Study of the Pathobiology of Bronchopulmonary Dysplasia in Newborns

Status Completed

Clinical Trial Summary

OBJECTIVES:

I. Create a clinical sample bank of neonates with lung disease to test hypotheses regarding the pathogenesis of bronchopulmonary dysplasia (BPD).

II. Determine whether a developmental deficiency of surfactant protein B (SP-B) contributes to the occurrence of respiratory distress and BPD in these patients.

III. Study metabolic abnormalities associated with inherited deficiency of SP-B in these patients.

IV. Determine whether plasma nitrotyrosine levels, a marker of peroxynitrite mediated oxidant stress, are elevated in premature infants who develop BPD.

V. Measure the temporal changes in critical components of the inflammatory process (cell composition, inducible nitric oxide synthase, hyaluronan (HA), receptor for HA mediated mobility, and selected cytokines) in bronchoalveolar lavage, blood, and urine samples obtained from these patients, and to correlate these changes with their clinical course.

VI. Examine changes in the insulin-like growth factor axis that occur in the lungs of infants with respiratory distress syndrome (RDS) and BPD.

VII. Determine the relationship between degradation of elastin and the clinical course of BPD.

VIII. Determine whether the normal fall in plasma endothelin-1 concentrations after birth are delayed in infants with RDS and BPD.

Clinical Trial Description

PROTOCOL OUTLINE:

Bronchoalveolar lavage and urine samples are obtained from patients on day of life 0, 1, 3, 7, 14, 21, and 28, and every 2 weeks thereafter until the infant is extubated. Serial blood samples are obtained from patients on day of life 0 (cord blood if possible), 1, 3, 7, 14, and 28, and prior to hospital discharge. Infants who require supplemental oxygen beyond 28 days of life will have 3 additional blood samples obtained at 6, 8, and 12 weeks of life. Those infants with established bronchopulmonary dysplasia who are admitted to the hospital at over 4 weeks of age have plasma samples obtained at the time of admission, and every 2 weeks thereafter for a maximum total of 5 samples. ;

Study Design

Primary Purpose: Screening

Related Conditions & MeSH terms

Bronchopulmonary Dysplasia
Respiratory Distress Syndrome
Respiratory Distress Syndrome, Adult
Respiratory Distress Syndrome, Newborn

Clinical Trial Details

NCT number	NCT00006058
Study type	Observational
Source	National Center for Research Resources (NCRR)
Contact
Status	Completed
Phase	N/A
Start date	September 1996

View Details

See also
Status	Clinical Trial	Phase
Terminated	`NCT04506619` - Safety and Efficacy Outcomes Following Previously Administered Short-Term Treatment With SHP607 in Extremely Premature Infants
Completed	`NCT04936477` - Ventilation-perfusion (V/Q) Ratio and Alveolar Surface Area in Preterm Infants	N/A
Recruiting	`NCT05285345` - Implementation of a Consensus-Based Discharge Protocol for Preterm Infants With Lung Disease
Completed	`NCT03649932` - Enteral L Citrulline Supplementation in Preterm Infants - Safety, Efficacy and Dosing	Phase 1
Terminated	`NCT02524249` - Early Versus Late Caffeine for ELBW Newborns	N/A
Completed	`NCT02249143` - Duration of Continuous Positive Airway Pressure and Pulmonary Function Testing in Preterm Infants	N/A
Active, not recruiting	`NCT01632475` - Follow-Up Study of Safety and Efficacy of Pneumostem® in Premature Infants With Bronchopulmonary Dysplasia
Completed	`NCT01460576` - Improving Prematurity-Related Respiratory Outcomes at Vanderbilt	N/A
Completed	`NCT00419588` - Growth of Airways and Lung Tissues in Premature and Healthy Infants
Unknown status	`NCT00254176` - Cysteine Supplementation in Critically Ill Neonates	Phase 2/Phase 3
Completed	`NCT00208039` - Pilot Trial of Surfactant Booster Prophylaxis For Ventilated Preterm Neonates	N/A
Completed	`NCT00319956` - Trial II of Lung Protection With Azithromycin in the Preterm Infant	Phase 2
Completed	`NCT00006401` - Inhaled Nitric Oxide for Preventing Chronic Lung Disease in Premature Infants	Phase 3
Terminated	`NCT05030012` - Maintaining Optimal HVNI Delivery Using Automatic Titration of Oxygen in Preterm Infants	N/A
Completed	`NCT00005376` - Premature Birth and Its Sequelae in Women	N/A
Completed	`NCT00011362` - Dexamethasone Therapy in VLBW Infants at Risk of CLD	Phase 3
Completed	`NCT00004805` - Study of the Effect of Four Methods of Cardiopulmonary Resuscitation Instruction on Psychosocial Response of Parents With Infants at Risk of Sudden Death	N/A
Completed	`NCT05152316` - The Baby Lung Study
Recruiting	`NCT04821453` - NAVA vs. CMV Crossover in Severe BPD	N/A
Active, not recruiting	`NCT04662151` - A Clinical Safety Study of AT-100 (rhSP-D) in Preterm Neonates at High Risk for Bronchopulmonary Dysplasia (BPD)	Phase 1

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.