Clinical trials: Extremely Premature Infant
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
Extremely Premature Infant, Pain
Creation of a Scale for Assessing Pain and Discomfort in Extremely Premature Infants (EDEX) Hospitalised in Neonatal Intensive Care, Inspired by the Early Infant Pain and Discomfort Scale (EDIN)
The goal of this study is to develop a new scale for assessing prolonged pain, dedicated to extremely premature infants born before 27 weeks of gestation, adapted to their particular ways of expressing pain and discomfort, which…
- Conditions
- Extremely Premature Infant, Pain, Discomfort Symptoms
- Trial name
- DOU-PREMA (NCT07481331)
- Volunteers
- 68 people
- Sponsor
- Centre Hospitalier Universitaire de la Réunion
Infant, Newborn, Infant, Small for Gestational Age
Donor Milk vs. Formula in Extremely Low Birth Weight (ELBW) Infants
The Milk Trial seeks to determine the effect on neurodevelopmental outcomes at age 22-26 months of donor human milk as compared to preterm infant formula as the in-hospital diet for infants whose mothers choose not to provide…
- Conditions
- Infant, Newborn, Infant, Small for Gestational Age, Infant, Extremely Low Birth Weight
- Trial name
- NCT01534481
- Testing
- Donor Milk, Preterm Formula
- Where
- 17 sites in United States
- Volunteers
- 483 people
- Sponsor
- NICHD Neonatal Research Network
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
Extreme Prematurity - Less Than 28 Weeks, Infant, Extremely Premature
The UK 22 Week Study
In the UK, babies born at 22 weeks of pregnancy have only been offered survival-focused care (sometimes called resuscitation or stabilisation) since 2019.
- Conditions
- Extreme Prematurity - Less Than 28 Weeks, Infant, Extremely Premature, Neonatal and Perinatal Conditions, Intensive Care, Neonatal
- Trial name
- NCT07616778
- Testing
- Not applicable (observational study)
- Where
- 50 sites in United Kingdom
- Volunteers
- 100 people
- Sponsor
- Imperial College London
Extremely Premature Infant, Anemia Neonatal
Heterologous Cord Blood-Derived Red Blood Cell for Transfusion in Extremely Preterm Infants
Anemia is a condition in which there are not enough red blood cells to carry oxygen throughout the body. It is very common in extremely preterm infants (born before 28 weeks of pregnancy), and many of these babies require red…
- Conditions
- Extremely Premature Infant, Anemia Neonatal, Blood Transfusion, Umbilical Cord Blood
- Trial name
- NCT07502781
- Testing
- Cord Blood Red Blood Cells, Standard Adult Donor Red Blood Cells
- Where
- Spain
- Volunteers
- 176 people
- Sponsor
- Hospital Clinic of Barcelona
Infant, Extremely Premature, Erythrocyte Transfusion
Red Blood Cells From Umbilical Cord for Transfusion of Preterm Infants
This study has been designed to demonstrate that red blood cell from umbilical cord blood (UCB-RBC) is a safe and available product for extremely preterm infants (EPI) transfusion and that transfusion of UCB-RBC is non-less…
- Conditions
- Infant, Extremely Premature, Erythrocyte Transfusion, Umbilical Cord Issue
- Trial name
- NCT05612919
- Testing
- Red blood cell from umbilical cord blood, Red blood cell from adult donor
- Where
- Spain
- Volunteers
- 41 people
- Sponsor
- Hospital Clinic of Barcelona
Extremely Premature Infant
Vitamin A in Cord Blood and Preterm Outcomes
This single-center prospective cohort study aims to describe the distribution of umbilical-cord blood vitamin A concentrations in extremely preterm infants (<32 weeks' gestation) and to evaluate whether low cord blood vitamin A…
- Trial name
- NCT07296393
- Volunteers
- 155 people
- Sponsor
- The First Hospital of Jilin University
Premature Birth, Extremely Low Birth Weight
DCS Study in Extremely Premature Newborns
The researchers are attempting to improve the cerebral monitoring of extremely low gestational age (ELGA) infants, such that in the future, real-time monitoring will be possible, to aid clinicians in management of these infants.
- Conditions
- Premature Birth, Extremely Low Birth Weight, Infant, Small for Gestational Age, Intracerebral Hemorrhage
- Trial name
- NCT04367181
- Testing
- Diffuse Correlation Spectroscopy (DCS), Amplitude Integrated Electroencephalography (aEEG)
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Maria Angela Franceschini
Very Low Birth Weight Infant, Premature Infants
Pilot Trial Investigating Every Other Day Dosing of Oral Iron in Premature Infants (IQONic)
Study focuses on determining if daily versus every-other-day (EOD) oral iron at the same dose per kilogram per day will achieve similar incidence of iron replete status at 36 weeks post-menstrual age in premature neonates
- Conditions
- Very Low Birth Weight Infant, Premature Infants, Anemia of Prematurity, Iron Deficiency, Anaemia in Children
- Trial name
- NCT06555315
- Testing
- 6 mg/kg of oral iron as ferrous sulfate administered every other day., 6 mg/kg of oral iron as ferrous sulfate administered every day.
- Where
- United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- CHRISTUS Health
Extremely Low Birth Weight Infants, Respiratory Distress Syndrome, Newborn
LUS AT BIRTH IN INFANTS BORN BEFORE 26 WEEKS
All infants born before 26 weeks born in a hospital included in the registry will receive a LU at birth, before the first dose of surfactant. We will register as well the length of IMV, NIV or the need of IMV in the whole sample.
- Trial name
- MINI-LUS (NCT06394583)
- Testing
- Lung ultrasound
- Volunteers
- 150 people
- Sponsor
- Andaluz Health Service
Premature Infant, Extremely Low Birth Weight
Time to Accurate Heart Rate on Neonatal Outcomes
The goal of this trial is to compare the time to first heart rate displayed for iRes Warmer with ResusView and using iRes Warmer without ResusView when used in the resuscitation (e.g.
- Conditions
- Premature Infant, Extremely Low Birth Weight, Extreme Prematurity
- Trial name
- GE-EKG (NCT04587934)
- Testing
- iRes Warmer with ResusView, iRes Warmer without ResusView
- Where
- United States
- Volunteers
- 42 people
- Sponsor
- Sharp HealthCare
Infant, Extremely Premature
Description of Practices Implemented in the Birth of Living Children Before 24 Weeks of Amenorrhea
Every year, at the Nice University Hospital, about sixty deliveries take place before 24 weeks of amenorrhea. The child is not viable because of his extreme immaturity.
- Trial name
- NCT03403894
- Testing
- Asking caregivers in their practice
- Where
- France
- Volunteers
- 35 people
- Sponsor
- Centre Hospitalier Universitaire de Nice
ROP, Jaundice, Neonatal
Hyperbilirubinemia and Retinopathy of Prematurity in Preterm Infants: a Retrospective Study.
The goal of this retrospective observational study is to [learn about the correlation between hyperbilirubinemia and retinopathy of prematurity in preterm infants.
- Conditions
- ROP, Jaundice, Neonatal, Premature, Very Low Birth Weight Infant
- Trial name
- biliROP (NCT05806684)
- Testing
- ROP
- Where
- Italy
- Volunteers
- 1,586 people
- Sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Extreme Prematurity, Extremely Low Birth Weight
RCT: The Effect of Held Position During Kangaroo Care on Physiological Parameters of Premature Infants
The goal of this superiority crossover randomised controlled trial is to investigate whether there is an optimal position at which to perform kangaroo mother care (KMC) in extremely preterm infants in the NICU.
- Conditions
- Extreme Prematurity, Extremely Low Birth Weight, Very Low Birth Weight Infant, Premature Birth
- Trial name
- NCT05686252
- Testing
- Held Position
- Where
- Ireland
- Volunteers
- 20 people
- Sponsor
- University College Cork
Infant, Extremely Premature, Acute Lung Injury
Intra-tracheal Instillation of Budesonide to Prevent Chronic Lung Disease
Preterm infants are randomized to received either Intra-tracheal instillation of budesonide using surfactant as vehicle or a placebo.
- Conditions
- Infant, Extremely Premature, Acute Lung Injury, Chronic Lung Disease of Prematurity, Budesonide
- Trial name
- STOPCLD (NCT05364385)
- Testing
- Infants in the study group (S/B group) will receive surfactant 2.5 mls/kg and Budesonide 0.5 mg (1mL)
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- University of Arizona
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
Infant, Premature, Infants, Extremely Premature
The Alberta BLOOM Preterm Neonate Study
This is a prospective, observational clinical cohort study involving 100 mothers and their very preterm infants born at less than 32 weeks gestation.
- Conditions
- Infant, Premature, Infants, Extremely Premature, Microbiota, Gastrointestinal Microbiome
- Trial name
- BLOOM-PTN (NCT03840980)
- Where
- Canada
- Volunteers
- 55 people
- Sponsor
- University of Calgary
Infant, Extremely Premature, Brain Injuries
Safeguarding the Brain of Our Smallest Infants Phase III
the SafeBoosC-III trial investigates the benefit and harms of treatment based on near-infrared spectroscopy monitoring compared with treatment as usual.
- Conditions
- Infant, Extremely Premature, Brain Injuries, Death, Brain, Death; Neonatal
- Trial name
- SafeBoosC (NCT03770741)
- Testing
- Modify cardio-respiratory support to avoid cerebral hypoxia, Treatment as usual
- Where
- Denmark
- Volunteers
- 1,601 people
- Sponsor
- Gorm Greisen
Neonatal Respiratory Distress Syndrome, Extremely Low Birth Weight Infant (ELBW)
Effective Approaches & Strategies to Ease Off Nasal CPAP In Preterm Infants
Though Nasal Continuous Positive Airway Pressure (NCPAP) is a commonly used form of non-invasive neonatal respiratory support, the optimal method of weaning off NCPAP is not well established.
- Conditions
- Neonatal Respiratory Distress Syndrome, Extremely Low Birth Weight Infant (ELBW), BronchoPulmonary Dysplasia
- Trial name
- EASEOFFNCPAP (NCT02819050)
- Testing
- NCPAP
- Volunteers
- 80 people
- Sponsor
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center