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| Name | Class |
|---|---|
| Bay State Medical Center | UNKNOWN |
| UConn Health | OTHER |
| University of Vermont Medical Center | OTHER |
| Connecticut Children's Medical Center |
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The investigators hypothesize that Recorded Home Oximetry (RHO) utilization will not increase rates of respiratory-related re-hospitalizations and ED visits, and will not impair growth compared to standard oxygen management protocols.
Evidence-based specific consensus guidelines for home regulated oxygen management do not currently exist. Current strategies for infants requiring outpatient supplemental home oxygen include brief checks of oxygen status during monthly clinic visits. Although the infants stay on monitors, no data in between visits is obtained to ensure that infants can maintain oxygen levels after weans are made. Before finally allowing oxygen to be removed, many centers also require an overnight sleep study in the hospital, to make sure that the infant's oxygen levels stay safe when the infant is in deep sleep. Because these methods rely solely on assumptions rather than individually recorded data, an infant's time on supplemental oxygen may be prolonged or insufficient. This study will evaluate both the currently used accepted therapy and a method of weaning that involves recording and sending oxygen data for analysis in between clinic visits.
Premature infants who require home oxygen therapy at time of discharge who meet eligibility criteria will be randomized into two arms:
Arm A ("Standard therapy"): Infants' oxygen will be increased, decreased, or maintained based on brief structured assessments during monthly clinic visits.
Arm B (Recorded Home Oximetry (RHO)): Infants will have the same monthly clinic assessments as in Arm A, but also will utilize Recorded Home Oximetry (RHO) to potentially increase, decrease or maintain oxygen between monthly visits.
Parents of all infants will be interviewed using structured quality-of-life questionnaires at the beginning and ending of the oxygen management process. Health care utilization (emergency department visits and rehospitalizations) and growth will be assessed 6 months after discontinuation of oxygen.
The investigators overall objective is to determine whether Recorded Home Oximetry (RHO) can improve caregiver quality of life, and can shorten Home Oxygen Therapy (HOT) duration and eliminate need for polysomnogram, without compromising safety. The investigators will determine respiratory-related re-hospitalizations, emergency department (ED) visits, and growth parameters to confirm safety of the proposed weaning strategies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A:Standard therapy | No Intervention | Infants' oxygen will be increased, decreased, or maintained based on brief structured assessments during monthly clinic visits. Polysomnograms will be utilized prior to final discontinuation of oxygen. RHO will only be utilized on the night prior to and during the polysomnogram to compare these two modalities. | |
| Arm B:RHO | Experimental | Infants will have the same monthly clinic assessments as in Arm A, but also will utilize RHO to potentially increase, decrease or maintain oxygen between monthly visits. Parents will transmit a minimum of 4 days of stored RHO data (min 8 hrs per day) every 4-7 days. Changes in oxygen needs will be made based on standardized objective criteria. To determine discontinuation of oxygen, RHO will be utilized instead of polysomnography. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RHO | Other | Recorded oximetry data will be downloaded from home oximeters, analyzed, and used to assist in supplemental oxygen weaning decisions. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Home Oxygen Therapy | Duration of home oxygen use from time of randomization (baseline visit) to successful discontinuation of home oxygen therapy (HOT). | NICU discharge date until successful discontinuation of home oxygen therapy (HOT), up to 26 months. |
| Caregiver Quality of Life | We will compare the difference between survey-derived quality-of-life scores, comparing parent response averages while on home oxygen therapy (HOT) versus 3 months post oxygen discontinuation scores in both arms. The infant scale is composed of 36 items comprising 5 dimensions. The item scaling is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores range from 0 to 100, with a higher score indicating a higher parent satisfaction and quality of life. | Monthly while on home oxygen therapy and at 3 months post discontinuation of therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Participants With Respiratory-related Emergency Department Visits and Rehospitalizations | We will assess rates of rehospitalization or ED visit throughout the weaning process and continue to assess until 6 months post discontinuation. | WIthin 6 months of discontinuation of home oxygen |
| Growth Parameters |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lawrence Rhein, MD, MPH | University of Massachusetts, Worcester | Principal Investigator |
| Heather White, BS | University of Massachusetts, Worcester | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Connecticut Health Center | Farmington | Connecticut | 06030 | United States | ||
| Kentucky Children's Hospital at University of Kentucky |
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Eligible patients were screened from November 2013 to December 2017. Subjects were screened either before NICU discharge with anticipation of HOT therapy or at their first pulmonary clinic visit. Each subject was consented at their first outpatient pulmonary clinic or NICU follow-up clinic with a pulmonary component.
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm A:Standard Therapy | Infants' oxygen will be increased, decreased, or maintained based on brief structured assessments during monthly clinic visits. Polysomnograms will be utilized prior to final discontinuation of oxygen. RHO will only be utilized on the night prior to and during the polysomnogram to compare these two modalities. |
| FG001 | Arm B:RHO | Infants will have the same monthly clinic assessments as in Arm A, but also will utilize RHO to potentially increase, decrease or maintain oxygen between monthly visits. Parents will transmit a minimum of 4 days of stored RHO data (min 8 hrs per day) every 4-7 days. Changes in oxygen needs will be made based on standardized objective criteria. To determine discontinuation of oxygen, RHO will be utilized instead of polysomnography. RHO: Recorded oximetry data will be downloaded from home oximeters, analyzed, and used to assist in supplemental oxygen weaning decisions. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm A:Standard Therapy | Infants' oxygen will be increased, decreased, or maintained based on brief structured assessments during monthly clinic visits. Polysomnograms will be utilized prior to final discontinuation of oxygen. RHO will only be utilized on the night prior to and during the polysomnogram to compare these two modalities. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Duration of Home Oxygen Therapy | Duration of home oxygen use from time of randomization (baseline visit) to successful discontinuation of home oxygen therapy (HOT). | A total of 166 infants were weaned successfully from HOT using one of our two methods, and a total of 140 subjects completed all study procedures through six months of follow-up post discontinuation of HOT. A total of 30 subjects were not weaned using either method due to being lost to follow-up, withdrawing, or parents self-weaning subject. | Posted | Median | 90% Confidence Interval | Days | NICU discharge date until successful discontinuation of home oxygen therapy (HOT), up to 26 months. |
|
Adverse events were tracked from enrollment until 6 months post home oxygen therapy discontinuation.
Grade 1: No Intervention Grade 2: Intervention without hospitalization concomitant-drug/non-drug therapy Grade 3: Hospitalization (Serious Adverse Event) Grade 4: Life Threatening, ICU Admission, Intubation (Serious Adverse Event) Grade 5: Death (Serious Adverse Event)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm A:Standard Therapy | Infants' oxygen will be increased, decreased, or maintained based on brief structured assessments during monthly clinic visits. Polysomnograms will be utilized prior to final discontinuation of oxygen. RHO will only be utilized on the night prior to and during the polysomnogram to compare these two modalities. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Viral Respiratory Event | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Former preterm infants are at an increased risk for respiratory adverse events and morbidity. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Respiratory Related Event | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Lawrence Rhein | University of Massachusetts Medical School | 508-334-6206 | Lawrence.Rhein@umassmemorial.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 14, 2016 | Jan 31, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| OTHER |
| Patient-Centered Outcomes Research Institute | OTHER |
| University of Kentucky | OTHER |
| Boston Children's Hospital | OTHER |
| Dartmouth-Hitchcock Medical Center | OTHER |
| Tufts Medical Center | OTHER |
| Westchester Medical Center | OTHER |
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Growth measurements were taken at each monthly clinic visit while on oxygen. The average for weight z-score change was calculated for each subject while on oxygen therapy. After oxygen discontinuation, growth measurements were taken at the 1 month and 6 month post wean visits. These two measurements were again averaged for each patient. The weight z-score change was found in both arms for pre and post weaning from home oxygen therapy. The weight z-score indicates the number of standard deviations away from the mean a participants weight is. A z-score of 0 is equal to the mean. Negative numbers indicate values lower than the mean and positive numbers indicate values higher than the mean. |
| Enrollment to 6 months post home oxygen therapy discontinuation |
| Growth Parameters, Weight-for-length Z-score Change | Growth measurements were taken at each monthly clinic visit while on oxygen. The average for weight for length z-score change was calculated for each subject while on oxygen therapy. After oxygen discontinuation, growth measurements were taken at the 1 month and 6 month post wean visits. These two measurements were again averaged for each patient. The weight for length z-score change was found in both arms for pre and post weaning from home oxygen therapy.The weight-for-length z-score indicates the number of standard deviations away from the mean a participants weight is. A z-score of 0 is equal to the mean. Negative numbers indicate values lower than the mean and positive numbers indicate values higher than the mean. | Enrollment through 6 months post discontinuation of home oxygen therapy |
| Lexington |
| Kentucky |
| 40536 |
| United States |
| Boston Children's Hospital | Boston | Massachusetts | 02115 | United States |
| Baystate Medical Center | Springfield | Massachusetts | 01199 | United States |
| UMass Memorial Medical Center | Worcester | Massachusetts | 01655 | United States |
| Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire | 03766 | United States |
| Boston Children's Hospital Physicians | Valhalla | New York | 10595 | United States |
| University of Vermont Medical Center | Burlington | Vermont | 05401 | United States |
| Physician Decision |
|
| Lost to Follow-up |
|
| 6 Month Follow-up Not Complete |
|
| BG001 |
| Arm B:RHO |
Infants will have the same monthly clinic assessments as in Arm A, but also will utilize RHO to potentially increase, decrease or maintain oxygen between monthly visits. Parents will transmit a minimum of 4 days of stored RHO data (min 8 hrs per day) every 4-7 days. Changes in oxygen needs will be made based on standardized objective criteria. To determine discontinuation of oxygen, RHO will be utilized instead of polysomnography. RHO: Recorded oximetry data will be downloaded from home oximeters, analyzed, and used to assist in supplemental oxygen weaning decisions. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Respiratory Support at 36 Weeks | Count of Participants | Participants |
|
| Diuretics | Count of Participants | Participants |
|
| Birth Weight | Mean | Standard Deviation | grams |
|
| Gestational Age (wks) | Mean | Standard Deviation | Birth Gestational Age (Weeks) |
|
| Length of NICU Stay (days) | Mean | Standard Deviation | days |
|
| OG001 | Arm B:RHO | Infants will have the same monthly clinic assessments as in Arm A, but also will utilize RHO to potentially increase, decrease or maintain oxygen between monthly visits. Parents will transmit a minimum of 4 days of stored RHO data (min 8 hrs per day) every 4-7 days. Changes in oxygen needs will be made based on standardized objective criteria. To determine discontinuation of oxygen, RHO will be utilized instead of polysomnography. RHO: Recorded oximetry data will be downloaded from home oximeters, analyzed, and used to assist in supplemental oxygen weaning decisions. |
|
|
|
| Primary | Caregiver Quality of Life | We will compare the difference between survey-derived quality-of-life scores, comparing parent response averages while on home oxygen therapy (HOT) versus 3 months post oxygen discontinuation scores in both arms. The infant scale is composed of 36 items comprising 5 dimensions. The item scaling is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores range from 0 to 100, with a higher score indicating a higher parent satisfaction and quality of life. | The final cohort included 196 infants, of those infants 105 parents completed at least one pre-parent satisfactory survey and one post-survey. | Posted | Mean | Standard Deviation | score on a scale | Monthly while on home oxygen therapy and at 3 months post discontinuation of therapy |
|
|
|
|
| Secondary | Participants With Respiratory-related Emergency Department Visits and Rehospitalizations | We will assess rates of rehospitalization or ED visit throughout the weaning process and continue to assess until 6 months post discontinuation. | Posted | Number | participants | WIthin 6 months of discontinuation of home oxygen |
|
|
|
| Secondary | Growth Parameters | Growth measurements were taken at each monthly clinic visit while on oxygen. The average for weight z-score change was calculated for each subject while on oxygen therapy. After oxygen discontinuation, growth measurements were taken at the 1 month and 6 month post wean visits. These two measurements were again averaged for each patient. The weight z-score change was found in both arms for pre and post weaning from home oxygen therapy. The weight z-score indicates the number of standard deviations away from the mean a participants weight is. A z-score of 0 is equal to the mean. Negative numbers indicate values lower than the mean and positive numbers indicate values higher than the mean. | We had data for 87 and 72 infants in the standard of care arm and RHO arm, respectively, during the O2 weaning process, and 80 and 73 infants after O2 discontinuation. | Posted | Mean | Standard Deviation | Weight z-score change | Enrollment to 6 months post home oxygen therapy discontinuation |
|
|
|
| Secondary | Growth Parameters, Weight-for-length Z-score Change | Growth measurements were taken at each monthly clinic visit while on oxygen. The average for weight for length z-score change was calculated for each subject while on oxygen therapy. After oxygen discontinuation, growth measurements were taken at the 1 month and 6 month post wean visits. These two measurements were again averaged for each patient. The weight for length z-score change was found in both arms for pre and post weaning from home oxygen therapy.The weight-for-length z-score indicates the number of standard deviations away from the mean a participants weight is. A z-score of 0 is equal to the mean. Negative numbers indicate values lower than the mean and positive numbers indicate values higher than the mean. | We had data for 87 and 72 infants in the standard of care arm and RHO arm, respectively, during the O2 weaning process, and 80 and 73 infants after O2 discontinuation. | Posted | Mean | Standard Error | Weight-for-Length z-score change | Enrollment through 6 months post discontinuation of home oxygen therapy |
|
|
|
| 41 |
| 99 |
| 28 |
| 99 |
| 13 |
| 99 |
| EG001 | Arm B:RHO | Infants will have the same monthly clinic assessments as in Arm A, but also will utilize RHO to potentially increase, decrease or maintain oxygen between monthly visits. Parents will transmit a minimum of 4 days of stored RHO data (min 8 hrs per day) every 4-7 days. Changes in oxygen needs will be made based on standardized objective criteria. To determine discontinuation of oxygen, RHO will be utilized instead of polysomnography. RHO: Recorded oximetry data will be downloaded from home oximeters, analyzed, and used to assist in supplemental oxygen weaning decisions. | 26 | 97 | 19 | 97 | 10 | 97 |
|
| Feeding Issue/G-Tube Complication | Gastrointestinal disorders | Systematic Assessment |
|
| Other | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Other serious adverse events related to prematurity |
|
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| D000091642 | Urogenital Diseases |
| Life Threatening, ICU admission or Intubation (G4) |
|
| Hospitalization (G3) |
|
| Intervention without hospitalization |
|
| Event During Respiratory Virus Season |
|
| Event During Non-Respiratory Season |
|
| Respiratory Related Events |
|
| Non-Respiratory Related Events |
|