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Cycled Phototherapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03927833
Recruitment Status : Recruiting
First Posted : April 25, 2019
Last Update Posted : September 9, 2020
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
NICHD Neonatal Research Network

Brief Summary:
Cycled phototherapy (PT) is likely to increase survival over that with continuous PT among extremely premature infants (< 750 g BW or <27 weeks GA).

Condition or disease Intervention/treatment Phase
Hyper Bilirubinemia Premature Infant Device: Phototherapy lights Phase 3

Detailed Description:

Were they not delivered early, extremely premature infants would normally develop in darkness within the uterus for 3-4 more months longer before birth. Yet, the routine care of these infants has involved the use of uninterrupted (continuous) exposure to bright light during phototherapy (PT), a treatment method that neonatologists have assumed has no serious adverse effects on even the most immature of newborns.

Immaturity, thin translucent skin, and a multitude of other problems may make extremely premature infants highly vulnerable to the photo-oxidative injury, lipid peroxidation, DNA damage, reduced cerebral and mesenteric blood flow, or other serious potential hazards of uninterrupted exposure to PT that have now been identified. Such hazards were not recognized when continuous PT was widely incorporated into neonatal care, and the survival rate of extremely premature infants (<27 wks gestation or <750 g birth weight) was much lower than today.

PT rapidly photoisomerizes bilirubin in the subcutaneous tissues and vasculature, and six trials of cycled PT have demonstrated that use of cycled PT reduces the total hours of PT and results in minimal or no increase in peak TSB over that with continuous PT in term or moderately preterm infants. Recent findings from a pilot study (NCT01944696) support a PT regimen for this Cycled Phototherapy protocol.

Infants born at one of the Neonatal Research Network centers, ≤ 750 grams at birth and/or < 27 weeks gestation at birth by best OB estimate will be considered for this study.

Those who qualify will be randomized to either cycled PT or continuous PT. The cycled phototherapy begins with >15 min/h cycled PT regimen and increased to 30 min/h if the TSB is 8.0-9.9 and 60 min/h if the TSB is >10 mg/dL. Those randomized to continuous phototherapy will undergo continuous exposure,as that is commonly used in NRN centers.

The PT lamp position will be adjusted to meet the irradiance (µW/cm2/nm) goal of 22 at the umbilicus. The irradiance goal in both groups will be increased from 22 to 33 at a TSB of 10-13 and to 40 at a TSB >13.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1700 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Pragmatic randomized clinical trial addressing patient safety.
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Cycled Phototherapy: A Safer Effective Method to Control the Serum Bilirubin Of Extremely Premature Infants?
Actual Study Start Date : July 15, 2020
Estimated Primary Completion Date : July 2022
Estimated Study Completion Date : August 2024

Arm Intervention/treatment
Active Comparator: Continuous Phototherapy
Continuous phototherapy
Device: Phototherapy lights
Phototherapy lights used continuously or timed, following an algorithm based upon TSB levels.

Experimental: Cycled Phototherapy
Cycled phototherapy at timed intervals, dependent upon total serum bilirum (TSB) levels.
Device: Phototherapy lights
Phototherapy lights used continuously or timed, following an algorithm based upon TSB levels.




Primary Outcome Measures :
  1. Number of participants survival to discharge [ Time Frame: Birth to hospital discharge, up to 120 days of life ]
    Number of Participants discharged from hospital alive, after birth.


Secondary Outcome Measures :
  1. Number of hours of Phototherapy [ Time Frame: Start until the end of intervention period (duration of 2 weeks) ]
    The reported values will be the mean total hours of phototherapy during the two week intervention period.

  2. Number of irradiance hours [ Time Frame: Start until the end of intervention period (duration of 2 weeks) ]
    The reported values will be the mean total hours of irradiance during the two week intervention period.

  3. Peak Concentration of Total Serum Bilirubin [ Time Frame: Start until the end of intervention period (duration of 2 weeks) ]
    The reported values will be the mean peak total serum bilirubin (mg/dL) during the two week intervention period.

  4. Concentration of Total Serum Bilirubin [ Time Frame: Start until the end of intervention period (duration of 2 weeks) ]
    The reported values will be the mean total serum bilirubin (mg/dL) during the two week intervention period.

  5. Number of Participants with Major neonatal morbidity [ Time Frame: Birth to hospital discharge, up to 120 days of life ]
    Major neonatal morbidity is defined as a severe ICH, ventricular enlargement of cystic white matter disease, BPD, late onset sepsis, NEC or spontaneous intestinal perforation, or >grade 3 ROP before discharge.

  6. Number of Participants with Severe ICH, as a component of the predischarge morbidity [ Time Frame: Birth to hospital discharge, up to 120 days of life ]
    As recorded for the sonongram with the most severe finding in the blood/echodensity in the ventricle or blood/echodensity in the parenchyma

  7. Number of Participants with Ventricular enlargement of cystic white matter disease, as a component predischarge morbidity [ Time Frame: Birth to hospital discharge, up to 120 days of life ]
    If a MRI was done: ventricular size enlarged, cystic PVL or porencephalic /posthemorrhagic cyst/multicystic encephalomalacia observed. If a MRI was not done: the same items as above for sonograms after day 28.

  8. Number of Participants with Bronchopulmonary dysplasia (BPD), as a component predischarge morbidity [ Time Frame: Birth to hospital discharge, up to 120 days of life ]
    BPD defined as highest FiO2 at 36 wk: >0.21

  9. Number of Participants with Late onset sepsis, as a component predischarge morbidity [ Time Frame: Birth to hospital discharge, up to 120 days of life ]
    Late onset blood culture positive septicemia/bacteremia at >72 hours of age.

  10. Number of Participants with Necrotising enterocolitis (NEC) or spontaneous intestinal perforation, as a component predischarge morbidity [ Time Frame: Birth to hospital discharge, up to 120 days of life ]
    Either proven NEC or spontaneous gastrointestinal perforation without proven NEC.

  11. Number of Participants with Grade 3 (or greater) retinopathy of prematurity (ROP), as a component predischarge morbidity [ Time Frame: Birth to hospital discharge, up to 120 days of life ]
    Stage 3 ROP observed in either eye.

  12. Number of Participants with Patent ductus arteriosus (PDA) treated with surgery or NSAIDS [ Time Frame: Birth to hospital discharge, up to 120 days of life ]
    PDA treated with surgery or NSAIDS (indomethacin, ibuprofen or acetaminophen)

  13. Number of Participants with Neurodevelopmental Impairment [ Time Frame: Birth to 26 months corrected age ]
    Neurodevelopmental Impairment (NDI), as assessed in a sub-population of follow-up of infants <27 wks gestation. Severe NDI will be defined by any of the following: a BSID III cognitive score < 70, Gross Motor Functional (GMF) Level of 3-5, blindness (<20/200 vision) or profound hearing loss (inability to understand commands despite amplification); moderate NDI will be defined as a BSID III cognitive score 70-84 and either a GMF level of 2 or a hearing deficit requiring amplification to understand commands or unilateral blindness; mild NDI will be defined by a cognitive score 70-84, or a cognitive score ≥ 85 and any of the following: presence of a GMF level 1 or hearing loss not requiring amplification. Normal (no NDI) will be defined by a cognitive score ≥ 85 and absence of any neurosensory deficits.

  14. Number of Participants with Neurodevelopmental Impairment or Death [ Time Frame: Birth to 26 months corrected age ]
    NDI defined in outcome #9



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Ages Eligible for Study:   22 Weeks to 27 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Infants is inborn
  2. Infant is ≤ 750 grams at birth and/or < 27 weeks gestation at birth by best OB estimate
  3. Infant is 12-36 hours of age.

Exclusion Criteria:

  1. Unable to enroll infant by 36 hours of age
  2. Previous phototherapy
  3. Known hemolytic disease
  4. TSB reported as >6.0 mg/dL before 12 hours age
  5. Major anomaly
  6. Overt nonbacterial infection
  7. Infant is likely to expire soon: Limiting or withdrawal of intensive care is being recommended to the parents, the parents are requesting withdrawal of care, or the pH is < 6.80 or persistent bradycardia with hypoxemia for >2h.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03927833


Contacts
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Contact: Jon Tyson, MD 713-500-5790 Jon.E.Tyson@uth.tmc.edu
Contact: Abhik Das, PhD 301-230-4640

Locations
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United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35233
Contact: Waldemar A. Carlo, MD    205-934-4680      
Principal Investigator: Waldemar A. Carlo, MD         
United States, California
Stanford University Not yet recruiting
Palo Alto, California, United States, 94304
Contact: Krisa P. Van Meurs, MD         
Principal Investigator: Krisa P. Van Meurs, MD         
United States, Georgia
Emory University Not yet recruiting
Atlanta, Georgia, United States, 30303
Contact: Ravi Patel, MD         
Principal Investigator: Ravi Patel, MD         
United States, Iowa
University of Iowa Not yet recruiting
Iowa City, Iowa, United States, 52242
Contact: Edward F Bell, MD         
Principal Investigator: Edward F Bell         
United States, New Mexico
University of New Mexico Recruiting
Albuquerque, New Mexico, United States, 87131
Contact: Kristi L. Watterberg, MD         
Principal Investigator: Kristi L. Watterberg, MD         
United States, New York
University of Rochester Not yet recruiting
Rochester, New York, United States, 14642
Contact: Carl T D'Angio, MD         
Principal Investigator: Carl T D'Angio, MD         
United States, North Carolina
RTI International Active, not recruiting
Durham, North Carolina, United States, 27705
Duke University Recruiting
Durham, North Carolina, United States, 27710
Contact: C. Michael Cotten, MD         
Sub-Investigator: C. Michael Cotten, MD MHS         
United States, Ohio
Cincinnati Children's Medical Center Recruiting
Cincinnati, Ohio, United States, 45267
Contact: Stephanie Merhar, MD         
Principal Investigator: Stephanie Merhar, MD         
Case Western Reserve University, Rainbow Babies and Children's Hospital Recruiting
Cleveland, Ohio, United States, 44106
Contact: Anna Maria Hibbs, MD         
Principal Investigator: Anna Maria Hibbs, MD         
Research Institute at Nationwide Children's Hospital Not yet recruiting
Columbus, Ohio, United States, 43205
Contact: Pablo Sanchez, MD         
Principal Investigator: Pablo Sanchez, MD         
United States, Pennsylvania
Univeristy of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Eric Eichenwald, MD         
Principal Investigator: Eric Eicenwald, MD         
United States, Rhode Island
Brown University - Women and Infants Hospital of Rhode Island Recruiting
Providence, Rhode Island, United States, 02905
Contact: Abbot R. Laptook, MD         
Principal Investigator: Abbot R Laptook, MD         
United States, Texas
University of Texas Southwestern Medical Center at Dallas Not yet recruiting
Dallas, Texas, United States, 75235
Contact: Myra Myckoff, MD         
Principal Investigator: Myra Myckoff, MD         
University of Texas Health Science Center at Houston Recruiting
Houston, Texas, United States, 77030
Contact: Jon E Tyson, MD MPH         
Principal Investigator: Jon E. Tyson, MD MPH         
United States, Utah
University of Utah Recruiting
Salt Lake City, Utah, United States, 84108
Contact: Robin Ohls, MD         
Principal Investigator: Robin Ohls, MD         
Sponsors and Collaborators
NICHD Neonatal Research Network
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
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Principal Investigator: Jon Tyson, MD The University of Texas Health Science Center, Houston
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Responsible Party: NICHD Neonatal Research Network
ClinicalTrials.gov Identifier: NCT03927833    
Other Study ID Numbers: NICHD-NRN-0061
UG1HD034216 ( U.S. NIH Grant/Contract )
UG1HD027904 ( U.S. NIH Grant/Contract )
UG1HD021364 ( U.S. NIH Grant/Contract )
UG1HD027853 ( U.S. NIH Grant/Contract )
UG1HD040689 ( U.S. NIH Grant/Contract )
UG1HD040492 ( U.S. NIH Grant/Contract )
UG1HD027851 ( U.S. NIH Grant/Contract )
UG1HD087229 ( U.S. NIH Grant/Contract )
UG1HD053109 ( U.S. NIH Grant/Contract )
UG1HD068278 ( U.S. NIH Grant/Contract )
UG1HD068244 ( U.S. NIH Grant/Contract )
UG1HD068263 ( U.S. NIH Grant/Contract )
UG1HD027880 ( U.S. NIH Grant/Contract )
UG1HD053089 ( U.S. NIH Grant/Contract )
UG1HD087226 ( U.S. NIH Grant/Contract )
U10HD036790 ( U.S. NIH Grant/Contract )
First Posted: April 25, 2019    Key Record Dates
Last Update Posted: September 9, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: NIH has had a long-standing policy to share and make available to the public the results and accomplishments of the activities that it funds. The NRN plans to share de-identified data after final publication in an NIH supported data repository such as the NICHD Data and Specimen Hub (https://dash.nichd.nih.gov)

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by NICHD Neonatal Research Network:
Infant, Newborn, Diseases
Phototherapy
Additional relevant MeSH terms:
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Premature Birth
Hyperbilirubinemia
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Pathologic Processes