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The effectiveness and safety of prophylactic use of antibiotic in neonates following premature rupture of membrane(PROM): a randomized control trial

The effectiveness and safety of prophylactic use of antibiotic in neonates following premature rupture of membrane(PROM): a randomized control trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IOR-15006744
Enrollment
Unknown
Registered
2015-07-14
Start date
2014-12-16
Completion date
Unknown
Last updated
2018-07-31

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

Conditions

premature rupture of membranes(PROM)

Interventions

Experimental group :bservational intervention with no prophylactic use of antibiotics until the tests or clinical manifestation indicating infection.
Control group :Prophylactic use of cefuroxime 30 mg/kg q12h ivgtt,48 hours.

Sponsors

West China Second University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Parents agree to take part in the trial and sign the informed consent; 2. Gestational weeks >=34 weeks; 3. Birth weight >=1500 grams; 4. Age <=24 hours; 5. With a history of premature rupture of membranes; 6. Test results of mothers are available.

Exclusion criteria

Exclusion criteria: 1. Received antbiotics before enrollment; 2. Diagnosised as bacterial infectious diseases before enrollment; 3. Allergic to cefuroxime; 4. The culture of mother's cervical secretionsis positive; 5. Mother had a fever within 48 hours before delivery(temperature >=38.5 degree C).

Design outcomes

Primary

MeasureTime frame
Rate of infection;Rate of infection related death;Rate of death;Rate of fungal infection;Rate of antibiotic related adverse reaction;;—

Countries

China

Contacts

Public ContactZhang Lingli
zhlingli@sina.com+86 028-85503205

Outcome results

None listed

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