Chest Shielding in Premature Infants During Phototherapy

NCT ID: NCT02552927

Last Updated: 2020-09-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-01

Study Completion Date

2019-02-13

Brief Summary

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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.

Detailed Description

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Conditions

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Patent Ductus Arteriosus in Premature Infants

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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CALF

Chest shield with aluminum foil

Group Type EXPERIMENTAL

Chest shield with aluminum foil (CALF)

Intervention Type DEVICE

SHIELD

Chest shield without aluminum foil

Group Type SHAM_COMPARATOR

SHIELD

Intervention Type DEVICE

Interventions

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Chest shield with aluminum foil (CALF)

Intervention Type DEVICE

SHIELD

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

23 Weeks

Maximum Eligible Age

33 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Rochester

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Javed Mannan, MD, MPH

Role: STUDY_DIRECTOR

University of Rochester

Locations

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University of Rochester

Rochester, New York, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 38909157 (View on PubMed)

Other Identifiers

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911

Identifier Type: OTHER

Identifier Source: secondary_id

55472

Identifier Type: -

Identifier Source: org_study_id

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