Clinical trials: Premature; Infant, open to volunteers
Respiratory Distress Syndrome in Premature Infant
REspiratory MEchanics for Delivering Individualised Exogenous Surfactant
This study is an interventional, non-pharmacological, multicentric, randomized, controlled, superiority, non-profit study. Its primary objective is to evaluate if the administration of surfactant based on FOT assessment will…
- Trial name
- REMEDIES (NCT05791331)
- Testing
- Surfactant administration following lung mechanics assessment in addition to clinical assessment, Surfactant administration following clinical assessment
- Where
- Italy
- Volunteers
- 458 people
- Sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Premature Birth, Premature Infant
Growing Little PEAPODS Study
The goal of this clinical trial is to learn more about how the food and nutrition babies receive while in the Neonatal Intensive Care Unit (NICU) influences their ability to gain weight and fat-free mass, and their future growth…
- Conditions
- Premature Birth, Premature Infant, Premature, Intrauterine Growth Restriction
- Trial name
- NCT06226051
- Testing
- PEAPOD Infant Body Composition measuring device
- Where
- United States
- Volunteers
- 120 people
- Sponsor
- University of Wisconsin, Madison
Neurodevelopmental Disorders, Motor Skills Disorders
Motor Development and Early Predictors of Psychomotor Outcomes in Preterm and Term Infants Assessed by MOS-R and Caregiver Questionnaire at 18 and 36 Months
This study examines how early motor behavior in infants relates to their later psychomotor development. Researchers will observe both preterm and full-term infants during the first months of life, using video-based assessments to…
- Conditions
- Neurodevelopmental Disorders, Motor Skills Disorders, Infant, Premature Development, Infant, Term Development
- Trial name
- NCT07296003
- Testing
- Vojta method
- Where
- 3 sites in Czechia
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Masaryk University
Preterm, Respiratory Distress Syndrome in Premature Infant
The Hemodynamic Impact of High-frequency Oscillatory Ventilation and Periodic Sighs in Preterm Infants
To evaluate the effectiveness of early lung recruitment using high-frequency oscillatory ventilation (HFOV) alone versus HFOV with superimposed sigh breaths in moderate-to-late preterm infants requiring invasive respiratory…
- Conditions
- Preterm, Respiratory Distress Syndrome in Premature Infant, Recruitment, Mechanical Ventilation
- Trial name
- NCT07896824
- Testing
- Superimposed sigh breaths, High frequency ventilation
- Volunteers
- 100 people
- Sponsor
- Alexandria University
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
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
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
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
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
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
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
Extremely Premature Infant
Humidity in Incubators for Tiny Infants
The objective of the study is to compare different supplemental incubator humidification strategies for infants <25 weeks' gestation admitted to the neonatal intensive care unit (NICU).
- Trial name
- HumidITI (NCT06399861)
- Testing
- Higher (90%) starting RH in the incubator with humidity supplementation stopped at day 10, Lower (70%) starting RH in the incubator with humidity supplementation stopped at day 10, Higher (90%) starting RH in the incubator with humidity supplementation stopped at day 28
- Where
- 9 sites in United States
- Volunteers
- 900 people
- Sponsor
- The University of Texas Health Science Center, Houston
Extremely Premature Infant, Pain
Creation of a Scale for Assessing Pain and Discomfort in Extremely Premature Infants (EDEX) Hospitalised in Neonatal Intensive Care, Inspired by the Early Infant Pain and Discomfort Scale (EDIN)
The goal of this study is to develop a new scale for assessing prolonged pain, dedicated to extremely premature infants born before 27 weeks of gestation, adapted to their particular ways of expressing pain and discomfort, which…
- Conditions
- Extremely Premature Infant, Pain, Discomfort Symptoms
- Trial name
- DOU-PREMA (NCT07481331)
- Volunteers
- 68 people
- Sponsor
- Centre Hospitalier Universitaire de la Réunion
Premature Infants
Using the Babble Boot Camp© Speech Therapy Approach With Babies Born Prematurely
Babble Boot Camp focuses on early speech and language development, environmental enrichment and supporting parent-infant interaction with the aim of improving communication outcomes and parental well-being in at risk children.
- Trial name
- BBCPrem (NCT07738224)
- Testing
- Babble Boot Camp
- Where
- 2 sites in Australia
- Volunteers
- 86 people
- Sponsor
- Murdoch Childrens Research Institute
Respiratory Distress Syndrome, Newborn, Respiratory Distress Syndrome in Premature Infant
Optimising Breathing Support at Extubation in Very Preterm Infants: A Clinical Study
Many babies born very preterm (<32 weeks of pregnancy) require support to breathe from a breathing machine (mechanical ventilator) via a breathing tube. Although this keeps babies alive, it can damage their lungs.
- Trial name
- PrePAP (NCT07251790)
- Testing
- Pre-extubation continuous positive airway pressure
- Where
- 3 sites in Australia
- Volunteers
- 134 people
- Sponsor
- Murdoch Childrens Research Institute