An interventional study of Phototherapy lights in Hyper Bilirubinemia and Premature Infant, sponsored by NICHD Neonatal Research Network. Active, not recruiting at 19 sites in United States. Open to participants aged 22 Weeks to 27 Weeks. Per ClinicalTrials.gov, last updated 2026-06-17.
Sponsored by NICHD Neonatal Research Network · Not applicable, Interventional, and Treatment
Cycled phototherapy (PT) is likely to increase survival over that with continuous PT among extremely premature infants (\< 750 g BW or \<27 weeks GA).
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.
2,554 studies on the registry are indexed under Premature Birth; 498 are open to participants now.
This study's planned enrollment of 1,700 is above the median of 84 across 1,689 interventional studies indexed under Premature Birth.
Browse Premature Birth studies →NICHD Neonatal Research Network is the lead sponsor of 63 studies on the registry; 5 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 7 (88%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Continuous phototherapy
Device: Phototherapy lights
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.
Number of participants survival to discharge
Number of Participants discharged from hospital alive, after birth.
Time frame: Birth to hospital discharge, up to 120 days of life
Number of hours of Phototherapy
The reported values will be the mean total hours of phototherapy during the two week intervention period.
Time frame: Start until the end of intervention period (duration of 2 weeks)
Number of irradiance hours
The reported values will be the mean total hours of irradiance during the two week intervention period.
Time frame: Start until the end of intervention period (duration of 2 weeks)
Peak Concentration of Total Serum Bilirubin
The reported values will be the mean peak total serum bilirubin (mg/dL) during the two week intervention period.
Time frame: Start until the end of intervention period (duration of 2 weeks)
Concentration of Total Serum Bilirubin
The reported values will be the mean total serum bilirubin (mg/dL) during the two week intervention period.
Time frame: Start until the end of intervention period (duration of 2 weeks)
Number of Participants with Major neonatal morbidity
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.
Time frame: Birth to hospital discharge, up to 120 days of life
Number of Participants with Severe ICH, as a component of the predischarge morbidity
As recorded for the sonongram with the most severe finding in the blood/echodensity in the ventricle or blood/echodensity in the parenchyma
Time frame: Birth to hospital discharge, up to 120 days of life
Number of Participants with Ventricular enlargement of cystic white matter disease, as a component predischarge morbidity
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.
Time frame: Birth to hospital discharge, up to 120 days of life
Number of Participants with Bronchopulmonary dysplasia (BPD), as a component predischarge morbidity
BPD defined as highest FiO2 at 36 wk: \>0.21
Time frame: Birth to hospital discharge, up to 120 days of life
Number of Participants with Late onset sepsis, as a component predischarge morbidity
Late onset blood culture positive septicemia/bacteremia at \>72 hours of age.
Time frame: Birth to hospital discharge, up to 120 days of life
Number of Participants with Necrotising enterocolitis (NEC) or spontaneous intestinal perforation, as a component predischarge morbidity
Either proven NEC or spontaneous gastrointestinal perforation without proven NEC.
Time frame: Birth to hospital discharge, up to 120 days of life
Number of Participants with Grade 3 (or greater) retinopathy of prematurity (ROP), as a component predischarge morbidity
Stage 3 ROP observed in either eye.
Time frame: Birth to hospital discharge, up to 120 days of life
Number of Participants with Patent ductus arteriosus (PDA) treated with surgery or NSAIDS
PDA treated with surgery or NSAIDS (indomethacin, ibuprofen or acetaminophen)
Time frame: Birth to hospital discharge, up to 120 days of life
Number of Participants with Neurodevelopmental Impairment
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.
Time frame: Birth to 26 months corrected age
Number of Participants with Neurodevelopmental Impairment or Death
NDI defined in outcome #9
Time frame: Birth to 26 months corrected age
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — 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)
This study is active, not recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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NICHD Neonatal Research Network