Cycled Phototherapy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

1700 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-16

Study Completion Date

2027-07-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Hyper Bilirubinemia Premature Infant

Keywords

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Infant, Newborn, Diseases Phototherapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Pragmatic randomized clinical trial addressing patient safety.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Continuous Phototherapy

Continuous phototherapy

Group Type ACTIVE_COMPARATOR

Phototherapy lights

Intervention Type DEVICE

Phototherapy lights used continuously or timed, following an algorithm based upon TSB levels.

Cycled Phototherapy

Cycled phototherapy at timed intervals, dependent upon total serum bilirum (TSB) levels.

Group Type EXPERIMENTAL

Phototherapy lights

Intervention Type DEVICE

Phototherapy lights used continuously or timed, following an algorithm based upon TSB levels.

Interventions

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Phototherapy lights

Phototherapy lights used continuously or timed, following an algorithm based upon TSB levels.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

22 Weeks

Maximum Eligible Age

27 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jon Tyson, MD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

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Identifier Type: -

Identifier Source: org_study_id

Cycled Phototherapy

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Study Groups

Continuous Phototherapy

Phototherapy lights

Cycled Phototherapy

Phototherapy lights

Interventions

Phototherapy lights

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NICHD Neonatal Research Network

Responsible Party

Principal Investigators

Jon Tyson, MD

Locations

University of Alabama at Birmingham

Stanford University

Sharp Mary Birch Hospital for Women & Newborns

Emory University

Northwestern Lurie Children's Hospital of Chicago

University of Iowa

University of Mississippi Medical Center - Children's of Mississippi

University of New Mexico

University of Rochester

RTI International

Duke University

Cincinnati Children's Medical Center

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

Research Institute at Nationwide Children's Hospital

Univeristy of Pennsylvania

Brown University - Women and Infants Hospital of Rhode Island

University of Texas Southwestern Medical Center at Dallas

University of Texas Health Science Center at Houston

University of Utah

Countries

Other Identifiers

UG1HD034216

UG1HD027904

UG1HD021364

UG1HD027853

UG1HD040689

UG1HD040492

UG1HD027851

UG1HD087229

UG1HD053109

UG1HD068278

UG1HD068244

UG1HD068263

UG1HD027880

UG1HD053089

UG1HD087226

UG1HD112079

UG1HD112097

UG1HD112100

3U24HD095254-07

NICHD-NRN-0061