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Incidence of Early Onset Neonatal Sepsis and Its Complications in At-Risk Asymptomatic Preterm Infants Not Receiving Empirical Antibiotics

Incidence of Early Onset Neonatal Sepsis and Its Complications in At-Risk Asymptomatic Preterm Infants Not Receiving Empirical Antibiotics

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
TCTR
Registry ID
TCTR20200515007
Enrollment
855
Registered
2020-05-15
Start date
2020-05-30
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Early neonatal sepsis Early neonatal sepsis&#44

Interventions

At risk of early neonatal sepsis as stated in inclusion criteria
Other
Preterm newborn infants GA < 35 weeks

Sponsors

Siriraj Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Inborn preterm infants of gestational age less than 35 weeks 2. Sterile cord cutting 3. Infants have at least one of risk factors for early neonatal sepsis below 3.1 Maternal chorioamnionitis diagnosed clinically by obstetricians 3.2 Maternal fever > 38oC within 24 hours before delivery 3.3 Presence of labour pain 3.4 Premature rupture of membranes 3.5 Cervical insufficiency 3.6 Induction of labor 3.7 Unexplained fetal distress

Exclusion criteria

Exclusion criteria: 1. Presence of symptoms suspected to result from of early onset neonatal sepsis within 3 hours after birth 2. Lethal congenital anomalies 3. Congenital infection from toxoplasmosis&#44; rubella&#44; cytomegalovirus&#44; herpes simplex&#44; syphilis&#44; and zika virus 4. Maternal age < 18 years old 5. Parents cannot fluently communicate in Thai 6. Not consented 7. Incomplete data

Design outcomes

Primary

MeasureTime frame
Incidence of early onset neonatal sepsis 72 hours after birth Positive hemoculture or cerebrospinal fluid culture within 72 hours

Secondary

MeasureTime frame
Incidence of antibiotic administration in the at&#45;risk infants within 72 hours after birth Antibiotics administration according to attending physicians decision

Countries

Thailand

Contacts

Public ContactBuranee Yangthara

Siriraj Hospital

buraneeyangthara@gmail.com0843270809

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026