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The Effects of Phototherapy in Preterm Infants Pda

NCT ID: NCT03675425

Last Updated: 2018-12-11

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.

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

Keywords

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Chest shielding Patent Ductus Arteriosus Chest Childing

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

Sponsors

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Zekai Tahir Burak Women's Health Research and Education Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Evrim Alyamaç Dizdar, MD

Role: STUDY_DIRECTOR

zekai tahir burak matarnity teaching hospital

Locations

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Zekai Tahir Burak Matarnity Teaching

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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148/2017

Identifier Type: -

Identifier Source: org_study_id