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Completed

NCT Number: NCT07245277

Effect of Vitamin D as Adjuvant Therapy in Preterm Infants With Neonatal Sepsis

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.

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Key information

Conditions

Neonatal SEPSIS Congenital, Hereditary, and Neonatal Diseases and Abnormalities Infant, Newborn, Diseases Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Preterm Infants Sepsis Systemic Inflammatory Response Syndrome

Age range

0 day–84 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hasan Sadikin General Hospital, Bandung, West Java, Indonesia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:

  • 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.
  • Parents or legal guardians are willing to participate in the study and sign the informed consent form.

Exclusion criteria

  • Patients with major congenital malformations such as anencephaly, encephalocele, holoprosencephaly, hydrocephalus, meningomyelocele, spina bifida, omphalocele, gastroschisis, or congenital heart disease.
  • If during the 7-day monitoring period, a patient who was initially able to feed develops a medical condition requiring fasting (NPO).
  • If during the 7-day monitoring period, a patient who initially had a medical condition requiring fasting is later able to feed again.

Treatment and study plan

Vitamin D

Drug

Vitamin D 400 IU for 7 days

Other names: L-VIT D3

Primary outcomes

  1. Change From Baseline in the Modified Töllner Sepsis Scoring System After 7 Days

    Time frame: 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

  2. Change From Baseline in the Sepsis Prediction Score After 7 Days

    Time frame: 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

  3. Change From Baseline in the C-Reactive Protein Levels After 7 Days

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Universitas Padjadjaran

Other

Registry information

Official study title

The Effect of Vitamin D Administration on Sepsis Score and C-Reactive Protein Levels in Preterm Infants With Neonatal Sepsis

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Nov 24, 2025
Registry last updated
Feb 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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