Chest Shielding in Premature Infants During Phototherapy (SLIGHT)

September 16, 2020 updated by: University of Rochester

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Rochester, New York, United States, 14642
        • University of Rochester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 months to 7 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CALF
Chest shield with aluminum foil
Device: Chest shield with aluminum foil (CALF)
Sham Comparator: SHIELD
Chest shield without aluminum foil
Device: SHIELD

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of symptomatic Patent ductus arteriosus
Time Frame: During first 2 weeks
During first 2 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Urinary Nitric oxide level
Time Frame: During first 2 weeks
During first 2 weeks

Other Outcome Measures

Outcome Measure
Time Frame
Incidence of Chronic lung disease
Time Frame: at 36 weeks post-menstrual age
at 36 weeks post-menstrual age
Incidence of Retinopathy of Prematurity
Time Frame: up to 44 weeks post-menstrual age
up to 44 weeks post-menstrual age
Peak level of total serum bilirubin
Time Frame: First 2 weeks
First 2 weeks
Duration of Phototherapy
Time Frame: First 2 weeks
First 2 weeks
Incidence of intraventricular hemorrhage
Time Frame: First 2 weeks
First 2 weeks
Incidence of surgical ligation for patent ductus arteriosus
Time Frame: First 4 weeks
First 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Rochester

Investigators

  • Study Director: Javed Mannan, MD, MPH, University of Rochester

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2015

Primary Completion (Actual)

February 13, 2019

Study Completion (Actual)

February 13, 2019

Study Registration Dates

First Submitted

August 17, 2015

First Submitted That Met QC Criteria

September 16, 2015

First Posted (Estimate)

September 17, 2015

Study Record Updates

Last Update Posted (Actual)

September 18, 2020

Last Update Submitted That Met QC Criteria

September 16, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 55472
  • 911 (Urochester)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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