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Clinical Studies

Closed for Enrollment

  • A Noninvasive Monitor for the Detection of Preclinical Heart Failure in Children with Congenital or Acquired Heart Disease Rochester, Minn.

    The primary objective of this study is to determine whether a Mayo-developed, highly miniaturized physiologic monitoring instrument can provide early detection of heart failure (HF) in children with congenital or acquired heart disease at risk for or with evidence of heart failure (HF).

  • Early Treatment Versus Delayed Conservative Treatment of the Patent Ductus Arteriosus in Preterm infants-a Multicenter Trial (PDA:TOLERATE) Rochester, Minn.

    The primary goal of the trial is to compare two different Patent Ductus Arteriosus (PDA) treatment approaches: 1) an "early treatment" approach or 2) a "conservative" approach. For the purposes of the study infants will be enrolled if they are delivered before 28 weeks gestation and have a moderate/large PDA present at 5-7 days after birth.

    The hypothesis is: treatment of a moderate size patent ductus arteriosus (PDA) will decrease the time needed for assisted respiratory support, diuretic therapy, and gavage feeding assistance, in addition to decreasing the incidence of ductus ligations or need for future outpatient cardiology follow-up appointments. The investigators hypothesize that one or more of these benefits will occur without an increase in the time taken to achieve full enteral feedings or in the incidence of necrotizing enterocolitis (NEC) or spontaneous intestinal perforations (SIP).The investigators will be comparing the effectiveness of early pharmacologic treatment with a control group of conservatively managed infants who will only receive treatment if they meet specific criteria for "rescue treatment".

  • Long-Term Pulse Oximeter Monitoring for Neonates with Bronchopulmonary Dysplasia Rochester, Minn.

    Neonates who are born prematurely or who experience respiratory problems shortly after birth are at risk for bronchopulmonary dysplasia (BPD).  BPD is the most common pulmonary morbidity in preterm neonates and affects approximately. Babies first diagnosed with BPD receive intense supportive care in the hospital, usually in a neonatal intensive care unit (NICU), where the length of stay can range from several weeks to a few months. Even after leaving the hospital, a baby might require long-term diuretic, bronchodilator or oxygen therapies at home. Although most children with BPD are weaned from supplemental oxygen by the end of their first year, a few with serious cases may need oxygen for through early childhood and beyond. Advances in perinatal care, changes in health care economics and research suggesting a negative impact of prolonged hospitalization on development of the preterm newborn have influenced discharge practices for neonates with BPD. The home environment increasingly has been recognized as the optimal setting for medically stable, technology-assisted neonates to receive the complex and demanding care they require.The goal of the proposed study is to determine whether a newly developed, highly-miniaturized oxygen saturation-monitoring instrument might be of use in the care of neonates with BPD who will transition from the neonatal intensive care unit (NICU) to the home environment.

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