Active — Not RecruitingNot Applicable

Cycled Phototherapy

United States1,700 participantsStarted 2020-07-16

Plain-language 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).

Who can participate

Age range22 Weeks – 27 Weeks

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

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

Exclusion criteria

✕. Unable to enroll infant by 36 hours of age
✕. Previous phototherapy
✕. Known hemolytic disease
✕. TSB reported as \>6.0 mg/dL before 12 hours age
✕. Major anomaly
✕. Overt nonbacterial infection
✕. 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.

What they're measuring

Number of participants survival to discharge

Timeframe: Birth to hospital discharge, up to 120 days of life

Trial details

NCT IDNCT03927833

SponsorNICHD Neonatal Research Network

Sponsor typeNETWORK

Study typeINTERVENTIONAL

Primary completion2025-11-04

View on ClinicalTrials.gov More Hyper Bilirubinemia trials