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Efficacy of oral selenium in treatment of sepsis in preterm neonates

Efficacy of oral selenium as an adjunct in the treatment of sepsis in preterm neonates: A double blind randomized controlled trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/07/070140
Enrollment
250
Registered
2024-07-07
Start date
Unknown
Completion date
Unknown
Last updated
2024-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: P369- Bacterial sepsis of newborn, unspecified

Interventions

Intervention1: Oral selenium supplementation: Selenium group will receive Selenium as Sodium Selenate in Liquid formulation containing 300 mcg/1.2 ml. Oral selenium will be supplemented as per weight
whichever is later, in addition to the standard treatment for neonatal sepsis as per unit protocol. Control Intervention1: Placebo: Control group will receive placebo as per weight of the neonate(i.b
whichever is later, in addition to the standard treatment for neonatal sepsis as per unit protocol.

Sponsors

Dr. DUMNE SWANEEK JAYANT
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Preterm neonates (Between 28-37 weeks of gestational age) with screen positive sepsis

Exclusion criteria

Exclusion criteria: Neonates with any one of the following : a. Abdominal Distension b. Altered GI aspirates c. Congenital GI malformations d. Formula-fed neonates e. Extremely Low Birth Weight

Design outcomes

Primary

MeasureTime frame
To compare the proportion of preterm neonates having consequences of neonatal sepsis (like septic shock, disseminated intravascular coagulation, multiorgan dysfunction, and mortality) in selenium and in the control groupTimepoint: At the end of 1 week, 2 weeks and 4 weeks

Secondary

MeasureTime frame
Document Serum Selenium LevelsTimepoint: At baseline & at the end of one week

Countries

India

Contacts

Public ContactDr Dumne Swaneek Jayant

Government Medical College and Hospital, Chhatrapati Sambhajinagar

drtruptijoshi@gmail.com9823900642

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026