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

Fakultas Kedokteran Universitas Padjadjaran

Status and phase: Completed; Phase 4

Conditions: Preterm Infants; Neonatal Sepsis

Treatments: Drug: Vitamin D

Study type: Interventional

Funder types: Other

Identifiers

NCT07245277

DP. 04.03/D.XIV.6.5/337/2025

Details and patient eligibility

About

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.

Full 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.

Enrollment: 78 patients

Sex: All

Ages: Under 84 days old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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78 participants in 3 patient groups

Antibiotics only

No Intervention group

Description:

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

Vitamin D 400 IU

Active Comparator group

Description:

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.

Treatment:

Drug: Vitamin D

Drug: Vitamin D

Vitamin D 800 IU

Active Comparator group

Description:

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.

Treatment:

Drug: Vitamin D

Drug: Vitamin D