An observational study in Premature Birth, Asthma in Children and Sleep-Disordered Breathing, sponsored by Ann & Robert H Lurie Children's Hospital of Chicago. Recruiting at 1 site in United States. Open to participants aged 30 Weeks to 83 Months. Per ClinicalTrials.gov, last updated 2026-09-15.
Sponsored by Ann & Robert H Lurie Children's Hospital of Chicago · Observational
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.
Asthma, SDB, and NDI are common consequences of preterm birth with significant impact on child and family quality of life and public health. To date, the mechanisms leading to these outcomes remain unclear, and improvements in neonatal care have not improved these outcomes. While early detection and intervention can reduce the burden of these outcomes, methods for early identification of infants destined for these morbidities is currently lacking. Utilizing the Pre-Vent cohort to investigate potential underlying causes and identify predictors for these conditions as we propose here is essential to inform future prevention and intervention strategies that promote optimal health and development.
Recent compelling data indicate that early postnatal intermittent hypoxemia (IH) events may play a role in undesirable outcomes. Early postnatal IH events in extremely preterm infants are associated with bronchopulmonary dysplasia (BPD), asthma medication at 2 years, and NDI at 18 months. The ability of IH to perturb maturation of long-term respiratory control has been demonstrated in neonatal rodents consistent with preterm infants being at heightened risk for childhood SDB. Although evidence is emerging that IH events are linked to poor outcomes in premature infants, the specific relationship between distinct IH patterns (e.g. duration, timing, frequency, and nadir) and longer-term respiratory and neurologic function remains to be elucidated.
2,550 studies on the registry are indexed under Premature Birth; 500 are open to participants now.
This study's planned enrollment of 500 is above the median of 120 across 806 observational studies indexed under Premature Birth.
Browse Premature Birth studies →Ann & Robert H Lurie Children's Hospital of Chicago is the lead sponsor of 180 studies on the registry; 28 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 5 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Asthma
Doctor diagnosed asthma as assessed in the International Study on Asthma and Allergies in Childhood questionnaire (ISAAC)
Time frame: 5 years ± 6 months of age
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.
Time frame: 5 years ± 6 months of age
Neurodevelopmental Impairment (NDI)
≤10th percentile in any of the National Institutes of Health (NIH) Toolbox domains may indicate neurodevelopmental impairment.
Time frame: 5 years ± 6 months of age
Respiratory Symptoms
Respiratory Symptoms reported on the ISAAC Questionnaire
Time frame: 5 yr. (+/- 6 months)
Medically attended respiratory illnesses
Medically attended respiratory illnesses in the past year by ISAAC questionnaire
Time frame: 5 yr. (+/- 6 months)
Asthma Severity
Asthma Severity by Modified Composite Asthma Severity Score (MCASI). Minimum value = 0. Max value = 21. Higher scores mean a worse outcome.
Time frame: 5 yr. (+/- 6 months)
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.
Time frame: 5 yr. (+/- 6 months)
Motor Function
Motor Function based on NIH Toolbox Motor Battery
Time frame: 5 yr. (+/- 6 months)
Gross Motor Function
Motor Function based on Gross Motor Functional Classification System
Time frame: 5 yr. (+/- 6 months)
Cognitive Function
Cognitive Function based on NIH Toolbox Cognitive Battery
Time frame: 5 yr. (+/- 6 months)
Executive Function
Executive Function based on Behavior rating inventory of executive function
Time frame: 5 yr. (+/- 6 months)
Social, Emotional and Behavioral Outcomes
Social, Emotional and Behavioral Outcomes based on NIH Toolbox Parent Proxy Emotion Battery
Time frame: 5 yr. (+/- 6 months)
Sensory Outcomes: Odor Identification
Sensory Outcomes based on NIH Toolbox Odor Identification Test
Time frame: 5 yr. (+/- 6 months)
Sensory Outcomes: Acuity
Sensory Outcomes based on NIH Toolbox Visual Acuity Test
Time frame: 5 yr. (+/- 6 months)
Pediatric Quality of life
Quality of life as assessed by the Pediatric Quality of Life parent proxy questionnaire
Time frame: 5 yr. (+/- 6 months)
Health utilization
Health utilization, based on broad health parent questionnaire
Time frame: 5 yr. (+/- 6 months)
Medications
Medications based on broad health parent questionnaire
Time frame: 5 yr. (+/- 6 months)
Doctor Diagnosed Asthma
Doctor Diagnosed Asthma based on ISAAC
Time frame: 6 mo through 5 yr. +6 months
Respiratory Symptoms
Respiratory Symptoms based on ISAAC
Time frame: 6 mo through 5 yr. +6 months
Medically attended respiratory illnesses
Medically attended respiratory illnesses in past year based on broad health parent questionnaire
Time frame: 6 mo through 5 yr. +6 months
Asthma Severity: Modified Composite Asthma Severity Index(MCASI)
Asthma Severity by MCASI score. Minimum value = 0. Max value = 21. Higher scores mean a worse outcome.
Time frame: 6 mo through 5 yr. +6 months
Asthma Severity: Global Initiative for Asthma criteria (GINA)
Asthma Severity using GINA criteria based on broad health parent questionnaire. A score of 19 or less indicates poorly controlled asthma, while a score greater than 19 indicates well-controlled asthma.
Time frame: 6 mo through 5 yr. +6 months
Health utilization
Health utilization, based on parent broad health questionnaire
Time frame: 6 mo through 5 yr. +6 months
Plan to share: No
No publications or documents are linked to this record.
Started Nov 2022 (actual). Primary completion is estimated for Jun 2027, 55 months after the start.
Of 372 non-industry observational studies under Premature Birth, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 63. This study's planned 55 months is above that.
Counting every sponsor, half of 387 studies reached it within 35 months; a quarter within 18 and three quarters within 61.
How these figures are worked out, and which studies are left out of them.
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Ann & Robert H Lurie Children's Hospital of Chicago →