Clinical Trials Logo
  1. Home
  2. Neonatal Jaundice
  3. NCT00076960
  4. Details
NCT00076960 Clinical Trial

Compassionate Use of Stanate (TM) [Stannsoporfin]

Neonatal Jaundice Clinical Trial

Official title:
Compassionate Use of Stannsoporfin as an Adjuvant to Phototherapy to Reduce the Need for Exchange Transfusions

Clinical Trial Details — Status: No longer available

Administrative data
NCT number NCT00076960
Other study ID # 99A
Secondary ID
Status No longer available
Phase
First received
Last updated

Study information
Verified date January 2016
Source Mallinckrodt
Contact n/a
Is FDA regulated No
Health authority
Study type Expanded Access

Clinical Trial Summary

The purpose of this protocol is to make Stanate (TM) [stannsoporfin, tin-mesoporphyrin] available to infants who meet the following criteria:

1. the infant has a very high level of bilirubin without an adequate clinical response to phototherapy;

2. the infant requires an exchange transfusion; and

3. the family refuses to allow the administration of blood products, particularly on religious grounds, such as within the Jehovah's Witness community.

Other known NCT identifiers
  • NCT01183988

Recruitment information / eligibility
Status No longer available
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group N/A to 1 Week
Eligibility - Term or near term neonate

- Elevated serum bilirubin

- Failing phototherapy

- Requires exchange transfusion

- Family refuses exchange transfusion on religious grounds

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Stanate (TM) [stannsoporfin, tin-mesoporphyrin]
Treatment with 4.5 mg/kg

Locations
Country Name City State
United States William Beaumont Hospital Royal Oak Michigan

Sponsors (1)
Lead Sponsor Collaborator
InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company

Country where clinical trial is conducted

United States, 

References & Publications (1)

Kappas A, Drummond GS, Munson DP, Marshall JR. Sn-Mesoporphyrin interdiction of severe hyperbilirubinemia in Jehovah's Witness newborns as an alternative to exchange transfusion. Pediatrics. 2001 Dec;108(6):1374-7. — View Citation

See also
  Status Clinical Trial Phase
Recruiting NCT04365998 - BUBOLight®, a New Phototherapy Device for the Treatment of the Newborn's Jaundice N/A
Completed NCT02222805 - Effect of Timing of Umbilical Cord Clamping on Anaemia at 8 and 12 Months and Later Neurodevelopment N/A
Completed NCT01622699 - Implementation of a Transcutaneous Bilirubinometer N/A
Completed NCT00692224 - Efficacy of Zinc in Reducing Hyperbilirubinemia Among High Risk Neonates - A Double Blind Randomized Trial Phase 1/Phase 2
Not yet recruiting NCT06080971 - Persistent Neonatal Jaundice on Neonates and Childern
Recruiting NCT06075290 - the Difference of Follow-up Methods of Neonatal Jaundice
Recruiting NCT05955144 - Clinical Validation of the Screening Tool Picterus JP Using Different Smartphones N/A
Recruiting NCT05127070 - Evaluating the NeoTree in Malawi and Zimbabwe
Completed NCT03306004 - Neonatal Jaundice: Knowledge, Attitudes and Practices of Mothers and Medical Trainees and Providers in and Around Ogbomosho N/A
Completed NCT02774434 - Efficacy Study of the Draeger Jaundice Meter (JM-105) in Neonates of ≥ 24 Weeks of Gestational Age N/A
Terminated NCT05365399 - Evaluation of a Smartphone-based Screening Tool for Neonatal Jaundice in a Ugandan Population N/A
Recruiting NCT03933423 - Home Based Phototherapy for Neonatal Jaundice N/A
Recruiting NCT06087874 - Preventive Effect of Perinatal Oral Probiotic Supplementation (POPS) on Neonatal Jaundice Phase 2
Recruiting NCT06399146 - Evaluation of Bilirubin Estimates in Newborns From Smartphone Digital Images in a Population in Botswana N/A
Recruiting NCT03183986 - Comparison of the Efficacy of Phototherapy Using Blue LED's With Wavelength 478 vs. 459 nm. N/A
Withdrawn NCT00917007 - Measurement of Carboxyhemoglobin by Gas Chromatography as an Index of Hemolysis
Completed NCT06227624 - Role of Oral Zinc in Reducing Neonatal Indirect Hyperbilirubinemia Phase 3
Completed NCT04433923 - Aluminium Foil as an Adjuvant to Phototherapy for Pathological Unconjugated Hyperbilirubinaemia in Full Term Infants N/A
Completed NCT04418180 - Fenofibrate Therapy in Pathological Unconjugated Hyperbilirubinemia in Full Term Infants N/A
Completed NCT06386731 - Continuous Versus Intermittent Phototherapy in Treatment of Neonatal Jaundice N/A