Clinical trials: Infants, Extremely Premature
Late-Onset Neonatal Sepsis, Extreme Prematurity
Dopamine vs. Norepinephrine for Hypotension in Very Preterm Infants With Late-onset Sepsis
Fluid-unresponsive hypotension needing cardiotropic drug treatment is a serious complication in very preterm neonates with suspected late-onset sepsis (LOS; defined as culture positive or negative bloodstream infection or…
- Conditions
- Late-Onset Neonatal Sepsis, Extreme Prematurity, Neonatal Hypotension
- Trial name
- NCT05347238
- Testing
- Dopamine, Norepinephrine
- Where
- 22 sites in United States, Canada and 3 more
- Volunteers
- 550 people
- Sponsor
- Mount Sinai Hospital, Canada
Kangaroo Care, Premature Infant
Efficacy of Lateral Kangaroo Care in Hemodynamic Stabilization of Premature Infant.
The objetive of the study is to evaluate the non-inferiority or the equivalence of the kangaroo care position, in lateral versus traditional one in prone measuring the stability of several parameters in premature infants less…
- Conditions
- Kangaroo Care, Premature Infant, Body Temperature
- Trial name
- Cangulat (NCT03990116)
- Testing
- Lateral, Prone
- Where
- Spain
- Volunteers
- 70 people
- Sponsor
- Laura Collados Gomez
Bronchopulmonary Dysplasia (BPD), ELGAN (22-28SA)
Mesenchymal Stromal Cell Therapy to Prevent Bronchopulmonary Dysplasia in Extreme Preterm Infants
This clinical trial aims to evaluate the safety and efficacy of mesenchymal stromal cell (MSC) therapy in extreme preterm infants to prevent bronchopulmonary dysplasia, the main respiratory complication of preterm birth.
- Trial name
- HULC-2 (NCT07058025)
- Testing
- Human Allogenic Umbilical Cord Mesenchymal Stromal Cells
- Where
- 8 sites in Canada
- Volunteers
- 168 people
- Sponsor
- Ottawa Hospital Research Institute
Bronchopulmonary Dysplasia, Death
Systemic Management in Extremely Preterm and Extremely Low Birth Weight Infants
to estimate incidences of major complications, such as bronchopulmonary dysplasia, death, and delivery room resuscitation among extremely preterm and extremely low birth weight infants in Northern China
- Trial name
- NCT06082414
- Testing
- no interventions
- Where
- China
- Volunteers
- 1,200 people, healthy volunteers welcome
- Sponsor
- Peking University
Preterm Birth, Extreme Prematurity
Sustained Aeration of Infant Lungs Trial
This study is a 2-arm randomized, controlled, multi-center clinical trial to determine which of two strategies at birth are best to optimally aerate the lung of preterm infants.
- Trial name
- SAIL (NCT02139800)
- Testing
- Sustained Inflation, Standard of Care
- Where
- 21 sites in United States, Australia and 7 more
- Volunteers
- 460 people
- Sponsor
- University of Pennsylvania
Infant Behavior, Infant Conditions
The Effects of Different Music Genres on Heart Rate Variability in Extremely and Very Low Birth Weight Newborns
AIM: to investigate the influence of different music genres on Heart Rate Variability (HRV) of preterm infants. Neonates undergo a daily randomized music listening program.
- Conditions
- Infant Behavior, Infant Conditions, Infant Morbidity
- Trial name
- NCT04049526
- Testing
- The influence of different music genres on Heart Rate Variability (HRV) in preterm infants
- Where
- Italy
- Volunteers
- 30 people
- Sponsor
- Ospedale di Circolo - Fondazione Macchi
Fluid Loss, Dehydration
The Application of Sterile Water to the Skin of Extremely Low Birth Weight (ELBW) Infants
Extremely low birth weight infants have significant water loss through their skin immediately after birth. This significant fluid loss is because they have large amounts of fluids, have immature skin and large surface area.
- Conditions
- Fluid Loss, Dehydration, Extreme Immaturity
- Trial name
- NCT02052284
- Testing
- Sterile water application
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- George Washington University
Extremely Premature Infant
Humidity in Incubators for Tiny Infants
The objective of the study is to compare different supplemental incubator humidification strategies for infants <25 weeks' gestation admitted to the neonatal intensive care unit (NICU).
- Trial name
- HumidITI (NCT06399861)
- Testing
- Higher (90%) starting RH in the incubator with humidity supplementation stopped at day 10, Lower (70%) starting RH in the incubator with humidity supplementation stopped at day 10, Higher (90%) starting RH in the incubator with humidity supplementation stopped at day 28
- Where
- 9 sites in United States
- Volunteers
- 900 people
- Sponsor
- The University of Texas Health Science Center, Houston
Extreme Prematurity,Extremely Low Birthweight, BPD - Bronchopulmonary Dysplasia
Impact of Higher Zinc Supplementation on Neonatal Weight Velocity
Preterm infants born prematurely are more likely to have low zinc levels because they have less time to build up zinc before birth.
- Conditions
- Extreme Prematurity,Extremely Low Birthweight, BPD - Bronchopulmonary Dysplasia, Growth
- Trial name
- NCT07896070
- Testing
- 1 mg/day Zinc Supplementation, 3 mg/day Zinc Supplementation
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Augusta University
Infant, Extremely Premature, Obstetric Labor, Premature
Multisite Inventory of Neonatal-Perinatal Interventions (MINI) Minimum Dataset
The goal of the Tiny Baby Collaborative Multicenter Inventory of Neonatal-Perinatal Interventions (MINI) minimum dataset is to serve as a registry detailing the outcomes and practices for all deliveries and infants admitted to…
- Conditions
- Infant, Extremely Premature, Obstetric Labor, Premature, Premature Birth, Intensive Care, Neonatal
- Trial name
- NCT05685745
- Where
- 59 sites in United States, Australia and 6 more
- Volunteers
- 5,000 people
- Sponsor
- The University of Texas Health Science Center, Houston
Kangaroo Care, Premature Infant
Intraventricular Hemorrhage in Kangaroo Care vs. Incubator Care
This clinical study aims to find out whether kangaroo care (skin-to-skin contact between parents and their extremely premature newborns) can help protect the babies' brains by reducing the risk of bleeding in the brain during the…
- Conditions
- Kangaroo Care, Premature Infant, IVH- Intraventricular Hemorrhage
- Trial name
- KANVIH (NCT07473882)
- Testing
- Lateral, Prone, Incubator care
- Where
- Spain
- Volunteers
- 314 people
- Sponsor
- Hospital Universitario 12 de Octubre
Infant, Newborn, Infant, Low Birth Weight
Inflammatory Cytokines Associated With Perinatal Brain Injury
This observational study assessed whether measurements of certain pro-inflammatory and anti-inflammatory cytokines in the blood (either singly or in combination) at birth and/or up to day of life 21 can predict cerebral palsy at…
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- Cytokines (NCT01035697)
- Where
- 18 sites in United States
- Volunteers
- 1,067 people, healthy volunteers welcome
- Sponsor
- NICHD Neonatal Research Network
Infant, Newborn, Infant, Low Birth Weight
Inhaled Nitric Oxide for Preterm Infants With Severe Respiratory Failure
This multicenter trial tested whether inhaled nitric oxide would reduce death or the need for oxygen in preterm infants (less than 34 weeks gestational age) with severe lung disease.
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- Preemie iNO (NCT00016523)
- Testing
- Inhaled nitric oxide
- Where
- 17 sites in United States
- Volunteers
- 420 people
- Sponsor
- NICHD Neonatal Research Network
Bronchopulmonary Dysplasia, Chronic Lung Disease of Prematurity
A Clinical Efficacy and Safety Study of OHB-607 in Preventing Bronchopulmonary Dysplasia in Extremely Premature Infants
The purpose of this study is to determine if an investigational drug can prevent Bronchopulmonary Dysplasia, reducing the burden of chronic lung disease in extremely premature infants, as compared to extremely premature infants…
- Conditions
- Bronchopulmonary Dysplasia, Chronic Lung Disease of Prematurity, Intraventricular Hemorrhage, Retinopathy of Prematurity (ROP)
- Trial name
- NCT03253263
- Testing
- OHB-607
- Where
- 62 sites in United States, Australia and 11 more
- Volunteers
- 295 people
- Sponsor
- OHB Neonatology Ltd.
Respiratory Distress Syndrome, Newborn, Respiratory Distress Syndrome in Premature Infant
Speed of Lung Inflation During Ventilation of Extremely Preterm Infants
Babies born extremely preterm (<28 weeks of pregnancy) require support to breathe. Some babies require help to breathe from a breathing machine (mechanical ventilator). While this keeps babies alive, it may damage their lungs.
- Trial name
- FLOW-VENT (NCT07101419)
- Testing
- Long PRT, Short PRT
- Where
- 3 sites in Australia
- Volunteers
- 68 people
- Sponsor
- Murdoch Childrens Research Institute
Prematurity; Extreme, Cerebral Circulatory Failure
Sonographic QUantification of Venous Circulation In the Preterm Brain
The aim of the study is to develop an accessible, reproducible ultrasound tool for objective clinical measurement of brain circulation in preterm infants in order to identify infants being at risk for preterm brain injury at an…
- Conditions
- Prematurity; Extreme, Cerebral Circulatory Failure, Intraventricular Hemorrhage, Periventricular Leukomalacia
- Trial name
- SQUIB (NCT04535375)
- Testing
- Doppler Ultrasound of venous cerebral circulation
- Where
- Belgium
- Volunteers
- 47 people
- Sponsor
- Universitair Ziekenhuis Brussel
Pneumococcal Infections, Streptococcus Pneumoniae
Immunogenicity of PCV-7 Vaccine in VLBW Infants
Premature infants are at a high risk for pneumonia. The PCV-7 vaccine effectively prevents the invasive disease from Streptococcus pneumoniae in full-term infants, but was not thoroughly studied in premature infants.
- Conditions
- Pneumococcal Infections, Streptococcus Pneumoniae, Infant, Newborn, Infant, Low Birth Weight
- Trial name
- PCV-7 (NCT00273325)
- Where
- 10 sites in United States
- Volunteers
- 368 people, healthy volunteers welcome
- Sponsor
- NICHD Neonatal Research Network
Qt Interval, Preterm Birth
QTc Intervals in Former Preterm/Extreme Low Birth Weight Infants: a Pooled Study Proposal
Pooling effort to collect previously reported data on QTc time in former preterm neonates, and compare these data to controls. At present and based on a recently conducted systematic search, there are conflicting data on the…
- Trial name
- NCT05243537
- Testing
- ECG (diagnostic)
- Where
- 2 sites in Belgium, Canada
- Volunteers
- 250 people, healthy volunteers welcome
- Sponsor
- Universitaire Ziekenhuizen KU Leuven
Prematurity; Extreme, Prematurity
Breastfeeding Support and Promotion Program to Improve the Health of Premature Babies (PAP-LM)
This study evaluates the effectiveness of a breastfeeding support and promotion program to increase exclusive breastfeeding rates in the preterm group.
- Trial name
- PAP-LM (NCT06653595)
- Testing
- Programme to Support Breastfeeding
- Where
- 2 sites in Spain
- Volunteers
- 162 people
- Sponsor
- University of Barcelona
Prematurity; Extreme
Pulmonary Vascular Disease and Cardiac Performance in Extreme Preterm Infants
Pulmonary vascular disease and cardiac performance in extreme preterm infants: A prospective cross-sectional study
- Trial name
- NCT04114435
- Testing
- Echocardiography
- Where
- Canada
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre