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This trial is complete. It is no longer accepting participants.

NCT00004381

NCT00004381
Completed Phase 2

Who may be able to join

Who might be able to join this trial:

  • Your newborn has high levels of bilirubin (a yellow pigment in the blood) in their blood
  • The high bilirubin is caused by a blood type mismatch between mother and baby (ABO hemolytic disease), confirmed by a positive Coombs' test
  • OR the high bilirubin is caused by a condition where the baby is missing an enzyme called G6PD (glucose-6-phosphate dehydrogenase deficiency)
  • The baby was born after at least 30 weeks of pregnancy (more than 210 days)
  • The baby weighs at least 1,500 grams (about 3 pounds 5 ounces) at birth

Who may not be able to join:

  • The mother took phenobarbital (a medication) during the last month of pregnancy
  • The baby has a kidney (renal) problem present from birth
  • The baby has a heart problem present from birth
  • The baby needed help breathing (assisted ventilation) at the time of delivery due to lack of oxygen
  • The baby has another major birth defect affecting the brain or nervous system, chromosomes, or digestive system
  • The baby has a known or suspected infection present from birth, such as cytomegalovirus (CMV), herpes, rubella, or syphilis

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.

Trial details

Status
Completed
Phase
Phase 2
Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Registry
clinicaltrials_gov
Start date
1 December 1999

Where this trial is recruiting

🇺🇸 United States

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 30 June 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

View original record on ClinicalTrials.gov