Chest Shielding in Premature Infants During Phototherapy
SLIGHT
Effect of Chest Shielding on the Incidence of Patent Ductus Arteriosus in Premature Infants Undergoing Phototherapy
2 other identifiers
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2015
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2015
CompletedFirst Submitted
Initial submission to the registry
August 17, 2015
CompletedFirst Posted
Study publicly available on registry
September 17, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 13, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
February 13, 2019
CompletedSeptember 18, 2020
September 1, 2020
3.5 years
August 17, 2015
September 16, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of symptomatic Patent ductus arteriosus
During first 2 weeks
Secondary Outcomes (1)
Urinary Nitric oxide level
During first 2 weeks
Other Outcomes (6)
Incidence of Chronic lung disease
at 36 weeks post-menstrual age
Incidence of Retinopathy of Prematurity
up to 44 weeks post-menstrual age
Peak level of total serum bilirubin
First 2 weeks
- +3 more other outcomes
Study Arms (2)
CALF
EXPERIMENTALChest shield with aluminum foil
SHIELD
SHAM COMPARATORChest shield without aluminum foil
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Rochester
Rochester, New York, 14642, United States
Related Publications (1)
Mannan J, Amin SB. Effect of chest shielding during phototherapy for hyperbilirubinemia on symptomatic patent ductus arteriosus - a double-blind randomized placebo-controlled trial. Pediatr Res. 2024 Dec;96(7):1771-1776. doi: 10.1038/s41390-024-03310-4. Epub 2024 Jun 22.
PMID: 38909157DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Javed Mannan, MD, MPH
University of Rochester
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 17, 2015
First Posted
September 17, 2015
Study Start
August 1, 2015
Primary Completion
February 13, 2019
Study Completion
February 13, 2019
Last Updated
September 18, 2020
Record last verified: 2020-09