Evidence map›Paper›PMID 34635771›Full record

Trial reportJournal of perinatology : official journal of the California Perinatal Association2022

Stannsoporfin with phototherapy to treat hyperbilirubinemia in newborn hemolytic disease.

Warren N Rosenfeld, Mark L Hudak, Nancy Ruiz, Shiva Gautam, Jasmine Study Group

Registry-linked trialAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Journal of perinatology : official journal of the California Perinatal Association, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01887327 (A Phase 2b Multicenter, Single Dose, Randomized, Double Blind, Placebo-Controlled, Parallel-Group Study Evaluating the Safety and Efficacy of Two Doses of Stannsoporfin in Combination With Phototherapy in Neonates), which is not on this map. Cited by 7 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 2 pooled it
2.0field-weighted citation impact, top 13% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01887327 phase2completednot on this map

A Phase 2b Multicenter, Single Dose, Randomized, Double Blind, Placebo-Controlled, Parallel-Group Study Evaluating the Safety and Efficacy of Two Doses of Stannsoporfin in Combination With Phototherapy in Neonates

TypeinterventionalSponsorInfaCare Pharmaceuticals Corporation, a Mallinckrodt CompanyRan2013 to 2016Enrolled91ConditionsJaundice, Neonatal, Hyperbilirubinemia, NeonatalArmsPhototherapy, Stannsoporfin, Placebo
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 2 syntheses or guidelines pooled it, 9 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Review
  4. Article
  5. Is it time for a precision health approach to the management of newborn hyperbilirubinemia?Journal of perinatology : official journal of the California Perinatal Association · 2024
    Review
  6. Review
  7. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors at 14 institutions in 2 countries.

Warren N RosenfeldDepartment of Pediatrics, Mount Sinai South Nassau Hospital, Oceanside, NY, USA. warren.rosenfeld@snch.org.ORCID http://orcid.org/0000-0003-1660-774X
Mark L HudakDepartment of Pediatrics, University of Florida at Jacksonville School of Medicine, Jacksonville, FL, USA.ORCID http://orcid.org/0000-0001-9405-3522
Nancy RuizMallinckrodt Pharmaceutical, Blanchardstown, Dublin, 15, Ireland.
Shiva GautamDepartment of Medicine, University of Florida at Jacksonville School of Medicine, Jacksonville, FL, USA.
Jasmine Study Group
Arrowhead Regional Medical Center · USUniversity of Florida · USUniversity of Louisville · USWinthrop-University Hospital · USRutgers, The State University of New Jersey · USUniversity of Tennessee Health Science Center · USStony Brook University Hospital · USVirginia Commonwealth University · USMedical University of South Carolina · USWakeMed · USMallinckrodt (Ireland) · IESt. Christopher's Hospital for Children · USUniversity Medical Center of Southern Nevada · USUniversity of California San Diego Medical Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo evaluate the efficacy and safety of tin mesoporphyrin (SnMP) in neonates with hyperbilirubinemia (HB) due to hemolysis. STUDY

designThis multicenter, placebo-controlled phase 2b study (NCT01887327) randomized newborns (35-42 weeks) with hemolysis started on phototherapy (PT) to placebo (Ctrl), SnMP 3.0 mg/kg, or SnMP 4.5 mg/kg given once IM within 30 min of initiation of PT.

resultsIn all, 91 patients were randomized (Ctrl: n = 30; 3 mg/kg SnMP: n = 30; 4.5 mg/kg SnMP: n = 31). At 48 h TSB significantly increased in Ctrl by 17.5% (95% CI 5.6-30.7; p = 0.004) and significantly decreased by -13% (95% CI -21.7 to -3.2; p = 0.013) in the 3.0 mg/kg and by -10.5% (95% CI -19.4 to -0.6; p = 0.041) in the 4.5 mg/kg group. Decreases in SnMP groups were significant (p < 0.0001) vs Ctrl.

conclusionSnMP with PT significantly reduced TSB by 48 h. SnMP may be useful as a treatment for HB in neonates with hemolysis.

Indexed as

Erythroblastosis, FetalHyperbilirubinemia, NeonatalFemaleHeme Oxygenase (Decyclizing)HemolysisHumansHyperbilirubinemiaInfant, NewbornMetalloporphyrinsPhototherapyHeme Oxygenase (Decyclizing)Metalloporphyrinstin mesoporphyrin

Identifiers

PMID34635771
OpenAlexW3206915917

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.