Clinical Trials Logo
  1. Home
  2. Hyperbilirubinemia
  3. NCT00004382
  4. Details
NCT00004382 Clinical Trial

Phase II Study of Tin Mesoporphyrin vs Phototherapy for Hyperbilirubinemia in Premature Newborns

Hyperbilirubinemia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00004382
Other study ID # 199/12022
Secondary ID RUH-0330795B
Status Completed
Phase Phase 2
First received October 18, 1999
Last updated September 8, 2008
Start date December 1999

Study information
Verified date September 2008
Source Office of Rare Diseases (ORD)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

OBJECTIVES: I. Compare the effectiveness of a single dose of tin mesoporphyrin and special blue light phototherapy in controlling hyperbilirubinemia in premature newborns in Greece.

II. Evaluate the dose of tin mesoporphyrin sufficient to alleviate the need for phototherapy without adverse effects in these newborns.

Description:

PROTOCOL OUTLINE: Patients are randomly assigned to a clinical group within 96 hours of birth. Patients are stratified by gestational age, clinical status, and age at treatment.

One group receives tin mesoporphyrin. Patients are crossed to phototherapy if the plasma bilirubin concentration reaches the treatment threshold.

The second group receives phototherapy with Special Blue fluorescent lamps for at least 24 hours. Patients receive a second phototherapy course if the plasma bilirubin concentration reaches the treatment threshold within 24 hours of the first course.

Recruitment information / eligibility
Status Completed
Enrollment 80
Est. completion date
Est. primary completion date August 2007
Accepts healthy volunteers No
Gender Both
Age group N/A to 24 Hours
Eligibility PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

- Premature infants of gestational age 210 to 251 days

- No blood group isoimmunization (direct Coombs' positive), e.g., rhesus or ABO

- No glucose-6-phosphate dehydrogenase deficiency

--Prior/Concurrent Therapy--

- No maternal phenobarbital in last month of pregnancy

--Patient Characteristics--

Renal: No congenital renal abnormality

Cardiovascular: No congenital heart abnormality

Pulmonary: No asphyxia requiring assisted ventilation at delivery

Other: No other major congenital abnormality, i.e.:

- Central nervous system

- Chromosomal

- Gastrointestinal

No evident or suspected congenital infection, i.e.:

- Cytomegalovirus

- Herpes

- Rubella

- Syphilis

Study Design

Allocation: Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• tin mesoporphyrin

Procedure:
• Phototherapy

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Rockefeller University
See also
  Status Clinical Trial Phase
Completed NCT00383318 - Demographic, Metabolic, and Genomic Description of Neonates With Severe Hyperbilirubinemia N/A
Completed NCT00360204 - Improving Health Outcomes for New Mothers and Babies Phase 3
Completed NCT00115544 - Safety and Pharmacology of Stanate Phase 2
Completed NCT01622699 - Implementation of a Transcutaneous Bilirubinometer N/A
Terminated NCT00741117 - Conjugated Hyperbilirubinemia and Pulse Oximetry N/A
Completed NCT00288600 - Efficacy of High-dose Intravenous Immunoglobulin Therapy for Hyperbilirubinemia Due Rh Hemolytic Disease Phase 4
Completed NCT02774434 - Efficacy Study of the Draeger Jaundice Meter (JM-105) in Neonates of ≥ 24 Weeks of Gestational Age N/A
Completed NCT01550627 - Effect of Intravenous Fluid Supplementation on Serum Bilirubin and Cardiorespiratory Parameters in Preterm Infants During Phototherapy Phase 0
Completed NCT00653874 - Transcutaneous Bilirubinometry in Healthy Term and Near-Term Neonates Phase 3
Recruiting NCT03564678 - Levocarnitine and Vitamin B Complex in Treating PEG-Asparaginase or Inotuzumab Ozogamicin-Induced Hyperbilirubinemia in Patients With Acute Lymphoblastic Leukemia Phase 2
Recruiting NCT04897113 - Study of Efficacy and Safety of the Plasmapheresis Method With Albumin Compensation Compared With the Plasmapheresis Method Without Albumin Compensation for Aging Biomarkers Correction in Men and Women Aged 40 to 55 Years Old N/A
Recruiting NCT01944696 - Cycled Phototherapy: A Safer Effective Treatment for Small Premature Infants? N/A
Completed NCT00635375 - Comparative Study of Phototherapy for Hyperbilirubinemia N/A
Completed NCT03195998 - Validity of Transcutaneous Bilirubin Monitoring in Preterm Infants
Terminated NCT02685189 - Long-Term Clinical Follow-Up of Children Enrolled in Stannsoporfin Clinical Trial Protocol No. 64,185-06-2(W)
Completed NCT02446951 - Implementation of a Clinical Decision Rule for Treatment of Neonatal Jaundice in the Emergency Department
Terminated NCT01136577 - Light-emitting Diodes (LED) Phototherapy for Hyperbilirubinemia of Term Newborn N/A
Completed NCT04271098 - The Investigation of the Causes of Hepatic Dysfunction in the Postoperative Period During Open-heart Surgeries
Completed NCT02691156 - Bilirubin Binding Capacity to Assess Bilirubin Load in Preterm Infants
Completed NCT00004381 - Phase II Randomized Study of Tin Mesoporphyrin for Neonatal Hyperbilirubinemia Phase 2