with the purpose of evaluating the safety and suitability of a two feeding systems in pre-term infants (one containing HMOs and one without…
- Trial name
- NCT04639518
- Testing
- Preterm formulas with HMO, Preterm formulas without HMO
- Where
- 4 sites in Germany, Poland and 1 more
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)
Premature Infant
Effect of a Mixture of New Probiotic Strains in Preterm Infants
An interventional, randomized, double-blind, placebo-controlled study will be conducted to investigate the effect of a new probiotic strain Lactobacillus PS11603 \& Bifidobacterium PS10402 in premature infants from 28 weeks + 0…
- Trial name
- PREBIOMA (NCT03701906)
- Testing
- Lactobacillus PS11603 & Bifidobacterium PS10402
- Where
- Spain
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- ProbiSearch SL
Prevention of Meningococcal Infection
Immunogenicity, Safety and Tolerability, of Chiron Meningococcal C Conjugate Vaccine Administered to Healthy Premature and Non Premature Children of 3 Months of Age
Immunogenicity, Safety and Tolerability, of Chiron Meningococcal C Conjugate Vaccine Administered to Healthy Premature and Non Premature Children of 3 months of age
- Trial name
- NCT00310674
- Testing
- Meningococcal C Conjugate Vaccine
- Where
- Italy
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- Novartis
Respiratory Syncytial Virus (RSV)
Phase Ib/IIa Clinical Trial of SIBP-A16 Injection in Premature Infants and Full-term Infants
This trial employs a randomized, double-blind, placebo/positive control, and dose-finding design to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary efficacy of SIBP-A16…
- Trial name
- NCT07363837
- Testing
- SIBP-A16 injection, Nirsevimab, SIBP-A16 buffer solution
- Where
- China
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Shanghai Institute Of Biological Products