Clinical trials: Preterm Neonates
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
Enterocolitis, Necrotizing, Bacteremia
Antibiotic "Dysbiosis" in Preterm Infants
Prolonged antibiotic use in preterm neonates has significant consequences on the developing intestinal microbiome, metabolome and host response, predisposing the neonate to various major morbidities, including necrotizing…
- Conditions
- Enterocolitis, Necrotizing, Bacteremia, Bronchopulmonary Dysplasia, Intraventricular Hemorrhage
- Trial name
- NCT02784821
- Testing
- Antibiotic, Gastric fluid, Breast milk
- Where
- United States
- Volunteers
- 98 people
- Sponsor
- University of Florida
Cystic Fibrosis
PTC124 for Cystic Fibrosis
In some patients with cystic fibrosis (CF), the disease is caused by a nonsense mutation (premature stop codon) in the gene that makes the cystic fibrosis transmembrane regulator (CFTR) protein.
- Trial name
- NCT00234663
- Testing
- PTC124
- Where
- 5 sites in United States
- Volunteers
- 24 people
- Sponsor
- PTC Therapeutics
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, Low Birth Weight Neonates
Metagenomic & Metabolomic Study: Bifidobacterium Probiotic Effects on Gut Microbiota & SCFA in Preterm NICU Infants
One million premature babies die due to prematurity complications, contributing the most to the causes of death in children under 5 years old.
- Trial name
- NCT07213414
- Testing
- Probiotics
- Where
- 3 sites in Indonesia
- Volunteers
- 72 people
- Sponsor
- Hasanuddin University
Prenatal Disorder, Premature Birth
Develop a Multi-disciplinary Approach for a Personalized Prenatal Diagnostics and Care for Twin Pregnancies
Different screening modalities evaluation to develop algorithms to predict pregnancy complications in twin pregnancies, and evaluation of serologic response to BNT162b2 Pfeizer/BioNTech vaccination.
- Conditions
- Prenatal Disorder, Premature Birth, Twin Pregnancy With Antenatal Problem, Twin; Pregnancy, Affecting Fetus or Newborn
- Trial name
- PRETWINSCREN (NCT04595214)
- Testing
- TTTS cases are treated by intra-uterine laser for separation.
- Where
- 7 sites in Belgium, Canada and 4 more
- Volunteers
- 1,200 people, healthy volunteers welcome
- Sponsor
- Assaf-Harofeh Medical Center
Premature Infant Disease
A Randomized Controlled Trial to Evaluate the Effect of White Noises and Parental Voices As Protectors Against Noise Damage in a Neonatal Intensive Care Unit
The goal of this Randomized Controlled Trial is to test the efficacy of listening to white noises and parental voices against environmental noise damage in premature babies admitted to the Newborn Intensive Care Unit.
- Trial name
- NCT06150404
- Testing
- White Noises and Maternal and/or Paternal voices
- Where
- Italy
- Volunteers
- 11 people
- Sponsor
- Istituto Giannina Gaslini
Preterm Birth, Umbilical Cord Clamping
Umbilical Cord Clamping Methods and Stem Cell Counts in Preterm Infants
This study evaluates the effect of different umbilical cord clamping methods on peripheral blood hematopoietic stem cell counts in preterm newborns.
- Trial name
- NCT07385326
- Testing
- Immediate Cord Clamping, Delayed Cord Clamping, Umbilical Cord Milking
- Where
- Turkey (Türkiye)
- Volunteers
- 49 people, healthy volunteers welcome
- Sponsor
- Era Tufan Benli
Preterm Neonates
Polyethylene Bag: a Way of Preventing Hypothermia During Central Venous Catheter Placement in Preterm Neonates?
Particular attention is paid to thermal management of preterm neonates in neonatal intensive care units because of the major risk of morbidity associated with hypothermia.
- Trial name
- PSac (NCT02798926)
- Testing
- polyethylene bag
- Where
- France
- Volunteers
- 63 people
- Sponsor
- Centre Hospitalier Universitaire, Amiens
Preterm Birth, Tube Feeding
Maternal Role in Oral Feed Establishment in Preterm Neonates
Hypothesis Preterm babies who receive sensory motor stimulation from their mothers as compared to trained nurses will 1. Start taking oral feed at the same time as compared to control group 2.
- Conditions
- Preterm Birth, Tube Feeding, Swallowing Disorder, Maternal Care Patterns
- Trial name
- NCT05484726
- Testing
- perioral sensory motor stimulation
- Where
- Pakistan
- Volunteers
- 130 people, healthy volunteers welcome
- Sponsor
- Fatima Memorial Hospital
Osteopenia Of Prematurity
A Preliminary Study of Bone Density in Neonates
The study is to measure how dense or solid the infant's bones are using a new ultrasound machine and how that density changes over time.
- Trial name
- NCT00631397
- Testing
- Ultrasound machine
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- University of South Florida
Dysphagia of Newborn
Cold Milk for Dysphagia in Preterm Infants
It is estimated that 30-70% of very low birth weight (VLBW) preterm infants will be diagnosed with swallowing dysfunction (dysphagia), which often leads to airway compromise in the form of laryngeal penetration and/or tracheal…
- Trial name
- NCT04421482
- Testing
- Standard room temperature (RTS) feeding of milk/formula, Cold temperature (CS, at 4-9°C) of milk/formula
- Where
- United States
- Volunteers
- 22 people
- Sponsor
- NYU Langone Health
Infant, Premature, Diseases, Respiratory Insufficiency Syndrome of Newborn
Impact of CPAP Level on V/Q Mismatch in Premature Infants
Continuous positive airway pressure (CPAP) is used in premature infants to maintain lungs open and facilitate gas exchange. When ventilation/perfusion (V/Q) mismatch is present, areas of the lung that are open for gas exchange do…
- Trial name
- NCT02983825
- Testing
- Continuous positive airway pressure (CPAP); level changes
- Where
- 3 sites in United States
- Volunteers
- 21 people
- Sponsor
- Children's Hospital of Philadelphia
Bronchopulmonary Dysplasia
Preservation of Blood in Extremely Preterm Infants
Current clinical protocols for blood sampling and analyses in extremely preterm infants rely on an infrastructure adapted to and developed for adult medicine.
- Trial name
- LIM (NCT04239690)
- Testing
- Micromethods for blood sample analysis
- Where
- Sweden
- Volunteers
- 201 people
- Sponsor
- David Ley
Preterm Birth, Visual Impairment
Eye and Growth in Adolescents Born Moderate-to-late Preterm
During recent years, the interest in studying the risks of being born moderate-to-late preterm (MLP), defined as birth between gestational week 32 to 36, has increased.
- Conditions
- Preterm Birth, Visual Impairment, Eye Abnormalities
- Trial name
- NCT04190147
- Testing
- Structural, functional and metabolic eye examinations
- Where
- Sweden
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Vastra Gotaland Region
Osteopenia (Disorder), Apnea of Prematurity
Effect of Caffeine on Preterm Infants' Bone Mineral Content
The primary objective was to determine whether caffeine therapy is associated with decreases bone mineral content using dual energy x-ray absorptiometry.
- Trial name
- NCT03084432
- Testing
- Dual Energy X-ray Absorptiometry
- Volunteers
- 42 people
- Sponsor
- Ain Shams University
Respiratory Distress Syndrome, Newborn
Feasibility Study of Placement and Surfactant Administration Through a Preterm Size Laryngeal Mask Airway in Very Low Birth Weight Neonates With Respiratory Distress Syndrome
Surfactant administration via a supraglottic airway device or laryngeal mask airway (SALSA) is a minimally invasive method of instilling surfactant in the trachea during spontaneous breathing and after applying nasal continuous…
- Trial name
- NCT06606444
- Testing
- Surfactant Administration Through Laryngeal or Supraglottic Airways
- Where
- Vietnam
- Volunteers
- 45 people
- Sponsor
- Karolinska Institutet
Respiratory Distress Syndrome, Chronic Lung Disease of Prematurity
Prevention of Chronic Lung Disease (CLD) in Preterm Infants
Pulmonary inflammation plays an important role in the early development of CLD. Postnatal glucocorticoids have been shown effective in the prevention or treatment of CLD with various success.
- Trial name
- NCT00883532
- Testing
- budesonide
- Where
- China
- Volunteers
- 300 people
- Sponsor
- China Medical University, China
Patent Ductus Arteriosus
International Experience in Timing And Choices for Ductal Closure in Patent Ductus Arteriosus:INTERPDA Trial
The three options for the treatment of patent ductus arterioles (PDA) in preterm infants are conservative approach, pharmacological intervention and surgical ligation.
- Trial name
- NCT02910609
- Testing
- Echocardiography
- Volunteers
- 1,000 people
- Sponsor
- Ankara University
Infant, Very Low Birth Weight, Neonatal Hypoglycemia
Continuous Glucose Monitoring and Preterm Infants
Neonatal hypoglycemia is associated with brain injury and impaired neurodevelopment outcomes in very low birth weight infants (VLBWI).
- Trial name
- CGM&VLBWI (NCT02583776)
- Testing
- Unblinded - CGM, Blinded - CGM
- Where
- 3 sites in United States, Italy
- Volunteers
- 50 people
- Sponsor
- University Hospital Padova