Chest Shielding in Premature Infants During Phototherapy (SLIGHT)

University of Rochester

Status: Completed

Conditions: Patent Ductus Arteriosus in Premature Infants

Treatments: Device: Chest shield with aluminum foil (CALF); Device: SHIELD

Study type: Interventional

Funder types: Other

Identifiers

NCT02552927

55472

911

Details and patient eligibility

About

This is a feasibility study where Infants will be randomized to either chest shielding with aluminum foil or chest shielding without aluminum foil while undergoing phototherapy for premature infants. The primary outcome is patent ductus arteriosus.

Enrollment: 50 patients

Sex: All

Ages: 23 to 33 weeks old

Volunteers: No Healthy Volunteers

Inclusion criteria

• less or equal to 29 weeks or 1000g at birth
• Admitted to the NICU (Neonatal intensive care unit) within 24 hours after birth
• English speaking parents

Exclusion criteria

• Congenital abnormalities
• Chromosomal disorders
• Cyanotic heart defects
• Nitric oxide
• Prophylactic phototherapy
• Unlikely to survive beyond 72 hours according to the attending neonatologist
• Do not require phototherapy

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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50 participants in 2 patient groups

CALF

Experimental group

Description:

Chest shield with aluminum foil

Treatment:

Device: Chest shield with aluminum foil (CALF)

SHIELD

Sham Comparator group

Description:

Chest shield without aluminum foil

Treatment:

Device: SHIELD