The Effects of Phototherapy in Preterm Infants Pda

Patent Ductus Arteriosus After Premature Birth Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03675425
• Other study ID #: 148/2017
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 8, 2018
• Est. completion date: February 28, 2019

Study information

• Verified date: July 2018
• Source: Zekai Tahir Burak Women's Health Research and Education Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 54
• Est. completion date: February 28, 2019
• Est. primary completion date: January 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 1 Week

Eligibility

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.

Related Conditions & MeSH terms

• Ductus Arteriosus, Patent
• Hyper Bilirubinemia
• Hyperbilirubinemia
• Patent Ductus Arteriosus After Premature Birth
• Premature Birth

Intervention

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,
• 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,

Locations

Country	Name	City	State
Turkey	Zekai Tahir Burak Matarnity Teaching	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Zekai Tahir Burak Women's Health Research and Education Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	echocardiographic examination	presence of Patent Ductus arteriozus	first week