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Neonatal Early-Onset Sepsis Calculator versus New Categorical Risk Assessment on Neonatal Outcomes of Infants Born > 35 Weeks’ Gestation: A randomized controlled non-inferiority trial

Neonatal Early-Onset Sepsis Calculator versus New Categorical Risk Assessment on Neonatal Outcomes of Infants Born > 35 Weeks’ Gestation: A randomized controlled non-inferiority trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20200515004
Enrollment
520
Registered
2020-05-15
Start date
2020-09-01
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

์Neonatal Early Onset Sepsis Neonatal sepsis

Interventions

Neonatal Early&#45
Onset Sepsis management guideline in which infant at risk for sepsis will be assessed by using Neonatal EOS calculator available at http://www.newbornsepsiscalculator.com. By filling out maternal and
the calculator will calculate the risk of EOS and provide management recommendations for the infant.,Neonatal Early&#45
Onset Sepsis management guideline in which infant at risk for sepsis will be assessed by using 2019 AAP categorical risk assessment for EOS and provide management recommendation according to the guide
Experimental Other,Active Comparator Other
Onset Sepsis Calculator,AAP 2019 Categorical risk assessment for neonatal sepsis

Sponsors

Faculty of Medicine Vajira Hospital, Navamindradhiraj University
Lead Sponsor
Faculty of Medicine Vajira Hospital&#44
Collaborator
Navamindradhiraj University
Collaborator

Eligibility

Sex/Gender
All
Age
No minimum to 2 Months

Inclusion criteria

Inclusion criteria: Infants born at Vajira hospital, gestational age above 35 weeks and one of the followings; 1.Infants whose mother has a fever greater than or equal to 38 degrees Celsius 2.Maternal vaginal and anal cultures are positive for GBS 3.Premature rupture of membrane for more than 18 hours after delivery 4.Mothers with suspected intra-amniotic infection 5.Preterm less than 37 week's gestation 6.infants with symptoms compatible with EOS within 72 hour after symptoms include respiratory distress, drowsiness, apnea, temperature instability and feeding intolerance

Exclusion criteria

Exclusion criteria: 1.Infants with congenital anomalies 2.Chromosomal abnormalities 3.Infants born outside Vajira Hospital 4.Maternal information is not available

Design outcomes

Primary

MeasureTime frame
Rate of culture negative sepsis At the begining of study, within 7 days, within 60 days Number of patients with culture negative sepsis (clinical sepsis determined by physician + neonatal

Secondary

MeasureTime frame
Rate of early onset sepsis (EOS) At the begining of study, within 7 days, within 60 days Number of patients with early onset sepsis (patients with positive blood culture)

Countries

Thailand

Contacts

Public ContactDissajee Lumbiganon

Faculty of Medicine Vajira Hospital, Navamindradhiraj University

dissajee@nmu.ac.th0953432892

Outcome results

None listed

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