An observational study in Premature Birth, Bronchopulmonary Dysplasia and Asthma, sponsored by Indiana University School of Medicine. Completed at 1 site in United States. Open to participants aged 2 Months to 36 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-03-04.
Sponsored by Indiana University School of Medicine · Observational
The purpose of this study is to evaluate the growth of the lung and how easily gas can be taken up by the lung in healthy infants born at full term without any breathing problems and infants born prematurely.
SPECIFIC AIM #1:
Determine the relationship between parenchymal tissue and alveolar volume with normal lung growth early in life.
We hypothesize that during the first two years of life that parenchymal surface area and alveolar volume increase with somatic growth; however, the ratio of surface area to volume remains constant, while ventilation within the lung becomes more homogenous.
SPECIFIC AIM #2:
Determine the pulmonary sequelae of premature birth and assess the effectiveness of early treatment strategies upon the pulmonary sequelae.
We hypothesize that premature birth impedes growth and development of the lung parenchyma and the airways. In addition, initiating continuous positive airway pressure (CPAP) and a permissive ventilatory strategy in very premature infants at birth will improve lung growth and lung function compared to treatment with early surfactant and conventional ventilation.
2,550 studies on the registry are indexed under Premature Birth; 500 are open to participants now.
This study's enrollment of 104 is below the median of 120 across 806 observational studies indexed under Premature Birth.
Browse Premature Birth studies →Indiana University School of Medicine is the lead sponsor of 89 studies on the registry; none are open to participants now.
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The study population will be selected from Infant Lung Disease Clinics at Riley Hospital, flyer in the community, and the neonatal intensive care unit (NICU) at Riley Hospial for Children, Indiana University and Methodist Hospital.
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Group 1:
Group 2:
Group 3:
Exclusion Criteria:
Group 1 and Group 2:
Group 3:
Group 1: The investigators will recruit 80 healthy infants born at \> 37 weeks gestation, and between 2 and 36 months of age. Infants will be excluded for any of the following reasons: 1. Congenital cardio-respiratory disease 2. Hospitalization for respiratory illness 3. Treatment with asthma medications 4. Small for gestational age at birth
Group 2: The investigators recruited 4 infants born at \> 37 weeks gestation and they were evaluated between 2 and 36 months of age when scheduled for high resolution computed tomography (HRCT) imaging for non-respiratory medical problems. Subjects were enrolled and HRCT of the chest were obtained. Infants were excluded for the following reasons: 1. Congenital cardio-respiratory disease 2. Hospitalization for respiratory illness 3. Treatment with asthma medications
Group 3: The investigators have recruited 45 infants born prematurely at 23-35 weeks gestation. Subjects were evaluated at corrected age at between 2 and 24 months. The subjects had no oxygen requirements, and were clinically stable outpatients when evaluated. Infants were excluded for any of the following reasons: 1. Congenital cardio-respiratory disease 2. Severe developmental delay
Pulmonary Function Testing
Forced expiratory Flows, Single-breath diffusion capacity and alveolar volume
Time frame: day of testing
The record gives a start of Jan 2007, a primary completion of Jan 2019 and a completion of Jan 2019. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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Indiana University School of Medicine