Chest Shielding in Premature Infants During Phototherapy (SLIGHT)
Primary Purpose
Patent Ductus Arteriosus in Premature Infants
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Chest shield with aluminum foil (CALF)
SHIELD
Sponsored by
About this trial
This is an interventional prevention trial for Patent Ductus Arteriosus in Premature Infants focused on measuring PDA, Jaundice, Phototherapy
Eligibility Criteria
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
Sites / Locations
- University of Rochester
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
CALF
SHIELD
Arm Description
Chest shield with aluminum foil
Chest shield without aluminum foil
Outcomes
Primary Outcome Measures
Incidence of symptomatic Patent ductus arteriosus
Secondary Outcome Measures
Urinary Nitric oxide level
Full Information
NCT ID
NCT02552927
First Posted
August 17, 2015
Last Updated
September 16, 2020
Sponsor
University of Rochester
1. Study Identification
Unique Protocol Identification Number
NCT02552927
Brief Title
Chest Shielding in Premature Infants During Phototherapy
Acronym
SLIGHT
Official Title
Effect of Chest Shielding on the Incidence of Patent Ductus Arteriosus in Premature Infants Undergoing Phototherapy
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
August 1, 2015 (Actual)
Primary Completion Date
February 13, 2019 (Actual)
Study Completion Date
February 13, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Rochester
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patent Ductus Arteriosus in Premature Infants
Keywords
PDA, Jaundice, Phototherapy
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CALF
Arm Type
Experimental
Arm Description
Chest shield with aluminum foil
Arm Title
SHIELD
Arm Type
Sham Comparator
Arm Description
Chest shield without aluminum foil
Intervention Type
Device
Intervention Name(s)
Chest shield with aluminum foil (CALF)
Intervention Type
Device
Intervention Name(s)
SHIELD
Primary Outcome Measure Information:
Title
Incidence of symptomatic Patent ductus arteriosus
Time Frame
During first 2 weeks
Secondary Outcome Measure Information:
Title
Urinary Nitric oxide level
Time Frame
During first 2 weeks
Other Pre-specified Outcome Measures:
Title
Incidence of Chronic lung disease
Time Frame
at 36 weeks post-menstrual age
Title
Incidence of Retinopathy of Prematurity
Time Frame
up to 44 weeks post-menstrual age
Title
Peak level of total serum bilirubin
Time Frame
First 2 weeks
Title
Duration of Phototherapy
Time Frame
First 2 weeks
Title
Incidence of intraventricular hemorrhage
Time Frame
First 2 weeks
Title
Incidence of surgical ligation for patent ductus arteriosus
Time Frame
First 4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
23 Weeks
Maximum Age & Unit of Time
33 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Javed Mannan, MD, MPH
Organizational Affiliation
University of Rochester
Official's Role
Study Director
Facility Information:
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Chest Shielding in Premature Infants During Phototherapy
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