Clinical trials: Infant, Extremely Premature
Neonatology
A Stylet Use May be Beneficial for Elective and Rescue Intubation of Prematurely Born Infants
Contrary to recent findings suggesting that stylets offer no advantage in general infant intubations, this study focuses on their potential benefits for premature infants undergoing elective or rescue intubation in the delivery…
- Trial name
- NCT06316765
- Testing
- Intubation with stylet
- Volunteers
- 70 people
- Sponsor
- Charles University, Czech Republic
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
Anemia, Necrotizing Enterocolitis
RBC Irradiation, Anemia and Gut Injury
The purpose of this trial is to study the effect that anemia and red blood cell (RBC) transfusions have on oxygen levels in the digestive tracts of extremely low birth weight (ELBW) infants and to look for possible markers in a…
- Trial name
- RBC-mNIRS (NCT02741648)
- Testing
- Near Infrared Spectroscopy, Non-invasive Image-based Anemia Assessment
- Where
- 3 sites in United States
- Volunteers
- 324 people
- Sponsor
- Emory University
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
Weight Gain, Human Milk
Growth and Weight Gain in ELBW Infants Fed an Exclusively Human Milk Based Diet With Prolacta®
Preterm infants are susceptible to postnatal growth restriction. Breast milk is the recommended source of nutrition for preterm infants.
- Conditions
- Weight Gain, Human Milk, Preterm Infants, Extremely Low Birth Weight
- Trial name
- NCT03886844
- Testing
- Human milk fortifier based on human milk (Prolacta)
- Where
- 2 sites in Austria
- Volunteers
- 196 people
- Sponsor
- Medical University of Vienna
Bilirubin Encephalopathy
Bilirubin Neurotoxicity (BN) and Neurodevelopmental Impairment (NDI) in Extremely Preterm (EP) Infants: Avoidable by Reducing the Usual Intravenous Lipid (UL) Administration
The purpose of this study is to evaluate the effect of usual versus reduced lipid intake on unbound bilirubin levels, brainstem auditory evoked responses, and neurodevelopmental outcome at 2 years in extremely preterm infants.
- Trial name
- NCT04584983
- Testing
- usual prescribed intralipid (UL) regimen, restricted prescribed intralipid (RL) regimen
- Where
- United States
- Volunteers
- 134 people
- Sponsor
- The University of Texas Health Science Center, Houston
Infant, Newborn, Infant, Low Birth Weight
Generic Database of Very Low Birth Weight Infants
The Generic Database (GDB) is a registry of very low birth weight infants born alive in NICHD Neonatal Research Network (NRN) centers.
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- GDB (NCT00063063)
- Testing
- No Intervention
- Where
- 31 sites in United States
- Volunteers
- 80,000 people
- Sponsor
- NICHD Neonatal Research Network
Bronchopulmonary Dysplasia, Encephalomalacia
Randomized Trial of Hydrocortisone in Very Preterm High-Risk Infants
The purpose of this study is to determine whether treatment of very preterm infants at high-risk for lung and brain injury with low dose hydrocortisone results in improved pulmonary and neurologic outcomes.
- Conditions
- Bronchopulmonary Dysplasia, Encephalomalacia, Premature Birth
- Trial name
- NCT00167544
- Testing
- Hydrocortisone
- Where
- United States
- Volunteers
- 64 people
- Sponsor
- Nationwide Children's Hospital
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
Infant, Newborn, Infant, Low Birth Weight
Supplemental Therapeutic Oxygen for Prethreshold Retinopathy of Prematurity
The purpose of this trial was to determine the efficacy and safety of supplemental therapeutic oxygen for infants with prethreshold retinopathy of prematurity (ROP) to reduce the probability of progression to threshold ROP and…
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- STOP-ROP (NCT01203436)
- Testing
- Supplemental Oxygen Management, Conventional Oxygen Management
- Where
- 9 sites in United States
- Volunteers
- 649 people
- Sponsor
- NICHD Neonatal Research Network
Infant, Premature, Diseases, Perinatal Morbidity
Prognosis of Extremely Premature Birth
Pregnant women at risk of giving birth before 28 weeks' gestational age will be enrolled. Fetal circulation will be studied and blood for inflammatory parameters will be collected.
- Conditions
- Infant, Premature, Diseases, Perinatal Morbidity, Development, Problem;Growth
- Trial name
- BabyPEP (NCT01150396)
- Where
- 2 sites in Norway
- Volunteers
- 160 people
- Sponsor
- University of Bergen
Apnea of Prematurity, Preterm Infant
Detection of Respiratory Events Using Acoustic Monitoring in Extremely Preterm Infants
Extremely preterm infants, born before 29 weeks of pregnancy, often face breathing difficulties, also known as respiratory events, due to their undeveloped lungs and respiratory systems.
- Conditions
- Apnea of Prematurity, Preterm Infant, Periodic Breathing, Hypopnea
- Trial name
- DREAM 2 (NCT07552025)
- Testing
- Wireless acoustic sensor, Semi-structured interview, Nox T3s portable sleep monitoring device
- Where
- Canada
- Volunteers
- 50 people
- Sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
Infant, Extremely Premature
Milking the Umbilical Cord for Extreme Preterm Infants
Milking the umbilical cord from the placental end toward the infant has been shown to benefit preterm infants when compared to either clamping the umbilical cord immediately or waiting delaying the clamping of the cord.
- Trial name
- NCT01666847
- Testing
- Milking the umbilical cord before cord clamping
- Where
- 2 sites in United States
- Volunteers
- 59 people, healthy volunteers welcome
- Sponsor
- St. Louis University
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
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
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
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
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
Respiration; Insufficient or Poor, Newborn, Infant, Premature, Diseases
Comparison Of Respiratory Support After Delivery on Infants Born Before 28 Weeks Gestational Age
Trial purpose: For infants born <28 weeks of age, can initial respiratory resuscitation with new system (low imposed work of breathing and prongs) reduce the frequency of delivery room intubations compared to standard treatment…
- Trial name
- CORSAD (NCT02563717)
- Testing
- T-piece used for respiratory support (several manufacturers), New system used for respiratory support
- Where
- 6 sites in Iceland, Lithuania and 3 more
- Volunteers
- 250 people
- Sponsor
- Baldvin Jonsson
Bronchopulmonary Dysplasia, Pulmonary Hypertension
Pulmonary Hypertension in Extremely Preterm Infants
Extremely preterm infants are at risk for developing bronchopulmonary dysplasia (BPD) and associated chronic pulmonary hypertension (PH), a consequence of altered pulmonary vasculature.
- Conditions
- Bronchopulmonary Dysplasia, Pulmonary Hypertension, Premature Birth
- Trial name
- PiEP (NCT05136235)
- Testing
- Echocardiography, NT-proBNP
- Volunteers
- 350 people
- Sponsor
- Universitair Ziekenhuis Brussel