Premature InfantsNCT01994954
A Randomized Trial of Outpatient Oxygen Weaning Strategies in Premature Infants
A study testing RHO in people with Premature Infants, run by University of Massachusetts, Worcester at 8 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages Up to 37 weeks
- Conditions the study is for
- Premature Infants
- What is being tested?
- RHO
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 196 participants
- Where
- 8 sitesUnited States
- Study dates
- Nov 2013to Feb 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 37 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infant with birth gestational age ≤ 37 (37 0/7) wks postmenstrual age (PMA) who has requirement for supplemental O2 at time of NICU discharge, as determined by primary NICU team.
- Infant receiving pediatric pulmonology care at the Center for Healthy Infant Lung Development
- Parent aged 18 years or older
- English or Spanish-speaking.
Who cannot join
- Parents whose infants has presence of pulmonary hypertension at enrollment
- Parents whose infant with syndrome or other diagnosis with known high risk for persistent hypoxia (cardiac disease, Trisomy 21, Pierre-Robin Sequence, etc.)
- Parents whose infant has requirement for O2 flow rate > 1 L/min or tracheostomy
- Any infants who also require caffeine at discharge from the NICU
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Boston Children's Hospital
Boston, Massachusetts, 02115
University of Vermont Medical Center
Burlington, Vermont, 05401
University of Connecticut Health Center
Farmington, Connecticut, 06030
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03766
Kentucky Children's Hospital at University of Kentucky
Lexington, Kentucky, 40536
Baystate Medical Center
Springfield, Massachusetts, 01199
Boston Children's Hospital Physicians
Valhalla, New York, 10595
UMass Memorial Medical Center
Worcester, Massachusetts, 01655
About this study
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.
Read more
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.
- Conditions
- Premature Infants
- Being tested
- RHO
- Keywords
- newborn intensive care unit, NICU, supplemental oxygen
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RHOOther
Recorded oximetry data will be downloaded from home oximeters, analyzed, and used to assist in supplemental oxygen weaning decisions.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: RHO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of Home Oxygen Therapy
Duration of home oxygen use from time of randomization (baseline visit) to successful discontinuation of home oxygen therapy (HOT).
Measured: 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.
Measured: Monthly while on home oxygen therapy and at 3 months post discontinuation of therapy
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Enrollment through 6 months post discontinuation of home oxygen therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2013 (estimated)
- Study startNov 2013
- Primary completionDec 2017
- Study completionFeb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Premature InfantsStudies of the same condition, open and under way.
- More trials run by University of Massachusetts, WorcesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 196 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Worcester
- Sponsor type
- University, hospital or other
- Collaborators
- Bay State Medical Center, UConn Health, University of Vermont Medical Center, Connecticut Children's Medical Center, Patient-Centered Outcomes Research Institute, University of Kentucky, Boston Children's Hospital, Dartmouth-Hitchcock Medical Center, Tufts Medical Center, Westchester Medical Center
- Responsible party
- Sponsor
- Investigators
- Lawrence Rhein, MD, MPH, Principal investigator, University of Massachusetts, WorcesterHeather White, BS, Study director, University of Massachusetts, Worcester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01994954
- Sponsor's protocol ID
- IP00009772
- Status last verified
- May 2023
- First submitted
- 20 Nov 2013
- Last updated
- 30 May 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of Outpatient Oxygen Weaning Strategies in Premature Infants
- ClinicalTrials.gov ID
- NCT01994954
- Acronym / sponsor ID
- IP00009772
- Conditions
- Premature Infants
- Keywords
- newborn intensive care unit, NICU, supplemental oxygen
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 196 participants (actual)
- Lead sponsor
- University of Massachusetts, WorcesterUniversity, hospital or other
- Collaborators
- Bay State Medical Center, UConn Health, University of Vermont Medical Center, Connecticut Children's Medical Center, Patient-Centered Outcomes Research Institute, University of Kentucky, Boston Children's Hospital, Dartmouth-Hitchcock Medical Center, Tufts Medical Center, Westchester Medical Center
- Study start
- Nov 2013 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Feb 2019 (actual)
- First posted
- 26 Nov 2013 (estimated)
- Results
- Posted 2 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: RHOInfants 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. |
Who may qualify
- Ages
- Up to 37 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Infant with birth gestational age ≤ 37 (37 0/7) wks postmenstrual age (PMA) who has requirement for supplemental O2 at time of NICU discharge, as determined by primary NICU team.
- Infant receiving pediatric pulmonology care at the Center for Healthy Infant Lung Development
- Parent aged 18 years or older
- English or Spanish-speaking.
Key exclusion criteria (4 listed)
- Parents whose infants has presence of pulmonary hypertension at enrollment
- Parents whose infant with syndrome or other diagnosis with known high risk for persistent hypoxia (cardiac disease, Trisomy 21, Pierre-Robin Sequence, etc.)
- Parents whose infant has requirement for O2 flow rate > 1 L/min or tracheostomy
- Any infants who also require caffeine at discharge from the NICU
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RHORecorded oximetry data will be downloaded from home oximeters, analyzed, and used to assist in supplemental oxygen weaning decisions. | Other | Arm B:RHO |
Primary outcome
Duration of Home Oxygen Therapy
Time frame: NICU discharge date until successful discontinuation of home oxygen therapy (HOT), up to 26 months.
Duration of home oxygen use from time of randomization (baseline visit) to successful discontinuation of home oxygen therapy (HOT).
Caregiver Quality of Life
Time frame: Monthly while on home oxygen therapy and at 3 months post discontinuation of therapy
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.
3 secondary outcomes
Participants With Respiratory-related Emergency Department Visits and Rehospitalizations
Time frame: WIthin 6 months of discontinuation of home oxygen
Growth Parameters
Time frame: Enrollment to 6 months post home oxygen therapy discontinuation
Growth Parameters, Weight-for-length Z-score Change
Time frame: Enrollment through 6 months post discontinuation of home oxygen therapy
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lawrence Rhein, MD, MPH principal investigator
University of Massachusetts, Worcester
Heather White, BS study director
University of Massachusetts, Worcester
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RHO in people with Premature Infants, run by University of Massachusetts, Worcester at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of Home Oxygen Therapy (time frame: NICU discharge date until successful discontinuation of home oxygen therapy (HOT), up to 26 months.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2023.