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OpenTrials
Completed

NCT Number: NCT02552927

Chest Shielding in Premature Infants During 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.

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Key information

Conditions

Patent Ductus Arteriosus in Premature Infants Hyperbilirubinemia Jaundice Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Skin Manifestations

Age range

23 week–33 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Rochester

Rochester, New York, 14642, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Chest shield with aluminum foil (CALF)

Device

SHIELD

Device

Primary outcomes

  1. Incidence of symptomatic Patent ductus arteriosus

    Time frame: During first 2 weeks

Secondary outcomes

  1. Urinary Nitric oxide level

    Time frame: During first 2 weeks

Other outcomes

  1. Incidence of Chronic lung disease

    Time frame: at 36 weeks post-menstrual age

  2. Incidence of Retinopathy of Prematurity

    Time frame: up to 44 weeks post-menstrual age

  3. Peak level of total serum bilirubin

    Time frame: First 2 weeks

  4. Duration of Phototherapy

    Time frame: First 2 weeks

  5. Incidence of intraventricular hemorrhage

    Time frame: First 2 weeks

  6. Incidence of surgical ligation for patent ductus arteriosus

    Time frame: First 4 weeks

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Registry information

Official study title

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

Acronym: SLIGHT

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Sep 17, 2015
Registry last updated
Sep 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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