Clinical trials: Preterm Infant Health, open to volunteers
Extreme Prematurity, Enteral Nutrition
High-energy Human Milk Diets in the First Two Weeks After Birth to Reduce BPD in Extremely Preterm Infants
This Phase II, parallel-group, masked, randomized clinical trial aims to evaluate whether a DHA/ARA-enriched, fortified human milk diet administered during the first 14 days of life reduces respiratory morbidity and improves lung…
- Conditions
- Extreme Prematurity, Enteral Nutrition, Bronchopulmonary Dysplasia
- Trial name
- MEND-BPD (NCT07307612)
- Testing
- High-energy group, Standard-energy group
- Where
- United States
- Volunteers
- 150 people
- Sponsor
- University of Alabama at Birmingham
Preterm Infant Development, Preterm Infant Health
Neonatal Data and Biobank to Study Factors Influencing Development in Preterm Infants Born at <32 Weeks' Gestation and/or <1500 g Birth Weight
The Neo-Life project aims to establish a prospective neonatal data and biobank to investigate factors influencing the short- and long-term development of very preterm infants.
- Conditions
- Preterm Infant Development, Preterm Infant Health, Prematurity Complications, Premature Birth
- Trial name
- Neo-Life (NCT07490912)
- Where
- Germany
- Volunteers
- 1,300 people
- Sponsor
- University Hospital of Cologne
Parents of Premature Infants, Intelligent Intervention
Effects of Intelligent Parent-child Bonding Intervention on the Physical, Psychological and Social Health of Parents of Premature Infants During Hospitalization and Return Home
The study purpose is to construct and validate the effects of "intelligent parent-child bonding intervention" on the physical, psychological and social health of parents of premature infants.
- Conditions
- Parents of Premature Infants, Intelligent Intervention, Parent-child Connection
- Trial name
- NCT06987227
- Testing
- Intelligent intervention to enhance parent-child connection, Routine care
- Where
- Taiwan
- Volunteers
- 360 people, healthy volunteers welcome
- Sponsor
- National Defense Medical Center, Taiwan
Ventilator-Associated Pneumonia (VAP), Neonatal, Bronchopulmonary Dysplasia (BPD)
National Surveillance and Prevention of Neonatal VAP
The goal of this observational study is to improve how hospital-acquired lung infections (called ventilator-associated pneumonia, or VAP) are diagnosed, treated and prevented in very low birth weight (VLBW) infants, babies born…
- Conditions
- Ventilator-Associated Pneumonia (VAP), Neonatal, Bronchopulmonary Dysplasia (BPD), Antibiotic-Resistant Organisms (AROs), Health-Care Associated Infection (HAI)
- Trial name
- NCT07109791
- Where
- Canada
- Volunteers
- 1,500 people
- Sponsor
- University of Alberta
5 Year Old Children Born Prematurely
Early Detection of Developmental Abnormalities of Preterm Infants at 5 Years of Age
The project is a national, prospective, multicenter, interventional pilot project focused on the follow up of 5 year old children that were born prematurely.
- Trial name
- NCT07391527
- Testing
- Pediatric check-up
- Where
- 4 sites in Czechia
- Volunteers
- 210 people
- Sponsor
- Institute of Health Information and Statistics of the Czech Republic
Preterm Infants, Term Infants
The Intestinal Innate Immune System in Newborns. Development and Inflammation in Health and Disease
The goal of this observational study is to determine the normal development of the human intestinal immune system in premature and mature neonatal life and to determine the pathophysiology behind life-threatening gastrointestinal…
- Conditions
- Preterm Infants, Term Infants, Necrotising Enterocolitis, Atresia; Bowel
- Trial name
- INTINE (NCT06092463)
- Where
- 2 sites in Denmark
- Volunteers
- 275 people, healthy volunteers welcome
- Sponsor
- Copenhagen University Hospital, Rigshospitalet
Preterm
Preschool Outcomes of a Previous RCT - ReDiMOM (NCT04540575)
This study will evaluate neurodevelopmental, health, and economic outcomes in preschool children born very preterm that participated in a randomized trial of an economic intervention designed to increase breastmilk feedings while…
- Trial name
- NCT07702357
- Testing
- This is a an observational prospective cohort study of a previous interventional trial (NCT04540575)
- Where
- United States
- Volunteers
- 256 people
- Sponsor
- Rush University Medical Center
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
Preterm Birth
E-health-supported Diagnostic and Intervention in Preterm Born Children and Their Families
The app-based diagnostic and support approach with a focus on mental and somatic symptoms is intended to strengthen the resilience of premature born children and families and to identify risk and resilience factors.The overall…
- Trial name
- NeoUp2 (NCT06939192)
- Testing
- Intervention Group (APP), Treatment as usual-Group (TAU)
- Where
- Germany
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- University Hospital Tuebingen
Infant Conditions, Infant, Premature, Diseases
The Alberta BLOOM Premature Child Study
This is a prospective, observational clinical cohort study involving 405 children born premature (at less than 37 weeks gestation) and their mother/parent/guardian.
- Conditions
- Infant Conditions, Infant, Premature, Diseases, Asthma, Asthma in Children
- Trial name
- BLOOM-PCS (NCT05011071)
- Where
- Canada
- Volunteers
- 535 people
- Sponsor
- University of Calgary
Mental Health Wellness 1, Preterm Birth
Reducing Pregnancy Risks: The Mastery Lifestyle Intervention
This randomized controlled trial will test an intervention called the Mastery Lifestyle Intervention (the MLI) that was developed from data of 1000+pregnant Hispanic women related to risks of preterm birth.
- Trial name
- MLI (NCT05012072)
- Testing
- The Mastery Lifestyle Intervention
- Where
- United States
- Volunteers
- 238 people
- Sponsor
- Microgen LLC
Family Resilience, Parent-Infant Bonding
Development and Evaluation of an Intelligent Parent-Infant Connection-Based Intervention to Strengthen Family Resilience in Preterm Infant Care
This study aims to develop, optimize, and evaluate the effectiveness of a family resilience intervention centered on intelligent parent-infant connection for parents of preterm infants.
- Conditions
- Family Resilience, Parent-Infant Bonding, Parents of Premature Infants, Intelligent Intervention
- Trial name
- NCT07373002
- Testing
- Intelligent Intervention to enhance Parent-Infant Connection and Family Resilience, Routine Care
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- National Defense Medical Center, Taiwan
BPD - Bronchopulmonary Dysplasia, Pulmonary Hypertension
Controlled Remote Monitoring and Optimization of Oxygen Therapy in Preterm Infants
The project is a national, prospective, multicenter, interventional pilot project focused on controlled remote monitoring and optimization of oxygen therapy for premature infants in the Czech Republic.
- Trial name
- NCT07161908
- Testing
- Pulse oximeter
- Where
- 4 sites in Czechia
- Volunteers
- 70 people
- Sponsor
- Institute of Health Information and Statistics of the Czech Republic
Bronchopulmonary Dysplasia (BPD), Chronic Lung Disease of Newborn
Long-Term Burden of BPD and Health-Related Quality of Life (BronQ Family)
The objective of this study is to examine the long-term impact of having a child with Bronchopulmonary Dysplasia (BPD) on the parents and caregivers from the time of diagnosis through adulthood.
- Conditions
- Bronchopulmonary Dysplasia (BPD), Chronic Lung Disease of Newborn, HRQOL (Health Related Quality Of Life)
- Trial name
- BronQ Family (NCT07134387)
- Testing
- N/A, no intervention, participation in survey
- Where
- Germany
- Volunteers
- 480 people, healthy volunteers welcome
- Sponsor
- Global Foundation for the Care of Newborn Infants
Prematurity
Milk And Growth In Children (MAGIC) Born Very Preterm: A Randomized Trial
The goal of this multi-center randomized, parallel group trial is to determine the effect of human milk diets ranging between 180 and 200 mL/kg/day on the body composition outcomes of moderately preterm infants born between 27…
- Trial name
- MAGIC (NCT06420531)
- Testing
- Human milk
- Where
- 4 sites in United States
- Volunteers
- 486 people
- Sponsor
- University of Alabama at Birmingham
NEC - Necrotizing Enterocolitis, NEC
Mechanisms Affecting the Gut of Preterm Infants Receiving Blood Transfusion With Different Enteral Feed Interventions
MAGPIE-2 is a prospective observational study designed to investigate the physiological mechanisms linking blood transfusion and enteral feeding practices to gut perfusion and oxygenation in very preterm infants.
- Conditions
- NEC - Necrotizing Enterocolitis, NEC, Preterm Babies, Preterm Infant Health
- Trial name
- MAGPIE-2 (NCT07191678)
- Where
- United Kingdom
- Volunteers
- 270 people
- Sponsor
- Imperial College Healthcare NHS Trust
Ventilator Associated Pneumonia, Bronchopulmonary Dysplasia
Frequent Standardized Oral Care Using Human Milk in the Neonatal Intensive Care Unit
Premature infants are susceptible to complications related to infrequent and non-standardized oral care. Although the benefits of frequent standardized oral care are known to reduce oral dysbiosis (increased level of potentially…
- Conditions
- Ventilator Associated Pneumonia, Bronchopulmonary Dysplasia, Respiratory Disease
- Trial name
- NCT06000761
- Testing
- Standardized oral Care
- Where
- United States
- Volunteers
- 218 people
- Sponsor
- University of Florida
Preterm
Long Term Health Cohort of Premature Infants
Establish a clinical diagnosis and treatment and long-term follow-up database of preterm infants, and analyze the effects of prenatal factors (including genetic characteristics, maternal diseases, etc.), postnatal diagnosis and…
- Trial name
- NCT05017389
- Testing
- Griffiths development scales
- Where
- China
- Volunteers
- 1,200 people
- Sponsor
- Shanghai Children's Medical Center
Preterm Birth, Preeclampsia
The ROOT Study: Scaling the 'Standard of Care Plus' Obstetric Nutrition Model to Optimize Maternal and Infant Health
The 'Standard of Care Plus' ('PLUS') model in the ROOT Study consists of analyzing select micronutrient and gene variants of pregnant females to construct trimester-specific and personalized nutrition and lifestyle…
- Conditions
- Preterm Birth, Preeclampsia, Gestational Diabetes Mellitus (GDM), Small for Gestational Age (SGA)
- Trial name
- ROOT (NCT07559773)
- Testing
- 'Standard of Care PLUS'
- Volunteers
- 500 people
- Sponsor
- GrowBaby Life Project
Premature Baby, Pulmonary Hypertension of Newborn
Measuring Heart Health in Both Term, Preterm and Unwell Newborn Babies With an Advanced Ultrasound Method: Speckle Tracking Echocardiography
This study aims to improve how neonatologists check the heart function of newborn babies, especially those who are sick. While standard heart ultrasound scans are useful, a more advanced and sensitive technique called 2D speckle…
- Conditions
- Premature Baby, Pulmonary Hypertension of Newborn, Hypoxic Ischaemic Encephalopathy (HIE), Congenital Diaphragmatic Hernia
- Trial name
- NCT07364682
- Where
- United Kingdom
- Volunteers
- 190 people, healthy volunteers welcome
- Sponsor
- Birmingham Women's NHS Foundation Trust