The Effects of Phototherapy in Preterm Infants Pda

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-08

Study Completion Date

2019-02-28

Brief Summary

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The study was designed to assess whether chest shielding during phototherapy reduces the incidence of PDA, as assessed by serial echocardiographic examinations, in a population of extremely preterm infants born at lower 30 week gestation.

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Detailed Description

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Phototherapy is a therapeutic intervention frequently used for management of neonatal hyperbilirubinaemia in extremely premature infants, especially in the first week when patency of the ductus is a clinical problem. Phototherapy has also been implicated in increased ductal patency. One randomized, controlled trial showed that chest shielding during phototherapy reduced the incidence and severity of PDA by 50% in preterm infants. These findings were mainly based on clinical evaluation of the ductus with echocardiographic studies performed only on a subgroup of infants noted to have a murmur on clinical examination.

Conditions

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Patent Ductus Arteriosus After Premature Birth Hyper Bilirubinemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Group 1: non chest shielding

non chest shielding generic name: non dosage: non frequency and duration: in first 48 h eco with pad diameter will be measured in before and after phototherapy,

Group Type EXPERIMENTAL

Group 1: non chest shielding

Intervention Type OTHER

non chest childin: infants will be randomized into two different phototherapy groups eco with pad diameter will be measured in before and after phototherapy,

Group 2: chest shielding

chest shielding generic name: Phototrephy dosage: non frequency and duration: in first 48 h echo with pad diameter will be measured in before and after phototherapy,

Group Type PLACEBO_COMPARATOR

Group 2: chest shielding

Intervention Type OTHER

chest childing: infants will be randomized into two different phototherapy groups eco with pad diameter will be measured in before and after phototherapy,

Interventions

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Group 1: non chest shielding

non chest childin: infants will be randomized into two different phototherapy groups eco with pad diameter will be measured in before and after phototherapy,

Intervention Type OTHER

Group 2: chest shielding

chest childing: infants will be randomized into two different phototherapy groups eco with pad diameter will be measured in before and after phototherapy,

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Gestational week ≤ 30 weeks receiving phototherapy due to jaundice and infants who can perform echocardiography before and after treatment will be included in the study.

Exclusion Criteria

* Babies with congenital heart disease.
* Infants with major structural anomalies and infants who can not undergo echocardiography before or after treatment.

Minimum Eligible Age

3 Days

Maximum Eligible Age

1 Week

Eligible Sex

ALL

Accepts Healthy Volunteers

No