Cycled Phototherapy

Last updated: June 5, 2025
Sponsor: NICHD Neonatal Research Network
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Primary Biliary Cholangitis

Treatment

Phototherapy lights

Clinical Study ID

NCT03927833
NICHD-NRN-0061
UG1HD027880
UG1HD087229
UG1HD040689
UG1HD053089
UG1HD087226
UG1HD068263
UG1HD027853
UG1HD053109
UG1HD068244
UG1HD034216
UG1HD027904
UG1HD021364
UG1HD040492
3U24HD095254-07
UG1HD112079
UG1HD027851
UG1HD068278
UG1HD112100
UG1HD112097
U10HD036790
  • Ages 22-27
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Infants is inborn

  2. Infant is ≤ 750 grams at birth and/or < 27 weeks gestation at birth by best OBestimate

  3. Infant is 12-36 hours of age.

Exclusion

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 beingrecommended to the parents, the parents are requesting withdrawal of care, or the pHis < 6.80 or persistent bradycardia with hypoxemia for >2h.

Study Design

Total Participants: 1700
Treatment Group(s): 1
Primary Treatment: Phototherapy lights
Phase:
Study Start date:
July 16, 2020
Estimated Completion Date:
July 31, 2027

Study 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.

Connect with a study center

  • University of Alabama at Birmingham

    Birmingham, Alabama 35233
    United States

    Site Not Available

  • Stanford University

    Palo Alto, California 94304
    United States

    Site Not Available

  • Sharp Mary Birch Hospital for Women & Newborns

    San Diego, California 92123
    United States

    Site Not Available

  • Emory University

    Atlanta, Georgia 30303
    United States

    Site Not Available

  • Northwestern Lurie Children's Hospital of Chicago

    Chicago, Illinois 60611
    United States

    Site Not Available

  • University of Iowa

    Iowa City, Iowa 52242
    United States

    Site Not Available

  • University of Mississippi Medical Center - Children's of Mississippi

    Jackson, Mississippi 39216
    United States

    Site Not Available

  • University of New Mexico

    Albuquerque, New Mexico 87131
    United States

    Site Not Available

  • University of Rochester

    Rochester, New York 14642
    United States

    Site Not Available

  • Duke University

    Durham, North Carolina 27710
    United States

    Site Not Available

  • RTI International

    Durham, North Carolina 27705
    United States

    Site Not Available

  • Cincinnati Children's Medical Center

    Cincinnati, Ohio 45267
    United States

    Site Not Available

  • Case Western Reserve University, Rainbow Babies and Children's Hospital

    Cleveland, Ohio 44106
    United States

    Site Not Available

  • Research Institute at Nationwide Children's Hospital

    Columbus, Ohio 43205
    United States

    Site Not Available

  • Univeristy of Pennsylvania

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • Brown University - Women and Infants Hospital of Rhode Island

    Providence, Rhode Island 02905
    United States

    Site Not Available

  • University of Texas Southwestern Medical Center at Dallas

    Dallas, Texas 75235
    United States

    Site Not Available

  • University of Texas Health Science Center at Houston

    Houston, Texas 77030
    United States

    Site Not Available

  • University of Utah

    Salt Lake City, Utah 84108
    United States

    Site Not Available

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