Incidence of Early Onset Neonatal Sepsis and Its Complications in At-Risk Asymptomatic Preterm Infants Not Receiving Empirical Antibiotics
- Conditions
- Early neonatal sepsis,empirical antibioticsEarly neonatal sepsis
- Registration Number
- TCTR20200515007
- Lead Sponsor
- Siriraj Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending (Not yet recruiting)
- Sex
- All
- Target Recruitment
- 855
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
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, rubella, cytomegalovirus, herpes simplex, syphilis, and zika virus
4.Maternal age < 18 years old
5.Parents cannot fluently communicate in Thai
6.Not consented
7.Incomplete data
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of early onset neonatal sepsis 72 hours after birth Positive hemoculture or cerebrospinal fluid culture within 72 hours
- Secondary Outcome Measures
Name Time Method Incidence of antibiotic administration in the at-risk infants within 72 hours after birth Antibiotics administration according to attending physicians decision