The Effects of Phototherapy in Preterm Infants Pda

December 9, 2018 updated by: Zekai Tahir Burak Women's Health Research and Education Hospital

Chest Shielding for Prevention of a Patent Ductus Arteriosus in Preterm Infants Receiving Phototherapy Effect of Phototherapy

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

54

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey, 06230
        • Zekai Tahir Burak Matarnity Teaching

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 days to 1 week (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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,
Other: 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,
Placebo Comparator: 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,
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,

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
echocardiographic examination
Time Frame: first week
presence of Patent Ductus arteriozus
first week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zekai Tahir Burak Women's Health Research and Education Hospital

Investigators

  • Study Director: Evrim Alyamaç Dizdar, MD, zekai tahir burak matarnity teaching hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 8, 2018

Primary Completion (Anticipated)

January 30, 2019

Study Completion (Anticipated)

February 28, 2019

Study Registration Dates

First Submitted

July 15, 2018

First Submitted That Met QC Criteria

September 16, 2018

First Posted (Actual)

September 18, 2018

Study Record Updates

Last Update Posted (Actual)

December 11, 2018

Last Update Submitted That Met QC Criteria

December 9, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 148/2017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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