Neonatal Sepsis, Preterm Infants
Conditions
Keywords
adjuvant therapy, neonatal sepsis, preterm infants, vitamin D
Brief summary
The goal of this clinical trial is to learn the effect of vitamin D as an adjunctive therapy for preterm neonates with sepsis measured by the outcomes, which are sepsis score and C-reactive protein after 7 days. The main questions it aims to answer are: Is there a difference in the results of the sepsis score (Modified Tollner Score and Sepsis Prediction Score) between groups of preterm neonates with sepsis who were given vitamin D as adjuvant therapy at doses of 400 IU/day, 800 IU/day, and those who were only given antibiotics? Is there a difference in CRP levels between groups of preterm neonates with sepsis who were given vitamin D as adjuvant therapy at doses of 400 IU/day, 800 IU/day, and those who were only given antibiotics? Participants will be divided into 3 groups: Group 1 consisted of subjects who were given only antibiotics due to medical conditions requiring fasting. Group 2 consisted of subjects who were able to receive enteral nutrition, were given antibiotics, and were supplemented with vitamin D3 at a dose of 400 IU once daily for 7 days. Group 3 consisted of subjects who were able to receive enteral nutrition, were given antibiotics, and were supplemented with vitamin D3 at a dose of 800 IU once daily for 7 days.
Detailed description
The target population in this study is preterm neonates diagnosed with sepsis. This is a multicenter study. The accessible population in this study is patients who are treated in the Neonatal High Care Unit (NHCU) and Neonatal Intensive Care Unit (NICU) at Dr. Hasan Sadikin General Hospital Bandung and Bandung Kiwari Hospital, who meet the inclusion criteria and do not meet the exclusion criteria, and whose parents or guardians are willing to participate in the study by signing the informed consent form.
Interventions
DRUGVitamin D
Vitamin D 400 IU for 7 days
Sponsors
Fakultas Kedokteran Universitas Padjadjaran
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
0 Days to 84 Days
Healthy volunteers
No
Inclusion criteria
Inclusion criteria for the case group used in this study are neonates (aged 0-28 days or with a maximum postmenstrual age of 42 weeks) with a gestational age of 28-36 weeks who are treated in the Neonatal High Care Unit (NHCU) and Neonatal Intensive Care Unit (NICU) at Dr. Hasan Sadikin General Hospital, Bandung, and Bandung Kiwari Hospital, Bandung and who meet the following inclusion criteria: 1. Patients diagnosed with neonatal sepsis based on positive blood or cerebrospinal fluid cultures, or who meet the criteria for suspected sepsis with a Rodwell hematologic scoring system result of ≥3. 2. Parents or legal guardians are willing to participate in the study and sign the informed consent form.
Exclusion criteria
1. Patients with major congenital malformations such as anencephaly, encephalocele, holoprosencephaly, hydrocephalus, meningomyelocele, spina bifida, omphalocele, gastroschisis, or congenital heart disease. 2. If during the 7-day monitoring period, a patient who was initially able to feed develops a medical condition requiring fasting (NPO). 3. If during the 7-day monitoring period, a patient who initially had a medical condition requiring fasting is later able to feed again.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in the Modified Töllner Sepsis Scoring System After 7 Days | Baseline (day-0) and at day-7 | Modified Töllner sepsis scoring system consists of clinical parameters including appearance, microcirculation, hypotonia, bradycardia/tachycardia, apnea of prematurity, respiratory distress, hepatomegaly, gastrointestinal symptoms, leucocyte count, Immature to Total Neutrophil (I/T) ratio, thrombocytopenia, C-reactive protein. Minimum value: 0 Maximum value: 26 Higher scores mean a worse outcome for neonatal sepsis |
| Change From Baseline in the Sepsis Prediction Score After 7 Days | Baseline (day-0) and at day-7 | Sepsis Prediction Score consists of clinical parameters including body temperature, decrease feeding volume/residuals, platelet counts, blood glucose changes, C-reactive protein, circulatory changes, increase of oxygen requirement, deterioration of respiratory function. Minimum value: 0 Maximum value: 8 Higher scores mean a worse outcome for neonatal sepsis |
| Change From Baseline in the C-Reactive Protein Levels After 7 Days | Baseline (day-0) and at day-7 | The blood sample was taken from the neonate to test for C-reactive protein (CRP) on day 0 and day 7. Minimum value: 0 Higher scores mean a worse outcome for neonatal sepsis |
Countries
Indonesia
Contacts
STUDY_DIRECTORReni Ghrahani, MD, Ph.D
Child Health Department Hasan Sadikin General Hospital Universitas Padjadjaran
STUDY_DIRECTORFiva A Kadi, MD, Ph.D
Child Health Department Hasan Sadikin General Hospital Universitas Padjadjaran
Participant flow
Recruitment details
Participants were recruited from the neonatal intensive care unit (NICU) and neonatal high care unit (NHCU) from 2 medical centers; at a regional hospital and a tertiary care hospital in Bandung, Indonesia, between August 2025 and December 2025
Pre-assignment details
There were no events or washout periods between participant enrollment and assignment.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Customized Age | 10 days |
| Birth Weight | 1536.7 gram STANDARD_DEVIATION 386.4 |
| Gestational Age | 32 weeks |
| Race and Ethnicity Not Collected | 0 Participants |
| Respiratory support Low flow | 1 Participants |
| Respiratory support Non-invasive ventilation | 6 Participants |
| Respiratory support Ventilator | 13 Participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 33 Participants |
| Vitamin D concentration in participants | 11.67 ng/mL |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 8 / 35 | 0 / 20 | 1 / 23 |
| other Total, other adverse events | 0 / 35 | 0 / 20 | 0 / 23 |
| serious Total, serious adverse events | 0 / 35 | 0 / 20 | 0 / 23 |
Outcome results
None listed