Hypoxia NeonatalPOMATNCT04249193
Pulse Oximetry Measurement and Transfusions
An observational study of Hypoxia Neonatal and Premature, run by Christiana Care Health Services at 3 sites in United States.
Trial summary
The primary purpose of this observational study was to determine if pRBC transfusions decrease the frequency of intermittent hypoxia events in very low birth weight infants (VLBW) during the first six weeks of life. The impact on non-pRBC transfusions on the frequency of intermittent hypoxia was also assessed. Read more about this study
- Who is it for?
- Ages Up to 6 weeks
- Conditions the study is for
- Hypoxia Neonatal, Premature, Blood Transfusion
- What is being tested?
- Transfusion
- How many people
- 75 participants
- Where
- 3 sitesUnited States
- Study dates
- Apr 2014to Oct 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
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 6 weeks
- All sexes
- Child
Study population: Premature neonates
Who may be able to join
- 23+0 to 28+6 weeks gestational age at birth
Who cannot join
- Infants with life-limiting diagnoses
- Cyanotic heart disease
- In utero fetal transfusion
- Twin to twin transfusion syndrome
- Isoimmune hemolytic disease
- Severe acute hemorrhage
Show all 11Show fewer
- Acute shock
- Sepsis with coagulopathy
- Need for perioperative transfusion
- Parents opposed to transfusion of blood
- Parents with hemoglobinopathy or congenital anemia
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Pennsylvania Hospital
Philadelphia, Pennsylvania, 19107
Temple University Hospital
Philadelphia, Pennsylvania, 19140
About this study
Official title: Effect of Blood Transfusions on Intermittent Hypoxic Episodes in Very Low Birth Weight Infants
The primary purpose of this observational study was to determine if pRBC transfusions decrease the frequency of intermittent hypoxia events in very low birth weight infants (VLBW) during the first six weeks of life. The impact on non-pRBC transfusions on the frequency of intermittent hypoxia was also assessed.
- Conditions
- Hypoxia Neonatal, Premature, Blood Transfusion
- Being tested
- Transfusion
- Keywords
- Transfusion, Intermittent hypoxia
- Medical subject headings
- Asphyxia Neonatorum, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TransfusionOther
pRBC and non-pRBC transfusions
| Study group | Role | What they receive |
|---|---|---|
| Transfusion | Not described Receives: Other: Transfusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in number of Intermittent hypoxia
An intermittent hypoxemia event is defined as a fall in oxygen saturations to less than 80% for >/= 10 secs and <3 minutes with a minimal time interval of 4 seconds between events.
Measured: Change in number of intermittent hypoxia before (approximately 8 hours) and after transfusion (approximately 8 hours).
Secondary outcomes (1)
Hypoxia
Percent time with oxygen saturations less than 85%, 80% and 75%.
Measured: 8 hours prior to transfusion and 8 hours after transfusion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2020
- Study startApr 2014
- Primary completionOct 2017
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypoxia NeonatalStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Christiana Care Health Services
- Sponsor type
- University, hospital or other
- Collaborators
- Temple University Hospital, University of Pennsylvania, Pennsylvania Hospital
- Responsible party
- Principal investigator, Kelley Kovatis, Christiana Care Health Services
- Investigators
- Kelley Z Kovatis, MD, Principal investigator, Christiana Care Health Services, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04249193
- Sponsor's protocol ID
- DDD603862
- Acronym
- POMAT
- Status last verified
- Mar 2020
- First submitted
- 24 Jan 2020
- Last updated
- 13 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Blood Transfusions on Intermittent Hypoxic Episodes in Very Low Birth Weight Infants
- ClinicalTrials.gov ID
- NCT04249193
- Acronym / sponsor ID
- POMAT / DDD603862
- Conditions
- Hypoxia Neonatal, Premature, Blood Transfusion
- Keywords
- Transfusion, Intermittent hypoxia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Christiana Care Health ServicesUniversity, hospital or other
- Collaborators
- Temple University Hospital, University of Pennsylvania, Pennsylvania Hospital
- Study start
- Apr 2014 (actual)
- Primary completion
- Oct 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 30 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose of this observational study was to determine if pRBC transfusions decrease the frequency of intermittent hypoxia events in very low birth weight infants (VLBW) during the first six weeks of life. The impact on non-pRBC transfusions on the frequency of intermittent hypoxia was also assessed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transfusion | – | Other: Transfusion |
Who may qualify
- Ages
- Up to 6 weeks
- Sex
- All
- Age groups
- Child
- Study population
- Premature neonates
Key inclusion criteria (1 listed)
- 23+0 to 28+6 weeks gestational age at birth
Key exclusion criteria (11 listed)
- Infants with life-limiting diagnoses
- Cyanotic heart disease
- In utero fetal transfusion
- Twin to twin transfusion syndrome
- Isoimmune hemolytic disease
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 |
|---|---|---|
| TransfusionpRBC and non-pRBC transfusions | Other | Transfusion |
Primary outcome
Change in number of Intermittent hypoxia
Time frame: Change in number of intermittent hypoxia before (approximately 8 hours) and after transfusion (approximately 8 hours).
An intermittent hypoxemia event is defined as a fall in oxygen saturations to less than 80% for >/= 10 secs and <3 minutes with a minimal time interval of 4 seconds between events.
1 secondary outcome
Hypoxia
Time frame: 8 hours prior to transfusion and 8 hours after transfusion.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2020.
- Individual participant dataSharing planned: No
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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.
Kelley Z Kovatis, MD principal investigator
Christiana Care Health Services, Inc
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypoxia Neonatal and Premature, run by Christiana Care Health Services at 3 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 1 inclusion and 11 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 13 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in number of Intermittent hypoxia (time frame: Change in number of intermittent hypoxia before (approximately 8 hours) and after transfusion (approximately 8 hours).). 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 13 Mar 2020.