Local Version of the Multi-center PREVENT Study Evaluating Cardio-respiratory Instability in Premature Infants
Evaluating Cardiorespiratory Development in Premature Babies
2 other identifiers
observational
99
1 country
2
Brief Summary
Infants who are born prematurely have immature nervous and cardiorespiratory systems. These are systems infants use to breathe, to move oxygen throughout their bodies, and to maintain safe and stable levels of oxygen and carbon dioxide. The goal of this study is to better understand how these immature systems affect long term development, such as brain, heart, and motor function (movement) with several innovative, integrated physiological measures. We hope this will allow us to begin to find better ways to help premature infants breathe and to optimize their development.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Sep 2018
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 22, 2018
CompletedFirst Posted
Study publicly available on registry
August 31, 2018
CompletedStudy Start
First participant enrolled
September 9, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 3, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
ExpectedNovember 12, 2024
November 1, 2024
3.5 years
August 22, 2018
November 11, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Change in cardiorespiratory coupling between 28 weeks postmenstrual age and 1 year
Average cross-spectral coherence between heart rate and respiratory rate summed within the high frequency band (above 0.15 Hz; ratiometric units). Higher coherence indicates better coupling.
1 year
Secondary Outcomes (1)
Neurodevelopmental outcomes as measured with the Neurological, Sensory, Motor, Developmental Assessment (NSMDA) functional grade
1 year
Other Outcomes (2)
Change in right ventricle-pulmonary circulation (RV-PC) axis function between 32 and 36 weeks postmenstrual age
36 weeks postmenstrual age
Changes in circulating levels of fibroblast growth factor 2 (FGF2) and granulocyte macrophage colony stimulating factor (G-CSF) between 32 and 36 weeks postmenstrual age
36 weeks postmenstrual age
Study Arms (1)
Premature Birth
Premature babies born under 29 weeks gestational age, admitted into the neonatal intensive care unit within 7 days of life.
Eligibility Criteria
Premature babies born under 29 weeks of gestational age, who are admitted into the neonatal intensive care unit within a week of birth.
You may qualify if:
- birth between 24 and 29 weeks of gestation
- less than 1 week of age
You may not qualify if:
- known congenital anomalies
- imminent death
- factors that preclude reliable follow-up
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611, United States
Northwestern Memorial Hospital
Chicago, Illinois, 60611, United States
Biospecimen
Buccal DNA swab
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Aaron Hamvas
Ann & Robert H Lurie Children's Hospital of Chicago
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 22, 2018
First Posted
August 31, 2018
Study Start
September 9, 2018
Primary Completion
March 3, 2022
Study Completion (Estimated)
December 31, 2026
Last Updated
November 12, 2024
Record last verified: 2024-11