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Do we need to do sepsis screen in neonates with breathing difficulty alone without risk factors for early onset sepsis

Guiding Antibiotics based on blood culture with or without sepsis screen in late preterm and term babies with respiratory distress requiring respiratory support â?? Randomized Controlled Trial.

Status
Recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/10/028208
Enrollment
100
Registered
2020-10-01
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: P221- Transient tachypnea of newborn

Interventions

Intervention1: Not doing sepsis screen: In late preterm and term babies with RDS requiring respiratory support, only blood culture will be taken and sepsis screen will not be sent Control Intervention

Sponsors

MADHUKAR RAINBOW CHILDRENS HOSPITAL
Lead Sponsor
MADHUKAR RAINBOW CHILDRENS HOSPITAL
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: Neonate with gestation age of 34 weeks or more having respiratory distress in the first 6 hours of life requiring respiratory support

Exclusion criteria

Exclusion criteria: Any neonate less than 34 weeks gestation Respiratory distress starting later than 6 hrs Surgical neonate Outborn baby who has already received antibiotics

Design outcomes

Primary

MeasureTime frame
Duration of respiratory support (High flow nasal cannula/ CPAP/ventilation)Timepoint: Duration of respiratory support (High flow nasal cannula/ CPAP/ventilation)

Secondary

MeasureTime frame
1. Babies requiring inotropic support 2. Feed intolerance/time to reach full feeds 3. Duration of antibiotics depending upon clinical judgment 4. Duration of hospital stay 5. Mortality 6. Financial implications Timepoint: Till discharge from hospital

Countries

India

Contacts

Public ContactNAVEEN PARKASH GUPTA

MAHDUKAR RAINBOW CHILDRENS HOSPITAL

drgupta.naveen@gmail.com

Outcome results

None listed

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