Bronchopulmonary DysplasiaNCT02524249
Early Versus Late Caffeine for ELBW Newborns
A study testing Caffeine in people with Bronchopulmonary Dysplasia and Apnea of Prematurity, run by Wayne State University at 1 site in United States.
Trial summary
Caffeine is routinely used in the management of apnea of prematurity. Extremely low birth weight (ELBW) infants are at higher risk of mortality and various neonatal morbidities such as bronchopulmonary dysplasia (BPD) for which caffeine has been shown to be beneficial in very low birth weight (VLBW) infants. Read more about this study
- Who is it for?
- Ages Up to 4 weeks
- Conditions the study is for
- Bronchopulmonary Dysplasia, Apnea of Prematurity
- What is being tested?
- Caffeine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2015to Jun 2019
- Phase
- Interventional
- 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 4 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- newborns with birth weight less than or equal to 1000grams and less than 28 weeks of gestation are included if intubated by 12 hours of life
Who cannot join
- newborns with known congenital malformation
- newborns whose parents refuse consent for the study
- newborns who are on high frequency ventilation and/or receiving more than 80% oxygen at 12 hours of age
- newborns deemed non-viable by the clinical team (defined as those neonates born at <24 weeks gestation and whose parents are offered withdrawal of support or do not resuscitate by clinical team for severity of cardiorespiratory illness at or before 12 hours of age)
- newborns diagnosed with congenital heart disease within the first 12 hours of life (presence of a ventricular septum defect and a patent ductus arteriosus is not an exclusion criteria)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Double Blind Controlled Trial of Early Versus Late Caffeine for Extremely Low Birth Weight Newborns
Caffeine is routinely used in the management of apnea of prematurity. Extremely low birth weight (ELBW) infants are at higher risk of mortality and various neonatal morbidities such as bronchopulmonary dysplasia (BPD) for which caffeine has been shown to be beneficial in very low birth weight (VLBW) infants. The investigators' previous unpublished retrospective studies and recently published retrospective studies demonstrated that early caffeine given within 48 hours of age tended to decrease the incidence of death and BPD in ELBW newborns. Retrospective design can be biased as newborns with mild lung disease may have received caffeine early for extubation. There are several studies on pharmacodynamics and pharmacokinetics of caffeine. The data regarding cumulative dosage of caffeine, caffeine levels and BPD outcome is deficient.
Primary objective of this study is to test the hypothesis that early caffeine given within 24 hours of life will decrease incidence of mortality and BPD in ventilated ELBW newborns.
This study will also test an additional hypothesis that higher caffeine dosage and caffeine levels are associated with decreased mortality and postnatal morbidities in studied newborns.
Read the detailed description
Parents will be approached either prenatally for an impending delivery of ELBW newborn or within 16 hours of birth. 90 newborns will be randomized to receive early caffeine within 24 hours of life (the "study drug") and 90 newborns will receive a placebo. Either the early caffeine (the "study drug") or placebo will be continued throughout the first 15 days of life. Newborns in the early caffeine group will receive an IV bolus of 20mg/kg followed by IV or PO 5mg/kg daily for 14 days. The clinical team can choose to give PO caffeine if the newborn tolerates >75% of fluid goals by feeds. The clinical and research teams will be blinded; neither will know whether the newborn is receiving early caffeine or placebo. The clinical team will be allowed to use open labeled caffeine as deemed medically necessary after 24 hours of receiving either the early caffeine or placebo. Often this clinical need would be at the time of extubation (peri-extubation) and comprises the "late" caffeine group, which is also the placebo group. Perinatal and postnatal clinical characteristics will be prospectively collected. Clinical team may choose to hold study drug if newborns are placed on high frequency ventilation or if they need sedation drips for surgical procedures. Two blood samples will be collected one at day 7 and one at day 14 for caffeine levels. Data safety monitoring committee will be review mortality and morbidity in each group on a quarterly basis or after recruitment of every 30 newborns whichever happens earlier.
- Conditions
- Bronchopulmonary Dysplasia, Apnea of Prematurity
- Being tested
- Caffeine, Placebo (dextrose)
- Medical subject headings
- Bronchopulmonary Dysplasia, Apnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CaffeineDrug
Placebo (dextrose)Drug
| Study group | Role | What they receive |
|---|---|---|
| Early caffeine group | Active comparator | 55 newborns will be randomized to receive caffeine within 24 hours of life. They will receive 20mg/kg IV bolus followed by IV or PO 5mg/kg daily for the next 14 days. The clinical team may decide to give PO caffeine if the newborn tolerates >75% of fluid goals by feeds. Receives: Drug: Caffeine |
| Late caffeine group | Placebo comparator | 55 newborns will be randomized to receive a placebo (dextrose) in the first 24 hours of life. They will receive a 20mg/kg IV bolus followed by IV or PO 5mg/kg daily for the next 14 days. The clinical team may decide to give the placebo orally is the newborn tolerates >75% of fluid goals by feeds. Receives: Drug: Placebo (dextrose) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative incidence of death and bronchopulmonary dysplasia
Measured: 36 weeks post menstrual age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2015 (estimated)
- Study startSep 2015
- Primary completionJun 2019
- Study completionJun 2019
Why it stopped: Frequent protocol violations
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bronchopulmonary DysplasiaStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wayne State University
- Sponsor type
- University, hospital or other
- Collaborators
- The Gerber Foundation
- Responsible party
- Principal investigator, Dr. Nithin Shashikanth Chouthai, Wayne State University
- Investigators
- Nitin S Chouthai, MD, Principal investigator, Wayne State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02524249
- Sponsor's protocol ID
- 1506014098
- Status last verified
- Jun 2019
- First submitted
- 12 Aug 2015
- Last updated
- 2 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Double Blind Controlled Trial of Early Versus Late Caffeine for Extremely Low Birth Weight Newborns
- ClinicalTrials.gov ID
- NCT02524249
- Acronym / sponsor ID
- 1506014098
- Conditions
- Bronchopulmonary Dysplasia, Apnea of Prematurity
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Frequent protocol violations
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Wayne State UniversityUniversity, hospital or other
- Collaborators
- The Gerber Foundation
- Study start
- Sep 2015
- Primary completion
- Jun 2019 (actual)
- Study completion
- Jun 2019 (actual)
- First posted
- 14 Aug 2015 (estimated)
- 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.
Caffeine is routinely used in the management of apnea of prematurity. Extremely low birth weight (ELBW) infants are at higher risk of mortality and various neonatal morbidities such as bronchopulmonary dysplasia (BPD) for which caffeine has been shown to be beneficial in very low birth weight (VLBW) infants. The investigators' previous unpublished retrospective studies and recently published retrospective studies demonstrated that early caffeine given within 48 hours of age tended to decrease the incidence of death and BPD in ELBW newborns. Retrospective design can be biased as newborns with mild lung disease may have received caffeine early for extubation. There are several studies on pharmacodynamics and pharmacokinetics of caffeine. The data regarding cumulative dosage of caffeine, caffeine levels and BPD outcome is deficient.
Primary objective of this study is to test the hypothesis that early caffeine given within 24 hours of life will decrease incidence of mortality and BPD in ventilated ELBW newborns.
This study will also test an additional hypothesis that higher caffeine dosage and caffeine levels are associated with decreased mortality and postnatal morbidities in studied newborns.
Detailed description
Parents will be approached either prenatally for an impending delivery of ELBW newborn or within 16 hours of birth. 90 newborns will be randomized to receive early caffeine within 24 hours of life (the "study drug") and 90 newborns will receive a placebo. Either the early caffeine (the "study drug") or placebo will be continued throughout the first 15 days of life. Newborns in the early caffeine group will receive an IV bolus of 20mg/kg followed by IV or PO 5mg/kg daily for 14 days. The clinical team can choose to give PO caffeine if the newborn tolerates >75% of fluid goals by feeds. The clinical and research teams will be blinded; neither will know whether the newborn is receiving early caffeine or placebo. The clinical team will be allowed to use open labeled caffeine as deemed medically necessary after 24 hours of receiving either the early caffeine or placebo. Often this clinical need would be at the time of extubation (peri-extubation) and comprises the "late" caffeine group, which is also the placebo group. Perinatal and postnatal clinical characteristics will be prospectively collected. Clinical team may choose to hold study drug if newborns are placed on high frequency ventilation or if they need sedation drips for surgical procedures. Two blood samples will be collected one at day 7 and one at day 14 for caffeine levels. Data safety monitoring committee will be review mortality and morbidity in each group on a quarterly basis or after recruitment of every 30 newborns whichever happens earlier.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early caffeine group | Active comparator | Drug: Caffeine55 newborns will be randomized to receive caffeine within 24 hours of life. They will receive 20mg/kg IV bolus followed by IV or PO 5mg/kg daily for the next 14 days. The clinical team may decide to give PO caffeine if the newborn tolerates >75% of fluid goals by feeds. |
| Late caffeine group | Placebo comparator | Drug: Placebo (dextrose)55 newborns will be randomized to receive a placebo (dextrose) in the first 24 hours of life. They will receive a 20mg/kg IV bolus followed by IV or PO 5mg/kg daily for the next 14 days. The clinical team may decide to give the placebo orally is the newborn tolerates >75% of fluid goals by feeds. |
Who may qualify
- Ages
- Up to 4 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- newborns with birth weight less than or equal to 1000grams and less than 28 weeks of gestation are included if intubated by 12 hours of life
Key exclusion criteria (5 listed)
- newborns with known congenital malformation
- newborns whose parents refuse consent for the study
- newborns who are on high frequency ventilation and/or receiving more than 80% oxygen at 12 hours of age
- newborns deemed non-viable by the clinical team (defined as those neonates born at <24 weeks gestation and whose parents are offered withdrawal of support or do not resuscitate by clinical team for severity of cardiorespiratory illness at or before 12 hours of age)
- newborns diagnosed with congenital heart disease within the first 12 hours of life (presence of a ventricular septum defect and a patent ductus arteriosus is not an exclusion criteria)
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 | Drug | Early caffeine group |
| Placebo (dextrose) | Drug | Late caffeine group |
Primary outcome
Cumulative incidence of death and bronchopulmonary dysplasia
Time frame: 36 weeks post menstrual age
Results and safety
The study was stopped early (reason given: Frequent protocol violations). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2022.
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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.
Nitin S Chouthai, MD principal investigator
Wayne State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Caffeine in people with Bronchopulmonary Dysplasia and Apnea of Prematurity, run by Wayne State University 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 1 inclusion and 5 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: stopped early, as of the sponsor's last update on 2 May 2022. 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.
Are results available for this study?
The study was stopped early (reason given: Frequent protocol violations). Results are not available in the source record.
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?
Cumulative incidence of death and bronchopulmonary dysplasia (time frame: 36 weeks post menstrual age). 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 2 May 2022.