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Shorter symptom based antibiotic course for early onset neonatal sepsis

Fixed versus symptom based duration of antibiotics in probable Early onset neonatal sepsis An open label Randomized Controlled Trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/08/072739
Enrollment
156
Registered
2024-08-20
Start date
Unknown
Completion date
Unknown
Last updated
2024-09-16

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: Drugs: Ciprofloxacin or Ampicillin-Sulbactum and Amikacin: Route,Dose and frequency: 1.Ciprofloxacin (Intravenous)- 15mg/kg/dose 12 hourly 2.Ampicillin/sulbactum (Intravenous)-50mg/kg

Sponsors

Government Medical College and Hospital
Lead Sponsor
Shiwani Thakur
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: Inborn neonates with gestational age = 32 week and birth weight =1500gm with maternal and neonatal factors at birth will be assessed for eligibility for persistence of symptoms at 48-72 hours and negative blood culture.

Exclusion criteria

Exclusion criteria: Severe birth asphyxia, IVH, PICC/UVC,bleeding, meningitis, other sepsis trial

Design outcomes

Primary

MeasureTime frame
Antibiotic utilization ratio for early onset sepsisTimepoint: At end of first week of life—

Secondary

MeasureTime frame
1.Clinical deterioration during intervention period of 7 days 2.Total antibiotic utilization ratio 3. Total sepsis episodesTimepoint: 1.within 1 week of intervention 2.at the end of hospital stay (34-40 weeks corrected gestational age depending upon birth sickness & gestational age)—

Countries

India

Contacts

Public ContactShiwani Thakur

Government Medical College and Hospital

supreetkhurana85@gmail.com7087612359

Outcome results

None listed

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