Clinical trials: Preterm Infant, active
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
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
Preterm Birth, Very Preterm Infant
NICU-to-Home Dyadic Support for Very Preterm Infants and Families
This feasibility study will evaluate delivery of the Supporting Play Exploration and Early Development Intervention after neonatal intensive care unit discharge for very preterm infants and their families.
- Conditions
- Preterm Birth, Very Preterm Infant, Infant Development, Neonatal Intensive Care Unit
- Trial name
- MN-SPEEDI (NCT07820462)
- Testing
- Homebased SPEEDI, Telehealth SPEEDI
- Where
- 2 sites in United States
- Volunteers
- 40 people
- Sponsor
- University of Minnesota
Preterm Infant, Sleep
Circadian-Synchronized Breast Milk Feeding and Sleep in Preterm Infants: A Multicenter Randomized Controlled Trial
This clinical trial aims to find out whether a circadian-synchronized breast milk feeding approach can help improve sleep in preterm infants in the neonatal intensive care unit (NICU).
- Trial name
- NCT07645677
- Testing
- Circadian-Synchronized Breast Milk Feeding, Routine Breast Milk Feeding
- Where
- 6 sites in China
- Volunteers
- 120 people
- Sponsor
- Shanghai Jiao Tong University School of Medicine
Punctate White Matter Lesions, Neurodevelopmental Outcomes
MRI-Based Neurodevelopmental Risk Stratification in Infants With White Matter Injury
The goal of this observational study is to develop and evaluate an MRI-based assessment system for predicting neurodevelopmental outcomes in infants with punctate white matter lesions (PWML).
- Conditions
- Punctate White Matter Lesions, Neurodevelopmental Outcomes, Preterm Infants
- Trial name
- NCT07860749
- Where
- 10 sites in China
- Volunteers
- 260 people
- Sponsor
- First Affiliated Hospital Xi'an Jiaotong University
Preterm Infants, Orogastric Feeding
Effects of Different Positions During Skin-to-Skin Contact in Preterm Infants Receiving Orogastric Feeding
This study will be conducted as a randomized controlled crossover study to evaluate the effects of different positions during skin-to-skin contact on physiological parameters, comfort, and feeding tolerance in preterm infants…
- Conditions
- Preterm Infants, Orogastric Feeding, Feeding Tolerance, Skin to Skin Contact
- Trial name
- NCT07857512
- Testing
- Skin-to-Skin Contact in a Semi-Elevated Right Lateral Position, Skin-to-Skin Contact in an Upright Position, Control
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Istanbul University - Cerrahpasa
Preterm Birth Complication, Preterm Birth
Personalized Care for Prenatal Stress Reduction & Prevention of Preterm Birth (PTB) Disparities
The goal of this clinical trial is to learn if a personalized prenatal support program [(Personalized Toolkit Building a Comprehensive Approach to Resource optimization and Empowerment in Pregnancy \& Beyond, (PTBCARE+)] works to…
- Conditions
- Preterm Birth Complication, Preterm Birth, Preterm Birth Recurrence, Preeclampsia
- Trial name
- PTBCARE+ (NCT06915428)
- Testing
- Care coordination, Electronic massage, support gift #1
- Where
- United States
- Volunteers
- 1,228 people
- Sponsor
- University of North Carolina, Chapel Hill
Patent Ductus Arteriosus in Preterm Infants
Radiological Markers for PDA Management in Preterm Infants
The aim of this Randomized controlled trial is to determine whether Echo with Organ Doppler-guided management strategy for hemodynamically significant patent ductus arteriosus (hsPDA) improves the short-term outcomes compared…
- Trial name
- NCT07812064
- Testing
- Organ doppler, Echocardiography
- Volunteers
- 88 people
- Sponsor
- Assiut University
Skin to Skin Care for Preterm Infants
Skin-to-skin Care Using the Skincubator: Feasibility and Safety Trial
The purpose of this study is to assess the impact of the Skincubator on average daily duration of Skin-to-skin Care (SSC), to assess the safety of Skincubator-supported SSC during NICU hospitalization, to evaluate feasibility and…
- Trial name
- NCT07721662
- Testing
- Skincubator-supported SSC, t-SSC
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- The University of Texas Health Science Center, Houston
Apnea of Prematurity, Preterm Infant
Detection of Respiratory Events Using Acoustic Monitoring in Extremely Preterm Infants
Extremely preterm infants, born before 29 weeks of pregnancy, often face breathing difficulties, also known as respiratory events, due to their undeveloped lungs and respiratory systems.
- Conditions
- Apnea of Prematurity, Preterm Infant, Periodic Breathing, Hypopnea
- Trial name
- DREAM 2 (NCT07552025)
- Testing
- Wireless acoustic sensor, Semi-structured interview, Nox T3s portable sleep monitoring device
- Where
- Canada
- Volunteers
- 50 people
- Sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
Infant, Premature, Diseases, Birth, Preterm
The NEU - CAP Trial
The aim of NEU-CAP is to investigate the clinical impact of using a colorimetric carbon dioxide (CO₂) detector during non-invasive ventilation (NIV). Infants born before 32 weeks of gestation will be included in this trial.
- Conditions
- Infant, Premature, Diseases, Birth, Preterm, Respiratory Distress Neonatal
- Trial name
- NEU-CAP (NCT07754032)
- Testing
- Local standard care of monitoring non-invasive ventilation, CO₂-guided Non-Invasive Ventilation
- Volunteers
- 1,860 people
- Sponsor
- Leiden University Medical Center
Preterm Infant
Clinical Impact of Non-invasive Neurally Adjusted Ventilatory Assist in Very Preterm Infants
This is a prospective observational study investigating the impact of NIV-NAVA on short-term clinical outcomes and long-term neurodevelopment in very preterm infants.
- Trial name
- NCT06786039
- Testing
- Non-invasive NAVA
- Where
- 2 sites in South Korea
- Volunteers
- 80 people
- Sponsor
- Korea University Anam Hospital
Premature, Preterm Infant Health
Vitamin A Supplementation and Breast Milk Vitamin A Levels in Mothers of Preterm Infants
Preterm infants are at increased risk of vitamin A deficiency because they are born with low vitamin A stores and depend largely on breast milk to meet their nutritional needs.
- Conditions
- Premature, Preterm Infant Health, Vitamin A Deficiency, Human Milk
- Trial name
- VITAL (NCT07736768)
- Testing
- Oral multivitamin containing vitamin A
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- University of Mississippi Medical Center
Study of Predictors of Successful Extubation in Preterm Infants, Extubation Succeeded
Neonatal Diaphragmatic Activity-Linked Extubation Conditions and Timing
The objective of this study is to evaluate the role of diaphragmatic electrical activity monitoring (collected by esophageal probe) around extubation of preterm patients in order to consider its use as a standardized objective…
- Conditions
- Study of Predictors of Successful Extubation in Preterm Infants, Extubation Succeeded, Extubation Failure, Preterm
- Trial name
- NEODIALECT (NCT07709988)
- Volunteers
- 20 people
- Sponsor
- Centre Hospitalier Intercommunal Creteil
Term Infant, Late Preterm Infant
Brain Uptrain to Improve Learning and Development
The purpose of this study is to see if an early literacy and developmental program in addition to shared reading can increase developmental test scores at 24 months of age.
- Trial name
- BUILD (NCT06638801)
- Testing
- Coach-led caregiver-implemented early literacy and developmental programming, Reach Out and Read Training
- Where
- United States
- Volunteers
- 188 people
- Sponsor
- University of Alabama at Birmingham
Preterm, Infant Death
Comparative Outcomes Related to Delivery-room Cord Milking In Low-resourced Kountries- PreTerm
The goal of this multicenter, cluster-randomized, crossover trial is to determine if umbilical cord milking compared to early cord clamping will reduce in-hospital mortality in non-vigorous preterm infants born between 30 weeks…
- Trial name
- CORDMILK-PT (NCT06240715)
- Testing
- Umbilical cord milking
- Where
- 9 sites in India
- Volunteers
- 800 people
- Sponsor
- Nemours Children's Clinic
Nutrition Intervention, Quality Improvement
Optimizing Early Nutrition Management of Extremely and/or Very Preterm Infants
A clinical quality improvement bundle on early nutrition supplementation is developed to improving the clinical outcomes (including growth, organ function, and neurodevelopment outcomes) of extremely and/or very preterm infants.
- Conditions
- Nutrition Intervention, Quality Improvement, Preterm Infant
- Trial name
- NCT07538999
- Testing
- A nutritional improving bundle for the intervention group, Routine nutritional strategies for the control group
- Where
- China
- Volunteers
- 200 people
- Sponsor
- Children's Hospital of Fudan University
Preterm, Parent-Child Relations
Sensory Optimization of the Hospital Environment
The long-term goal of this project is to improve the health and well-being of preterm infants and their parents. Although there is evidence to support positive multisensory interventions in the NICU, these interventions are often…
- Conditions
- Preterm, Parent-Child Relations, Parents, Development, Infant
- Trial name
- SOOTHE (NCT05230199)
- Testing
- SENSE multisensory program, Monitored standard of care
- Where
- United States
- Volunteers
- 215 people
- Sponsor
- University of Southern California
Preterm Infants, Vital Sign Monitoring
Neonatal Wireless Transmission System: Hospital Adoption and Planning for Implementation Study
To explore the feasibility, acceptability, and implementation considerations associated with the adoption of the NeWTS system within NHS neonatal services.
- Trial name
- NEWTS HAPI-1 (NCT07650045)
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Cambridge University Hospitals NHS Foundation Trust