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Bronchopulmonary Dysplasia clinical trials

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NCT ID: NCT01373008 Recruiting - Clinical trials for Bronchopulmonary Dysplasia

Inhaled Extra-fine Hydrofluoalkane-beclomethasone (QVAR) in Premature Infants With Bronchopulmonary Dysplasia (BPD)

Start date: June 2011
Phase: Phase 2
Study type: Interventional

Premature infants with chronic lung disease (bronchopulmonary dysplasia [BPD]) are commonly treated with inhaled steroids, an optional treatment according to textbooks and guidelines . However, the evidence supporting this treatment in spontaneously breathing infants is limited, and based on only two randomized, placebo-controlled trials (RCT) with relative small number of infants . The Cochrane review concluded that these studies do not allow firm conclusions with regard to the efficacy of inhaled steroids in non-ventilated infants . Thus, there is no doubt that there is a need for more RCT in order to ascertain the role of inhaled steroids in infants with BPD. Because of its physical properties that theoretically make QVAR an attractive therapy in infants and studies showing it to be as effective as and with similar safety profile as other inhaled steroids in children, the investigators hypothesized that inhaled QVAR will be an effective therapy in infants with BPD.

NCT ID: NCT01353313 Active, not recruiting - Clinical trials for Bronchopulmonary Dysplasia

Hydrocortisone for BPD

Start date: August 11, 2011
Phase: Phase 3
Study type: Interventional

The Hydrocortisone and Extubation study will test the safety and efficacy of a 10 day course of hydrocortisone for infants who are less than 30 weeks estimated gestational age and who are intubated at 14-28 days of life. Infants will be randomized to receive hydrocortisone or placebo. This study will determine if hydrocortisone improves infants'survival without moderate or severe BPD and will be associated with improvement in survival without moderate or severe neurodevelopmental impairment at 22 - 26 months corrected age.

NCT ID: NCT01329432 Recruiting - Clinical trials for Bronchopulmonary Dysplasia

Surfactant Administration During Spontaneous Breathing

TAKE CARE
Start date: December 2010
Phase: Phase 4
Study type: Interventional

Spontaneous breathing supported by nasal continuous positive airway pressure (nCPAP) is thought to have some advantages compared with mechanical ventilation in premature infants. In addition, early surfactant administration has been shown to be superior to delayed use. The aim of this pilot study was to describe the feasibility of TAKE CARE (early administration of surfactant in spontaneous breathing) procedure and compare its short-term and long-term results with InSurE procedure.

NCT ID: NCT01297205 Completed - Clinical trials for Bronchopulmonary Dysplasia

Safety and Efficacy Evaluation of PNEUMOSTEM® Treatment in Premature Infants With Bronchopulmonary Dysplasia

Start date: December 2010
Phase: Phase 1
Study type: Interventional

PNEUMOSTEM® is human umbilical cord blood derived mesenchymal stem cells and it is intended to treat premature infants with bronchopulmonary dysplasia. This study is to assess the safety and the efficacy of this study drug.

NCT ID: NCT01268215 Recruiting - Clinical trials for Bronchopulmonary Dysplasia

Pilot Study of Topical Steroid for Prevention of Chronic Lung Disease in Extremely Premature Infants.

Start date: July 2010
Phase: Phase 2
Study type: Interventional

A Pilot study to evaluate the safety and the efficacy of endotracheal instillation of pulmonary surfactant, with or without topical steroid (Budesonide), as a prophylactic treatment for Bronchopulmonary Dysplasia (a form of chronic lung disease) in extremely low birth weight infants. Cytokines (a group of inflammatory mediators) are measured in the tracheal aspirate before and after instillation of the study drugs.

NCT ID: NCT01223287 Completed - Infant, Premature Clinical Trials

Physiologic Definition of Bronchopulmonary Dysplasia

PhysiologicDef
Start date: May 2005
Phase: N/A
Study type: Observational

This observational study was conducted to design and test a physiologic definition for bronchopulmonary dysplasia at 36 weeks of life. Infants were studied in a supine position with the pulse oximeter in position with good signal prior to collecting baseline data. Feedings and medications were given 30 minutes before the evaluation. Baseline data was collected on infant's current oxygen. Then, the infants were weaned to room air for 30 minutes. If saturations remain ≥90%, the infant was considered to have passed the oxygen reduction challenge (to NOT have BPD). The infant should then be placed back in his/her baseline oxygen. If the infant has saturations <90% for 5 continuous minutes or <80% for 15 seconds, the infant should be immediately placed back in his/her baseline oxygen, and the infant was considered to have NOT passed the challenge (to have BPD).

NCT ID: NCT01223274 Completed - Clinical trials for Bronchopulmonary Dysplasia

Delivery Room CPAP in Extremely Low Birth Weight Infants

DR-CPAP
Start date: July 2002
Phase: Phase 1/Phase 2
Study type: Interventional

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 facemask and continuous positive airway pressure (CPAP) or positive pressure ventilation (PPV) with positive end-expiratory pressure (PEEP), if the infant required PPV (the intervention group); or (b) 100% oxygen and no CPAP and no PEEP if the infant required PPV (the control group).

NCT ID: NCT01207869 Active, not recruiting - Clinical trials for Bronchopulmonary Dysplasia

Intratracheal Umbilical Cord-derived Mesenchymal Stem Cells for Severe Bronchopulmonary Dysplasia

Start date: July 2010
Phase: Phase 1
Study type: Interventional

Mesenchymal stem cells (MSCs) have been reported to be effective to prevent alveolar growth arrest in experimental bronchopulmonary dysplasia (BPD). The aim is to treat the extremely premature infant with severe BPD to establish whether intratracheal instillation of umbilical cord-derived MSCs (ucMSCs) is safe and effective as a rescue treatment for severe BPD.

NCT ID: NCT01203488 Completed - Sepsis Clinical Trials

Vitamin A Supplementation for Extremely-Low-Birth-Weight Infants

Vitamin A
Start date: January 1996
Phase: Phase 1/Phase 2
Study type: Interventional

This multi-site, randomized trial was conducted to determine the safety and effectiveness of a higher dose of vitamin A and determine if this would increase the rate of survival without bronchopulmonary dysplasia (BPD) and reduce the risk of sepsis. Infants with birth weights from 401-1000g and who were on mechanical ventilation or supplemental oxygen at 24-96 hours of age were enrolled. Subjects were randomized to either the Vitamin A or a control group. Infants in the Vitamin A group were given a dose of 5000 IU (0.1 ml) intramuscularly on Mondays, Wednesdays, and Fridays for four weeks. Control infants received a sham procedure rather than placebo injections.

NCT ID: NCT01203358 Completed - Clinical trials for Bronchopulmonary Dysplasia

Exosurf Neonatal and Survanta for Treatment of Respiratory Distress Syndrome

Surfactant 1
Start date: January 1991
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this study is to compare the efficacy of two surfactants, Exosurf Neonatal (Burroughs Wellcome Co.) and Survanta (Ross Laboratories), for the treatment of neonatal respiratory distress syndrome.