Stannsoporfin With Light Therapy for Newborn Babies With Jaundice (NCT01887327) | Clinical Trial Compass
CompletedPhase 2
Stannsoporfin With Light Therapy for Newborn Babies With Jaundice
United States91 participantsStarted 2013-10-16
Plain-language summary
It is normal for red blood cells to die, even in newborn babies. The waste from that is called bilirubin. The liver clears bilirubin out of the body.
Some babies are born with illness that makes red blood cells die too fast, so the liver is not strong enough to keep up with it.
The yellowish color in eyes or skin means there is too much bilirubin in the body. It can be dangerous if a baby's bilirubin gets too high.
Special lights are put on jaundiced babies (called phototherapy) to help the liver get rid of bilirubin.
This study tests an experimental drug to see if it can help the liver even more, by safely cutting down the amount of bilirubin the body is making in the first place.
Who can participate
Age range1 Hour – 72 Hours
SexALL
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Inclusion criteria
✓. Term and near term infants ≥35 and ≤ 43 weeks gestational age (GA), age 0-48 hours with antibody (ABO) or rhesus factor (Rh) incompatibility (anti C, c, D, E or e) who are Coombs positive, or age 0-72 hours with G6PD deficiency
✓. Parental or guardian consent
✓. Birth weight ≥ 2500 grams
✓. At or above the age-specific threshold for initiating phototherapy (PT) per the American Academy of Pediatrics (AAP) guidelines based on measurement of total serum bilirubin (TSB)
✓. Parents agree to observe light precautions for 10 days post treatment
Exclusion criteria
✕. Elevated direct bilirubin ≥2 mg/dL, OR \> 20% of the total serum bilirubin
✕. Alanine aminotransferase (ALT) \> 2 times the upper limit of normal (ULN) and/or aspartate aminotransferase (AST) \> 3 times ULN
✕. Abnormal renal function defined as creatinine and/or blood urea nitrogen \>2 times the ULN
✕
What they're measuring
1
Total Serum Bilirubin (mg/dL)
Timeframe: Baseline, 48 hours post-treatment
Trial details
NCT IDNCT01887327
SponsorInfaCare Pharmaceuticals Corporation, a Mallinckrodt Company
. Any other clinically significant abnormalities on screening laboratory evaluation \[including electrocardiogram (ECG)\] that in the opinion of the investigator makes the patient unsuitable for the clinical trial
✕. Apgar score ≤6 at age 5 minutes
✕. An unexplained existing rash or skin erythema
✕. Prior exposure to PT
✕. Clinical suggestion of neonatal thyroid disease or current uncontrolled thyroid disease in the mother (maternal Hashimoto's disease is not exclusionary)