HypoxiaPhase 3NCT01875159
Effects of Caffeine on Intermittent Hypoxia in Infants Born Preterm
A Phase 3 study testing Caffeine citrate 6 mg/kg/day in people with Hypoxia, run by American SIDS Institute at 1 site in United States.
Trial summary
The purpose of this pilot study is to document the extent to which intermittent hypoxia persists beyond the age of discontinuing clinical methylxanthine, and will assess the effect of caffeine treatment on the number of intermittent hypoxia episodes and the total number of seconds with a hemoglobin oxygen saturation… Read more about this study
- Who is it for?
- Ages 33 to 37 weeks
- Conditions the study is for
- Hypoxia
- What is being tested?
- Caffeine citrate 6 mg/kg/day
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to Dec 2011
- Phase
- Phase 3
- 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 33 to 37 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Gestational age of 25 + 0 to 32 + 0 weeks PMA at birth, and 34 + 0 to 375 + 6 weeks PMA at randomization
- Prior treatment with caffeine based on routine clinical indications, and clinical caffeine now discontinued ≥5 days before randomization
- Previously tolerated clinical treatment with caffeine
- Breathing room air (no current supplemental O2 treatment; may have previously required respiratory support)
- Parental consent to enroll in pilot study
Who cannot join
- Congenital syndrome or other medical diagnosis associated with known risk for neurodevelopmental abnormality, including intraventricular hemorrhage Grade 3 or greater, cyanotic congenital heart disease, confirmed central nervous system infection, or fetal alcohol syndrome
- Currently receiving supplemental oxygen, ventilatory support, or nasal airflow therapy
- Clinical decision to restart caffeine prior to completing 5 days of continuous physiologic monitoring after clinical caffeine stopped
- Anticipated inability to meet protocol requirements
Trial locations and contacts
1 site in 1 country.
United States1 site
Uniformed Services University of Health Sciences
Bethesda, Maryland, 20814
About this study
Official title: Pilot Study of Effects of Caffeine on Intermittent Hypoxia in Infants Born Preterm
The purpose of this pilot study is to document the extent to which intermittent hypoxia persists beyond the age of discontinuing clinical methylxanthine, and will assess the effect of caffeine treatment on the number of intermittent hypoxia episodes and the total number of seconds with a hemoglobin oxygen saturation (HbO2 SAT) below 90%.
Read the detailed description
Infants with prior clinical treatment with caffeine in the neonatal intensive care unit (NICU) will be enrolled and continuous physiologic data recording of oxygen hemoglobin saturation (HbO2 SAT) and heart rate will begin as early as 33 weeks postmenstrual age (PMA). Randomization will occur when enrolled infants reach a corrected gestational age of at least 34 weeks PMA AND clinical caffeine has been discontinued for at least 5 days. Infants will be randomized to receive caffeine or to continue with usual care. The group randomized to start caffeine will receive an oral loading dose of caffeine citrate of 20 mg/kg on Day #1, followed by a single daily oral maintenance dose of 6 mg/kg starting on Day #2 and continued daily thereafter until 40 weeks PMA. The continuous oximeter recordings will be stopped at the same time. The number of intermittent hypoxia events/hour per week will be compared between the caffeine group and the usual care (no-caffeine) group for each week of physiologic data recordings.
- Conditions
- Hypoxia
- Being tested
- Caffeine citrate 6 mg/kg/day
- Keywords
- Prematurity, Apnea of prematurity, Intermittent hypoxia
- Medical subject headings
- Hypoxia, Premature Birth, Apnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caffeine citrate 6 mg/kg/dayDrug
Also called Cafcit
Comparison of caffeine citrate 6 mg/kg/day versus no caffeine (usual care) on extent of intermittent hypoxia at 35, 36, 37, 38, 39, and 40 weeks postmenstrual age.
| Study group | Role | What they receive |
|---|---|---|
| Caffeine | Experimental | Caffeine citrate 6 mg/kg/day Receives: Drug: Caffeine citrate 6 mg/kg/day |
| Active Comparator: no caffeine | No intervention | Compare extended use of caffeine citrate 6 mg/kg/day to no caffeine (usual care) in regard to extent of intermittent hypoxia from 35 weeks postmenstrual age (PMA) to 40 weeks PMA. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Episodes of Intermittent Hypoxia Per Hour
Number of episodes of Intermittent hypoxia per hour of pulse oximeter recording less than 90% oxygen saturation
Measured: 35, 36, 37, 38 weeks postmenstrual age
Number of Seconds of Intermittent Hypoxia Per Hour
Number of seconds of Intermittent hypoxia per hour of pulse oximeter recording less than 90% oxygen saturation
Measured: 35, 36, 37, 38 weeks postmenstrual age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2013 (estimated)
- Study startJul 2010
- Primary completionDec 2011
- Study completionDec 2011
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypoxiaStudies 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- American SIDS Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carl Hunt, American SIDS Institute
- Investigators
- Betty McEntire, PhD, Study director, American SIDS Instittute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01875159
- Sponsor's protocol ID
- ASI 01
- Status last verified
- Mar 2015
- First submitted
- 3 Jun 2013
- Last updated
- 17 Mar 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Rhein LM, Dobson NR, Darnall RA, Corwin MJ, Heeren TC, Poets CF, McEntire BL, Hunt CE; Caffeine Pilot Study Group. Effects of caffeine on intermittent hypoxia in infants born prematurely: a randomized clinical trial. JAMA Pediatr. 2014 Mar;168(3):250-7. doi: 10.1001/jamapediatrics.2013.4371.
PubMed 24445955
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Effects of Caffeine on Intermittent Hypoxia in Infants Born Preterm
- ClinicalTrials.gov ID
- NCT01875159
- Acronym / sponsor ID
- ASI 01
- Conditions
- Hypoxia
- Keywords
- Prematurity, Apnea of prematurity, Intermittent hypoxia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- American SIDS InstituteUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 11 Jun 2013 (estimated)
- Results
- Posted 17 Mar 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this pilot study is to document the extent to which intermittent hypoxia persists beyond the age of discontinuing clinical methylxanthine, and will assess the effect of caffeine treatment on the number of intermittent hypoxia episodes and the total number of seconds with a hemoglobin oxygen saturation (HbO2 SAT) below 90%.
Detailed description
Infants with prior clinical treatment with caffeine in the neonatal intensive care unit (NICU) will be enrolled and continuous physiologic data recording of oxygen hemoglobin saturation (HbO2 SAT) and heart rate will begin as early as 33 weeks postmenstrual age (PMA). Randomization will occur when enrolled infants reach a corrected gestational age of at least 34 weeks PMA AND clinical caffeine has been discontinued for at least 5 days. Infants will be randomized to receive caffeine or to continue with usual care. The group randomized to start caffeine will receive an oral loading dose of caffeine citrate of 20 mg/kg on Day #1, followed by a single daily oral maintenance dose of 6 mg/kg starting on Day #2 and continued daily thereafter until 40 weeks PMA. The continuous oximeter recordings will be stopped at the same time. The number of intermittent hypoxia events/hour per week will be compared between the caffeine group and the usual care (no-caffeine) group for each week of physiologic data recordings.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Caffeine | Experimental | Drug: Caffeine citrate 6 mg/kg/dayCaffeine citrate 6 mg/kg/day |
| Active Comparator: no caffeine | No intervention | –Compare extended use of caffeine citrate 6 mg/kg/day to no caffeine (usual care) in regard to extent of intermittent hypoxia from 35 weeks postmenstrual age (PMA) to 40 weeks PMA. |
Who may qualify
- Ages
- 33 to 37 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Gestational age of 25 + 0 to 32 + 0 weeks PMA at birth, and 34 + 0 to 375 + 6 weeks PMA at randomization
- Prior treatment with caffeine based on routine clinical indications, and clinical caffeine now discontinued ≥5 days before randomization
- Previously tolerated clinical treatment with caffeine
- Breathing room air (no current supplemental O2 treatment; may have previously required respiratory support)
- Parental consent to enroll in pilot study
Key exclusion criteria (4 listed)
- Congenital syndrome or other medical diagnosis associated with known risk for neurodevelopmental abnormality, including intraventricular hemorrhage Grade 3 or greater, cyanotic congenital heart disease, confirmed central nervous system infection, or fetal alcohol syndrome
- Currently receiving supplemental oxygen, ventilatory support, or nasal airflow therapy
- Clinical decision to restart caffeine prior to completing 5 days of continuous physiologic monitoring after clinical caffeine stopped
- Anticipated inability to meet protocol requirements
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 |
|---|---|---|
| Caffeine citrate 6 mg/kg/dayAlso: CafcitComparison of caffeine citrate 6 mg/kg/day versus no caffeine (usual care) on extent of intermittent hypoxia at 35, 36, 37, 38, 39, and 40 weeks postmenstrual age. | Drug | Caffeine |
Primary outcome
Episodes of Intermittent Hypoxia Per Hour
Time frame: 35, 36, 37, 38 weeks postmenstrual age
Number of episodes of Intermittent hypoxia per hour of pulse oximeter recording less than 90% oxygen saturation
Number of Seconds of Intermittent Hypoxia Per Hour
Time frame: 35, 36, 37, 38 weeks postmenstrual age
Number of seconds of Intermittent hypoxia per hour of pulse oximeter recording less than 90% oxygen saturation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 24445955Rhein LM, Dobson NR, Darnall RA, Corwin MJ, Heeren TC, Poets CF, McEntire BL, Hunt CE; Caffeine Pilot Study Group. Effects of caffeine on intermittent hypoxia in infants born prematurely: a randomized clinical trial. JAMA Pediatr. 2014 Mar;168(3):250-7. doi: 10.1001/jamapediatrics.2013.4371.
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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.
Betty McEntire, PhD study director
American SIDS Instittute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Caffeine citrate 6 mg/kg/day in people with Hypoxia, run by American SIDS Institute at 1 site 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 5 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 17 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Mar 2015). 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?
Episodes of Intermittent Hypoxia Per Hour (time frame: 35, 36, 37, 38 weeks postmenstrual age). 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?
On the ClinicalTrials.gov record for NCT01875159, which also lists 1 linked publication.
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 17 Mar 2015.