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Effectiveness of Phototherapy With and Without Probiotics

NCT ID: NCT06173856

Last Updated: 2023-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-10

Study Completion Date

2023-01-15

Brief Summary

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Raised serum bilirubin levels can cause kernicterus and premature infants are at increased risk due to metabolic immaturity. The standard treatment for neonatal jaundice is phototherapy but probiotics along with it can reduce the duration of phototherapy and hospitalization stay, secondarily can reduce the risk of nosocomial infection.

Detailed Description

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Raised serum bilirubin levels can cause kernicterus and premature infants are at increased risk due to metabolic immaturity. The comparative analytical study was conducted after the ethical approval for one year (Jan 2022-Jan 2023) in the neonatal unit of The University of Lahore Teaching Hospital, Lahore, Pakistan. 76 preterm neonates fulfilling the selection criteria were included in the study and divided into two groups.

Standard phototherapy was applied in both groups and group A probiotic (Saccharomyces boulardii) 125mg, twice daily, orally (in 5cc of milk whichever the baby was taking) was given till discharge from the hospital. The primary outcome measurements were the duration of phototherapy and the length of hospitalization.

Conditions

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Hyperbilirubinemia, Neonatal

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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Phototherapy group

LED phototherapy (430-470nm)

Group Type ACTIVE_COMPARATOR

LED phototherapy

Intervention Type OTHER

LED phototherapy (430-470nm) alone will be applied.

phototherapy with probiotics group

In group B, LED phototherapy (430-470nm) with probiotics (125mg Saccharomyces boulardii, twice a day, orally mixed in 5cc of milk whichever the neonate is taking).

Group Type EXPERIMENTAL

LED phototherapy

Intervention Type OTHER

LED phototherapy (430-470nm) alone will be applied.

Interventions

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LED phototherapy

LED phototherapy (430-470nm) alone will be applied.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* All the Neonates with indirect hyperbilirubinemia,
* Born at ;37 weeks of gestation
* Both male and female neonates were included in the study

Exclusion Criteria

* Neonates with sepsis,
* bilirubin level in exchange transfusion range
* direct hyperbilirubinemia
* Neonates with respiratory distress syndrome, severe birth asphyxia, intubated and critically sick
Minimum Eligible Age

0 Hours

Maximum Eligible Age

1 Week

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fatima Jinnah Medical University

OTHER

Sponsor Role lead

Responsible Party

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Naeem Afzal

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Humaira Waseem

Lahore, , Pakistan

Site Status

Countries

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Pakistan

Other Identifiers

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KAU-1

Identifier Type: -

Identifier Source: org_study_id