Patent Ductus Arteriosus in Premature InfantsSLIGHTNCT02552927
Chest Shielding in Premature Infants During Phototherapy
A study testing Chest shield with aluminum foil (CALF) and SHIELD in people with Patent Ductus Arteriosus in Premature Infants, run by University of Rochester at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 23 to 33 weeks
- Conditions the study is for
- Patent Ductus Arteriosus in Premature Infants
- What is being tested?
- Chest shield with aluminum foil (CALF) and SHIELD
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2015to 13 Feb 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 23 to 33 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Being tested
- Chest shield with aluminum foil (CALF), SHIELD
- Keywords
- PDA, Jaundice, Phototherapy
- Medical subject headings
- Jaundice
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chest shield with aluminum foil (CALF)Device
SHIELDDevice
| Study group | Role | What they receive |
|---|---|---|
| CALF | Experimental | Chest shield with aluminum foil Receives: Device: Chest shield with aluminum foil (CALF) |
| SHIELD | Sham comparator | Chest shield without aluminum foil Receives: Device: SHIELD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of symptomatic Patent ductus arteriosus
Measured: During first 2 weeks
Secondary outcomes (1)
Urinary Nitric oxide level
Measured: During first 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2015 (estimated)
- Study start1 Aug 2015
- Primary completion13 Feb 2019
- Study completion13 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Patent Ductus Arteriosus in Premature InfantsStudies of the same condition, open and under way.
- More trials run by University of RochesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Javed Mannan, MD, MPH, Study director, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02552927
- Sponsor's protocol ID
- 55472
- Other IDs
- 911
- Acronym
- SLIGHT
- Status last verified
- Sep 2020
- First submitted
- 17 Aug 2015
- Last updated
- 18 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38909157
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Chest Shielding on the Incidence of Patent Ductus Arteriosus in Premature Infants Undergoing Phototherapy
- ClinicalTrials.gov ID
- NCT02552927
- Acronym / sponsor ID
- SLIGHT / 55472
- Keywords
- PDA, Jaundice, Phototherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- 1 Aug 2015 (actual)
- Primary completion
- 13 Feb 2019 (actual)
- Study completion
- 13 Feb 2019 (actual)
- First posted
- 17 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CALF | Experimental | Device: Chest shield with aluminum foil (CALF)Chest shield with aluminum foil |
| SHIELD | Sham comparator | Device: SHIELDChest shield without aluminum foil |
Who may qualify
- Ages
- 23 to 33 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- Congenital abnormalities
- Chromosomal disorders
- Cyanotic heart defects
- Nitric oxide
- Prophylactic phototherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chest shield with aluminum foil (CALF) | Device | CALF |
| SHIELD | Device | SHIELD |
Primary outcome
Incidence of symptomatic Patent ductus arteriosus
Time frame: During first 2 weeks
1 secondary outcome
Urinary Nitric oxide level
Time frame: During first 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2020.
- Derived from this study: PubMed 38909157Mannan 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Javed Mannan, MD, MPH study director
University of Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chest shield with aluminum foil (CALF) and SHIELD in people with Patent Ductus Arteriosus in Premature Infants, run by University of Rochester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of symptomatic Patent ductus arteriosus (time frame: During first 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02552927, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2020.