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Completed

NCT Number: NCT04373980

Conventional Versus LED Phototherapy and Their Effect on Lymphocytes Subsets of Full Term Neonates With Hyperbilirubinemia

The aim of this study is to investigate the influence of the use of different types of phototherapy on different lymphocytes subsets CD4 and CD8 in the treatment of hyperbilirubinemia in neonates.

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Key information

Conditions

Neonatal Hyperbilirubinemia Congenital, Hereditary, and Neonatal Diseases and Abnormalities Hyperbilirubinemia Hyperbilirubinemia, Neonatal Infant, Newborn, Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Phototherapy Complication

Age range

1 day–28 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ain Shams University

Cairo, 1138, Egypt

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

Term neonates with a gestational week higher than 37weeks, according to the guidelines of the American Academy of Pediatrics (2004) which stated that gestational ages of newborns are determined according to the first day of the mother's last menstrual period (by the mother's statement) and were additionally confirmed by the Ballard scoring system (Ballard et al., 1991) and antenatal ultrasonographic estimation or obstetric records if present.

  • Clinically significant indirect hyperbilirubinemia requiring phototherapy in the first week of life.
  • No pathologic etiological factors for hyperbilirubinemia

Exclusion criteria

  • Total bilirubin level of >20 mg/dl.
  • Prematurity.
  • Sepsis.
  • Congenital anomaly.
  • Elevation in direct bilirubin level.
  • History of immune deficiency the family.
  • History of preeclampsia or any other diseases or drug use of the mother

Treatment and study plan

Phototherapy

Device

estimate CD4 and CD8 subsets in neonates with unconjugated hyperbilirubinemia after exposure to phototherapy

Primary outcomes

  1. Effect of types of phototherapy on change in CD4 and CD8 lymphocytes subsets

    Time frame: 2 days

    Detection of CD4 and CD8 absolute counts(x10³/uL) : was done before and 48 hours after phototherapy and for controls at time of examination using monoclonal antibodies and measured by flow cytometry

Sponsors and collaborators

Lead sponsor

Rania Ali El-Farrash

Other

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
May 5, 2020
Registry last updated
May 5, 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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