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Aminophylline can prevent kidney dysfunction in birth asphyxiated newborn or not

Role of Aminophylline in prevention of incidence of acute kidney injury in term severe perinatal asphyxia:A Randomized Open Label controlled Trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/04/024842
Enrollment
80
Registered
2020-04-24
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

Health Condition 1: P96- Other conditions originating in the perinatal period Health Condition 2: P19-P29- Respiratory and cardiovascular disorders specific to the perinatal period

Interventions

Intervention1: Drug Aminophylline: Aminophylline 5 mg/kg body weight i.v single dose within 1 hour of life Control Intervention1: Placebo: Placebo in the form of normal saline

Sponsors

Medical College Kolkata
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All the consecutively born term newborn (37 weeks-41 weeks 6 days) with severe perinatal asphyxia as per NNPD criteria.

Exclusion criteria

Exclusion criteria: 1.Parents not provides consent. 2.Infants with any congenital malformation detected by antenatal USG or by clinical examination.

Design outcomes

Primary

MeasureTime frame
Incidence of acute kidney injury in term severe birth asphyxia in study group receiving aminophylline and in control group receiving normal standard of care.Timepoint: Day 5 of life

Secondary

MeasureTime frame
Comparison of oliguria in both groups,comparison of peak creatinine level in each group,comparison of death in both groups,comparison of incidence of HIE in both groups.comparison of incidence of seizure,hyperkalemia,hyperglycemia,fluid overload,inotrope and ventilator requirement in both groups.Timepoint: Within day 5 of life

Countries

India

Contacts

Public ContactSukanta Dutta

Medical College,Kolkata

dr.dineshmunian@gmail.com9163288916

Outcome results

None listed

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