Clinical trials: Prematurity; Extreme
Transient Hypothyroxinemia of Prematurity (THOP)
Study of Thyroid Hormones in Prematures
The investigators hypothesize that continuous infusion of 4 µg/Kg/day T4 with 30 µg/Kg/day oral potassium iodide (KI) for 42 days from birth will reduce by 30% or more (from an estimated 30% to 21%) the proportion of extremely…
- Trial name
- THOP2 (NCT02103998)
- Testing
- thryoid hormone T4 + oral potassium iodide (KI) for 42 days, D5W - 5% dextrose water
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- New York Medical College
Extreme Prematurity, Neurodevelopmental Abnormality
Osteopathic Manipulative Medicine to Reduce Developmental Delays
This randomized clinical trial seeks to determine if osteopathic manipulative medicine (OMM) increases the likelihood of improved neurodevelopmental outcomes as estimated by the Test of Infant Motor Performance (TIMP).
- Trial name
- NCT04652063
- Testing
- Osteopathic Manipulative Medicine
- Where
- 2 sites in United States
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- University of Rochester
Prematurity; Extreme
Risk of Chronic Diseases in Young Adults Born Preterm: Relationship With Inflammation and Oxidative Stress Biomarkers.
The purpose of the HAPI project is to study the overall health of preterm infants once they reach adulthood. The investigators would like to compare the health of adults born preterm with that of adults born full-term.
- Trial name
- NCT03261609
- Testing
- preterm birth
- Where
- Canada
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- St. Justine's Hospital
Infant, Newborn, Infant, Low Birth Weight
Antenatal Phenobarbital to Prevent Neonatal Intracranial Hemorrhage
This large randomized trial tested whether phenobarbital given to a pregnant woman about to deliver a premature infant would prevent brain injuries in their newborns.
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- Phenobarbital (NCT00009620)
- Testing
- Phenobarbital, Saline
- Where
- 11 sites in United States
- Volunteers
- 610 people, healthy volunteers welcome
- Sponsor
- NICHD Neonatal Research Network
Infant, Newborn, Infant, Low Birth Weight
In Utero Magnesium Sulfate Exposure: Effects on Extremely-Low-Birth-Weight Infants
This study examined the effect of magnesium sulfate (MgSO4) exposure on adverse outcome in extremely low birth weight (ELBW) infants.
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- MgSO4 (NCT01203501)
- Where
- 15 sites in United States
- Volunteers
- 1,339 people, healthy volunteers welcome
- Sponsor
- NICHD Neonatal Research Network
Respiratory Distress Syndrome, Preterm Birth
LISA vs INSURE in Extremely Low Birth Weight Infants. A Manikin Study
This is an unblinded, randomized, controlled, crossover (AB/BA) trial of surfactant treatment with LISA vs. INSURE in a manikin simulating an extremely low birth weight infant.
- Conditions
- Respiratory Distress Syndrome, Preterm Birth, Surfactant Deficiency Syndrome Neonatal
- Trial name
- NCT04944108
- Testing
- LISA approach, Insure approach
- Where
- 2 sites in Italy
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- University Hospital Padova
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
Premature, Extremely Low Birth Weight Infants, Polyunsaturated Fatty Acid Levels
PUFA Supplementation in Premature Infants
The purpose of this study is to determine if buccal administration of a concentrated formulation of long-chain polyunsaturated fatty acids (LCPUFA) can help to maintain docosahexaenoic acid (DHA) levels in extremely low birth…
- Trial name
- NCT01955044
- Testing
- LCPUFA supplement
- Where
- 3 sites in United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Endeavor Health
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
Infant, Newborn, Infant, Low Birth Weight
Development of Standards for the New Ballard Maturation Score
The primary purpose of this study was to evaluate the accuracy of gestational age (GA) estimates by using the New Ballard Score (NBS) in newborns 24 to 27 weeks GA with accurate obstetric estimates of GA.
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- Ballard (NCT01203449)
- Where
- 11 sites in United States
- Volunteers
- 1,090 people, healthy volunteers welcome
- Sponsor
- NICHD Neonatal Research Network
Preterm, Very Low Birth Weight Infant
Weight Gain in Extremely Premature Infant With Targeted Versus Adjusted Fortification
Investigation about the effect on weight gain in extremely low birth weight preterm with individualized fortification, according to human milk analysis versus fortification adjusted according to urea serum concentration.
- Conditions
- Preterm, Very Low Birth Weight Infant, Feeding, Breast, Food, Fortified
- Trial name
- FORTIN (NCT04982133)
- Testing
- Protein supplementation based on plasma urea concentration every other week or human milk analysis on experiment
- Where
- Spain
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- Hospital Universitario La Paz
Endothelial Dysfunction, Sublingual Capillary Glycocalyx and Density
Prematurity as Predictor of Children's Cardiovascular-renal Health
Extreme preterm birth interferes with the development of the cardiovascular system. Both macro- as well as microvasculature undergoes extensive, organ specific maturation.
- Conditions
- Endothelial Dysfunction, Sublingual Capillary Glycocalyx and Density, Visual Disturbances and Blindness, Ventricular Dysfunction, Left
- Trial name
- PREMATCH (NCT02147457)
- Where
- Belgium
- Volunteers
- 180 people, healthy volunteers welcome
- Sponsor
- Universitaire Ziekenhuizen KU Leuven
Prematurity; Extreme
Exercise Intervention to Rescue the Adverse Effect of Preterm Birth on Cardiovascular and Pulmonary Health.
In spite of advances in neonatal intensive care allowing the first generation survivors of extreme prematurity to now reach young adulthood, these individuals present with reduced exercise capacity; a strong predictor of later…
- Trial name
- NCT03504215
- Testing
- Exercise Intervention
- Where
- Canada
- Volunteers
- 68 people, healthy volunteers welcome
- Sponsor
- St. Justine's Hospital
Bronchopulmonary Dysplasia
Early Predictors of Bronchopulmonary Dysplasia in Extremely Preterm Infants
Bronchopulmonary dysplasia (BPD) remains one of the most common complications in extremely preterm infants despite advances in neonatal intensive care.
- Trial name
- EPIRESP (NCT07771387)
- Where
- Austria
- Volunteers
- 140 people, healthy volunteers welcome
- Sponsor
- Medical University of Vienna
Prematurity; Extreme
Assessment of Renal Function in Adults Born Preterm: The HAPI-Kidney Study
Every year in Canada, 1500 babies are born ≤29 weeks' gestational age (GA) and the majority survive to adulthood. Preterm birth occurs during a critical period of nephrogenesis.
- Trial name
- NCT04735315
- Testing
- Preterm birth
- Where
- Canada
- Volunteers
- 157 people, healthy volunteers welcome
- Sponsor
- St. Justine's Hospital
Preterm Labor, Premature Birth
Effectiveness of ACS in Extreme Preemies
This is a randomized prospective clinical study that will evaluate the effects of antenatal corticosteroid administration (ACS) vs.
- Trial name
- NCT02351310
- Testing
- Betamethasone
- Volunteers
- healthy volunteers welcome
- Sponsor
- Pediatrix
Premature Infants, Cerebral Palsy
Interrater Reliability of Infant Motor Profile
The aim of this study is to assess risky infants (or diagnosed infants) with Infant Motor Profile, and analyze interrater and intrarater reliability of this test.
- Conditions
- Premature Infants, Cerebral Palsy, Down Syndrome, Metabolic Disorders
- Trial name
- IMP (NCT03188107)
- Testing
- Video based assessment
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Abant Izzet Baysal University
Infant, Extremely Premature, Voice
Maternal Voice on Alleviating Pain in Premature Undergoing Heel Lance Procedure and Enhancing Mother-Infant Bonding
A total of 64 preterm infants born before 37 weeks of gestation and their mothers were randomly assigned to the experimental and control groups.
- Conditions
- Infant, Extremely Premature, Voice, Pain, Bonding
- Trial name
- NCT04158206
- Testing
- Maternal voice
- Where
- Taiwan
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- National Yang Ming Chiao Tung University
Measles, Mumps
Responses of Premature Infants to Measles-Mumps-Rubella (MMR) and Varicella Vaccines
The purpose of this study is to see if the MMR and chickenpox vaccines work as well in premature infants as in children that were carried to full term.
- Conditions
- Measles, Mumps, Rubella, Varicella
- Trial name
- NCT00138255
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
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