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A clinical trial to study the effect of prophylactic intravenous calcium in preventing neonatal early onset hypocalcemia.

Efficacy of prophylactic intravenous calcium administration in first 5 days of life in high risk neonates to prevent early onset neonatal hypocalcemia

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2009/091/000537
Enrollment
Unknown
Registered
2009-12-09
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

None listed

Interventions

Intervention1: standard intravenous fluid with calcium gluconate 10%: 4ml/kg/day Control Intervention1: standard intravenous fluid: according to total fluid requirement

Sponsors

DR.MOHD ASIF GHUFRAN KHAN
Lead Sponsor
DR.AMIT UPADHYAY(DM)
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: 1-preterm infants(<34 weeks) 2-newborns of diabetic mothers who require i.v fluids 3-severe perinatal asphyxia defined as apgar score<5 at 5 minutes

Exclusion criteria

Exclusion criteria: babies will be excluded if there is documented symptomatic hypocalcemia at admission(ionic calcium <4mg/dl)

Design outcomes

Primary

MeasureTime frame
serum ionic calciumTimepoint: 72 and 120 hours of life—

Secondary

MeasureTime frame
1-Need for IV calcium bolus for documented/symptomatic hypocalcemia 2-Local side effects of calcium infusion 3-Number of IV cannula changeTimepoint: first 120 hours of life—

Countries

India

Contacts

Public ContactDR.AMIT UPADHYAY
anuamit7@rediffmail.com09837405009

Outcome results

None listed

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