InfaCare 64,185-204

Overview

Status: Not yet recruiting
Keywords: Neonates , Phototherapy , Stannsoporfin , Pediatrics , Jaundice
IRB Number: 00066244
Specialty: Neonatology
Sub Specialties:

Brief Summary

The primary objective of this clinical trial is to assess the safety and efficacy of stannsoporfin in combination with PT in term and near-term neonates.

Secondary efficacy outcome measures are:

      Percent change from baseline in TSB (the baseline TSB is the TSB that qualifies for randomization) at 6, 12, 18, 24, 30 and 36 hours

 

      Total serum bilirubin area under the curve (AUC) above the baseline TSB (0 to 48 hours post-dose)

 

      Peak serum bilirubin.

 

      Incidence of rebound hyperbilirubinemia defined as an increase in TSB above the age- specific threshold for initiating PT following the discontinuation of the initial PT

 

      Incidence of readmission to hospital for hyperbilirubinemia due to a TSB at or above the age specific threshold for PT

 

      Duration of clinical requirement for PT defined as the interval between the initiation of PT and the first transcutaneous bilirubin (TcB) measurement that is below the age specific threshold for PT. A TSB will be drawn and must also be below the age specific threshold for PT. The prior TcB will be used as the end of the need for PT.

 

      Safety outcome measures are:

 

Incidence of adverse events and serious adverse events (SAE’s)

      Changes in vital sign measurements

 

      Results of physical exam (PE)

 

      Results of neurologic exam

 

      ECG assessments

Principal Investigator: Julie Shakib
Department: Pediatric Administration
Co Investigator: Michael Spigarelli

Contact Information

Name:Priscilla Cowan
Phone: 801-585-0903
Email: priscilla.rosen@hsc.utah.edu

Inclusion Criteria

1a. Term and near term infants ≥35 and ≤ 43 weeks GA, age 0-48 hours (at the time the qualifying TSB is drawn)with ABO or Rh incompatibility (anti C, c, D, E or e) who are DAT positive, or age 0-72 hours (at the time the qualifying TSB is drawn) with G6PD deficiency as confirmed by a documented blood test OR

1b. Term and near-term infants ≥35 and ≤ 43 weeks GA, age 0-48 hours (at the time the qualifying TSB is drawn) with ABO or Rh incompatibility (anti C, c, D, E or e) who are DAT-negative (or status unknown) and have an increased reticulocyte count (>6%).

2. Parental or guardian consent

3. Birth weight ≥ 2500 grams

4. At or above the age-specific threshold for initiating PT per the AAP guidelines based on measurement of TSB

5. Parents agree to observe light precautions for 10 days post treatment

Exclusion Criteria

1. Elevated direct bilirubin ≥2 mg/dL, OR > 20% of the total serum bilirubin

2. Alanine aminotransferase (ALT) > 2 times the upper limit of normal (ULN) and/or aspartate aminotransferase (AST) > 3 times ULN

3. Abnormal renal function defined as creatinine and/or blood urea nitrogen >2 times the ULN

4. Any other clinically significant abnormalities on screening laboratory evaluation (including ECG) that in the opinion of the investigator makes the patient unsuitable for the clinical trial

5. Apgar score ≤6 at age 5 minutes

6. An unexplained existing rash or skin erythema

7. Prior exposure to PT

8. Clinical suggestion of neonatal thyroid disease or current uncontrolled thyroid disease in the mother (maternal Hashimoto’s disease is not exclusionary)

9. Cardio-respiratory distress, defined as a respiratory rate >60 breaths per minute at time of enrollment

10. Any abnormal auditory or ophthalmologic findings on screening physical exam

11. ECG finding of prolonged QTcB during the 3 screening ECGs: average QTcB > 480ms for neonates on day 1 (0-24 hrs) or day 2 (>24-48 hrs) of life or an average QTcB>460 ms for neonates on day 3 (>48-72 hrs) of life

12. Treatment or need for treatment of the neonate with medications that may prolong the QT interval (Appendix C: Drugs Used in Newborns Known to Prolong the QT Interval) or family history of long QT syndrome

13. Known porphyrias or risk factors for porphyrias, including family history

14. A maternal history of systemic lupus erythematosus

15. Maternal use of phenobarbital 30 days before, or after delivery, if breast-feeding

16. Maternal current drug or alcohol abuse, or maternal history of drug or alcohol abuse that, in the opinion of the Investigator, would not make the patient a suitable candidate for participation in the clinical trial

17. Significant congenital anomalies or infections

18. Risk of requiring surgery or exposure to operating room (OR) lights in the first 2 weeks of life

18. Persistent hypoglycemia unresponsive to medical intervention defined as 3 consecutive readings of blood glucose <40mg/dl over a 3 hour period

19. Current temperature instability defined as 3 consecutive readings <36ºC and/or >37.5ºC  (axillary) over a 3 hour period.

20. Use of IVIG or albumin prior to study drug administration

21. Post-delivery treatment with medications that are known or suspected to displace bilirubin from albumin (e.g., ceftriaxone or sulfa-based antibiotics)

22. Use of photosensitizing drugs or agents (appendix D)

23. Post-delivery treatment with medications that are known or suspected to displace bilirubin from albumin (Appendix E)

24. Exposure to any investigational medications or devices after delivery, or participation in another clinical trial while participating in this trial.

25. Any other concurrent medical condition, which in the opinion of the Investigator, makes the patient unsuitable for the clinical trial