Stannsoporfin with phototherapy to treat hyperbilirubinemia in newborn hemolytic disease.
Journal
Journal of perinatology : official journal of the California Perinatal Association
ISSN: 1476-5543
Titre abrégé: J Perinatol
Pays: United States
ID NLM: 8501884
Informations de publication
Date de publication:
Jan 2022
Jan 2022
Historique:
received:
16
05
2021
accepted:
23
09
2021
revised:
09
08
2021
pubmed:
13
10
2021
medline:
30
4
2022
entrez:
12
10
2021
Statut:
ppublish
Résumé
To evaluate the efficacy and safety of tin mesoporphyrin (SnMP) in neonates with hyperbilirubinemia (HB) due to hemolysis. This 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. In 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. SnMP with PT significantly reduced TSB by 48 h. SnMP may be useful as a treatment for HB in neonates with hemolysis.
Identifiants
pubmed: 34635771
doi: 10.1038/s41372-021-01223-2
pii: 10.1038/s41372-021-01223-2
doi:
Substances chimiques
Metalloporphyrins
0
tin mesoporphyrin
0KAE1U0G7Q
Heme Oxygenase (Decyclizing)
EC 1.14.14.18
Types de publication
Journal Article
Multicenter Study
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
110-115Investigateurs
R Alissa
(R)
F Banfro
(F)
A Barringham
(A)
L Bettica
(L)
R Bimbi
(R)
A Brown
(A)
L G Camp
(LG)
B Chakraborty
(B)
L Clark
(L)
S Crawford
(S)
R Dhanireddy
(R)
A Eldemerdash
(A)
O Fofah
(O)
G Rhodes Ryan
(G)
N Hanna
(N)
M Hudak
(M)
A Jewell
(A)
N Katof
(N)
F D Kehinde
(FD)
S Kicklighter
(S)
J Kim
(J)
V Lowery
(V)
A Maddox
(A)
E Maduekwe
(E)
L Meloy
(L)
J Nason
(J)
K Pollock
(K)
D Reyes
(D)
S Richter
(S)
W Rosenfeld
(W)
N Shafi
(N)
K Shattuck
(K)
P Smith
(P)
D Stewart
(D)
M Thomas
(M)
C Wagner
(C)
W Wong
(W)
Informations de copyright
© 2021. The Author(s), under exclusive licence to Springer Nature America, Inc.
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