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Active, not recruitingNCT03709199Updated Apr 17, 2025

Long Term Follow up of Children Enrolled in the REDvent Study

An observational study in Respiratory Distress Syndrome, Adult, Ventilator-Induced Lung Injury and Neurocognitive Dysfunction, sponsored by Children's Hospital Los Angeles. Active, not recruiting at 1 site in United States. Open to participants aged 1 Month to 18 Years. Per ClinicalTrials.gov, last updated 2025-04-17.

Sponsored by Children's Hospital Los Angeles · Observational

From the registry’s dates

  • Primary completion was expected by May 2026, 5 months ago, but the record still lists the study as active, not recruiting.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
176
Ages
1 Month to 18 Years
Sex
All
01

Study summary

This is a prospective observational follow-up study of children enrolled in a single center randomized controlled trial (REDvent).

Nearly 50% of adult Acute Respiratory Distress Syndrome (ARDS) survivors are left with significant abnormalities in pulmonary, physical, neurocognitive function and Health Related Quality of Life (HRQL) which may persist for years.Data in pediatric ARDS (PARDS) survivors is limited. More importantly, there are no data identifying potentially modifiable factors during ICU care which are associated with long term impairments, which may include medication choices, or complications from mechanical ventilator (MV) management in the ICU including ventilator induced lung injury (VILI) or ventilator induced diaphragm dysfunction (VIDD).

The Real-time effort driven ventilator (REDvent) trial is testing a ventialtor management algorithm which may prevent VIDD and VILI. VIDD and VILI have strong biologic plausibility to affect the post-ICU health of children with likely sustained effects on lung repair and muscle strength. Moreover, common medication choices (i.e. neuromuscular blockade, corticosteroids) or other complications in the ICU (i.e. delirium) are likely to have independent effects on the long term health of these children. This proposed study will obtain serial follow-up of subjects enrolled in REDvent (intervention and control patients). The central hypothesis is that preventing VIDD, VILI and shortening time on MV will have a measureable impact on longer term function by mitigating abnormalities in pulmonary function (PFTs), neurocognitive function and emotional health, functional status and HRQL after hospital discharge for children with PARDS.

For all domains, the investigators will determine the frequency, severity and trajectory of recovery of abnormalities amongst PARDS survivors after ICU discharge, identify risk factors for their development, and determine if they are prevented by REDvent. They will leverage the detailed and study specific respiratory physiology data being obtained in REDvent, and use a variety of multi-variable models for comprehensive analysis. Completion of this study will enable the investigators to identify ICU related therapies associated with poor long term outcome, and determine whether they can be mitigated by REDvent.

02

Conditions studied

  • Respiratory Distress Syndrome, Adult
  • Ventilator-Induced Lung Injury
  • Neurocognitive Dysfunction
  • Quality of Life
  • Respiration Disorders
03

In context

Respiratory Distress Syndrome

1,597 studies on the registry are indexed under Respiratory Distress Syndrome; 312 are open to participants now.

This study's enrollment of 176 is above the median of 100 across 540 observational studies indexed under Respiratory Distress Syndrome.

Browse Respiratory Distress Syndrome studies →

Lead sponsor

Children's Hospital Los Angeles is the lead sponsor of 150 studies on the registry; 46 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Month to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

This is a long term follow-up of children already enrolled in the RED-vent study.

Inclusion criteria

  1. Children > 1 month (at least 44 weeks Corrected Gestational Age) and ≤ 18 years of age AND
  2. Supported on mechanical ventilation for pulmonary parenchymal disease (i.e., pneumonia, bronchiolitis, Pediatric Acute Respiratory Distress Syndrome (PARDS)) with Oxygen Saturation Index (OSI) ≥ 5 or Oxygenation Index (OI) ≥4 115 AND
  3. Who are within 48 hours of initiation of invasive mechanical ventilation (allow for up to 72 hours for those transferred from another institution) AND
  4. Enrolled in the REDvent Study

Exclusion criteria

Exclusion Criteria (1-5 are REDvent exclusion):

  1. Contraindications to use of an esophageal catheter (i.e. severe mucosal bleeding, nasal encephalocele, transphenoidal surgery) OR
  2. Contraindications to use of RIP bands (i.e. omphalocele, chest immobilizer or cast) OR
  3. Conditions precluding diaphragm ultrasound measurement (i.e. abdominal wall defects, pregnancy) OR
  4. Conditions precluding conventional methods of weaning (i.e., status asthmaticus, severe lower airway obstruction, critical airway, intracranial hypertension, Extra Corporeal Life Support (ECLS), intubation for UAO, tracheostomy, DNR, severe chronic respiratory failure, spinal cord injury above lumbar region, cyanotic heart disease (unrepaired or palliated)) OR
  5. Primary Attending physician refuses (will be cleared with primary attending before approaching the patient) OR
  6. Death in the ICU OR
  7. New DNR orders during acute illness in ICU OR
  8. Primary Language not English or Spanish OR
  9. Children in foster care or a ward of the state.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
176 participants (actual)
Patient registry
No

Interventions

  • Diagnostic testVentilation Inhomogeneity

    Ventilation inhomogeneity will be measured using the Lung Clearance Index (LCI), derived from multiple breath Nitrogen washout during tidal breathing, measured by a mouthpiece or mask covering nose and mouth.

    Also known as: Lung Clearance Index

  • Diagnostic testDiaphragm Ultrasound

    Diaphragm thickness and contractile activity measured during tidal breathing.

  • Diagnostic testRespiratory Inductance Plethysmography

    Measure of thoraco-abdominal asynchrony during tidal breathing

    Also known as: Phase Angle

  • Diagnostic testSpirometry

    Measurement of Forced Expiratory Volume (FEV1), Forced Vital Capacity and other lung volumes using standard pulmonary function techniques

    Also known as: Pulmonary Function Tests

  • Diagnostic testFunctional Residual Capacity

    Measurement using body box plethysmography of functional residual capacity and other lung volumes using standard pulmonary function techniques

    Also known as: Pulmonary Function Tests

  • Diagnostic testMIP/MEP

    Measurement of maximal inspiratory and expiratory pressures during airway occlusion

  • Diagnostic test6 minute walk test

    Measurement of cardio-respiratory function and capabilities during treadmill walking for 6 minutes.

  • Diagnostic testNeurocognitive Testing

    Detailed in person neuro-cognitive testing using standardized inventories using either the Battelle Developmental Inventory, second edition (Battelle-2) (age birth to 5 years 11 months) and the Wechsler Intelligence Scale for Children, fifth edition (WISC-5, for age 6 years to 19 years).

  • Diagnostic testEmotional Health Assessment

    In person and written assessments of children and parents using the Behavioral Assessment System for Children, third edition (BASC-3) for children ≥ 2 years and the UCLA PTSD Reaction Index (UCLA RI) for children ≥ 8 years.

  • Diagnostic testHealth Related Quality of Life

    Standardized instruments to assess (in person, over the phone, or via mail) health related quality of life in children. Parent and child questionnaires.

    Also known as: PEDS-QL

  • Diagnostic testFunctional Status

    Survey of overall functional status, administrated by asking a series of questions to patient and families.

    Also known as: Functional Status Scale

  • Diagnostic testRespiratory Status Questionnaire

    Survey of respiratory health, administrated by asking a series of questions to patient and families.

06

What researchers measure

Primary outcomes

  1. Ventilation In-homogeneity using lung clearance index with nitrogen washout

    Measured by lung clearance index during multiple breath nitrogen washout testing reported as percent predicted based on age and height as well as a raw number typically ranging from 5-15.

    Time frame: 6 months after ICU discharge

  2. Neurocognitive function using a standardized score derived from Batelle-2 or WISC-5 cognitive tests

    Standardized IQ-like score derived from Batelle-2 or WISC-5 cognitive tests based on age. Children \< 6 years will receive the Batelle-2 and children \>=6 will receive the WISC-5. Overall score will be use for analysis with a higher value indicating better cognitive function. The range of "average" cognitive function lies between 90-109. Both tests are scored on the same scale

    Time frame: 3 months after ICU discharge

  3. Health Related Quality of Life as measured by PedsQL generic core scale

    PedsQL generic core scale, with range from 0-100, with the higher score indicating better health related quality of life

    Time frame: 3 months after ICU discharge

  4. Functional Status as measured by the pediatric functional status scale

    Functional status scale which is scored from normal (score =1) to very severe dysfunction (score =5) in each of 6 domains. The sum score of all domains will be used for analysis, yielding a minimum possible score of 6 and a maximum possible score of 30. Analysis will focus on a change in FSS from baseline (assessed as functional status 1 month prior to ICU admission). An increase in the FSS from baseline to 3 months will be considered as a decline in functional status.

    Time frame: 3 months after ICU discharge

Secondary outcomes

  1. Functional Residual Capacity (Lung volume at end-expiration).

    Measured by body box plethysmography and nitrogen washout techniques, normalized by age, height and gender. Values below or above normative values will be considered abnormal.

    Time frame: Prior to Hospital Discharge and no more than 1 month after ICU discharge

  2. Functional Residual Capacity (Lung volume at end-expiration).

    Measured by body box plethysmography and nitrogen washout techniques, normalized by age, height and gender. Values below or above normative values will be considered abnormal.

    Time frame: 6 months after ICU discharge

  3. Phase Angle (a measure of thoraco-abdominal asynchrony and abnormal respiratory mechanics)

    Respiratory Inductance Plethysmography belts are used during tidal breathing to measure thoraco-abdominal asyncrhony. Higher values will be considered abnormal with a range from 0-180.

    Time frame: Prior to Hospital Discharge and no more than 1 month after ICU discharge

  4. Phase Angle (a measure of thoraco-abdominal asynchrony and abnormal respiratory mechanics)

    Respiratory Inductance Plethysmography belts are used during tidal breathing to measure thoraco-abdominal asyncrhony. Higher values will be considered abnormal with a range from 0-180.

    Time frame: 6 Months after ICU Discharge

  5. Diaphragm Thickness on exhalation

    Diaphragm ultrasound measurement of thickness at end exhalation measured in zone of apposition of right hemi-diaphragm

    Time frame: Prior to Hospital Discharge and no more than 1 month after ICU discharge

  6. Diaphragm Thickness on exhalation

    Diaphragm ultrasound measurement of thickness at end exhalation measured in zone of apposition of right hemi-diaphragm

    Time frame: 6 months after ICU discharge

  7. Diaphragm Thickness on inspiration

    Diaphragm ultrasound measurement of thickness at end inspiration measured in zone of apposition of right hemi-diaphragm

    Time frame: Prior to Hospital Discharge and no more than 1 month after ICU discharge

  8. Diaphragm Thickness on inspiration

    Diaphragm ultrasound measurement of thickness at end inspiration measured in zone of apposition of right hemi-diaphragm

    Time frame: 6 months after ICU discharge

  9. Diaphragm Thickening fraction (measure of contractile activity)

    Diaphragm ultrasound measurement calculated as (thickness at end inspiration-thickness at end expiration)/(thickness at end expiration) measured in zone of apposition of right hemi-diaphragm.

    Time frame: Prior to Hospital Discharge and no more than 1 month after ICU discharge

  10. Diaphragm Thickening fraction (measure of contractile activity)

    Diaphragm ultrasound measurement calculated as (thickness at end inspiration-thickness at end expiration)/(thickness at end expiration) measured in zone of apposition of right hemi-diaphragm.

    Time frame: 6 months after ICU discharge

  11. Ventilation In-homogeneity using lung clearance index with nitrogen washout

    Measured by lung clearance index during multiple breath nitrogen washout testing reported as percent predicted based on age and height as well as a raw number typically ranging from 5-15.

    Time frame: Prior to Hospital Discharge and no more than 1 month after ICU discharge

  12. Forced Expiratory Volume in 1 second (FEV1)

    Spirometry based measures of pulmonary function of forced expiratory volume, normalized based on age, height, and gender and reported as percent predicted.

    Time frame: Prior to Hospital Discharge and no more than 1 month after ICU discharge

  13. Forced Expiratory Volume in 1 second (FEV1)

    Spirometry based measures of pulmonary function of forced expiratory volume, normalized based on age, height, and gender and reported as percent predicted.

    Time frame: 6 months after ICU discharge

  14. Forced Vital Capacity (FVC)

    Spirometry based measures of pulmonary function of forced vital capacity, normalized based on age, height, and gender and reported as percent predicted.

    Time frame: Prior to Hospital Discharge and no more than 1 month after ICU discharge

  15. Forced Vital Capacity (FVC)

    Spirometry based measures of pulmonary function of forced vital capacity, normalized based on age, height, and gender and reported as percent predicted.

    Time frame: 6 months after ICU discharge

  16. Forced expiratory flow at 25-75% (FEF 25-75)

    Spirometry based measures of pulmonary function of forced expiratory flow at 25-75% of breath, normalized based on age, height, and gender and reported as percent predicted.

    Time frame: Prior to Hospital Discharge and no more than 1 month after ICU discharge

  17. Forced expiratory flow at 25-75% (FEF 25-75)

    Spirometry based measures of pulmonary function of forced expiratory flow at 25-75% of breath, normalized based on age, height, and gender and reported as percent predicted.

    Time frame: 6 months post ICU discharge

  18. VT - tidal volume from spirometry during tidal breathing

    Lung volume measurements obtained during tidal breathing, normalized in ml/kg ideal body weight.

    Time frame: Prior to Hospital Discharge and no more than 1 month after ICU discharge

  19. VT - tidal volume from spirometry during tidal breathing

    Lung volume measurements obtained during tidal breathing, normalized in ml/kg ideal body weight.

    Time frame: 6 months after ICU discharge

  20. Total Lung Capacity- TLC measured during spirometry

    Lung volume measurements obtained during pulmonary function tests with spirometry and body box plethysmography to calculate total lung capacity, normalized by age, height and gender.

    Time frame: Prior to Hospital Discharge and no more than 1 month after ICU discharge

  21. Total Lung Capacity- TLC measured during spirometry

    Lung volume measurements obtained during pulmonary function tests with spirometry and body box plethysmography to calculate total lung capacity, normalized by age, height and gender.

    Time frame: 6 months after ICU discharge

  22. Forced vital capacity- measured during spirometry

    Lung volume measurements obtained during pulmonary function tests with spirometry to calculate forced vital capacity, normalized by age, height and gender.

    Time frame: Prior to Hospital Discharge and no more than 1 month after ICU discharge

  23. Forced vital capacity- measured during spirometry

    Lung volume measurements obtained during pulmonary function tests with spirometry to calculate forced vital capacity, normalized by age, height and gender.

    Time frame: 6 months after ICU discharge

  24. Respiratory Muscle Strength Maximum inspiratory pressure (MIP)

    Maximal inspiratory pressure measurements during airway occlusion in cm H20

    Time frame: Prior to Hospital Discharge and no more than 1 month after ICU discharge

  25. Respiratory Muscle Strength Maximum inspiratory pressure (MIP)

    Maximal inspiratory pressure measurements during airway occlusion in cm H20

    Time frame: 6 months after ICU discharge

  26. Respiratory Muscle Strength Maximum expiratory pressure (MEP)

    Maximal expiratory pressure measurements during airway occlusion in cm H20

    Time frame: Prior to Hospital Discharge and no more than 1 month after ICU discharge

  27. Respiratory Muscle Strength Maximum expiratory pressure (MEP)

    Maximal expiratory pressure measurements during airway occlusion in cm H20

    Time frame: 6 months after ICU discharge

  28. Neurocognitive function using a standardized score derived from Batelle-2 or WISC-5 cognitive tests

    Standardized IQ-like score derived from Batelle-2 or WISC-5 cognitive tests. Overall score will be use for analysis with a higher value indicating better cognitive function. The range of "average" cognitive function lies between 90-109.

    Time frame: 12 months after ICU discharge

  29. Health Related Quality of Life as measured by PedsQL generic core scale

    PedsQL generic core scale, with range from 0-100, with the higher score indicating better health related quality of life

    Time frame: ICU discharge

  30. Health Related Quality of Life as measured by PedsQL generic core scale

    PedsQL generic core scale, with range from 0-100, with the higher score indicating better health related quality of life

    Time frame: 1 month after ICU discharge

  31. Health Related Quality of Life as measured by PedsQL generic core scale

    PedsQL generic core scale, with range from 0-100, with the higher score indicating better health related quality of life

    Time frame: 2 months after ICU discharge

  32. Health Related Quality of Life as measured by PedsQL generic core scale

    PedsQL generic core scale, with range from 0-100, with the higher score indicating better health related quality of life

    Time frame: 6 months after ICU discharge

  33. Health Related Quality of Life as measured by PedsQL generic core scale

    PedsQL generic core scale, with range from 0-100, with the higher score indicating better health related quality of life

    Time frame: 12 months after ICU discharge

  34. Functional Status as measured by the pediatric functional status scale

    Functional status scale which is scored from normal (score =1) to very severe dysfunction (score =5) in each of 6 domains. The sum score of all domains will be used for analysis, yielding a minimum possible score of 6 and a maximum possible score of 30. Analysis will focus on a change in FSS from baseline (assessed as functional status 1 month prior to ICU admission). An increase in the FSS from baseline will be considered as a decline in functional status.

    Time frame: ICU discharge

  35. Functional Status as measured by the pediatric functional status scale

    Functional status scale which is scored from normal (score =1) to very severe dysfunction (score =5) in each of 6 domains. The sum score of all domains will be used for analysis, yielding a minimum possible score of 6 and a maximum possible score of 30. Analysis will focus on a change in FSS from baseline (assessed as functional status 1 month prior to ICU admission). An increase in the FSS from baseline will be considered as a decline in functional status.

    Time frame: 1 month after ICU discharge

  36. Functional Status as measured by the pediatric functional status scale

    Functional status scale which is scored from normal (score =1) to very severe dysfunction (score =5) in each of 6 domains. The sum score of all domains will be used for analysis, yielding a minimum possible score of 6 and a maximum possible score of 30. Analysis will focus on a change in FSS from baseline (assessed as functional status 1 month prior to ICU admission). An increase in the FSS from baseline will be considered as a decline in functional status.

    Time frame: 2 months after ICU discharge

  37. Functional Status as measured by the pediatric functional status scale

    Functional status scale which is scored from normal (score =1) to very severe dysfunction (score =5) in each of 6 domains. The sum score of all domains will be used for analysis, yielding a minimum possible score of 6 and a maximum possible score of 30. Analysis will focus on a change in FSS from baseline (assessed as functional status 1 month prior to ICU admission). An increase in the FSS from baseline will be considered as a decline in functional status.

    Time frame: 6 months after ICU discharge

  38. Functional Status as measured by the pediatric functional status scale

    Functional status scale which is scored from normal (score =1) to very severe dysfunction (score =5) in each of 6 domains. The sum score of all domains will be used for analysis, yielding a minimum possible score of 6 and a maximum possible score of 30. Analysis will focus on a change in FSS from baseline (assessed as functional status 1 month prior to ICU admission). An increase in the FSS from baseline will be considered as a decline in functional status.

    Time frame: 12 months after ICU discharge

  39. Respiratory Status - questionnaire detailing respiratory medications and therapies as well as healthcare utilization.

    Series of questions to detail respiratory based morbidity

    Time frame: ICU discharge

  40. Respiratory Status - questionnaire detailing respiratory medications and therapies as well as healthcare utilization.

    Series of questions to detail respiratory based morbidity

    Time frame: 1 month after ICU discharge

  41. Respiratory Status - questionnaire detailing respiratory medications and therapies as well as healthcare utilization.

    Series of questions to detail respiratory based morbidity

    Time frame: 2 months after ICU discharge

  42. Respiratory Status - questionnaire detailing respiratory medications and therapies as well as healthcare utilization.

    Series of questions to detail respiratory based morbidity

    Time frame: 3 months after ICU discharge

  43. Respiratory Status - questionnaire detailing respiratory medications and therapies as well as healthcare utilization.

    Series of questions to detail respiratory based morbidity

    Time frame: 6 months after ICU discharge

  44. Respiratory Status - questionnaire detailing respiratory medications and therapies as well as healthcare utilization.

    Series of questions to detail respiratory based morbidity

    Time frame: 12 months after ICU discharge

  45. Emotional Health Outcomes using the (BASC-3) to assess emotional and behavioral abnormalities and UCLA Reaction Index to assess post traumatic stress

    The Behavioral Assessment System for Children, third edition (BASC-3) for children ≥ 2 years will be used to assess for emotional and behavioral abnormalities as a survey tool. The UCLA PTSD Reaction Index (UCLA RI) will be used for children ≥ 8 years. The UCLA RI is a semi-structured interview assessing for exposure to traumatic events and PTS in children.

    Time frame: 3 months after ICU discharge

  46. Emotional Health Outcomes using the (BASC-3) to assess emotional and behavioral abnormalities and UCLA Reaction Index to assess post traumatic stress

    The Behavioral Assessment System for Children, third edition (BASC-3) for children ≥ 2 years will be used to assess for emotional and behavioral abnormalities as a survey tool. The UCLA PTSD Reaction Index (UCLA RI) will be used for children ≥ 8 years. The UCLA RI is a semi-structured interview assessing for exposure to traumatic events and PTS in children.

    Time frame: 12 months after ICU discharge

Other outcomes

  1. 6 minute walk test

    Measure of cardio-respiratory function after treadmill walking

    Time frame: Prior to Hospital Discharge and no more than 1 month after ICU discharge

  2. 6 minute walk test

    Measure of cardio-respiratory function after treadmill walking

    Time frame: 6 months after ICU discharge

07

Study locations

1 site
  • Children's Hospital Los Angeles
    Los Angeles, California 90027, United States
08

References and documents

Individual participant data

Plan to share: No — There is no plan to share IPD with other researchers

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 17, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03709199
Lead sponsor
Children's Hospital Los Angeles
Responsible party
Robinder Khemani (Principal Investigator, Children's Hospital Los Angeles) — Principal investigator
First posted
Oct 17, 2018
Start date
Oct 1, 2018
Primary completion
May 1, 2026 (estimated)
Completion
May 1, 2026 (estimated)
Last update
Apr 17, 2025

Study contacts

Robinder Khemani, MD
principal investigator · Children's Hospital Los Angeles

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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