Back to resultsThe Effects of Phototherapy in Preterm Infants Pda
Primary Purpose
Patent Ductus Arteriosus After Premature Birth, Hyper Bilirubinemia
Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Group 1: non chest shielding
Group 2: chest shielding
Sponsored by
About this trial
This is an interventional other trial for Patent Ductus Arteriosus After Premature Birth focused on measuring Chest shielding, Patent Ductus Arteriosus, Chest Childing
Eligibility Criteria
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.
Sites / Locations
- Zekai Tahir Burak Matarnity Teaching
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Group 1: non chest shielding
Group 2: chest shielding
Arm Description
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,
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,
Outcomes
Primary Outcome Measures
echocardiographic examination
presence of Patent Ductus arteriozus
Secondary Outcome Measures
Full Information
NCT ID
NCT03675425
First Posted
July 15, 2018
Last Updated
December 9, 2018
Sponsor
Zekai Tahir Burak Women's Health Research and Education Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03675425
Brief Title
The Effects of Phototherapy in Preterm Infants Pda
Official Title
Chest Shielding for Prevention of a Patent Ductus Arteriosus in Preterm Infants Receiving Phototherapy Effect of Phototherapy
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Unknown status
Study Start Date
July 8, 2018 (Actual)
Primary Completion Date
January 30, 2019 (Anticipated)
Study Completion Date
February 28, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zekai Tahir Burak Women's Health Research and Education Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patent Ductus Arteriosus After Premature Birth, Hyper Bilirubinemia
Keywords
Chest shielding, Patent Ductus Arteriosus, Chest Childing
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
54 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group 1: non chest shielding
Arm Type
Experimental
Arm Description
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,
Arm Title
Group 2: chest shielding
Arm Type
Placebo Comparator
Arm Description
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,
Intervention Type
Other
Intervention Name(s)
Group 1: non chest shielding
Intervention Description
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
Intervention Name(s)
Group 2: chest shielding
Intervention Description
chest childing: infants will be randomized into two different phototherapy groups eco with pad diameter will be measured in before and after phototherapy,
Primary Outcome Measure Information:
Title
echocardiographic examination
Description
presence of Patent Ductus arteriozus
Time Frame
first week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Days
Maximum Age & Unit of Time
1 Week
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Evrim Alyamaç Dizdar, MD
Organizational Affiliation
zekai tahir burak matarnity teaching hospital
Official's Role
Study Director
Facility Information:
Facility Name
Zekai Tahir Burak Matarnity Teaching
City
Ankara
ZIP/Postal Code
06230
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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The Effects of Phototherapy in Preterm Infants Pda
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