Clinical trials: Infant, Extremely Premature
Bronchopulmonary Dysplasia, Respiratory Distress Syndrome in Premature Infant
Budesonide With Intratracheal Surfactants in Extremely Preterm Infants
This is a phase I/II trial in preterm infants aimed at identifying the optimal dose of budesonide with bovine lipid extract surfactant as vehicle for intratracheal administration.
- Trial name
- BITS (NCT04019106)
- Testing
- Budesonide in bovine lipid extract surfactant (BLES)
- Where
- 2 sites in Canada
- Volunteers
- 30 people
- Sponsor
- University of Manitoba
Extreme Prematurity,Extremely Low Birthweight, Extremely Low Birth Weight
Comparison of the Shukla and UN-1 Formulae in the Placement of the Umbilical Venous Catheter Among Neonates
Umbilical vein catheters (UVC) are commonly inserted in newborns especially neonates admitted to the Neonatal Intensive Care Unit (NICU).These catheters are used since 1959.
- Conditions
- Extreme Prematurity,Extremely Low Birthweight, Extremely Low Birth Weight, Very Low Birth Weight Infant, Neonatal Hypoglycemia
- Trial name
- NCT05022433
- Testing
- UVC insertion
- Where
- Singapore
- Volunteers
- 170 people
- Sponsor
- Singapore General Hospital
Extreme Prematurity, Intraventricular Hemorrhage
Single-dose Prophylactic INdomethacin in Extremely Preterm Infants
In Canada, about 900 babies each year are born very early (<26 weeks of gestation) and have a high chance of dying or having a serious bleed in the brain.
- Conditions
- Extreme Prematurity, Intraventricular Hemorrhage, Morbidity;Newborn
- Trial name
- SPIN (NCT06572917)
- Testing
- Indomethacin
- Where
- 15 sites in United States, Australia and 1 more
- Volunteers
- 500 people
- Sponsor
- University of British Columbia
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
Infant, Newborn, Infant, Low Birth Weight
Delivery Room CPAP in Extremely Low Birth Weight Infants
This pilot study was designed to determine the feasibility of randomizing extremely low birth weight (ELBW) infants <28 weeks' gestation who required resuscitation to one of two resuscitation methods, either: (a) 100% oxygen by…
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- DR-CPAP (NCT01223274)
- Testing
- CPAP/PEEP, Standard management practices
- Where
- 6 sites in United States
- Volunteers
- 104 people
- Sponsor
- NICHD Neonatal Research Network
Infant, Extremely Low Birth Weight, Feeding Behavior
Somatosensory Modulation of Salivary Gene Expression and Oral Feeding in Preterm Infants
Two innovative approaches, pulsatile orocutaneous entrainment of non-nutritive suck via orosensory entrainment (NTrainer) device technology and serial salivary gene expression analyses, will be merged to examine the relation…
- Trial name
- NCT02696343
- Testing
- NTrainer
- Where
- 4 sites in United States
- Volunteers
- 121 people
- Sponsor
- University of Nebraska Lincoln
Infant, Newborn, Infant, Low Birth Weight
Follow-up Visit of High Risk Infants
The NICHD Neonatal Research Network's Follow-Up study is a multi-center cohort in which surviving extremely low birth-weight infants born in participating network centers receive neurodevelopmental, neurosensory and functional…
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- FU (NCT00009633)
- Testing
- No Intervention
- Where
- 31 sites in United States
- Volunteers
- 68,000 people
- Sponsor
- NICHD Neonatal Research Network
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
Hemodynamic Instability
Multimodal Monitoring of Hemodynamics in Extremely Low Birth Weight Preterm Infant in a Canadian Tertiary Level Unit
Low blood pressure is a common problem in the premature newborn and can affect over 30% of all Extremely Low Gestational Age Neonates (ELGAN) babies delivered less than 28 weeks completed.
- Trial name
- MUSE (NCT03841929)
- Testing
- Hemodynamic report
- Where
- Canada
- Volunteers
- 128 people
- Sponsor
- University of Alberta
Infant, Newborn, Infant, Low Birth Weight
Glutamine Supplementation to Prevent Death or Infection in Extremely Premature Infants
This large multicenter double-masked clinical trial tested whether supplementation of standard neonatal parenteral nutrition with glutamine would reduce the risk of death or late-onset sepsis in extremely-low-birth-weight (ELBW…
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- Glutamine (NCT00005775)
- Testing
- Glutamine
- Where
- 15 sites in United States
- Volunteers
- 1,433 people
- Sponsor
- NICHD Neonatal Research Network
Infant, Extremely Low Birth Weight, Lung Diseases, Obstructive
Growth, Health and Development in Children Born Extremely Preterm
Background: In a national Norwegian cohort of children born before 28 weeks gestation or with a birth weight less than 1000 g born in 1999 and 2000, 372 survived.
- Conditions
- Infant, Extremely Low Birth Weight, Lung Diseases, Obstructive, Disorder of Bone Density and Structure, Unspecified, Cognition Disorders
- Trial name
- PEP11 (NCT01150071)
- Where
- 2 sites in Norway
- Volunteers
- 232 people
- Sponsor
- University of Bergen
Infant, Newborn, Infant, Low Birth Weight
Growth Observational Study
This study was a multicenter, prospective cohort study to define postnatal longitudinal growth for very low birth weight (VLBW) infants.
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- Growth (NCT01203475)
- Where
- 13 sites in United States
- Volunteers
- 1,660 people, healthy volunteers welcome
- Sponsor
- NICHD Neonatal Research Network
Preterm Birth, Inadequate Milk Production
Milk Volume Outcomes Following Oral Nicotinamide Riboside Supplementation in Mothers of Extremely Preterm Infants
This study aims to evaluate the feasibility and effects of nicotinamide riboside (NR) supplementation in lactating mothers of infants expected to be hospitalized in the neonatal intensive care unit (NICU) for at least four weeks.
- Trial name
- MOONRISE (NCT04614714)
- Testing
- Nicotinamide Riboside (NR)
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- University of California, Davis
Deficits, Neurologic, Extreme Prematurity
SafeBoosC III Two-year Follow-up
The SafeBoosC-III 2 year follow up study will follow up on all patients randomised in the SafeBoosC-III clinical trial (NCT03770741).
- Conditions
- Deficits, Neurologic, Extreme Prematurity, Brain Damage
- Trial name
- NCT05134116
- Testing
- Treatment as usual + cerebral oximetry monitoring the first 72 hours of life
- Where
- Denmark
- Volunteers
- 1,601 people
- Sponsor
- Gorm Greisen
Periviable Infants, Extreme Prematurity
PeriviAble DeLiveries: ALIgning PArental aNd PhysiCian PrioritiEs (ALLIANCE)
Background: There is significant variation in how clinicians currently present information to parents in periviable labour. Whilst each conversation with an individual set of parents will vary, the current level of variation is…
- Conditions
- Periviable Infants, Extreme Prematurity, Communication
- Trial name
- ALLIANCE (NCT05265195)
- Testing
- Mixed Methods study
- Where
- United Kingdom
- Volunteers
- 340 people
- Sponsor
- Manchester University NHS Foundation Trust
Retinopathy of Prematurity (ROP), Intraventricular Hemorrhage
Safety and Efficacy Outcomes Following Previously Administered Short-Term Treatment With SHP607 in Extremely Premature Infants
The purpose of this study is to evaluate long-term safety and efficacy outcomes following previously administered short-term exposure to SHP607, as compared to a standard neonatal care group.
- Conditions
- Retinopathy of Prematurity (ROP), Intraventricular Hemorrhage, Bronchopulmonary Dysplasia, Chronic Lung Disease of Prematurity
- Trial name
- NCT04506619
- Testing
- No Intervention
- Where
- 8 sites in United States, Italy and 1 more
- Volunteers
- 26 people
- Sponsor
- Oak Hill Bio Ltd
Premature Infants
Urine Concentration of S100B in Extremely Premature Infants
S100B, a calcium-binding protein, is found predominantly in the central nervous system (CNS) and is increased in CSF and blood after CNS injury. There are two objectives to this study.
- Trial name
- NCT00747591
- Where
- United States
- Volunteers
- 68 people
- Sponsor
- University of Utah
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
Patency of the Ductus Arteriosus Acetaminophen Extreme Prematurity
Long Term Follow-up of the TREOCAPA Study (TREOCAPA-LT)
The ductus arteriosus (DA) is a large channel connecting the main pulmonary trunk with the descending aorta. In extremely preterm infants, the DA frequently fails to close and this results in a condition called patent ductus…
- Trial name
- TREOCAPA-LT (NCT06064825)
- Testing
- 2 year follow-up of neurodevelopment using a parental questionnaire
- Where
- 8 sites in France
- Volunteers
- 500 people
- Sponsor
- Institut National de la Santé Et de la Recherche Médicale, France
Infection, Candida
Early Diagnosis of Candidiasis in Premature Infants
This observational study evaluated the performance of new lab tests in detecting candida species fungal infections in extremely low birth weight (ELBW) infants quickly and accurately.
- Conditions
- Infection, Candida, Candidiasis, Infant, Newborn
- Trial name
- Candida (NCT00109525)
- Where
- 20 sites in United States
- Volunteers
- 1,500 people, healthy volunteers welcome
- Sponsor
- NICHD Neonatal Research Network