Clinical trials: Preterm Infant Development
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
Infant, Premature
Preliminary Study to the Conception of a Non-invasive Neonatal Monitoring System With Development of a Database
Each year, 300 000 new borns are hospitalised in neonatology units in Europe. This period is very sensitive as newborns are exposed to a high risk of morbidity and mortality, with severe impact on neuro-developmental prognostic.
- Trial name
- Digi-NewB (NCT02863978)
- Testing
- Multimodal signal acquisitions
- Where
- 6 sites in France
- Volunteers
- 746 people
- Sponsor
- Rennes University Hospital
Sleep Problem, Neurobehavioral Manifestations
NapBiome: Targeting Gut Microbiota and Sleep Rhythm to Improve Developmental and Behavioral Outcomes in Early Childhood
The gut-brain axis plays a crucial role in the regulation and development of psychological and physical processes. The first year of life is a critical period for the development of the gut microbiome, which parallels important…
- Trial name
- NapBiome (NCT06396689)
- Testing
- Synbiotic
- Where
- 2 sites in Switzerland
- Volunteers
- 380 people, healthy volunteers welcome
- Sponsor
- Petra Zimmermann
Very Preterm Maturity of Infant, Very Low Birth Weight Infant
Individualized Nutrition to Optimize Preterm Infant Growth and Neurodevelopment
Human milk has several well-established benefits but does not adequately meet the increased nutritional demands of the growing preterm infant, necessitating additional nutrient supplementation in a process known as fortification.
- Trial name
- THRIVE (NCT06266455)
- Testing
- Standardized Fortification, Adjustable Fortification
- Where
- United States
- Volunteers
- 150 people
- Sponsor
- Children's National Research Institute
Development, Preterm Birth
Sensitivity Training For Parents of Preterm Infants
Immediately following birth, preterm infants face a period of stressful environmental inputs, which may have negative consequences on early brain development and subsequent neurobehavioral outcomes.
- Trial name
- NCT00883974
- Testing
- Sensitivity Training
- Where
- 2 sites in Australia
- Volunteers
- 45 people
- Sponsor
- University of Melbourne
Infant, Premature, Diseases, Infant
The Alberta BLOOM Long Term Follow Up Study
This is a prospective, observational clinical cohort study involving children born very preterm at less than 31 weeks and six days gestation.
- Conditions
- Infant, Premature, Diseases, Infant, Asthma, Asthma in Children
- Trial name
- BLOOM-LTFU (NCT04641000)
- Where
- Canada
- Volunteers
- 15 people
- Sponsor
- University of Calgary
Premature Birth of Newborn
The Effect of Perinatal Stress on the Development of Preterm Infants
In this project, the investigators will study a cohort of preterm infants, together with their parents, during NICU hospitalization and follow their developmental trajectory until the age of two.
- Trial name
- RESILIENCE (NCT02623400)
- Where
- Belgium
- Volunteers
- 174 people
- Sponsor
- Universitaire Ziekenhuizen KU Leuven
Infant, Premature, Diseases, Perinatal Morbidity
Prognosis of Extremely Premature Birth
Pregnant women at risk of giving birth before 28 weeks' gestational age will be enrolled. Fetal circulation will be studied and blood for inflammatory parameters will be collected.
- Conditions
- Infant, Premature, Diseases, Perinatal Morbidity, Development, Problem;Growth
- Trial name
- BabyPEP (NCT01150396)
- Where
- 2 sites in Norway
- Volunteers
- 160 people
- Sponsor
- University of Bergen
Pregnancy, Premature Birth
Development of a Nationally Scalable Model of Group Prenatal Care to Improve Birth Outcomes: "Expect With Me"
This study addresses the intractable challenges of adverse birth outcomes, including preterm delivery and low birthweight, by proposing the development, implementation and evaluation of a model of group prenatal care that could…
- Conditions
- Pregnancy, Premature Birth, Infant, Low Birth Weight, Postpartum Period
- Trial name
- NCT02169024
- Testing
- Expect With Me group prenatal care, Standard individual prenatal care
- Where
- 2 sites in United States
- Volunteers
- 2,402 people, healthy volunteers welcome
- Sponsor
- Yale University
Prematurity
Study of the Interprofessional Reproducibility of a Clinical Observation Scale for the Development of Very Premature Infants
The research concerns the study of the interprofessional reproducibility of a grid for observing the development of premature infants from 1 to 6 months corrected age.
- Trial name
- SPIN-NA (NCT07169110)
- Testing
- SPIN-NA Developmental Observation Grid Assessment via Home-Based Standardized Video Recording
- Where
- France
- Volunteers
- 35 people
- Sponsor
- University Hospital, Toulouse
Cholestasis, Psychomotor Disorders, Developmental
Preventing Cholestasis Using SMOFLipid®
Preterm infants of extreme low birth weight (ELBW, < 1000 gram birth weight) cannot immediately be nourished with mother´s or formula milk and are typically dependent on parenteral nutrition (PN) for a prolonged period of time.
- Trial name
- NCT01585935
- Testing
- SMOFLIPID, INTRALIPID
- Where
- Austria
- Volunteers
- 230 people
- Sponsor
- Medical University of Vienna
Infant, Premature
The Effect of Physical Therapy Intervention on Motor Performance in Bhutanese Preterm Infants
The purpose of this randomized controlled trial is to assess if physical therapy intervention works well to improve motor performance in Bhutanese preterm infants.The main question the study aims to answer is: Will physical…
- Trial name
- NCT06109350
- Testing
- Supporting play exploration and early developmental intervention(SPEEDI), Standard care
- Where
- Bhutan
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- JDWNRH
Music Therapy
Premature Family Music Therapy Intervention (PFMI)
The music therapy intervention it is dedicated to premature baby and their family at the Neonatal Intensive Care Unit (NICU)of the Woman-Child department "Hospital Del Ponte".
- Trial name
- PFMI (NCT04335240)
- Testing
- Premature family music therapy intervention to support parenting, attachment bond and preterm development
- Where
- Italy
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- Ospedale di Circolo - Fondazione Macchi
Premature Birth
Interdisciplinary Hospital-home Intervention on Motor Development in Premature Children
Motor development of the premature infant often exhibits deviations that trigger functional limitations and disability. In Colombia, one out of every five births corresponds to premature babies.
- Trial name
- NCT04563364
- Testing
- Interdisciplinary hospital-home intervention, Convencional treatment
- Where
- Colombia
- Volunteers
- 130 people, healthy volunteers welcome
- Sponsor
- Universidad de la Sabana
Infant, Extremely Low Birth Weight, Lung Diseases, Obstructive
Growth, Health and Development in Children Born Extremely Preterm
Background: In a national Norwegian cohort of children born before 28 weeks gestation or with a birth weight less than 1000 g born in 1999 and 2000, 372 survived.
- Conditions
- Infant, Extremely Low Birth Weight, Lung Diseases, Obstructive, Disorder of Bone Density and Structure, Unspecified, Cognition Disorders
- Trial name
- PEP11 (NCT01150071)
- Where
- 2 sites in Norway
- Volunteers
- 232 people
- Sponsor
- University of Bergen
Infant, Premature
Development of Maternal Voice Recognition in Preterm Neonates
Many cognitive functions in humans are based on asymmetrical brain networks. For example, in most adults, the language is essentially processed by the left hemisphere, while other auditory functions, such as voice recognition…
- Trial name
- PREMAVOIX (NCT02818595)
- Testing
- electroencephalogram (HR-EEG), Near Infra Red Spectroscopy (NIRS)
- Where
- France
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Centre Hospitalier Universitaire, Amiens
Preterm Infant
Development, ADL, Participation, and Quality of Life in Preterm Infants: Longitudinal Research
The three fundamental goals of early rehabilitation for preterm infant after leaving NICU are: optimizing function within each child's prognostic potential, preventing the development of secondary conditions that impact life-long…
- Trial name
- NCT06532695
- Testing
- No intervention will be provided.
- Where
- Taiwan
- Volunteers
- 210 people, healthy volunteers welcome
- Sponsor
- Chang Gung Memorial Hospital
Infant Development, Maternal Stress
Evaluation of Effectiveness of the Web-Based Monitoring Program Given to Mothers of Premature Babies
The study was planned to determine the effect of the web-based hospital and home follow-up program given to mothers of premature infants on infant growth-development, repeated hospitalization of the infant, maternal stress…
- Conditions
- Infant Development, Maternal Stress, Growth
- Trial name
- NCT06144450
- Testing
- Web-Based Monitoring Program
- Where
- Turkey (Türkiye)
- Volunteers
- 61 people, healthy volunteers welcome
- Sponsor
- Gazi University
Bronchopulmonary Dysplasia, Child Development
Maternal Omega-3 Supplementation to Reduce Bronchopulmonary Dysplasia
The aim of this randomized controlled trial is to determine whether docosahexaenoic acid (or DHA, an omega-3 lipid) supplementation in lactating mothers providing breast-milk to their infant born below 29 0/7 weeks of gestational…
- Conditions
- Bronchopulmonary Dysplasia, Child Development, Neonatal and Perinatal Conditions
- Trial name
- MOBYDIck (NCT02371460)
- Testing
- DHA-rich algal oil
- Where
- 16 sites in Canada
- Volunteers
- 461 people
- Sponsor
- CHU de Quebec-Universite Laval
Cerebral Palsy, Preterm Birth
Infant Aquatics Neurodevelopment Premature Infants
The objective of this research is to examine the effect of Infant Aquatics on the development of and neurodevelopment of preterm and near-term infants, using the GM as prognostic estimation of future development.
- Conditions
- Cerebral Palsy, Preterm Birth, Development
- Trial name
- IA-NPI (NCT01779661)
- Testing
- Infant Aquatics, Infant Massage
- Where
- Israel
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Sheba Medical Center