CompletedPhase 3

Efficacy and Safety of Stannsoporfin in Neonates

United States185 participantsStarted 2002-05-01

Plain-language summary

This is a multi-center, randomized, sham injection-controlled (placebo) masked trial of a single intramuscular injection of Stannsoporfin compared to "sham" (placebo) in healthy term and near-term newborns admitted to the well-baby nursery and enrolled with "intention to treat".

Who can participate

Age range

12 Hours – 36 Hours

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

. Born at the study hospital site and admitted to the well-baby nursery or admitted to the intensive-care nursery for \<12 hours for post delivery observation (delayed transition, temperature or dextrose instability, meconium staining and/or parental concern).
. All babies on oral feeding with stable cardiorespiratory status and deemed "healthy" upon clinical examination, with normal perfusion as defined by capillary filling of the fingernail.
. Term neonate (≥38 weeks of completed gestation), OR
. Near-term neonate (\>36\<38 weeks of completed gestation; \>2,000g birth weight), OR
. Near-term neonate (\>35\<38 weeks of completed gestation; \>2,500g birth weight)
. Care provided (primarily) in the well-baby nursery population;
0. Absence of concurrent cardiorespiratory distress, sepsis, major congenital anomalies or need for care in an intensive care nursery;
1. Not participating in another concurrent unrelated study.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Need for Phototherapy

Timeframe: 30 days

Trial details

NCT IDNCT02685137

SponsorInfaCare Pharmaceuticals Corporation, a Mallinckrodt Company

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2003-03-16

View on ClinicalTrials.gov More Nutritional and Metabolic Diseases trials