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Can neonates delivered to mothers with risk factors for infection be managed without antibiotics?

Oral antibiotics versus observational care in neonates born to mothers with risk factors for sepsis: a randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/01/011560
Enrollment
126
Registered
2018-01-25
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 delivered to mothers with risk factors for infection

Interventions

Intervention1: Placebo: Neonates born to mothers with risk factors for sepsis will be given placebo and closely monitored in the hospital Control Intervention1: Oral co-amoxyclav: Neonates born to mot

Sponsors

Banaras Hindu University
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All the following criteria must be met: 1. Gestational age of 34 weeks or more 2. Delivered to mothers with risk factors for sepsis, namely, leaking per vagina >18 hours or foul smelling liquor or intrapartum maternal fever 3. Asymptomatic 4. Able to feed orally

Exclusion criteria

Exclusion criteria: 1. Positive pressure ventilation for more than one minute in delivery room 2. Surgical conditions and major congenital anaomalies 3. Failure to obtain consent

Design outcomes

Primary

MeasureTime frame
Development of sepsisTimepoint: at 3 days of age—

Secondary

MeasureTime frame
Adverse effects of therapyTimepoint: at 7 days of age;Development of sepsisTimepoint: at 7 days and 1 month of age—

Countries

India

Contacts

Public ContactNupur Bajpayee

Banaras Hindu University

ashokkumar_bhu@hotmail.com9415300370

Outcome results

None listed

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