FindTrial
Sign In

Combination of intravenous and oral antibiotic therapy compared to intravenous antibiotic therapy for management of infection within first 3 days of life in newborn babies

Intravenous antibiotic therapy combined with oral antibiotic therapy vs intravenous antibiotic therapy in term and late preterm newborn with probable early onset sepsis: a randomized non inferiority trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/02/063125
Enrollment
270
Registered
2024-02-26
Start date
Unknown
Completion date
Unknown
Last updated
2024-03-04

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

Conditions

Health Condition 1: P368- Other bacterial sepsis of newborn

Interventions

Intervention1: intravenous amoxicillin clavulanic acid and amikacin and oral amoxicillin clavulanic acid: iv amoxicillin-clavulanic acid 50mg/Kg/day 12 hourly and amikacin 15mg/Kg/dose daily for 48 ho

Sponsors

Seth GS Medical College and KEM Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All late preterm and term with gestational age of 34 weeks or more with suspected early onset sepsis based on antenatal risk factors or by clinically.

Exclusion criteria

Exclusion criteria: Babies who are hemodynamically unstable in form of intubation, shock requiring ionotropes. When clinician wants to start antibiotics other than amoxicillin-clavulinic acid and amikacin as per the clinical status Parents do not give consent for the study

Design outcomes

Primary

MeasureTime frame
bacterial reinfectionTimepoint: 28 days—

Secondary

MeasureTime frame
duration of hospitalizationTimepoint: 4 months;clinical deterioration during initial admissionTimepoint: 4 months;quality of lifeTimepoint: 2 months;readmission in hospitalTimepoint: 1 month—

Countries

India

Contacts

Public ContactAnitha Haribalakrishna

Seth GS Medical College and KEM Hospital

ani.gem81@gmail.com09769660870

Outcome results

None listed

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