Skip to content

Antibiotic combinations for infection in newborn babies

EMPIRIC ANTIBIOTIC REGIMEN IN LATE ONSET COMMUNITY ACQUIRED NEONATAL SEPSIS

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2013/02/003372
Enrollment
90
Registered
2013-02-11
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: null- neonates with late onset sepsis

Interventions

Intervention1: Antibiotic regimen: Cloxacillin + Amikacin were administered to 40 and Cefotaxime + Gentamicin to 50 babies. Intervention2: Cloxacillin,Amikacin: Cloxacillin (100mg/kg/day)Intra Venous

Sponsors

Jawaharlal Institute of Post graduate Medical Education and Research JIPMER
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Neonates born outside JIPMER within the age group of 3 to 28 days with evidence of LOS by both clinical and lab parameters were the target group. The clinical parameters used were poor feeding, poor activity, seizures, apnoea, respiratory distress, umbilical discharge and abdominal distension while the septic screen tests included micro erythrocyte sedimentation rate (mESR), C- reactive protein (CRP), absolute neutrophil count (ANC) and band cell count. Babies with atleast one of the above clinical parameters and two positive septic screen tests were included in the study.

Exclusion criteria

Exclusion criteria: Babies with major congenital anomalies, extreme prematurity ( <28 weeks), very low birth weight ( <1500 grams), congenital heart disease, severe asphyxia (5 minute Apgar <5) and babies who had received antibiotics prior to admission were excluded from the study.

Design outcomes

Primary

MeasureTime frame
The primary outcomes were mortality prior to discharge from hospital, complications including shock, DIC, acidosis, renal failure and rehospitalisation within 2 weeks of discharge.Timepoint: within 2 weeks of discharge.

Secondary

MeasureTime frame
treatment failure, subsequent fungal infections, duration of hospital stay, cost analysis and problems on follow up.Timepoint: 2 weeks and 1 month after discharge

Countries

India

Contacts

Public ContactDR NIRANJAN BISWAL

Jawaharlal Institute of Post graduate Medical Education and Research (JIPMER)

sureshpaeds@gmail.com

Outcome results

None listed

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