Clinical trials: Premature Infant
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
Infant, Very Low Birth Weight, Growth Failure
Preterm Infants on Early Solid Foods
Introduction: Preterm infants with a birth weight less than 1500 grams have special nutritional needs in comparison to full-term neonates.
- Trial name
- PIES-Project (NCT01809548)
- Testing
- Early intervention group, Late intervention group
- Where
- Austria
- Volunteers
- 177 people
- Sponsor
- Medical University of Vienna
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
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
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
Respiratory Distress Syndrome, Newborn, Infant, Premature
Measuring Diaphragm Electrical Activity in Neonates Using a Smaller Inter-electrode Distance
Neurally Adjusted Ventilatory Assist (NAVA) is a mode of ventilation where the electrical activity of the diaphragm (EDI) - a signal representing the baby's respiratory drive - is used to control the timing and amount of assist…
- Trial name
- NCT05427929
- Testing
- NVR 4mm Edi catheter
- Where
- Canada
- Volunteers
- 10 people
- Sponsor
- Mount Sinai Hospital, Canada
Infant Malnutrition, Light-For-Dates With Signs of Fetal Malnutrition
Early DHA/ARA Supplementation in Growth-restricted Very Preterm Infants: A Randomized Clinical Trial
Growth-restricted very preterm infants (VPT) are born without adequate fat mass (FM) deposits and low docosahexaenoic acid (DHA) concentrations.
- Conditions
- Infant Malnutrition, Light-For-Dates With Signs of Fetal Malnutrition, Premature, Nutrition Disorder, Infant
- Trial name
- NCT06207071
- Testing
- DHA
- Where
- United States
- Volunteers
- 152 people, healthy volunteers welcome
- Sponsor
- University of Alabama at Birmingham
Infant, Premature, Diseases, Premature Birth of Newborn
Elevated Midline Positioning During Diaper Change in Preterm Infants
Diaper changing is one of the most frequent routine care procedures in the neonatal intensive care unit (NICU) and is known to cause physiological instability and behavioral stress responses in preterm infants.
- Conditions
- Infant, Premature, Diseases, Premature Birth of Newborn, Pain
- Trial name
- NCT07865897
- Testing
- 30-Degree Elevated Midline Positioning, Standard Lateral Position Diaper Change
- Volunteers
- 80 people
- Sponsor
- Akdeniz University
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
Motor Delay, Infant Development
Wearable Sensor Toolkit for Infant Motor Development
The purpose of this study is to develop and test a fully automated, wireless sensor-based toolkit for infants that can capture early indicators (0-3 months) of motor deficits during activities of daily life and track motor…
- Conditions
- Motor Delay, Infant Development, Motor Development of Premature Infants, Motor Coordination or Function; Developmental Disorder
- Trial name
- NCT07866495
- Where
- 2 sites in United States
- Volunteers
- 90 people
- Sponsor
- Shirley Ryan AbilityLab
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
Premature Infant, Respiratory Distress Syndrome in Premature Infant
30% or 60% Oxygen at Birth to Improve Neurodevelopmental Outcomes in Very Low Birthweight Infants
Preterm birth, or birth before 37 weeks' gestation, is increasingly common, occurring in 8 percent of pregnancies in Canada. Preterm birth is associated with many health complications, particularly when the birth happens before…
- Conditions
- Premature Infant, Respiratory Distress Syndrome in Premature Infant, Neurodevelopmental Outcome
- Trial name
- HiLo (NCT03825835)
- Testing
- 30% oxygen group, 60% oxygen group
- Where
- 14 sites in Canada, Ireland
- Volunteers
- 1,203 people
- Sponsor
- University of Alberta
Preterm Birth Complication, Infant Self-regulation
Effects of a Parent-Mediated Self-Regulation Support Intervention in Preterm Infants
This study aimed to evaluate the effects of a parent-mediated self-regulation support intervention on self-regulation skills in preterm infants and on parenting stress, perceived social support, and parental cooperation.
- Conditions
- Preterm Birth Complication, Infant Self-regulation, Parenting Behavior
- Trial name
- NCT07850297
- Testing
- Parent-Mediated Self-Regulation Support Intervention
- Where
- Turkey (Türkiye)
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Feryal Savcı
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
Prematurity, Very Preterm Maturity of Infant
Sleep in SNOO Smart Sleeper Bassinet in Preterm Infants
The goal of this clinical trial is to compare sleeping in a SNOO Smart Sleeper bassinet (SNOO) with sleeping in traditional bassinet conditions in premature infants. The main questions it aims to answer are: 1.
- Trial name
- NCT05711927
- Testing
- SNOO Smart Sleeper, Traditional bassinet
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Columbia University
Retinopathy of Prematurity (ROP)
Analyzing Retinal Microanatomy in Retinopathy of Prematurity to Improve Care
Retinopathy of prematurity (ROP) is a disorder of development of the retina and its vasculature that can impact vision in vulnerable preterm neonates for a lifetime.
- Trial name
- (BabySTEPS3) (NCT07738874)
- Testing
- Ultra-widefield Optical Coherence Tomography (UWF-OCT), Wide-field ophthalmic imaging system
- Where
- 2 sites in United States
- Volunteers
- 175 people
- Sponsor
- Duke University
Infant, Premature
Influence of Intestinal Microbiota Implantation in Preterm Infants on Microbiota and Immune Orientation at 3 Years
The main objective of this research is to study the links between changes in the intestinal microbiota (in terms of diversity) during the first 6 weeks of life for preterm infants and the presence / absence of a TH1 immune status…
- Trial name
- PrimiBiota (NCT02738411)
- Where
- 3 sites in France
- Volunteers
- 130 people
- Sponsor
- Centre Hospitalier Universitaire de Nīmes
Social Withdrawal of Childhood or Adolescence, Preterm Infant
The Effect of a Neonatologist's Standardized Guidance Intervention on Preterm Infants With Relational Withdrawal.
The objective of this project is to determine the effect of the verbal intervention on the decrease in sustained social withdrawal in late and moderately late preterm infants.
- Trial name
- NCT03212547
- Testing
- Verbal Intervention
- Where
- 2 sites in Chile
- Volunteers
- 110 people
- Sponsor
- Clinica Alemana de Santiago
Newborn Respiratory Distress, Preterm Infant
Short Term Effects of Synchronized vs. Non-synchronized NIPPV in Preterm Infants.
Comparing the cardio-respiratory adaptation and differences to non invasive ventilation techniques, nasal intermittent positive pressure ventilation (NIPPV) non synchronized vs synchronized (SNIPPV) in preterm newborns…
- Trial name
- SyncNIV (NCT03289936)
- Testing
- NIPPV, SNIPPV
- Where
- Italy
- Volunteers
- 30 people
- Sponsor
- University of Turin, Italy
Premature Birth, Growth Failure
Predictors of Postnatal Growth Failure in Preterm Infants
This prospective observational study aims to identify the clinical and nutritional predictors of postnatal growth failure among preterm infants admitted to the Neonatal Intensive Care Unit of Assiut University Children's Hospital.
- Conditions
- Premature Birth, Growth Failure, Very Low Birth Weight Infant
- Trial name
- NCT07818681
- Volunteers
- 120 people
- Sponsor
- Assiut University