Apnea of PrematurityPhase 2NCT06327152
Caffeine Use in the Management of Preterm Infants
A Phase 2 study testing Caffeine in people with Apnea of Prematurity, run by University of California, Irvine at 1 site in United States.
Trial summary
This study aims to assess whether extending the duration of caffeine therapy will help preterm infants achieve full oral feeding faster. Read more about this study
- Who is it for?
- Ages 1 week to 40 weeks
- Conditions the study is for
- Apnea of Prematurity
- What is being tested?
- Caffeine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Feb 2024to 31 Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 1 week to 40 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants born at equal to or less than 32 weeks and 0 days gestational age AND
- Equal to or greater than 34 weeks and 0 days corrected gestation at time of enrollment.
- Off respiratory support for at least 2 days (nasal canula oxygen, high flow nasal canula, continuous positive airway pressure (CPAP), mechanical ventilation).
- On caffeine and meet criteria to discontinue caffeine.
- No significant cardiopulmonary events for at least 5 days (apnea > 20 seconds, apnea with heart rate (HR) < 80 beats per minute (bpm), HR < 80 bpm with desaturation < 85% or color change).
Who cannot join
- Infants with critical congenital heart disease.
- Infants with neuromuscular conditions affecting respiration.
- Infants with overt brain injury (i.e. severe Grade 3-4 intraventricular hemorrhage, cystic periventricular leukomalacia) that may affect oral feeding.
- Infants with major genetic disorders.
- Infants with anatomic anomalies that will hinder oral feeding.
- Infants who have already progressed to Step 3 (of 5) of our institution's oral feeding protocol (oral feeds 4 times per day).
- Infants who develop necrotizing enterocolitis after enrollment.
- Failure to obtain consent or declined by parents.
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to assess whether extending the duration of caffeine therapy will help preterm infants achieve full oral feeding faster.
Read the detailed description
This study is a randomized, double-blinded, placebo-controlled trial. Infants will be randomized to receive either caffeine or placebo for up to maximum of four additional weeks after meeting clinical criteria to discontinue caffeine. Initiation of oral feeding will be based on standard of care as determined by a neonatal occupational therapist and clinical cues. Oral feedings will be advanced by a standardized 5 step oral feeding protocol. The time it takes to achieve full oral feeds between the treatment and control groups will be compared.
- Conditions
- Apnea of Prematurity
- Being tested
- Caffeine, Sterile Water Placebo
- Keywords
- Feeding, Caffeine
- Medical subject headings
- Apnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CaffeineDrug
Infants randomized to receive caffeine will continue to receive caffeine at the current weight-based dose (which is the standard of care maintenance dose of 10-15 mg/kg/day) given every 24 hours. The weight-based dose calculated using the weight at the time of enrollment will be the weight-based dose used for the duration of the study. The dose will be weight adjusted every 7 days, starting on the day of enrollment. Caffeine will be given enterally, via nasogastric tube or by mouth.
The study drug (caffeine) will be administered for a maximum of 4 weeks. The study drug will be discontinued after 4 weeks or when the infant reaches Step 4 of our institution's oral feeding protocol (oral feeding 6 times per day), whichever comes first. The study drug will also be discontinued if the open-label maintenance caffeine is started by the clinical team based on clinical indications.
Sterile Water PlaceboOther
Infants randomized to the placebo group will be given sterile water at an equivalent volume to the volume if caffeine were to be given, using the previous weight-based caffeine dose. The placebo will be given every 24 hours. The dose/volume will be weight adjusted every 7 days, starting on the day of enrollment. The placebo will be given enterally, via nasogastric tube or by mouth.
The placebo will be administered for a maximum of 4 weeks. The placebo will be discontinued after 4 weeks or when the infant reaches Step 4 of our institution's oral feeding protocol (oral feeding 6 times per day), whichever comes first. The placebo will also be discontinued if the open-label maintenance caffeine is started by the clinical team based on clinical indications.
| Study group | Role | What they receive |
|---|---|---|
| Caffeine Group | Active comparator | Infants randomized to receive caffeine will continue to receive caffeine at standard of care maintenance dose of 10-15 mg/kg/day given every 24 hours. The dose will be weight adjusted every 7 days, starting on the day of enrollment. Caffeine will be given enterally, via nasogastric tube or by mouth. Receives: Drug: Caffeine |
| Placebo Group | Placebo comparator | Infants randomized to the placebo group will be given sterile water at an equivalent volume to the volume if caffeine were to be given, using the previous weight-based caffeine dose. The placebo will be given every 24 hours. The dose/volume will be weight adjusted every 7 days, starting on the day of enrollment. The placebo will be given enterally, via nasogastric tube or by mouth. Receives: Other: Sterile Water Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to full feeds
The primary outcome is time (in days) to full oral bottle feeding or breastfeeding or a combination of both. Full oral bottle feeding is defined as 48 hours of consistent intake of at least 150ml/kg/day of formula or breastmilk. If the subject is on combination of bottle and breastfeeding, two consecutive days of positive weight gain will be used in place of 150ml/kg/day as primary outcome measure.
Measured: From first nutritive oral feed until full oral feeds achieved, up to 6 weeks
Secondary outcomes (4)
Time to discharge
Time to discharge measured in days of hospitalization after randomization
Measured: Randomization until discharge, up to 6 weeks
Post menstrual age (PMA) at time of discharge
Post menstrual age at discharge
Measured: Randomization until discharge, up to 6 weeks
Number of significant cardiopulmonary events
Number of significant cardiopulmonary events defined as apnea > 20 seconds, apnea with heart rate (HR) < 80 beats per minute (bpm), HR < 80 bpm with desaturation < 85% or color change. Significant events are ones that occur while infant is asleep or lying down.
Measured: Randomization until discharge, up to 6 weeks
Weight change
Weight change measured by change in grams
Measured: Randomization until discharge, up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2024
- Study start22 Feb 2024
- Primary completionDec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Apnea of PrematurityStudies of the same condition, open and under way.
- More trials run by University of California, IrvineThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a randomized, double-blinded, placebo-controlled trial of 40 preterm infants born at less than or equal to 32 weeks and 0 days gestation. Infants will be randomized to receive either caffeine or placebo for up to maximum of additional four (4) weeks after meeting clinical criteria to come off caffeine.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cherry Uy, University of California, Irvine
- Investigators
- Cherry Uy, MD, Principal investigator, UC Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06327152
- Sponsor's protocol ID
- 2659
- Status last verified
- Nov 2025
- First submitted
- 13 Mar 2024
- Last updated
- 10 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Caffeine Use in the Management of Preterm Infants
- ClinicalTrials.gov ID
- NCT06327152
- Acronym / sponsor ID
- 2659
- Conditions
- Apnea of Prematurity
- Keywords
- Feeding, Caffeine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Study start
- 22 Feb 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 25 Mar 2024 (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.
This study aims to assess whether extending the duration of caffeine therapy will help preterm infants achieve full oral feeding faster.
Detailed description
This study is a randomized, double-blinded, placebo-controlled trial. Infants will be randomized to receive either caffeine or placebo for up to maximum of four additional weeks after meeting clinical criteria to discontinue caffeine. Initiation of oral feeding will be based on standard of care as determined by a neonatal occupational therapist and clinical cues. Oral feedings will be advanced by a standardized 5 step oral feeding protocol. The time it takes to achieve full oral feeds between the treatment and control groups will be compared.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- This is a randomized, double-blinded, placebo-controlled trial of 40 preterm infants born at less than or equal to 32 weeks and 0 days gestation. Infants will be randomized to receive either caffeine or placebo for up to maximum of additional four (4) weeks after meeting clinical criteria to come off caffeine.
| Arm | Type | Receives |
|---|---|---|
| Caffeine Group | Active comparator | Drug: CaffeineInfants randomized to receive caffeine will continue to receive caffeine at standard of care maintenance dose of 10-15 mg/kg/day given every 24 hours. The dose will be weight adjusted every 7 days, starting on the day of enrollment. Caffeine will be given enterally, via nasogastric tube or by mouth. |
| Placebo Group | Placebo comparator | Other: Sterile Water PlaceboInfants randomized to the placebo group will be given sterile water at an equivalent volume to the volume if caffeine were to be given, using the previous weight-based caffeine dose. The placebo will be given every 24 hours. The dose/volume will be weight adjusted every 7 days, starting on the day of enrollment. The placebo will be given enterally, via nasogastric tube or by mouth. |
Who may qualify
- Ages
- 1 week to 40 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Infants born at equal to or less than 32 weeks and 0 days gestational age AND
- Equal to or greater than 34 weeks and 0 days corrected gestation at time of enrollment.
- Off respiratory support for at least 2 days (nasal canula oxygen, high flow nasal canula, continuous positive airway pressure (CPAP), mechanical ventilation).
- On caffeine and meet criteria to discontinue caffeine.
- No significant cardiopulmonary events for at least 5 days (apnea > 20 seconds, apnea with heart rate (HR) < 80 beats per minute (bpm), HR < 80 bpm with desaturation < 85% or color change).
Key exclusion criteria (8 listed)
- Infants with critical congenital heart disease.
- Infants with neuromuscular conditions affecting respiration.
- Infants with overt brain injury (i.e. severe Grade 3-4 intraventricular hemorrhage, cystic periventricular leukomalacia) that may affect oral feeding.
- Infants with major genetic disorders.
- Infants with anatomic anomalies that will hinder oral feeding.
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 |
|---|---|---|
| CaffeineInfants randomized to receive caffeine will continue to receive caffeine at the current weight-based dose (which is the standard of care maintenance dose of 10-15 mg/kg/day) given every 24 hours. The weight-based dose calculated using the weight at the time of enrollment will be the weight-based dose used for the duration of the study. The dose will be weight adjusted every 7 days, starting on the day of enrollment. Caffeine will be given enterally, via nasogastric tube or by mouth. The study drug (caffeine) will be administered for a maximum of 4 weeks. The study drug will be discontinued after 4 weeks or when the infant reaches Step 4 of our institution's oral feeding protocol (oral feeding 6 times per day), whichever comes first. The study drug will also be discontinued if the open-label maintenance caffeine is started by the clinical team based on clinical indications. | Drug | Caffeine Group |
| Sterile Water PlaceboInfants randomized to the placebo group will be given sterile water at an equivalent volume to the volume if caffeine were to be given, using the previous weight-based caffeine dose. The placebo will be given every 24 hours. The dose/volume will be weight adjusted every 7 days, starting on the day of enrollment. The placebo will be given enterally, via nasogastric tube or by mouth. The placebo will be administered for a maximum of 4 weeks. The placebo will be discontinued after 4 weeks or when the infant reaches Step 4 of our institution's oral feeding protocol (oral feeding 6 times per day), whichever comes first. The placebo will also be discontinued if the open-label maintenance caffeine is started by the clinical team based on clinical indications. | Other | Placebo Group |
Primary outcome
Time to full feeds
Time frame: From first nutritive oral feed until full oral feeds achieved, up to 6 weeks
The primary outcome is time (in days) to full oral bottle feeding or breastfeeding or a combination of both. Full oral bottle feeding is defined as 48 hours of consistent intake of at least 150ml/kg/day of formula or breastmilk. If the subject is on combination of bottle and breastfeeding, two consecutive days of positive weight gain will be used in place of 150ml/kg/day as primary outcome measure.
4 secondary outcomes
Time to discharge
Time frame: Randomization until discharge, up to 6 weeks
Post menstrual age (PMA) at time of discharge
Time frame: Randomization until discharge, up to 6 weeks
Number of significant cardiopulmonary events
Time frame: Randomization until discharge, up to 6 weeks
Weight change
Time frame: Randomization until discharge, up to 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2025.
- Individual participant dataSharing planned: No
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Manual T-piece Versus Ventilator Positive Pressure Ventilation During Resuscitation of Extremely Premature Neonates
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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.
Cherry Uy, MD principal investigator
UC Irvine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Caffeine in people with Apnea of Prematurity, run by University of California, Irvine 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 8 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: under way, not looking for participants, as of the sponsor's last update on 10 Nov 2025. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Time to full feeds (time frame: From first nutritive oral feed until full oral feeds achieved, up to 6 weeks). 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 10 Nov 2025.