Combination therapy with erythropoietin, magnesium sulfate and hypothermia for hypoxic-ischemic encephalopathy: an open-label pilot study to assess the safety and feasibility.
Combined Modality Therapy
Drug Administration Schedule
Erythropoietin
/ administration & dosage
Feasibility Studies
Female
Humans
Hypothermia, Induced
/ adverse effects
Hypoxia-Ischemia, Brain
/ therapy
Infant, Newborn
Magnesium Sulfate
/ administration & dosage
Male
Pilot Projects
Prospective Studies
Erythropoietin
Hypoxic-ischemic encephalopathy
Magnesium sulfate
Therapeutic hypothermia
Journal
BMC pediatrics
ISSN: 1471-2431
Titre abrégé: BMC Pediatr
Pays: England
ID NLM: 100967804
Informations de publication
Date de publication:
08 01 2019
08 01 2019
Historique:
received:
14
09
2018
accepted:
28
12
2018
entrez:
10
1
2019
pubmed:
10
1
2019
medline:
20
2
2020
Statut:
epublish
Résumé
Although therapeutic hypothermia improves the outcome of neonatal hypoxic-ischemic encephalopathy (HIE), its efficacy is still limited. This preliminary study evaluates the safety and feasibility of the combination therapy with erythropoietin (Epo), magnesium sulfate and hypothermia in neonates with HIE. A combination therapy with Epo (300 U/kg every other day for 2 weeks), magnesium sulfate (250 mg/kg for 3 days) and hypothermia was started within 6 h of birth in neonates who met the institutional criteria for hypothermia therapy. All patients received continuous infusion of dopamine. Vital signs and adverse events were recorded during the therapy. Short-term and long-term developmental outcomes were also evaluated. Nine patients were included in the study. The mean age at first intervention was 3.9 h (SD, 0.5). Death, serious adverse events or changes in vital signs likely due to intervention were not observed during hospital care. All nine patients completed the therapy. At the time of hospital discharge, eight patients had established oral feeding and did not require ventilation support. Two patients had abnormal MRI findings. At 18 months of age, eight patients received a follow-up evaluation, and three of them showed signs of severe neurodevelopmental disability. The combination therapy with 300 U/kg Epo every other day for 2 weeks, 250 mg/kg magnesium sulphate for 3 days and therapeutic hypothermia is feasible in newborn patients with HIE. ISRCTN33604417 retrospectively registered on 14 September 2018.
Sections du résumé
BACKGROUND
Although therapeutic hypothermia improves the outcome of neonatal hypoxic-ischemic encephalopathy (HIE), its efficacy is still limited. This preliminary study evaluates the safety and feasibility of the combination therapy with erythropoietin (Epo), magnesium sulfate and hypothermia in neonates with HIE.
METHODS
A combination therapy with Epo (300 U/kg every other day for 2 weeks), magnesium sulfate (250 mg/kg for 3 days) and hypothermia was started within 6 h of birth in neonates who met the institutional criteria for hypothermia therapy. All patients received continuous infusion of dopamine. Vital signs and adverse events were recorded during the therapy. Short-term and long-term developmental outcomes were also evaluated.
RESULTS
Nine patients were included in the study. The mean age at first intervention was 3.9 h (SD, 0.5). Death, serious adverse events or changes in vital signs likely due to intervention were not observed during hospital care. All nine patients completed the therapy. At the time of hospital discharge, eight patients had established oral feeding and did not require ventilation support. Two patients had abnormal MRI findings. At 18 months of age, eight patients received a follow-up evaluation, and three of them showed signs of severe neurodevelopmental disability.
CONCLUSION
The combination therapy with 300 U/kg Epo every other day for 2 weeks, 250 mg/kg magnesium sulphate for 3 days and therapeutic hypothermia is feasible in newborn patients with HIE.
TRIAL REGISTRATION
ISRCTN33604417 retrospectively registered on 14 September 2018.
Identifiants
pubmed: 30621649
doi: 10.1186/s12887-018-1389-z
pii: 10.1186/s12887-018-1389-z
pmc: PMC6325796
doi:
Substances chimiques
Erythropoietin
11096-26-7
Magnesium Sulfate
7487-88-9
Banques de données
ISRCTN
['ISRCTN33604417']
Types de publication
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
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