Purpose

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

Conditions

Eligibility

Eligible Ages
Between 22 Weeks and 27 Weeks
Eligible Genders
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Pragmatic randomized clinical trial addressing patient safety.
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
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.

Recruiting Locations

University of Texas Health Science Center at Houston
Houston, Texas 77030
Contact:
Jon E Tyson, MD MPH

More Details

Status
Recruiting
Sponsor
NICHD Neonatal Research Network

Study Contact

Jon Tyson, MD
713-500-5790
Jon.E.Tyson@uth.tmc.edu

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.