An interventional study of RHO in Premature Infants, sponsored by University of Massachusetts, Worcester. Completed at 8 sites in United States. Open to participants aged Up to 37 Weeks. Per ClinicalTrials.gov, last updated 2023-05-30.
Sponsored by University of Massachusetts, Worcester · Not applicable, Interventional, and Diagnostic
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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Exclusion Criteria:
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.
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.
Other: RHO
Recorded oximetry data will be downloaded from home oximeters, analyzed, and used to assist in supplemental oxygen weaning decisions.
Duration of Home Oxygen Therapy
Duration of home oxygen use from time of randomization (baseline visit) to successful discontinuation of home oxygen therapy (HOT).
Time frame: 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.
Time frame: Monthly while on home oxygen therapy and at 3 months post discontinuation of therapy
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.
Time frame: WIthin 6 months of discontinuation of home oxygen
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.
Time frame: 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.
Time frame: Enrollment through 6 months post discontinuation of home oxygen therapy
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.
| Milestone | Arm A:Standard Therapy | Arm B:RHO |
|---|---|---|
| Started | 99 | 97 |
| Completed | 74 | 67 |
| Not completed | 25 | 30 |
| Withdrew: Death | 1 | 0 |
| Withdrew: Withdrawal by subject | 9 | 14 |
| Withdrew: Physician decision | 2 | 2 |
| Withdrew: Lost to follow-up | 8 | 10 |
| Withdrew: 6 month follow-up not complete | 5 | 4 |
Duration of home oxygen use from time of randomization (baseline visit) to successful discontinuation of home oxygen therapy (HOT).
| Days | Arm A:Standard Therapy | Arm B:RHO |
|---|---|---|
| Duration of Home Oxygen Therapy | 66 (42 to 113) | 58 (24 to 127) |
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.
| score on a scale | Arm A:Standard Therapy | Arm B:RHO |
|---|---|---|
| Pre-Wean from HOT | 74.5 ± 16.3 | 70.4 ± 15.0 |
| Post-Wean from HOT | 78.6 ± 18.6 | 75.9 ± 17.4 |
We will assess rates of rehospitalization or ED visit throughout the weaning process and continue to assess until 6 months post discontinuation.
| participants | Arm A:Standard Therapy | Arm B:RHO |
|---|---|---|
| All Events | 41 | 25 |
| Serious Adverse Event | 28 | 19 |
| Life Threatening, ICU admission or Intubation (G4) | 7 | 6 |
| Hospitalization (G3) | 30 | 19 |
| Intervention without hospitalization | 39 | 26 |
| Event During Respiratory Virus Season | 29 | 17 |
| Event During Non-Respiratory Season | 26 | 15 |
| Respiratory Related Events | 26 | 20 |
| Non-Respiratory Related Events | 25 | 14 |
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.
| Weight z-score change | Arm A: Standard of Care, Pre-Weaning | Arm B: Intervention Arm; Pre-Weaning | Arm A: Standard of Care; Post-Weaning | Arm B: Intervention Arm; Post-Weaning |
|---|---|---|---|---|
| Growth Parameters | -0.13 ± 0.03 | -0.01 ± 0.03 | 0.02 ± 0.03 | 0.03 ± 0.03 |
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.
| Weight-for-Length z-score change | Arm A: Standard of Care, Pre-Weaning | Arm B: Intervention Arm; Pre-Weaning | Arm A: Standard of Care; Post-Weaning | Arm B: Intervention Arm; Post-Weaning |
|---|---|---|---|---|
| Growth Parameters, Weight-for-length Z-score Change | -0.17 ± 0.06 | -0.06 ± 0.07 | -0.14 ± 0.07 | 0.01 ± 0.07 |
Collected over Adverse events were tracked from enrollment until 6 months post home oxygen therapy discontinuation.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Arm A:Standard Therapy | 41/99 (41.4%) | 28/99 (28.3%) | 13/99 (13.1%) |
| Arm B:RHO | 26/97 (26.8%) | 19/97 (19.6%) | 10/97 (10.3%) |
| Event | Arm A:Standard Therapy | Arm B:RHO |
|---|---|---|
| Viral Respiratory EventRespiratory, thoracic and mediastinal disorders | 16/99 | 18/97 |
| Feeding Issue/G-Tube ComplicationGastrointestinal disorders | 8/99 | 1/97 |
| OtherRespiratory, thoracic and mediastinal disorders | 4/99 | 0/97 |
| Event | Arm A:Standard Therapy | Arm B:RHO |
|---|---|---|
| Respiratory Related EventRespiratory, thoracic and mediastinal disorders | 13/99 | 10/97 |
| Age, Customized(Participants) | Arm A:Standard Therapy | Arm B:RHO | Total |
|---|---|---|---|
| Less than 1 Year of Age | 99 | 97 | 196 |
| Sex: Female, Male(Participants) | Arm A:Standard Therapy | Arm B:RHO | Total |
|---|---|---|---|
| Female | 41 | 33 | 74 |
| Male | 58 | 64 | 122 |
| Ethnicity (NIH/OMB)(Participants) | Arm A:Standard Therapy | Arm B:RHO | Total |
|---|---|---|---|
| Hispanic or Latino | 12 | 6 | 18 |
| Not Hispanic or Latino | 61 | 65 | 126 |
| Unknown or Not Reported | 26 | 26 | 52 |
| Race (NIH/OMB)(Participants) | Arm A:Standard Therapy | Arm B:RHO | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 1 | 1 |
| Asian | 1 | 4 | 5 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 12 | 13 | 25 |
| White | 57 | 59 | 116 |
| More than one race | 7 | 5 | 12 |
| Unknown or Not Reported | 22 | 15 | 37 |
| Region of Enrollment(participants) | Arm A:Standard Therapy | Arm B:RHO | Total |
|---|---|---|---|
| United States | 99 | 97 | 196 |
| Respiratory Support at 36 Weeks(Participants) | Arm A:Standard Therapy | Arm B:RHO | Total |
|---|---|---|---|
| Mechanical Ventilation | 3 | 6 | 9 |
| Non-Invasive Positive Pressure (CPAP/HFNC) | 52 | 48 | 100 |
| Low-Flow Nasal Cannula (LFNC) | 36 | 32 | 68 |
| Room Air | 2 | 5 | 7 |
| Unknown | 6 | 6 | 12 |
| Diuretics(Participants) | Arm A:Standard Therapy | Arm B:RHO | Total |
|---|---|---|---|
| Yes | 52 | 51 | 103 |
| No | 41 | 38 | 79 |
| Unknowns | 6 | 8 | 14 |
| Birth Weight(grams) | Arm A:Standard Therapy | Arm B:RHO | Total |
|---|---|---|---|
| Mean | 938.2 ± 439.1 | 929.5 ± 442.6 | 933.9 ± 439.6 |
2 further baseline measures are reported on the registry.
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University of Massachusetts, Worcester