Clinical trials: Infant, Preterm
Poor Growth in Extremely Preterm Infants, Necrotizing Enterocolitis
Early Routine vs. Selective Human Milk Fortification in Extremely Preterm Infants
The aim of the project is to study the effects of fortification (using a Human Milk Donor Fortifier) of an exclusive preterm human milk diet on outcome of extremely preterm neonates, born at less or equal to 27 weeks.
- Trial name
- NCT04284280
- Testing
- Routine vs Selective use of Human Milk Donor Fortifier
- Where
- United States
- Volunteers
- 170 people
- Sponsor
- Crouse Hospital
Preterm Infant, Hypothermia, Newborn
Early Kangaroo Mother Care in Gambian Hospitalised Unstable Neonates
The mortality effect of kangaroo mother care in stable newborns <2000g is well established but mortality effect in unstable newborns is not conclusively known.
- Conditions
- Preterm Infant, Hypothermia, Newborn, Death, Kangaroo Mother Care
- Trial name
- eKMC (NCT03555981)
- Testing
- Early Kangaroo Mother Care, Standard care
- Where
- The Gambia
- Volunteers
- 279 people
- Sponsor
- London School of Hygiene and Tropical Medicine
Patent Ductus Arteriosus in Preterm Infants, Patent Ductus Arteriosus After Premature Birth
Prophylactic IV Paracetamol in Extremely Premature Infants
Purpose of the research Everyone is born with an opening between the chambers of the heart, called a ductus arteriosus. In most people, it closes on its own, but in infants born at less than 30 weeks or less than 1250 grams…
- Conditions
- Patent Ductus Arteriosus in Preterm Infants, Patent Ductus Arteriosus After Premature Birth, Patent Ductus Arteriosus (PDA), Patent Ductus Arteriosus in Premature Infants
- Trial name
- NCT07067177
- Testing
- Paracetamol (drug)
- Where
- 3 sites in Palestinian Territories
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Al-Quds University
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
Preterm Infant
Acoustics as a Metric of Airway Pressure in Premature Infants Using Bubble Continuous Positive Airway Pressure
This is an observational, proof-of-concept, feasibility study where 30 preterm infants on bubble CPAP with gestational age < 32+0 weeks will be recruited from the neonatal intensive care unit (NICU) at the Montreal Children's…
- Trial name
- Bubble CPAP (NCT07060833)
- Testing
- External pressure transducer, Standard microphone, Wireless acoustic sensor
- Where
- Canada
- Volunteers
- 30 people
- Sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
Prematurity; Extreme, Prematurity; Decision Support
Health-Related Quality-of-Life and Household Financial and Wellbeing Impacts of Prematurity and Necrotising Enterocolitis (NEC).
PREM-IMPACT is a UK-based observational study exploring how caring for a very premature baby-particularly one affected by necrotising enterocolitis (NEC)-impacts families over the first year after hospital discharge.
- Conditions
- Prematurity; Extreme, Prematurity; Decision Support, Necrotising Enterocolitis, Preterm
- Trial name
- PREM-IMPACT (NCT07192393)
- Where
- 7 sites in United Kingdom
- Volunteers
- 90 people
- Sponsor
- Imperial College London
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
RDS of Prematurity, Preterm Birth
Study to Assess Safety and Performance of Neola®, a Novel Lung Monitoring Device for Neonates
Clinical pilot study to assess safety and performance of Neola®, a novel lung monitoring device for neonates
- Conditions
- RDS of Prematurity, Preterm Birth, Lung Diseases
- Trial name
- NCT06917326
- Testing
- Monitoring
- Where
- Sweden
- Volunteers
- 10 people
- Sponsor
- Neola Medical AB
Preterm Infant
Trial to Improve Multisensory Neural Processing, Language & Motor Outcomes in Preterm Infants
Every year, almost all of ½ million infants born prematurely in the US and 15 million worldwide suffer from abnormal brain maturation resulting from interactions between immaturity and atypical sensory experiences after birth.
- Trial name
- NCT03232931
- Testing
- Therapist skin-to-skin Care, Contingent parent's voice exposure, Parental skin-to-skin care
- Where
- 3 sites in United States
- Volunteers
- 248 people
- Sponsor
- Emory University
Procedural Pain, Preterm Infants
Effectiveness of Gentle Touch Technique on Pain Level During Painful Procedures in Preterm Infants
Preterm infants in neonatal intensive care units frequently undergo painful procedures that may affect their physiological stability, including pain level and respiratory parameters.
- Trial name
- NCT07470398
- Testing
- Gentle Touch Technique
- Where
- 3 sites in Iraq
- Volunteers
- 60 people
- Sponsor
- Karbala University
Low Birth Weight, Premature Birth
Comparison of Outcomes of Early Kangaroo Mother Care and Standard Method Care in Healthy Low Birth Weight Preterm Neonates at a Tertiary Care Hospital
The goal of this clinical trial is to learn whether early initiation of kangaroo mother care (KMC) can improve clinical outcomes in healthy low birth weight preterm neonates (gestational age 30-37 weeks, birth weight <2000 g).
- Conditions
- Low Birth Weight, Premature Birth, Preterm Infant
- Trial name
- NCT07259486
- Testing
- Kangaroo Mother Care, Standard Medical Care (SMC)
- Where
- Pakistan
- Volunteers
- 100 people
- Sponsor
- University of Health Sciences Lahore
Patent Ductus Arteriosus, Preterm Infant
Early Prediction of Spontaneous Patent Ductus Arteriosus (PDA) Closure and PDA-Associated Outcomes
Patent ductus arteriosus (PDA), very common in preterm infants, is the delayed closure of a fetal blood vessel that limits blood flow through the lungs.
- Conditions
- Patent Ductus Arteriosus, Preterm Infant, Bronchopulmonary Dysplasia, Neurodevelopmental Abnormality
- Trial name
- NCT03782610
- Where
- 4 sites in United States
- Volunteers
- 526 people
- Sponsor
- Nationwide Children's Hospital
Role of Oral Care in Mechanically Ventilated Preterm Infants
Oral Care With Maternal Milk in Mechanically Ventilated Preterm Infants
70 Neonates in neonatal intensive care unit , ain shams university , children hospital
- Trial name
- NCT07451964
- Testing
- oral care with maternal milk, oral care with sodium bicarbonate
- Where
- Egypt
- Volunteers
- 70 people
- Sponsor
- Ain Shams University
Neonates and Preterm Infants, Cardiopulmonary
Triple EIT (Electrical Impedance Tomography)
This study plans to learn more about ways to look at participant's lungs using new machines called Electrical Impedance Tomography (EIT). The EIT does not use harmful radiation like CT or x-ray.
- Trial name
- NCT07247474
- Testing
- Electrical impedance tomography (EIT)
- Where
- United States
- Volunteers
- 140 people, healthy volunteers welcome
- Sponsor
- University of Colorado, Denver
Pumping, Breast, Milk, Human
Reducing Disparity in Receipt of Mother's Own Milk in Very Low Birth Weight Infants
In the US, the burden of very low birth weight (VLBW; <1500 g) birth is borne disproportionately by black (non-Hispanic black/African American) mothers who are 2.2-2.6 times more likely than nonblack mothers to deliver VLBW…
- Conditions
- Pumping, Breast, Milk, Human, Infant, Very Low Birth Weight, Preterm Birth
- Trial name
- ReDiMOM (NCT04540575)
- Testing
- NICU Acquires MOM, Mother Provides MOM
- Where
- United States
- Volunteers
- 362 people
- Sponsor
- Rush University Medical Center
Preterm Birth, Mother-Infant Interaction
Continuous Delivery Room Skin-to-skin-study for Moderate and Late Preterm Infants
The goal of this randomized controlled trial is to compare the effect of direct skin-to-skin contact in moderate and late preterm infants.
- Conditions
- Preterm Birth, Mother-Infant Interaction, Infant Development
- Trial name
- COSY (NCT05975203)
- Testing
- skin-to-skin contact
- Where
- Germany
- Volunteers
- 60 people
- Sponsor
- University of Cologne
Very Preterm Infants Born < 30 Weeks of Gestation
Quantitative 3D UltraSound Brain Imaging: Development of New Bedside Biomarkers to Better Predict Neurodevelopmental Outcomes in Preterm Infants
Prematurity is a leading cause of neurodevelopmental disorders (NDDs) tightly associated with white matter damage, including punctate white matter lesions (PWMLs).
- Trial name
- QUSBI (NCT07358819)
- Testing
- Cranial ultrasound, Brain MRI, PARCA-R questionnaire
- Where
- France
- Volunteers
- 360 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Preterm Infants, Respiratory Distress Syndrome (Neonatal)
Pressure Targeting During High Flow Therapy in Premature Infants
The goal of this study is to see if a new approach to breathing support ('Pressure Targeted High Flow') is as effective as standard of care ('Continuous Positive Airway Pressure') in prematurely born infants.
- Conditions
- Preterm Infants, Respiratory Distress Syndrome (Neonatal), BPD - Bronchopulmonary Dysplasia
- Trial name
- NeoMATCH (NCT07418502)
- Testing
- Pressure Targeted High Flow, CPAP
- Where
- 2 sites in United States
- Volunteers
- 78 people
- Sponsor
- University of Texas at Austin
Bronchopulmonary Dysplasia, Preterm Infant Development
PremaBiom: Metatranscriptomics of the Respiratory Microbiome to Predict the Occurrence of Bronchopulmonary Dysplasia in Preterm Infants
The goal of this clinical trial is to understand the impact of respiratory microbiome maturation in respiratory health of preterm infants under 32 gestational weeks.
- Conditions
- Bronchopulmonary Dysplasia, Preterm Infant Development, Asthma Childhood, Bronchiolitis
- Trial name
- PremaBiom (NCT07411261)
- Testing
- Nasal swab, blood sampling, Mother milk sampling
- Where
- 6 sites in France
- Volunteers
- 270 people
- Sponsor
- University Hospital, Caen
Very Preterm Infants (<32 Weeks of Gestation)
Administration of Extracellular Vesicles From Donor Human Milk in Preterm Infants
The AdVEMPrem study is exploring whether tiny particles called extracellular vesicles (EVs), which are naturally found in human milk, can help protect very premature babies from serious gut problems such as necrotizing…
- Trial name
- AdVEMPrem (NCT07402083)
- Testing
- Donor human milk extracellular vesicles (DHM-EVs)
- Where
- Spain
- Volunteers
- 20 people
- Sponsor
- Instituto de Investigacion Sanitaria La Fe