Despite improved survival of extremely premature infants in recent decades, neonatal intensive care unit (NICU) graduates are diagnosed with asthma, sleep disordered breathing (SDB) in childhood, and neurodevelopmental impairments (NDI) at significant rates, disproportionate to their term peers. Early detection and intervention are critical to mitigate the impact of these impairments. Mechanisms leading from premature birth to these undesirable outcomes remain unclear, and accurate prognostic measures are lacking.
This study wants to learn if these problems are related to certain patterns of breathing that babies had while they were in the NICU.
Enrolled in any Institutional Review Board (IRB) protocol of the Pre-Vent Study that had signed consent, or in any IRB protocol of the Pre-Vent Study that authorized re-contact for future research
Born <29 weeks gestational age
Age at enrollment less than 7 years old
Subject was withdrawn from the Pre-Vent study after signing Pre-Vent consent form, for any reason
Subject had no physiological data recorded as part of Pre-Vent
Lack of regulatory approval from local IRB or Department of Children and Family Services (DCFS) to recontact subjects
Adopted by non-consenting family
The study population will be drawn from surviving, previously consented children in the existing Pre-Vent study cohort or in any IRB protocol of the Pre-Vent study that authorized re-contact for future research, which was drawn from Neonatal Intensive Care Unit Populations in Chicago, IL; Cleveland, OH; Birmingham, AB; or Miami, FL, USA. Up to 500 children will be enrolled after parent/guardian provides informed consent. Parents, guardians or primary caretakers will act as proxies for providing information about the children.
Cohort
Prospective
Not listed
Asthma
Doctor diagnosed asthma as assessed in the International Study on Asthma and Allergies in Childhood questionnaire (ISAAC)
Sleep Disordered Breathing (SDB)
Sleep-Related Breathing Disorder (SRBD) score \>= 0.33. Scores \>0.33 are considered positive and suggestive of high-risk for a pediatric sleep-related breathing disorder.
Neurodevelopmental Impairment (NDI)
≤10th percentile in any of the National Institutes of Health (NIH) Toolbox domains may indicate neurodevelopmental impairment.
Respiratory Symptoms
Respiratory Symptoms reported on the ISAAC Questionnaire
Medically attended respiratory illnesses
Medically attended respiratory illnesses in the past year by ISAAC questionnaire
Asthma Severity
Asthma Severity by Modified Composite Asthma Severity Score (MCASI). Minimum value = 0. Max value = 21. Higher scores mean a worse outcome.
Sleep Disordered Breathing (SDB)
Score on SDB questionnaire. Scores \>0.33 are considered positive and suggestive of high-risk for a pediatric sleep-related breathing disorder.
Click on the lead sponsor to view all of their trials.
Ann & Robert H Lurie Children's Hospital of Chicago
Lead sponsor
University of Virginia
Collaborator
Case Western Reserve University
Collaborator
University of Miami
Collaborator
Northwestern University
Collaborator
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
University of Alabama at Birmingham
Collaborator
