Safe Threshold to Discontinue Phototherapy in Hemolytic Disease of Newborn

Официальное название

Safe Threshold to Discontinue Phototherapy in Term and Late Preterm Infant With Hemolytic Disease of Newborn: A Randomized Controlled Trial

Обзор

We hypothesized that adopting a lower rather than a higher threshold for phototherapy discontinuation will be associated with reduced rates of rebound hyperbilirubinemia in term and late preterm neonates with hemolytic disease of newborn. Objectives: The investigators aimed to compare the safety of implementing low-threshold, compared to high- threshold, of TSB for phototherapy interruption in term and late preterm neonates with hemolytic disease of newborn.

Подробное описание

Neonates in high-threshold group phototherapy will be ceased if TSB level is 50-100 µmol/L below the appropriate 2004 AAP phototherapy threshold, whereas neonates in the low-threshold group phototherapy will be stopped if TSB reached ˃100 µmol/L below the AAP threshold.

Phototherapy will be commenced for neonates in both groups according to AAP guidelines.Neonates will be treated with intensified overhead blue LEDs phototherapy if they have a TSB level at or above phototherapy threshold. Neonates will be started on intensified 360◦ LED phototherapy if they have TSB level within 50µmol/L below the exchange threshold. The administration of IVIG is indicated in infants with isoimmune hemolytic disease if TSB lies within 34 to 51 micromol/L of the threshold for exchange transfusion and not responding to initial intensified phototherapy.Infants with a TSB concentration above the thresholds for exchange should have immediate intensified 360◦ LED phototherapy, and preparation for exchange transfusion will be started.Infants showed clinical signs of acute bilirubin encephalopathy will have an immediate exchange transfusion.

Вмешательства

• Устройство phototherapy
  Phototherapy will be commenced for neonates in both groups according to AAP guidelines.Neonates will be treated with intensified overhead blue LEDs phototherapy if they have a TSB level at or above phototherapy threshold. Neonates will be started on intensified 360◦ LED phototherapy if they have TSB level within 50µmol/L below the exchange threshold. The administration of IVIG is indicated in infants with isoimmune hemolytic disease if TSB lies within 34 to 51 micromol/L of the threshold for exc

Первичные конечные точки

• Rebound hyperbilirubinemia [Срок оценки: 28 days]

Вторичные конечные точки (7)

• Duration of phototherapy [Срок оценки: 28 days]
• Length of hospital stay [Срок оценки: 28 days]
• Adverse effects related to phototherapy [Срок оценки: 28 days]
• Rebound hyperbilirubinemia between 3-7 days after phototherapy stoppage [Срок оценки: 28 days]
• Rebound TSB level that exceeded the appropriate AAP phototherapy threshold by ≥35 µmol/L after phototherapy stoppage [Срок оценки: 28 days]
• Rebound TSB level that exceeded the appropriate AAP exchange transfusion threshold after phototherapy storage [Срок оценки: 28 days]
• Total Cost of NICU Care [Срок оценки: 90 days]

Критерии участия

Критерии включения

Healthy term and late-preterm neonates more than or equal 35 weeks gestation with hemolytic disease of newborn will be included. Enrolled infants should have evidence of hemolysis as defined by any of the following criteria:

• positive DAT and blood group iso-immunization (ABO / RH incompatibility);and /or
• HGB decline by 2g/dl within 24hour.

Критерии исключения

• Major congenital abnormalities,
• Surgical problems,
• Direct hyperbilirubinemia
• Sepsis

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Саудовская Аравия · 1 центр

• Madinah maternity and children's hospital — Madinah

Идентификаторы

NCT: NCT04218318 · H-03-M-084

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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