Clinical trials: Preterm Infants
Sepsis, Necrotizing Enterocolitis
Circulating Markers in Preterm Infants With Perinatal and Neonatal Inflammation
Circulating markers to diagnose complications (sepsis, necrotizing enterocolitis) in preterm infants are often inaccurate, partly due to the lack of comprehensive studies with temporal evaluation from birth until a disease onset.
- Conditions
- Sepsis, Necrotizing Enterocolitis, Chorioamnionitis, Feeding Intolerance
- Trial name
- NEOINFLAM (NCT03320785)
- Where
- China
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Per Torp Sangild
Prematurity, Necrotizing Enterocolitis
Neutrophil Extracellular Trap Formation in Newborn Infants at Risk for Inflammatory Syndromes
The purpose of this study is to characterize the time to maturation of neutrophil extracellular trap(NET) formation capability in polymorphonuclear leukocytes(PMNs) isolated from newborn premature and term infants.
- Trial name
- NCT01106209
- Where
- 2 sites in United States
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- University of Utah
Very Preterm Infant, Very Low Birthweight
LIFT-UP: Randomized Controlled Trial of Fortification of Human Milk
The goal of the LIFT-UP randomized controlled trial is to evaluate the efficacy of feeding routinely and fortified human milk using a standardized clinical protocol to very low birthweight (VLBW) or very preterm (VPT) infants in…
- Trial name
- LIFT-UP RCT (NCT06765863)
- Testing
- Human Milk Fortifier, Volume targets
- Where
- 4 sites in India
- Volunteers
- 776 people, healthy volunteers welcome
- Sponsor
- Harvard School of Public Health (HSPH)
Coronavirus Infection (COVID-19), Pulmonary Arterial Hypertension
Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS)
The study investigators are interested in learning more about how drugs, that are given to children by their health care provider, act in the bodies of children and young adults in hopes to find the most safe and effective dose…
- Conditions
- Coronavirus Infection (COVID-19), Pulmonary Arterial Hypertension, Urinary Tract Infections in Children, Hypertension
- Trial name
- POPS or POP02 (NCT04278404)
- Testing
- The POP02 study is collecting bodily fluid samples (i.e., whole blood, effluent samples) of children prescribed the following drugs of interest per standard of care:
- Where
- 52 sites in United States, Canada
- Volunteers
- 5,000 people, healthy volunteers welcome
- Sponsor
- Duke University
Weight Gain
"Impact of Kangaroo Mother Care Plus Massage Therapy on Growth of Preterm Low Birth Weight Infants at Discharge"
Kangaroo mother care plus massage therapy will lead to improved growth of preterm low birth weight infants at discharge.
- Trial name
- NCT05640297
- Testing
- KMC with Massage therapy
- Where
- Bangladesh
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Premature Birth
Effects of Swaddling on Infants During Feeding
The purpose of this randomized, within-subject, cross-over study is to examine if swaddling affects bottle feeding performance in infants born preterm.
- Trial name
- NCT02661360
- Testing
- Swaddling Intervention for Preterm Infants, Unswaddled Control
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- NYU Langone Health
Lung-protective Ventilation, Respiratory Function Monitor
Optimization of Ventilation Strategies in Preterm and Term Infants in a Single-center Intervention Study
This study was a non-blinded, non-randomized intervention study in a single-center clinical setting, analyzing ventilation quality with and without RFM visibility.
- Trial name
- NCT05512689
- Testing
- Ventilations while using a respiratory function monitor
- Where
- Austria
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- Medical University of Vienna
Intraventricular Hemorrhage of Prematurity
Research on Prevention, Early Detection, and Clinical Evaluation of Intracranial Hemorrhage in Preterm Infants
1. Establish a reference curve for the lateral ventricular diameter of premature infants and determine the intervention threshold for hydrocephalus after hemorrhage in premature infants based on the reference curve, providing a…
- Trial name
- ROPEDACEOIHIPI (NCT07157020)
- Testing
- ommaya capsule implantation technique
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Second Affiliated Hospital of Wenzhou Medical 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
Bottle Feeding, Premature
A Comparison Study of Feeding Prematures in the Side-lying Position on the Right and Left Side - a Pilot Study.
Methods and techniques to improve the quality and safety of oral feeding in preterm infants are still a significant challenge in modern neonatology.
- Trial name
- NCT04987983
- Testing
- Experimental SLP-R, Experimental SLP-L
- Where
- Poland
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Polish Mother Memorial Hospital Research Institute
Premature Infant
Efficacy Study of an Audio Device Outside Incubator Allowing Broadcasting Maternal Voice on Stability in Preterm Infants
The study aims to evaluate the impact on the preterm infants' short-term physiological, neurodevelopmental states by employing maternal voice intervention in NICU routine care.
- Trial name
- NCT05543005
- Testing
- maternal voice intervention
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Chia-Jung Lin
Influenza
Study of Live, Attenuated Influenza Vaccination in Preterm and Full-Term Infants
Severe influenza respiratory disease is increasingly recognized in children. Influenza hospitalization rates in high-risk infants, such as premature infants, are increased some five-fold over rates in other children.
- Trial name
- NCT01194297
- Testing
- Live attenuated influenza vaccine, Inactivated influenza vaccine
- Volunteers
- 3 people, healthy volunteers welcome
- Sponsor
- University of Rochester
Preterm Birth
Human Milk in Preterm Infants
Current NICU protocol introduces human milk fortifier at 8 days of feeding. This study will introduce human milk fortifier at day 1. The primary outcome is the effect on growth velocity at 28 days and 36 weeks post menstrual age.
- Trial name
- NCT05228535
- Testing
- Human milk fortifier
- Where
- United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Augusta University
Respiratory Syncytial Virus
A Phase 1b/2a Randomized, Double-Blind, Placebo-controlled, Dose-escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI8897, a Monoclonal Antibody With an Extended Half-life Against Respiratory Syncytial Virus, in Healthy Preterm Infants
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of an extended half-life anti-respiratory syncytial virus (RSV) monoclonal antibody compared to placebo when administered to healthy preterm…
- Trial name
- MEDI8897 1b (NCT02290340)
- Testing
- MEDI8897 10 mg, MEDI8897 25 mg, MEDI8897 50 mg
- Where
- 13 sites in United States, Chile and 1 more
- Volunteers
- 151 people, healthy volunteers welcome
- Sponsor
- MedImmune LLC
Premature Infant, Mental Health Issue (E.G., Depression, Psychosis, Personality Disorder, Substance Abuse)
Preventing Vulnerable Child Syndrome in the NICU With Cognitive Behavioral Therapy (PreVNT Trial)
This study is being done to see if outcomes for both a premature infant's parents and the infant born prematurely who have spent time in the neonatal intensive care unit (NICU) can be improved through parent cognitive behavioral…
- Conditions
- Premature Infant, Mental Health Issue (E.G., Depression, Psychosis, Personality Disorder, Substance Abuse), Development, Child, Parent-Child Relations
- Trial name
- PreVNT (NCT03906435)
- Testing
- Cognitive Behavioral Therapy
- Where
- United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- University of Texas Southwestern Medical Center
Hypophosphataemia, Osteopenia of Prematurity
Investigating a New Way of Giving Medicine to Newborn and Preterm Babies
There is a deficit in the number of 'age-appropriate' formulations available for the delivery of medicines to children. Liquid preparations are considered the 'gold standard' for delivering medicines to children however many of…
- Trial name
- NCT01676844
- Testing
- Oral thin film therapy (Potassium acid phosphate oral thin films), Standard therapy (Potassium acid phosphate oral solution)
- Where
- United Kingdom
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- University of Strathclyde
Breastfeeding, Preterm Infant
The Effect of the SNS-Based Feeding on Transition to Exclusive Breastfeeding in Preterm Infants
This study investigated the effect of the Supplemental Nursing System (SNS)-based feeding on the time to transition to exclusive breastfeeding, sucking success, and the time to discharge in preterm infants
- Conditions
- Breastfeeding, Preterm Infant, Sucking Behavior
- Trial name
- NCT05815706
- Testing
- MEDELA Supplemental nursing system
- Where
- Turkey (Türkiye)
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Istanbul Medeniyet University
Death, Nosocomial Infection
Prophylactic Probiotics in Premature Infants
This study tries to determine whether the oral administration of a specific probiotic (good bacteria) in premature infants hospitalized in a neonatal intensive care unit may prevent infections and the development of a severe…
- Trial name
- C3P (NCT00727363)
- Testing
- Lactobacillus reuteri
- Where
- 8 sites in Colombia
- Volunteers
- 751 people, healthy volunteers welcome
- Sponsor
- Colombian Neonatal Research Network
Infant, Premature, Diseases
Study the Safety and Efficacy of Probiotics Use in Premature Infants
Prophylactic enteral probiotics may enhance clinical markers and biomarkers of preterm infants' health, and may also play a role in reducing NEC and associated morbidity.
- Trial name
- NCT01891604
- Testing
- breast milk with Bifidobacterium Longum subp. Infantis R0033, breast milk
- Volunteers
- healthy volunteers welcome
- Sponsor
- University of Manitoba
Bronchopulmonary Dysplasia, Prematurity
Impact of Extended CPAP on Bronchopulmonary Dysplasia
The purpose of this pilot study is to compare if keeping infants on CPAP (continuous positive airway pressure) support for an extended period of time until they are 32 weeks corrected gestational age or 1250 grams (approximately…
- Trial name
- NCT05547139
- Testing
- Protocolized weaning of respiratory support
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Christiana Care Health Services