Clinical trials: Preterm Infant
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
Preterm Infants at Developmental Risk
HEP Tele-Rehabilitation for Preterm Infants at Developmental Risk: A Feasibility Study
Several early intervention approaches based on sensory and motor environmental enrichment have demonstrated neurobehavioral benefits and improvements in motor and cognitive skills in infants.
- Trial name
- HEP®-Preterm (NCT07727733)
- Testing
- Intervention
- Where
- Turkey (Türkiye)
- Volunteers
- 16 people
- Sponsor
- Medipol University
Preterm Infant, Infant, Premature
Pilot Study of the SENSITIVE Care Program for Preterm Infants in the Neonatal Intensive Care Unit
The goal of this clinical trial is to learn whether the Sensory Integrative Intervention (SENSITIVE) Care Program helps reduce stress and improve mother-infant interaction in preterm infants receiving care in the Neonatal…
- Conditions
- Preterm Infant, Infant, Premature, Neonatal Intensive Care Unit (NICU)
- Trial name
- SENSITIVE Care (NCT07728760)
- Testing
- SENSITIVE Care Program, Standard Neonatal Intensive Care
- Where
- Indonesia
- Volunteers
- 8 people
- Sponsor
- Gadjah Mada University
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
PPROM, Respiratory Distress Syndrome in Premature Infants
Does a Rescue Course of Betamethasone in Pregnant Women With PPROM Decrease Neonatal Morbidity?
The purpose of this study is to determine if a repeat course of betamethasone given to pregnant women with preterm premature rupture of membranes (PPROM) will decrease the infant's length of stay in the neonatal intensive care…
- Trial name
- NCT02939742
- Testing
- Betamethasone
- Where
- United States
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- The University of Texas Medical Branch, Galveston
Preterm Infant, Growth Delay
The Milk, Growth and Microbiota Study
Late preterm infants, who are born at 34, 35 or 36 weeks gestation, often have difficulty feeding, establishing growth, and fighting off infection.
- Conditions
- Preterm Infant, Growth Delay, Microbial Colonization, Breastfeeding
- Trial name
- MGM (NCT03220282)
- Testing
- Donor milk, Preterm infant formula
- Where
- United States
- Volunteers
- 48 people
- Sponsor
- University of California, San Francisco
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
Preterm Birth, Breast Milk Expression
Targeting Human Milk Fortification to Improve Preterm Infant Growth and Brain Development
This study is a randomized trial comparing 2 methods of human milk fortification for preterm infants in the neonatal intensive care unit (NICU).
- Conditions
- Preterm Birth, Breast Milk Expression, Nutrition Disorder, Infant, Brain Development Abnormality
- Trial name
- NCT03977259
- Testing
- Individually targeted fortification
- Where
- United States
- Volunteers
- 130 people
- Sponsor
- Brigham and Women's Hospital
Habituation, Psychophysiological, Preterm, Infant
Habituation's Mechanisms in Preterm and Term Infants
Each year in France, 7 % of newborns are born preterm (before 37 weeks of gestational age (GA)). The investigators called very preterm infants those who were born before 33 weeks of GA.
- Trial name
- HABIPREMA (NCT02496104)
- Testing
- Package n°1 of the APIB
- Where
- France
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- University Hospital, Brest
Preterm Infant, Exposure to Radiofrequency
Impact of Chronic Exposure to Radiofrequency Electromagnetic Fields on Neurophysiological Development in the Preterm Neonate
The massive use of highly technological devices in Neonatal Intensive Care Units may expose preterm neonates to electromagnetic fields, especially radiofrequencies, at low doses but continuously and chronically.
- Trial name
- NeuroPrem-RF (NCT03928457)
- Testing
- Parental questionnaire, Daily continuous recording of radiofrequency exposure levels, Follow-up of daily infants environmental and clinical parameters
- Where
- France
- Volunteers
- 40 people
- Sponsor
- Centre Hospitalier Universitaire, Amiens
High Risk Infant, Neurodevelopmental Disorder (Diagnosis)
SAFE Early Intervention for At-Risk Infants
This randomized controlled study aims to investigate the effects of the SAFE early intervention approach on upper extremity function, fine motor skills, and developmental outcomes in high-risk infants aged 3-12 months.
- Conditions
- High Risk Infant, Neurodevelopmental Disorder (Diagnosis), Preterm
- Trial name
- SAFE-EFFECT (NCT07596147)
- Testing
- SAFE Early Intervention Program, NDT TREATMENT
- Where
- Turkey (Türkiye)
- Volunteers
- 34 people
- Sponsor
- Gazi University
Post Traumatic Stress Symptoms, Preterm Infant
EMDR Therapy in Preterm-Born Infants With Post-Traumatic Stress Symptoms
This study examines a trauma-focused treatment for very young children who were born prematurely and developed post-traumatic stress related symptoms after medical care.
- Trial name
- EMDR-INFANTS (NCT07590778)
- Testing
- Eye Movement Desensitization and Reprocessing (EMDR) storytelling method
- Where
- Netherlands
- Volunteers
- 10 people
- Sponsor
- Tanja Holtackers
Prematurity, Infections, NIRS
The Peripheral(-Muscle) Oxygenation and Perfusion Score as a New Non-invasive Tool to Predict Elevations in C-reactive Protein Levels in Neonates
This is a prospective, single-center Phase II observational study investigating the predictive value of the "Peripheral(-muscle) Oxygenation and Perfusion Score" (POP-Score), a novel non-invasive composite index, for early…
- Conditions
- Prematurity, Infections, NIRS, Near Infrared Spectroscopy, Preterm Neonates
- Trial name
- POP-Score (NCT07109856)
- Testing
- POP-Score Assessment, Near-Infrared Spectroscopy (NIRS)
- Where
- Austria
- Volunteers
- 93 people
- Sponsor
- Medical University of Graz
Neonates and Preterm Infants, Infant Respiratory Distress Syndrome
Duration of Surfactant Administration and Impact on Stabilisation of Vital Parameters in Very Preterm Neonates: 1 Minutes Versus 5 Minutes
Respiratory distress syndrome (RDS) is common in very preterm infants due to surfactant deficiency. Surfactant replacement therapy is lifesaving, and current guidelines recommend the less invasive surfactant administration (LISA)…
- Conditions
- Neonates and Preterm Infants, Infant Respiratory Distress Syndrome, Surfactant Deficiency Syndrome Neonatal, Surfactant
- Trial name
- SurfStab I (NCT07261787)
- Testing
- Poractant alfa (Curosurf®) - 1-minute administration, Poractant alfa (Curosurf®) - 5-minute administration
- Where
- Austria
- Volunteers
- 76 people
- Sponsor
- Medical University of Graz
Cerebral Palsy, Cerebral Palsy (CP)
Assessing Intellectual and Motor Outcomes in High-risk Infants
Cerebral palsy (CP) is a condition when a baby has a brain injury that affects their movement and muscle tone. Some people with CP can have other developmental issues, like learning impairments, but many do not and have isolated…
- Conditions
- Cerebral Palsy, Cerebral Palsy (CP), Cerebral Palsy Children, High-risk Infants
- Trial name
- AIM-High (NCT06857539)
- Where
- 4 sites in Ireland
- Volunteers
- 600 people, healthy volunteers welcome
- Sponsor
- University College Cork
Preterm Infant Development, COVID - 19
Development of Preterm Infants Born During the COVID-19 Pandemic
This study aims to evaluate differences in cognitive and psychomotor development among preterm infants (born before 34 weeks of gestation) delivered during the COVID-19 pandemic at Hospital de la Santa Creu i Sant Pau, compared…
- Trial name
- NCT07569523
- Testing
- Evaluation of cognitive and psychomotor development through the Bayley Scales Of Infant and Toddler Development and Wechsler Preschool and Primary Scale of Intelligence
- Volunteers
- 120 people
- Sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau