Chest Shielding in Premature Infants During Phototherapy

Patent Ductus Arteriosus in Premature Infants Clinical Trial

— SLIGHT  

Official title:

Effect of Chest Shielding on the Incidence of Patent Ductus Arteriosus in Premature Infants Undergoing Phototherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02552927
• Other study ID #: 55472
• Secondary ID: 911
• Status: Completed
• Phase: N/A
• Start date: August 1, 2015
• Est. completion date: February 13, 2019

Study information

• Verified date: September 2020
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: February 13, 2019
• Est. primary completion date: February 13, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 23 Weeks to 33 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Ductus Arteriosus, Patent
• Patent Ductus Arteriosus in Premature Infants
• Premature Birth

Intervention

Device:
• Chest shield with aluminum foil (CALF)

• SHIELD

Locations

Country	Name	City	State
United States	University of Rochester	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
University of Rochester

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence of Chronic lung disease		at 36 weeks post-menstrual age
Other	Incidence of Retinopathy of Prematurity		up to 44 weeks post-menstrual age
Other	Peak level of total serum bilirubin		First 2 weeks
Other	Duration of Phototherapy		First 2 weeks
Other	Incidence of intraventricular hemorrhage		First 2 weeks
Other	Incidence of surgical ligation for patent ductus arteriosus		First 4 weeks
Primary	Incidence of symptomatic Patent ductus arteriosus		During first 2 weeks
Secondary	Urinary Nitric oxide level		During first 2 weeks