The Effects of Phototherapy in Preterm Infants Pda

Study Overview
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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.

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

Conditions
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Patent Ductus Arteriosus After Premature Birth, Hyper Bilirubinemia

Intervention / Treatment
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* Other: Group 1: non chest shielding
* Other: Group 2: chest shielding


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 3 Days
Maximum Age: 1 Week

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1: non chest shielding<br>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<br>* non chest childin: infants will be randomized into two different phototherapy groups eco with pad diameter will be measured in before and after phototherapy,<br>|
| Placebo Comparator: Group 2: chest shielding<br>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<br>* chest childing: infants will be randomized into two different phototherapy groups eco with pad diameter will be measured in before and after phototherapy,<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chest Childing, Chest shielding, Patent Ductus Arteriosus