Clinical trials: Premature; Infant
Premature Birth of Newborn
Supporting and Enhancing NICU Sensory Experiences (SENSE)
Seventy preterm infants born less than or equal to 32 weeks gestation were put into either the sensory-based intervention (experiment) group or traditional care (control) group. Consecutive admissions at St.
- Trial name
- SENSE (NCT03316547)
- Testing
- SENSE Program
- Where
- United States
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Washington University School of Medicine
Preterm Infant, Full-term Infant
A Novel Parent Education Program for Early Intervention
One in ten infants born in the USA is born preterm before 37 weeks of gestation and 50% of those will have motor and cognitive delays requiring intervention at school age.
- Trial name
- NCT04266717
- Testing
- Baby Play Intervention, Milestone Education
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- University of Delaware
Heart Rate Variability, Preterm Infant
Skin to Skin and Heart Rate Variability
The objective of this study is to monitor heart rate variability in preterm infants receiving respiratory support, including conventional mechanical ventilation, during skin-to-skin care.
- Trial name
- NCT05018910
- Testing
- Skin to Skin
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- University of New Mexico
Intubated Infants Were Intend to Extubation Using Noninvasive Ventilation Strategies
A Trial Comparing Noninvasive Ventilation Strategies in Preterm Infants Following Extubation
Respiratory distress syndrome (RDS) is the main cause of respiratory failure in preterm neonates, its incidence varying from 80% to 25% depending on gestational age.When optimal prenatal care is provided, the best approach to…
- Trial name
- NCT03181958
- Testing
- NHFOV, NCPAP, NIPPV
- Where
- China
- Volunteers
- 1,493 people
- Sponsor
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Bronchopulmonary Dysplasia of Newborn
Safety of Sildenafil in Premature Infants With Severe Bronchopulmonary Dysplasia
This is a multicenter, randomized, placebo-controlled, sequential dose-escalating, double-masked, safety study of sildenafil in premature infants (inpatient in Neonatal Intensive Care Units (NICUs)) with severe bronchopulmonary…
- Trial name
- SILDI-SAFE (NCT04447989)
- Testing
- Sildenafil
- Where
- 25 sites in United States
- Volunteers
- 125 people
- Sponsor
- Christoph Hornik
Episodic Hypoxemia in Mechanically Ventilated Preterm Infants
Volume Guarantee Ventilation in Preterm Infants With Frequent Episodes of Hypoxemia
Preterm infants undergoing mechanical ventilation often present with respiratory instability which leads to fluctuations in ventilation and oxygenation.
- Trial name
- NCT01727505
- Testing
- Sequence A: Conventional-Volume Guarantee, Sequence B: Volume Guarantee-Conventional
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- University of Miami
Prematurity, Anemia
Transfusions and Nitric Oxide Level in Preterm Infants
The purpose of this study is to better understand S-nitrosohemeglobin (SNO-Hb) in transfused blood of extremely preterm infants.
- Conditions
- Prematurity, Anemia, Necrotizing Enterocolitis
- Trial name
- NCT00787124
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- Duke University
Respiratory Distress Syndrome
Comparative Effectiveness Study of Bubble CPAP Devices in the NICU
Multiple different devices are available to provide Bubble CPAP to preterm and newborn infants. The most significant difference between these devices is the size of the bubble produced by the exhalation limb.
- Trial name
- NCT02392806
- Testing
- Bubble CPAP- BabiPlus, Respiralogics, Bubble CPAP- B&B Bubbler, B&B Medical devices
- Where
- United States
- Volunteers
- 43 people
- Sponsor
- Marya Strand, MD
Respiratory Distress Syndrome, Newborn
Aerosolized Surfactant in Neonatal RDS
Respiratory distress syndrome (RDS), caused by surfactant deficiency, is the leading cause of mortality and morbidity in preterm infants.
- Trial name
- AS-02 (NCT02294630)
- Testing
- Surfactant
- Where
- United States
- Volunteers
- 159 people
- Sponsor
- Sood, Beena G., MD, MS
Premature Birth, Neonatal Hypoxic Conditions
Effects of Vanilla on Hypoxic Intermittent Events in Premature Infants
The purpose of this study is to evaluate the effect of vanilla odor on hypoxic intermittent events in premature infants born between 32.0 and 33.6 weeks of gestational age.
- Trial name
- Vanilla (NCT02630147)
- Testing
- Vanilla scent
- Where
- Canada
- Volunteers
- 32 people
- Sponsor
- Université de Sherbrooke
Retinopathy of Prematurity
Synergistic Pharmacologic Intervention for Prevention of ROP (SPIPROP Study)
Phase 2, open-label, randomized, multi-center studies in infants and premature infants are necessary to determine treatment and preventative strategies for ROP.
- Trial name
- SPIPROP (NCT02344225)
- Testing
- Caffeine citrate, Ibuprofen, Ketorolac
- Where
- United States
- Volunteers
- 14 people
- Sponsor
- State University of New York - Downstate Medical Center
Premature Birth, Brain Injury
Melatonin As A Novel Neuroprotectant In Preterm Infants- Dosage Study
Preterm babies are at risk of brain injury. Melatonin, a naturally occurring hormone, may reduce this risk. The unborn baby receives melatonin from the mother but following premature delivery there maybe a period of prolonged…
- Trial name
- MIND (NCT00649961)
- Testing
- Melatonin injection
- Where
- 2 sites in United Kingdom
- Volunteers
- 18 people
- Sponsor
- Imperial College London
Infant Respiratory Distress Syndrome, Respiratory Insufficiency
Nasal High Frequency Ventilation in Preterm Infants: A Pilot Study
The purpose of this study is to test whether application of high frequency ventilation through a nasal tube can lower blood carbon dioxide levels in stable preterm infants.
- Conditions
- Infant Respiratory Distress Syndrome, Respiratory Insufficiency, Apnea of Prematurity
- Trial name
- NCT00296231
- Testing
- Nasal high frequency ventilation
- Where
- United States
- Volunteers
- 14 people
- Sponsor
- Tarah T Colaizy
Congenital Heart Disease, Periventricular Leucomalacia
Randomized Trial of Maternal Progesterone Therapy
Neurodevelopmental disability is now recognized as the most common long-term complication after cardiac surgery in neonates. Research studies have shown that progesterone is critical to the development of the brain and in a…
- Conditions
- Congenital Heart Disease, Periventricular Leucomalacia, Brain Development, Cardiac Surgery
- Trial name
- NCT02133573
- Testing
- Progesterone, Vaginal lubricant
- Where
- United States
- Volunteers
- 102 people
- Sponsor
- Children's Hospital of Philadelphia
Respiratory Distress Syndrome, Newborn, Respiratory Tract Diseases
Nasal HFOV Versus Nasal CPAP to Reduce Post-extubation pCO2
To investigate whether nasal high frequency oscillation ventilation (nHFOV) immediately after extubation reduces the arterial partial pressure of carbon dioxide (paCO2) at 72 hours after extubation in comparison with nasal…
- Trial name
- NCT02340299
- Testing
- nHFOV, nCPAP
- Where
- Germany
- Volunteers
- 6 people
- Sponsor
- Charite University, Berlin, Germany
Cystic Fibrosis
Novel Therapeutic Approaches for Treatment of CF Patients With W1282X Premature Termination Codon Mutations
Based on previous clinical findings, the investigator hypothesize that ivacaftor will have synergistic effects with drugs that facilitate truncated but partially active W1282X CFTR protein processing (tezacaftor) in patients with…
- Trial name
- NCT03624101
- Testing
- Symdeko, Ivacaftor and Symdeko
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- University of Alabama at Birmingham
Retinopathy of Prematurity (ROP)
Long-term Safety and Efficacy Outcome Study Comparing Children Previously Enrolled in Study ROPP-2008-01 for the Prevention of Retinopathy of Prematurity (ROP)
The main purpose of this study is to evaluate the long-term efficacy and safety outcomes following short-term exposure to rhIGF-1/rhIGFBP-3 versus standard neonatal care in Study ROPP-2008-01 (NCT01096784).
- Trial name
- PEDAL (NCT02386839)
- Testing
- rhIGF-1/rhIGFBP-3
- Where
- 16 sites in United States, Italy and 4 more
- Volunteers
- 76 people
- Sponsor
- Shire
Parenteral Nutrition Associated Cholestasis
Prospective Randomized Clinical Trial of Intravenous Lipids and Cholestasis
The Investigators hypothesize that increased cumulative amount of lipid intake causes PNAC in late preterm and term neonates with major GI surgical disorders
- Trial name
- NCT01555957
- Testing
- intravenous lipid
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- University of Rochester
Infant, Premature, Nutrition, Enteral
Aspiration of Residual Gastric Contents
The primary purpose of this study is to determine nutrition outcomes and risks to gastrointestinal integrity and function of aspirating for routine gastric contents prior to each feeding in very low birth weight premature infants.
- Trial name
- NCT01863043
- Testing
- No aspiration of gastric contents, Routine aspiration of gastric contents
- Where
- United States
- Volunteers
- 146 people
- Sponsor
- University of Florida
Respiratory Distress Syndrome, Newborn, Premature Birth
SURFAXIN® Treatment for Prevention of Bronchopulmonary Dysplasia (BPD) in Very Low Birth Weight (VLBW) Infants.
SURFAXIN® (lucinactant) treatment will be examined in very low birth weight infants to prevent development of chronic lung disease, commonly known as bronchopulmonary dysplasia (BPD), in premature infants who have required…
- Conditions
- Respiratory Distress Syndrome, Newborn, Premature Birth, Bronchopulmonary Dysplasia
- Trial name
- NCT00215540
- Testing
- Lucinactant 175 mg/kg, Lucinactant 90 mg/kg
- Where
- United States
- Volunteers
- 136 people
- Sponsor
- Windtree Therapeutics