First-day High Dose Vitamin C, E in Severe Birth Asphyxia | NCT01743742 | Trialant

First-day High Dose Vitamin C, E in Severe Birth Asphyxia | NCT01743742 | Trialant

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Oral vitamin E, vitamin C	Experimental	Single dose of vitamin E drops 200 IU within 6 hours of birth and vitamin C tablet 250 mg in pulverised form (2 doses at 24 hr interval) via infant feeding tube	Drug: Vitamin E, Vitamin C

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To assess the role of first day high-dose vitamin E and vitamin C in reduction of adverse neurodevelopmental sequel in newborns with birth asphyxia.	Vitamin C and E were initiated orally within 6 hours of birth.	6 months

Secondary Outcomes

Measure	Description	Time Frame
Mortality and morbidity in newborns with birth asphyxia administered vitamin E and vitamin C.	Deaths and Sequel were measured.	From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 15 DAYS.

Other Outcomes

Measure	Description	Time Frame
Role of single high dose vitamin E and vitamin C in progression or resolution of Hypoxic ischemic encephalopathy.	progression of birth asphyxia in terms of HIE Sarnat grading.	at 12 hours
Role of single high dose vitamin E and vitamin C in progression or resolution of Hypoxic-ischemic encephalopathy.

Contacts/Locations Module

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
15724034	Result	Darlow BA, Buss H, McGill F, Fletcher L, Graham P, Winterbourn CC. Vitamin C supplementation in very preterm infants: a randomised controlled trial. Arch Dis Child Fetal Neonatal Ed. 2005 Mar;90(2):F117-22. doi: 10.1136/adc.2004.056440.

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