Pilot Trial Investigating Every Other Day Dosing of Oral Iron in Premature Infants (IQONic)

Официальное название

Pilot Non-inferiority Study Investigating Daily Versus Every Other Day Dosing of Oral Iron in Premature Infants.

Обзор

Study focuses on determining if daily versus every-other-day (EOD) oral iron at the same dose per kilogram per day will achieve similar incidence of iron replete status at 36 weeks post-menstrual age in premature neonates

Подробное описание

Iron is an important component of hemoglobin, and an essential part of erythropoiesis. It is also a necessary micronutrient for rapidly proliferating and differentiating cells and tissues especially in the brain. Iron deficiency in infancy has been associated with anemia and impaired neurodevelopmental outcomes that extend into childhood. Premature infants are at highest risk for iron deficiency because they are deprived of the iron accretion that occurs in the third trimester of pregnancy, are born with lower iron stores compared to their term counterparts, and have increased utilization and depletion of iron stores with their rapid growth rate.

In older populations, EOD iron supplementation is as effective as daily iron supplementation in the treatment of iron deficiency anemia, with studies revealing significantly fewer gastrointestinal side effects in those who are on EOD iron. Adults regulate their iron status through a feedback pathway involving hepcidin whereby iron-sufficient individuals will have upregulated hepcidin, which leads to decreased iron absorption and availability. Recent studies have revealed that pediatric patients and premature neonates regulate iron absorption through hepcidin in a similar fashion. Though the regulation of iron status through hepcidin has been studied in extremely premature neonates, the clinical effect of EOD dosing of iron has not yet been examined in this population.

This is a non-inferiority, blinded, randomized control trial designed to investigate if EOD iron is comparable to daily iron dosing in achieving iron replete status by reticulocyte hemoglobin measurements in premature infants.

Вмешательства

• Пищевая добавка 6 mg/kg of oral iron as ferrous sulfate administered every other day.
  6mg/kg of oral iron as ferrous sulfate administered every other day instead of 6 mg/kg of oral iron daily supplementation.
• Пищевая добавка 6 mg/kg of oral iron as ferrous sulfate administered every day.
  6 mg/kg of oral iron as daily ferrous sulfate instead of 6mg/kg of oral iron supplementation administered every other day.

Первичные конечные точки

• Determine if daily versus EOD oral iron at the same dose per kilogram per day will achieve similar incidence of iron replete status at 36 weeks PMA. [Срок оценки: 1 Week-36 Weeks]

Вторичные конечные точки (6)

• Characterize Ret-Hb levels in preterm infants. [Срок оценки: 12-24 Months]
• Identify the number of blood transfusions received between enrollment and 36 weeks' PMA between two groups. [Срок оценки: 12-24 Months]
• Determine prevalence of bronchopulmonary dysplasia between two groups. [Срок оценки: 12-24 Months]
• Identify the number of subjects with sepsis between two groups. [Срок оценки: 12-24 Months]
• Identify the number with necrotizing enterocolitis (NEC)/gastrointestinal perforations between two groups. [Срок оценки: 12-24 Months]
• Characterize growth between two groups. [Срок оценки: 12-24 Months]

Критерии участия

Критерии включения

• Children (Minor < 18 years of age)
• Neonates
• Hospitalized
• Premature infants who are on full enteral feeds and are started on oral iron
• Premature infants who completed 26 0/7 to 32 6/7 weeks' gestation at birth

Критерии исключения

• Infants with known congenital anomalies or chromosomal abnormalities (such as Trisomy 18 or Trisomy 21), conditions that affect iron metabolism (such as thalassemia or hemochromatosis), bleeding disorders or coagulopathy, and received iron parenterally prior to randomization

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

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

США · 1 центр

• CHRISTUS Children's — San Antonio

Публикации

• Sriranjan J, Kalata C, Fusch G, Thomas K, Goswami I. Prevalence and Implications of Low Reticulocyte-Hemoglobin Levels among Extreme Preterm Neonates: A Single-Center Retrospective Study. Nutrients. 2022 Dec 16;14(24):5343. doi: 10.3390/nu14245343. PMID 36558502
• Wang Y, Wu Y, Li T, Wang X, Zhu C. Iron Metabolism and Brain Development in Premature Infants. Front Physiol. 2019 Apr 25;10:463. doi: 10.3389/fphys.2019.00463. eCollection 2019. PMID 31105583
• McCarthy EK, Dempsey EM, Kiely ME. Iron supplementation in preterm and low-birth-weight infants: a systematic review of intervention studies. Nutr Rev. 2019 Dec 1;77(12):865-877. doi: 10.1093/nutrit/nuz051. PMID 31532494
• Nii M, Okamoto T, Sugiyama T, Aoyama A, Nagaya K. Reticulocyte hemoglobin content changes after treatment of anemia of prematurity. Pediatr Int. 2022 Jan;64(1):e15330. doi: 10.1111/ped.15330. PMID 36321339
• Puia-Dumitrescu M, Tanaka DT, Spears TG, Daniel CJ, Kumar KR, Athavale K, Juul SE, Smith PB. Patterns of phlebotomy blood loss and transfusions in extremely low birth weight infants. J Perinatol. 2019 Dec;39(12):1670-1675. doi: 10.1038/s41372-019-0515-6. Epub 2019 Oct 3. PMID 31582812
• Bahr TM, Tan S, Smith E, Beauman SS, Schibler KR, Grisby CA, Lowe JR, Bell EF, Laptook AR, Shankaran S, Carlton DP, Rau C, Baserga MC, Flibotte J, Zaterka-Baxter K, Walsh MC, Das A, Christensen RD, Ohls RK; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Serum ferritin values in neonates <29 weeks' gestation are highly variable and do not PMID 37596391
• Karakoc G, Orgul G, Sahin D, Yucel A. Is every other day iron supplementation effective for the treatment of the iron deficiency anemia in pregnancy? J Matern Fetal Neonatal Med. 2022 Mar;35(5):832-836. doi: 10.1080/14767058.2021.1910666. Epub 2021 Apr 18. PMID 33866933
• Stoffel NU, Zeder C, Brittenham GM, Moretti D, Zimmermann MB. Iron absorption from supplements is greater with alternate day than with consecutive day dosing in iron-deficient anemic women. Haematologica. 2020 May;105(5):1232-1239. doi: 10.3324/haematol.2019.220830. Epub 2019 Aug 14. PMID 31413088

Идентификаторы

NCT: NCT06555315 · 2024-091

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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