The Effects of Phototherapy in Preterm Infants Pda

Zekai Tahir Burak Women's Health Research and Education Hospital

Status: Unknown

Conditions: Patent Ductus Arteriosus After Premature Birth; Hyper Bilirubinemia

Treatments: Other: Group 1: non chest shielding; Other: Group 2: chest shielding

Study type: Interventional

Funder types: Other

Identifiers

NCT03675425

148/2017

Details and patient eligibility

About

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.

Full 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.

Enrollment: 54 estimated patients

Sex: All

Ages: 3 days to 1 week old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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54 participants in 2 patient groups, including a placebo group

Group 1: non chest shielding

Experimental group

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,

Treatment:

Other: Group 1: non chest shielding

Group 2: chest shielding

Placebo Comparator group

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,

Treatment:

Other: Group 2: chest shielding