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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-02

Study Completion Date

2025-12-08

Brief Summary

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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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Detailed Description

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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.

Conditions

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Neonatal Sepsis Preterm Infants

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Antibiotics only

Group 1 consisted of subjects who were given only antibiotics due to medical conditions requiring fasting.

Group Type NO_INTERVENTION

No interventions assigned to this group

Vitamin D 400 IU

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 Type ACTIVE_COMPARATOR

Vitamin D

Intervention Type DRUG

Vitamin D 400 IU for 7 days

Vitamin D 800 IU

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.

Group Type ACTIVE_COMPARATOR

Vitamin D

Intervention Type DRUG

Vitamin D 800 IU for 7 days

Interventions

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Vitamin D

Vitamin D 400 IU for 7 days

Intervention Type DRUG

Vitamin D

Vitamin D 800 IU for 7 days

Intervention Type DRUG

Other Intervention Names

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L-VIT D3 L-VIT D3

Eligibility Criteria

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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.

Minimum Eligible Age

0 Days

Maximum Eligible Age

84 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No