Physiological Phenotyping of Respiratory Outcomes in Infants Born Premature (P3)

Indiana University

Status: Active, not recruiting

Conditions: Premature Lungs

Treatments: Other: Diffusion Capacity of the Lung for Carbon Monoxide (DLCO)

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT03906708

1R01HL145679-01A1 (U.S. NIH Grant/Contract)

1809404763

Details and patient eligibility

About

The purpose of this study is to examine if infants are more likely to suffer from respiratory complications during their first year of life due to being born premature.

Full description

The overall objective of this study is to determine if infant respiratory morbidities after preterm birth are highly variable due to differential impairment of airway, parenchymal and vascular development that can be characterized as distinct physiologic phenotypes. If the nature and severity of these specific impairments of lung function are strongly associated with increased respiratory morbidities during infancy and that proteomic biomarkers can enhance the physiologic characterization of phenotype and prediction of late respiratory outcomes.

Enrollment: 249 patients

Sex: All

Ages: 24 to 36 weeks old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Infants born to mothers who are between the gestational ages of 24+0 and 36+6 weeks.

Exclusion criteria

• Cardiopulmonary defects
• Chromosomal defects
• Structural abnormalities of the upper airway, chest wall, or lungs
• Neurological/Neuromuscular disorders
• Infant not considered viable
• Family unlikely to be available for long term follow up
• Mothers under the age of 18.
• Non English speaking

Trial design

249 participants in 1 patient group

Premature Infants

Description:

Premature infants born between 24+0 and 36+6 weeks of gestation.

Treatment:

Other: Diffusion Capacity of the Lung for Carbon Monoxide (DLCO)