HyperbilirubinemiaNCT01944696
Cycled Phototherapy: A Safer Effective Treatment for Small Premature Infants?
A study testing phototherapy in people with Hyperbilirubinemia and Premature Newborns, run by The University of Texas Health Science Center, Houston at 6 sites in United States.
Trial summary
Cycled (intermittent) phototherapy will be compared to continuous (uninterrupted) phototherapy in the treatment of hyperbilirubinemia (newborn jaundice) in extremely low birth weight newborns in a pilot randomized controlled trial. Read more about this study
- Who is it for?
- Ages Up to 24 hours
- Conditions the study is for
- Hyperbilirubinemia, Premature Newborns, Extremely Low Birth Weight
- What is being tested?
- phototherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 6 sitesUnited States
- Study dates
- Mar 2014to Jan 2018
- 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 24 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- birth weight 401-1000 grams
- age less than or equal to 24 hours
Who cannot join
- hemolytic disease
- major anomaly
- overt nonbacterial infection
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites, 6 recruiting
- Recruiting
University of Alabama at Birmingham School of Medicine - UAB Hospital
Birmingham, Alabama, 35233
Wally F Carlo, MD, WCarlo@peds.uab.edu
Wally F Carlo, MD
- Recruiting
University of Cincinnati College of Medicine - Good Samaritan Hospital
Cincinnati, Ohio, 45220
Brenda Poindexter, MD, MS, Brenda.Poindexter@cchmc.org
Brenda Poindexter, MD, MS
- Recruiting
The University of Texas Southwestern Medical School - Clements University Hospital
Dallas, Texas, 75390
Myra Wyckoff, MD, Myra.Wyckoff@UTSouthwestern.edu
Myra Wyckoff, MD
- Recruiting
The University of Texas Health Science Center at Houston; Memorial Hermann-TMC-NICU
Houston, Texas, 77030
Jon E Tyson, MD, 713-500-5651, jon.e.tyson@uth.tmc.edu
Cody C Arnold, MD, (713) 500-5633, cody.c.arnold@uth.tmc.edu
- Not yet recruiting
Stanford University - Lucile Packard Children's Hospital
Palo Alto, California, 94304
David K Stevenson, MD, dstevenson@stanford.edu
Ron Wong, MD, rjwong@stanford.edu
- Recruiting
The University of Texas Health Science Center at San Antonio - University Hospital
San Antonio, Texas, 78229
Alvaro Moreira, MD, moreiraA@uthscsa.edu
Alvaro Moreira, MD
About this study
Cycled (intermittent) phototherapy will be compared to continuous (uninterrupted) phototherapy in the treatment of hyperbilirubinemia (newborn jaundice) in extremely low birth weight newborns in a pilot randomized controlled trial.
Hypothesis: Cycled phototherapy (PT) will provide the same benefits as continuous phototherapy in extremely low birth weight (ELBW) infants without the risks that have been associated with continuous phototherapy.
Read the detailed description
Phototherapy (PT) is widely used and assumed to be safe as well as effective in reducing total bilirubin (TB) levels. Our recent NICHD Network Trial showed that aggressive use of phototherapy reduces neurodevelopmental impairment (NDI), but may increase deaths among ELBW infants. Among ventilator treated infants <750 g birth weight (BW) (n =696), conservative Bayesian analyses (using a neutral prior probability) identified a 99% (posterior) probability that aggressive phototherapy reduced profound NDI but a 99% probability that it increased deaths relative to conservative phototherapy. The possibility that PT increases deaths among high risk infants is also suggested by the Collaborative Phototherapy trial (performed in the 1970s), the only large RCT in which LBW infants were randomly assigned to receive PT or no PT. The relative risk for death among those randomized to PT relative to those randomized to no PT was 1.32 (0.9-1.82) among all LBW infants and 1.49 (0.93-2.40) among ELBW infants. These findings are consistent with a major increase in mortality but have been ignored because the p was >0.05, an error often made in ignoring important potential treatment hazards when power is limited.
Multiple studies, most performed decades ago in larger infants, found that short on/off cycles of PT (e.g. 15 min on/60 min off, 1 h on/3 h off, or 1 h on/1 h off ) are as effective as uninterrupted PT to reduce TSB. (Cycles with >6 h off PT do not appear to be as effective as uninterrupted PT). The clinical use of uninterrupted rather than cycled PT appears to be based largely on the assumption that PT is safe for all infants.
- Being tested
- phototherapy
- Keywords
- hyperbilirubinemia, prematurity, extremely low birth weight (ELBW), phototherapy, cycled phototherapy, intermittent phototherapy
- Medical subject headings
- Hyperbilirubinemia, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
phototherapyOther
Cycled versus continuous phototherapy during the first 2 wks after birth, both administered at bilirubin thresholds used in the NICHD Neonatal Network Phototherapy trial .
| Study group | Role | What they receive |
|---|---|---|
| continuous (uninterrupted) phototherapy | Active comparator | standard phototherapy Receives: Other: phototherapy |
| 15 minute per hour cycled phototherapy | Experimental | 15 minute per hour cycled phototherapy Receives: Other: phototherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain stem auditory evoked response wave V latency
a measure of transient or permanent bilirubin neurotoxicity
Measured: 35 wks postmenstrual age or discharge
Secondary outcomes (1)
Peak Total Serum Bilirubin (tsb)
Total serum bilirubin (TSB) measurements will be obtained following a study protocol modeled on standard practice for monitoring TSB in ELBW newborns.
Measured: 14 days from birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2013 (estimated)
- Study startMar 2014
- Primary completionJan 2017 (estimated)
- Study completionJan 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HyperbilirubinemiaStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Stanford University, Lucile Packard Children's Hospital
- Responsible party
- Principal investigator, Jon Edward Tyson, The University of Texas Health Science Center, Houston
- Investigators
- Jon E Tyson, MD, Principal investigator, The University of Texas Health Science Center, HoustonDavid K Stevenson, MD, Principal investigator, Stanford School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01944696
- Sponsor's protocol ID
- HSC-MS-13-0406
- Status last verified
- Jun 2016
- First submitted
- 12 Sep 2013
- Last updated
- 16 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Tyson JE, Pedroza C, Langer J, Green C, Morris B, Stevenson D, Van Meurs KP, Oh W, Phelps D, O'Shea M, McDavid GE, Grisby C, Higgins R; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Does aggressive phototherapy increase mortality while decreasing profound impairment among the smallest and sickest newborns? J Perinatol. 2012 Sep;32(9):677-84. doi: 10.1038/jp.2012.64. Epub 2012 May 31.
PubMed 22652561Hintz SR, Stevenson DK, Yao Q, Wong RJ, Das A, Van Meurs KP, Morris BH, Tyson JE, Oh W, Poole WK, Phelps DL, McDavid GE, Grisby C, Higgins RD; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Is phototherapy exposure associated with better or worse outcomes in 501- to 1000-g-birth-weight infants? Acta Paediatr. 2011 Jul;100(7):960-5. doi: 10.1111/j.1651-2227.2011.02175.x. Epub 2011 Feb 25.
PubMed 21272067Arnold C, Tyson JE, Pedroza C, Carlo WA, Stevenson DK, Wong R, Dempsey A, Khan A, Fonseca R, Wyckoff M, Moreira A, Lasky R. Cycled Phototherapy Dose-Finding Study for Extremely Low-Birth-Weight Infants: A Randomized Clinical Trial. JAMA Pediatr. 2020 Jul 1;174(7):649-656. doi: 10.1001/jamapediatrics.2020.0559.
PubMed 32338720
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cycled Phototherapy: A Safer Effective Treatment for Small Premature Infants?
- ClinicalTrials.gov ID
- NCT01944696
- Acronym / sponsor ID
- HSC-MS-13-0406
- Keywords
- hyperbilirubinemia, prematurity, extremely low birth weight (ELBW), phototherapy, cycled phototherapy, intermittent phototherapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- Stanford University, Lucile Packard Children's Hospital
- Study start
- Mar 2014
- Primary completion
- Jan 2017 (estimated)
- Study completion
- Jan 2018 (estimated)
- First posted
- 18 Sep 2013 (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.
Cycled (intermittent) phototherapy will be compared to continuous (uninterrupted) phototherapy in the treatment of hyperbilirubinemia (newborn jaundice) in extremely low birth weight newborns in a pilot randomized controlled trial.
Hypothesis: Cycled phototherapy (PT) will provide the same benefits as continuous phototherapy in extremely low birth weight (ELBW) infants without the risks that have been associated with continuous phototherapy.
Detailed description
Phototherapy (PT) is widely used and assumed to be safe as well as effective in reducing total bilirubin (TB) levels. Our recent NICHD Network Trial showed that aggressive use of phototherapy reduces neurodevelopmental impairment (NDI), but may increase deaths among ELBW infants. Among ventilator treated infants <750 g birth weight (BW) (n =696), conservative Bayesian analyses (using a neutral prior probability) identified a 99% (posterior) probability that aggressive phototherapy reduced profound NDI but a 99% probability that it increased deaths relative to conservative phototherapy. The possibility that PT increases deaths among high risk infants is also suggested by the Collaborative Phototherapy trial (performed in the 1970s), the only large RCT in which LBW infants were randomly assigned to receive PT or no PT. The relative risk for death among those randomized to PT relative to those randomized to no PT was 1.32 (0.9-1.82) among all LBW infants and 1.49 (0.93-2.40) among ELBW infants. These findings are consistent with a major increase in mortality but have been ignored because the p was >0.05, an error often made in ignoring important potential treatment hazards when power is limited.
Multiple studies, most performed decades ago in larger infants, found that short on/off cycles of PT (e.g. 15 min on/60 min off, 1 h on/3 h off, or 1 h on/1 h off ) are as effective as uninterrupted PT to reduce TSB. (Cycles with >6 h off PT do not appear to be as effective as uninterrupted PT). The clinical use of uninterrupted rather than cycled PT appears to be based largely on the assumption that PT is safe for all infants.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| continuous (uninterrupted) phototherapy | Active comparator | Other: phototherapystandard phototherapy |
| 15 minute per hour cycled phototherapy | Experimental | Other: phototherapy15 minute per hour cycled phototherapy |
Who may qualify
- Ages
- Up to 24 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- birth weight 401-1000 grams
- age less than or equal to 24 hours
Key exclusion criteria (3 listed)
- hemolytic disease
- major anomaly
- overt nonbacterial infection
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 |
|---|---|---|
| phototherapyCycled versus continuous phototherapy during the first 2 wks after birth, both administered at bilirubin thresholds used in the NICHD Neonatal Network Phototherapy trial . | Other | 15 minute per hour cycled phototherapy, continuous (uninterrupted) phototherapy |
Primary outcome
Brain stem auditory evoked response wave V latency
Time frame: 35 wks postmenstrual age or discharge
a measure of transient or permanent bilirubin neurotoxicity
1 secondary outcome
Peak Total Serum Bilirubin (tsb)
Time frame: 14 days from birth
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2016.
- Background: PubMed 22652561Tyson JE, Pedroza C, Langer J, Green C, Morris B, Stevenson D, Van Meurs KP, Oh W, Phelps D, O'Shea M, McDavid GE, Grisby C, Higgins R; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Does aggressive phototherapy increase mortality while decreasing profound impairment among the smallest and sickest newborns? J Perinatol. 2012 Sep;32(9):677-84. doi: 10.1038/jp.2012.64. Epub 2012 May 31.
- Background: PubMed 21272067Hintz SR, Stevenson DK, Yao Q, Wong RJ, Das A, Van Meurs KP, Morris BH, Tyson JE, Oh W, Poole WK, Phelps DL, McDavid GE, Grisby C, Higgins RD; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Is phototherapy exposure associated with better or worse outcomes in 501- to 1000-g-birth-weight infants? Acta Paediatr. 2011 Jul;100(7):960-5. doi: 10.1111/j.1651-2227.2011.02175.x. Epub 2011 Feb 25.
- Derived from this study: PubMed 32338720Arnold C, Tyson JE, Pedroza C, Carlo WA, Stevenson DK, Wong R, Dempsey A, Khan A, Fonseca R, Wyckoff M, Moreira A, Lasky R. Cycled Phototherapy Dose-Finding Study for Extremely Low-Birth-Weight Infants: A Randomized Clinical Trial. JAMA Pediatr. 2020 Jul 1;174(7):649-656. doi: 10.1001/jamapediatrics.2020.0559.
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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.
Jon E Tyson, MD principal investigator
The University of Texas Health Science Center, Houston
David K Stevenson, MD principal investigator
Stanford School of Medicine
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing phototherapy in people with Hyperbilirubinemia and Premature Newborns, run by The University of Texas Health Science Center, Houston at 6 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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 16 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jon E Tyson, MD (713-500-5651, jon.e.tyson@uth.tmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brain stem auditory evoked response wave V latency (time frame: 35 wks postmenstrual age or discharge). 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 NCT01944696, which also lists 3 linked publications.
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 16 Jun 2016.