Results Summary
What was the research about?
Babies who are born too early often have serious health problems, such as difficulty breathing. To help their lungs develop, these babies may need extra oxygen at home after they leave the hospital. This treatment is called home oxygen therapy.
In this study, the research team compared two ways to manage oxygen levels to help decide when it’s time to decrease, and then finally stop, home oxygen therapy:
- Checking oxygen at monthly clinic visits
- Checking oxygen at monthly clinic visits and at home
What were the results?
Babies who had their oxygen checked at home safely stopped home oxygen therapy sooner than babies who had their oxygen checked only at monthly visits.
Parents’ quality of life didn’t differ between the two groups. Compared with the start of the study, parents in both groups reported higher quality of life three months after stopping home oxygen therapy.
Who was in the study?
The study included 197 babies who received home oxygen therapy and their parents. All babies received care at one of nine hospitals across the United States. Of the babies, 59 percent were white, 13 percent were black, 3 percent were Asian, and 25 percent were another race; 9 percent were Hispanic. Also, 63 percent were boys. On average, the babies weighed about 2 pounds when they were born, and their mothers were 27 weeks pregnant when they gave birth.
What did the research team do?
The research team assigned babies and their parents by chance to one of two groups. In one group, clinic staff tested the babies every month during visits to see if they should receive more, less, or the same amount of oxygen. Babies took part in a sleep study, where doctors watch babies’ oxygen levels overnight in the clinic, to see if they were ready to stop receiving oxygen.
Babies in the second group also visited the clinic monthly for testing. In addition, parents in this group checked their babies’ oxygen levels at home. For up to a week, parents checked oxygen levels as often as possible during the day and all night. Parents then sent oxygen data to the research team. Clinic staff used the data between visits to decide on changes or on stopping home oxygen therapy.
Parents filled out surveys about their quality of life at each clinic visit and three months after home oxygen therapy ended.
Doctors, parents of babies who were born too early, and people who worked for health insurance and medical equipment companies helped with the study.
What were the limits of the study?
Some parents in each group reduced or stopped home oxygen therapy without checking with the research team or their baby’s doctors, which may have changed the study’s results.
Future studies could explore ways to encourage parents to talk to doctors before stopping home oxygen therapy. Studies could also create oxygen level guides about managing home oxygen therapy.
How can people use the results?
Clinics, doctors, and parents can use the results when considering how to manage home oxygen therapy.
Professional Abstract
Objective
To compare the effectiveness of monthly clinic visits with and without recorded home oximetry (RHO) to safely wean premature infants off home oxygen therapy (HOT)
Study Design
| Design Element | Description |
|---|---|
| Design | Randomized controlled trial |
| Population | 197 premature infants who required HOT after neonatal intensive care unit discharge and their parents |
| Interventions/ Comparators |
|
| Outcomes | HOT duration, parental quality of life, adverse events such as weight loss or hospitalizations |
| Timeframe | 6-month follow-up for study outcomes |
This prospective randomized controlled trial compared two protocols for safely weaning premature infants off HOT: monthly clinic visits with in-clinic monitoring of oxygen saturations and the same protocol plus RHO between monthly clinic visits.
Researchers randomly assigned infants to one of two groups. In the first group, clinic staff assessed whether to increase, decrease, or maintain infant oxygen flow rates for infants receiving HOT during their monthly clinic visits. The staff conducted a formal overnight sleep study to determine whether to discontinue HOT.
In the second group, infants had the same monthly clinic assessments. In addition, parents used RHO to monitor infant oxygen saturation between clinic visits. During four- to seven-day evaluation periods, parents monitored oxygen continuously at night and as often as possible during the day. At the end of each period, parents sent RHO data to researchers. Researchers and clinic staff used the data to adjust oxygen flow rates between monthly clinic visits and to determine whether to discontinue HOT.
The study included 197 premature infants who required HOT after discharge from neonatal intensive care units and their parents. Infants received care at one of nine medical centers across the United States. Of the infants, 59% were white, 13% were black, 3% were Asian, and 25% were unknown or another race; 9% were Hispanic. The average gestational age was 27 weeks, the average birthweight was 934 grams, and 63% were male.
Researchers tracked total duration of HOT for infants discharged from the neonatal intensive care unit. At each clinic visit during HOT and again three months after discontinuation, parents also completed quality of life questionnaires.
Clinicians, families of premature infants, and health insurance and medical equipment industry representatives provided input on the study.
Results
The average time on HOT was shorter for infants who had RHO compared with infants who did not have it (p=0.03). Adverse events did not differ between the two groups.
The two groups did not differ significantly in parental quality of life scores. Both groups’ scores improved from first clinic visit to three months after HOT discontinuation (p<0.005).
Limitations
No verified oxygen saturation guidelines exist for HOT weaning; results may have differed if clinicians had used different criteria for HOT weaning than those used in this study. About 13% of parents in each group decreased oxygen flow rates or discontinued HOT on their own, without guidance from clinic staff, which may have affected results.
Conclusions and Relevance
RHO can be a safe and effective addition to in-clinic monitoring and may shorten duration of HOT for premature infants.
Future Research Needs
Future research could establish validated oxygen saturation guidelines for HOT weaning. Research could also explore ways to improve communication between parents and clinicians about discontinuing HOT.
Final Research Report
View this project's final research report.
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Peer-Review Summary
Peer review of PCORI-funded research helps make sure the report presents complete, balanced, and useful information about the research. It also assesses how the project addressed PCORI’s Methodology Standards. During peer review, experts read a draft report of the research and provide comments about the report. These experts may include a scientist focused on the research topic, a specialist in research methods, a patient or caregiver, and a healthcare professional. These reviewers cannot have conflicts of interest with the study.
The peer reviewers point out where the draft report may need revision. For example, they may suggest ways to improve descriptions of the conduct of the study or to clarify the connection between results and conclusions. Sometimes, awardees revise their draft reports twice or more to address all of the reviewers’ comments.
Peer reviewers commented and the researchers made changes or provided responses. Those comments and responses included the following:
- The reviewers requested an expanded discussion of how the researchers managed missing data in this study. The researchers responded that there were only 23 infants missing data on weaning off home oxygen therapy (HOT), and that these infants did not significantly differ from completers by treatment group, most demographic variables, or illness severity.
- Reviewers also questioned participants’ adherence to the treatment protocol, since most of the participants in the intervention group did not meet the goal of recorded home oximetry, which was to report their infants’ oxygen use measures at least four times per month. The researchers said that they tried to encourage the participants to respond every four to seven days but did not want to “pester” the participants to consistently meet that number. This issue is discussed in the exploratory analyses related to feasibility and acceptability of the intervention.
- The reviewers suggested it would be better to measure duration of home oxygen use from the time discharged premature infants came home instead of from the first outpatient visit. The researchers agreed and reanalyzed their primary endpoint using hospital discharge date as the start of HOT.
Conflict of Interest Disclosures
Project Information
Key Dates
Study Registration Information
^Lawrence Rhein, MD, MPH, was affiliated with Children's Hospital Boston when this project was initially awarded.